EMDN W01: Reagents

Complete hierarchy for EMDN group W01 in category W (In Vitro Diagnostic Medical Devices): 1,512 terminal codes, EMDN v2026. Terminal codes are the ones accepted in a EUDAMED device record.

Registered classes, as of 8 Sep 2026. For each code with at least 20 registrations under a legislation, the chip shows how devices registered in EUDAMED under that code are classed, counted once per primary UDI-DI and kept separate for each legislation. It is not a determination. The class of a device comes from the MDR and IVDR classification rules for its intended purpose. MDD and IVDD classes are the directive classification and can differ from the class the same device would have under MDR or IVDR.

  • W01Reagents
    • W0101Clinical Chemistry
      • W010103Electrolytes Reagents (Excluding Electrodes)
        • W01010301AmmoniaIVDD 100.0% IVD general · n=54terminal

          Registered in EUDAMED under IVDD with this code: 54 of 54 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 54 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010302BicarbonateIVDD 2 classes · n=43terminal

          Registered in EUDAMED under IVDD with this code, the 43 devices are split across classes (as of 8 Sep 2026).

          • 38 IVD general (88.3%)
          • 5 IVD self-testing (11.6%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010303CalciumIVDR 100.0% Class B · n=32IVDD 100.0% IVD general · n=146terminal

          Registered in EUDAMED under IVDR with this code: 32 of 32 devices carry Class B on their registration (as of 8 Sep 2026).

          • 32 Class B (100.0%)

          Registered in EUDAMED under IVDD with this code: 146 of 146 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 146 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010304ChlorideIVDD 100.0% IVD general · n=53terminal

          Registered in EUDAMED under IVDD with this code: 53 of 53 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 53 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010305Lithiumterminal
        • W01010306MagnesiumIVDR 100.0% Class B · n=22IVDD 100.0% IVD general · n=134terminal

          Registered in EUDAMED under IVDR with this code: 22 of 22 devices carry Class B on their registration (as of 8 Sep 2026).

          • 22 Class B (100.0%)

          Registered in EUDAMED under IVDD with this code: 134 of 134 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 134 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010307Phosphate Inorganic / PhosphorusIVDR 100.0% Class B · n=34IVDD 100.0% IVD general · n=128terminal

          Registered in EUDAMED under IVDR with this code: 34 of 34 devices carry Class B on their registration (as of 8 Sep 2026).

          • 34 Class B (100.0%)

          Registered in EUDAMED under IVDD with this code: 128 of 128 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 128 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010308PotassiumIVDD 100.0% IVD general · n=52terminal

          Registered in EUDAMED under IVDD with this code: 52 of 52 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 52 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010309SodiumIVDD 100.0% IVD general · n=52terminal

          Registered in EUDAMED under IVDD with this code: 52 of 52 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 52 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010399Electrolytes - OtherIVDR 2 classes · n=24IVDD 100.0% IVD general · n=59terminal

          Registered in EUDAMED under IVDR with this code, the 24 devices are split across classes (as of 8 Sep 2026).

          • 16 Class A (66.6%)
          • 8 Class B (33.3%)

          Registered in EUDAMED under IVDD with this code: 59 of 59 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 59 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

      • W010104Multiple Parameters - Clinical Chemistry
        • W01010401Multiple Enzymes Only - Clin. Chem Lab Reagents.terminal
        • W01010402Multiple Substrates Only - Clin. Chem Lab R.terminal
        • W01010403Multiple Electrolytes Only - Clin. Chem Lab R.IVDD 100.0% IVD general · n=33terminal

          Registered in EUDAMED under IVDD with this code: 33 of 33 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 33 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010404Multiple Parameters (Mix of All) - Clin. Chem Lab R.IVDR 100.0% Class B · n=22IVDD 100.0% IVD general · n=116terminal

          Registered in EUDAMED under IVDR with this code: 22 of 22 devices carry Class B on their registration (as of 8 Sep 2026).

          • 22 Class B (100.0%)

          Registered in EUDAMED under IVDD with this code: 116 of 116 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 116 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010499Multiple Clin. Chem Lab Reagents - OtherIVDR 3 classes · n=93IVDD 99.0% IVD general · n=401terminal

          Registered in EUDAMED under IVDR with this code, the 93 devices are split across classes (as of 8 Sep 2026).

          • 63 Class B (67.7%)
          • 17 Class C (18.2%)
          • 13 Class A (13.9%)

          Registered in EUDAMED under IVDD with this code: 397 of 401 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 397 IVD general (99.0%)
          • 4 Annex II List B (0.9%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

      • W010105Controls/Standards/Calibrators Clinical Chemistry
        • W01010501Multicomponent Controls (Clinical Chemistry)
          • W0101050101Assayed Multicomponent Controls (Cc)IVDR 3 classes · n=98IVDD 99.3% IVD general · n=153terminal

            Registered in EUDAMED under IVDR with this code, the 98 devices are split across classes (as of 8 Sep 2026).

            • 78 Class C (79.5%)
            • 18 Class B (18.3%)
            • 2 Class A (2.0%)

            Registered in EUDAMED under IVDD with this code: 152 of 153 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 152 IVD general (99.3%)
            • 1 Annex II List B (0.6%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0101050102Unassayed Multicomponent Controls (Cc)IVDR 2 classes · n=54IVDD 100.0% IVD general · n=24terminal

            Registered in EUDAMED under IVDR with this code, the 54 devices are split across classes (as of 8 Sep 2026).

            • 38 Class C (70.3%)
            • 16 Class B (29.6%)

            Registered in EUDAMED under IVDD with this code: 24 of 24 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 24 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0101050199Multicomponent Controls (Cc) - OtherIVDD 100.0% IVD general · n=75terminal

            Registered in EUDAMED under IVDD with this code: 75 of 75 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 75 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010502Specific Controls (Clinical Chemistry)
          • W0101050201Enzyme ControlsIVDR 2 classes · n=26IVDD 100.0% IVD general · n=50terminal

            Registered in EUDAMED under IVDR with this code, the 26 devices are split across classes (as of 8 Sep 2026).

            • 17 Class B (65.3%)
            • 9 Class C (34.6%)

            Registered in EUDAMED under IVDD with this code: 50 of 50 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 50 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0101050202Lipid ControlsIVDD 2 classes · n=36terminal

            Registered in EUDAMED under IVDD with this code, the 36 devices are split across classes (as of 8 Sep 2026).

            • 34 IVD general (94.4%)
            • 2 Annex II List B (5.5%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0101050203Bilirubin ControlsIVDD 100.0% IVD general · n=21terminal

            Registered in EUDAMED under IVDD with this code: 21 of 21 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 21 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0101050204Electrolyte ControlsIVDD 100.0% IVD general · n=44terminal

            Registered in EUDAMED under IVDD with this code: 44 of 44 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 44 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0101050205Diabetes ControlsIVDD 2 classes · n=95terminal

            Registered in EUDAMED under IVDD with this code, the 95 devices are split across classes (as of 8 Sep 2026).

            • 56 IVD general (58.9%)
            • 39 Annex II List B (41.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0101050207Urine ControlsIVDR 96.2% Class B · n=79IVDD 100.0% IVD general · n=58terminal

            Registered in EUDAMED under IVDR with this code: 76 of 79 devices carry Class B on their registration (as of 8 Sep 2026).

            • 76 Class B (96.2%)
            • 3 Class A (3.7%)

            Registered in EUDAMED under IVDD with this code: 58 of 58 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 58 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0101050208Csf Controlsterminal
          • W0101050299Specific Controls (Cc) - OtherIVDR 3 classes · n=62IVDD 97.3% IVD general · n=269terminal

            Registered in EUDAMED under IVDR with this code, the 62 devices are split across classes (as of 8 Sep 2026).

            • 44 Class B (70.9%)
            • 14 Class C (22.5%)
            • 4 Class A (6.4%)

            Registered in EUDAMED under IVDD with this code: 262 of 269 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 262 IVD general (97.3%)
            • 6 IVD self-testing (2.2%)
            • 1 Annex II List B (0.3%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010503Calibrators and Standards (Clinical Chemistry)
          • W0101050301Calibrators Multicomponent (Cc)IVDR 3 classes · n=69IVDD 99.6% IVD general · n=258terminal

            Registered in EUDAMED under IVDR with this code, the 69 devices are split across classes (as of 8 Sep 2026).

            • 40 Class B (57.9%)
            • 19 Class C (27.5%)
            • 10 Class A (14.4%)

            Registered in EUDAMED under IVDD with this code: 257 of 258 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 257 IVD general (99.6%)
            • 1 Annex II List B (0.3%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0101050302Calibrators Single Component (Cc)IVDR 3 classes · n=111IVDD 100.0% IVD general · n=76terminal

            Registered in EUDAMED under IVDR with this code, the 111 devices are split across classes (as of 8 Sep 2026).

            • 76 Class B (68.4%)
            • 29 Class C (26.1%)
            • 6 Class A (5.4%)

            Registered in EUDAMED under IVDD with this code: 76 of 76 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 76 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0101050303Aqueous Standards (Cc)IVDD 100.0% IVD general · n=41terminal

            Registered in EUDAMED under IVDD with this code: 41 of 41 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 41 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0101050399Calibrators and Standards (Clinical Chemistry) - OtherIVDR 3 classes · n=134IVDD 98.4% IVD general · n=131terminal

            Registered in EUDAMED under IVDR with this code, the 134 devices are split across classes (as of 8 Sep 2026).

            • 93 Class A (69.4%)
            • 26 Class B (19.4%)
            • 15 Class C (11.1%)

            Registered in EUDAMED under IVDD with this code: 129 of 131 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 129 IVD general (98.4%)
            • 2 Annex II List B (1.5%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

      • W010101Enzymes
        • W010101015'-NucleotidaseIVDD 100.0% IVD general · n=49terminal

          Registered in EUDAMED under IVDD with this code: 49 of 49 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 49 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010102Acid Phosphatase (Cc)terminal
        • W01010103Alanine Amino-TransferaseIVDR 100.0% Class B · n=53IVDD 100.0% IVD general · n=211terminal

          Registered in EUDAMED under IVDR with this code: 53 of 53 devices carry Class B on their registration (as of 8 Sep 2026).

          • 53 Class B (100.0%)

          Registered in EUDAMED under IVDD with this code: 211 of 211 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 211 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010104Aldolaseterminal
        • W01010105Alkaline Phosphatase - TotalIVDR 98.1% Class B · n=53IVDD 100.0% IVD general · n=182terminal

          Registered in EUDAMED under IVDR with this code: 52 of 53 devices carry Class B on their registration (as of 8 Sep 2026).

          • 52 Class B (98.1%)
          • 1 Class C (1.8%)

          Registered in EUDAMED under IVDD with this code: 182 of 182 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 182 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010106Alkaline Phosphatase Isoenzymes (Cc)terminal
        • W01010107Amylase - TotalIVDR 2 classes · n=42IVDD 100.0% IVD general · n=155terminal

          Registered in EUDAMED under IVDR with this code, the 42 devices are split across classes (as of 8 Sep 2026).

          • 30 Class C (71.4%)
          • 12 Class B (28.5%)

          Registered in EUDAMED under IVDD with this code: 155 of 155 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 155 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010108Amylase IsoenzymesIVDD 100.0% IVD general · n=23terminal

          Registered in EUDAMED under IVDD with this code: 23 of 23 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 23 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010109Angiotensin Converting Enzyme (Cc)IVDD 100.0% IVD general · n=29terminal

          Registered in EUDAMED under IVDD with this code: 29 of 29 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 29 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010110Aspartate Amino-TransferaseIVDR 2 classes · n=59IVDD 100.0% IVD general · n=213terminal

          Registered in EUDAMED under IVDR with this code, the 59 devices are split across classes (as of 8 Sep 2026).

          • 52 Class B (88.1%)
          • 7 Class C (11.8%)

          Registered in EUDAMED under IVDD with this code: 213 of 213 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 213 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010111CholinesteraseIVDD 100.0% IVD general · n=120terminal

          Registered in EUDAMED under IVDD with this code: 120 of 120 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 120 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010112Chymotrypsinterminal
        • W01010113Creatine Kinase - TotalIVDR 2 classes · n=28IVDD 100.0% IVD general · n=142terminal

          Registered in EUDAMED under IVDR with this code, the 28 devices are split across classes (as of 8 Sep 2026).

          • 19 Class B (67.8%)
          • 9 Class C (32.1%)

          Registered in EUDAMED under IVDD with this code: 142 of 142 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 142 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010114Creatine Kinase - Mb Activity (Cc)IVDR 2 classes · n=32IVDD 100.0% IVD general · n=89terminal

          Registered in EUDAMED under IVDR with this code, the 32 devices are split across classes (as of 8 Sep 2026).

          • 24 Class C (75.0%)
          • 8 Class B (25.0%)

          Registered in EUDAMED under IVDD with this code: 89 of 89 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 89 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010115Creatine Kinase IsoenzymesIVDD 100.0% IVD general · n=99terminal

          Registered in EUDAMED under IVDD with this code: 99 of 99 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 99 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010116Gamma GlutamyltransferaseIVDR 2 classes · n=44IVDD 100.0% IVD general · n=156terminal

          Registered in EUDAMED under IVDR with this code, the 44 devices are split across classes (as of 8 Sep 2026).

          • 40 Class B (90.9%)
          • 4 Class C (9.0%)

          Registered in EUDAMED under IVDD with this code: 156 of 156 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 156 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010117Glutamate DehydrogenaseIVDD 100.0% IVD general · n=26terminal

          Registered in EUDAMED under IVDD with this code: 26 of 26 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 26 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010118Hydroxybutyrate DehydrogenaseIVDD 100.0% IVD general · n=59terminal

          Registered in EUDAMED under IVDD with this code: 59 of 59 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 59 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010119Lactate Dehydrogenase L (Ldh - L --> P)IVDR 2 classes · n=31IVDD 100.0% IVD general · n=60terminal

          Registered in EUDAMED under IVDR with this code, the 31 devices are split across classes (as of 8 Sep 2026).

          • 24 Class B (77.4%)
          • 7 Class C (22.5%)

          Registered in EUDAMED under IVDD with this code: 60 of 60 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 60 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010120Lactate Dehydrogenase P ( Ldh - P --> L )IVDD 100.0% IVD general · n=95terminal

          Registered in EUDAMED under IVDD with this code: 95 of 95 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 95 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010121Lactate Dehydrogenase IsoenzymesIVDD 100.0% IVD general · n=40terminal

          Registered in EUDAMED under IVDD with this code: 40 of 40 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 40 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010122Leucine AminopeptidaseIVDD 100.0% IVD general · n=27terminal

          Registered in EUDAMED under IVDD with this code: 27 of 27 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 27 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010123LipaseIVDD 100.0% IVD general · n=116terminal

          Registered in EUDAMED under IVDD with this code: 116 of 116 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 116 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010124Lysozymeterminal
        • W01010125Malate Dehydrogenaseterminal
        • W01010126N-Acetyl-B, D-GlucosaminidaseIVDD 100.0% IVD general · n=28terminal

          Registered in EUDAMED under IVDD with this code: 28 of 28 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 28 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010127Pepsinterminal
        • W01010128Phospho Hexose Isomeraseterminal
        • W01010129Sorbitol Dehydrogenaseterminal
        • W01010130Trypsinterminal
        • W01010131Hexokinase Adpterminal
        • W01010132Adenosine Deaminase (Cc)terminal
        • W01010199Enzymes - OtherIVDR 3 classes · n=61IVDD 100.0% IVD general · n=205terminal

          Registered in EUDAMED under IVDR with this code, the 61 devices are split across classes (as of 8 Sep 2026).

          • 23 Class B (37.7%)
          • 21 Class C (34.4%)
          • 17 Class A (27.8%)

          Registered in EUDAMED under IVDD with this code: 205 of 205 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 205 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

      • W010102Substrates
        • W01010224PhospholipidsIVDD 100.0% IVD general · n=36terminal

          Registered in EUDAMED under IVDD with this code: 36 of 36 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 36 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010225Porphobilinogenterminal
        • W01010226Pyruvateterminal
        • W01010227Thymolterminal
        • W01010228Total Lipidsterminal
        • W01010229Total Porphyrineterminal
        • W01010230Total ProteinIVDR 98.2% Class B · n=56IVDD 100.0% IVD general · n=240terminal

          Registered in EUDAMED under IVDR with this code: 55 of 56 devices carry Class B on their registration (as of 8 Sep 2026).

          • 55 Class B (98.2%)
          • 1 Class C (1.7%)

          Registered in EUDAMED under IVDD with this code: 240 of 240 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 240 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010231TriglyceridesIVDR 100.0% Class B · n=57IVDD 100.0% IVD general · n=186terminal

          Registered in EUDAMED under IVDR with this code: 57 of 57 devices carry Class B on their registration (as of 8 Sep 2026).

          • 57 Class B (100.0%)

          Registered in EUDAMED under IVDD with this code: 186 of 186 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 186 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010232Uric AcidIVDR 98.1% Class B · n=54IVDD 97.2% IVD general · n=185terminal

          Registered in EUDAMED under IVDR with this code: 53 of 54 devices carry Class B on their registration (as of 8 Sep 2026).

          • 53 Class B (98.1%)
          • 1 Class A (1.8%)

          Registered in EUDAMED under IVDD with this code: 180 of 185 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 180 IVD general (97.2%)
          • 5 IVD self-testing (2.7%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010233ZincIVDD 100.0% IVD general · n=66terminal

          Registered in EUDAMED under IVDD with this code: 66 of 66 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 66 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010234Lipoprotein Electroporesisterminal
        • W01010235Protein Electroporesisterminal
        • W01010236Phenylketonuriaterminal
        • W01010299Substrates - OtherIVDR 3 classes · n=55IVDD 100.0% IVD general · n=227terminal

          Registered in EUDAMED under IVDR with this code, the 55 devices are split across classes (as of 8 Sep 2026).

          • 29 Class B (52.7%)
          • 14 Class A (25.4%)
          • 12 Class C (21.8%)

          Registered in EUDAMED under IVDD with this code: 227 of 227 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 227 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010201Albumin (Cc)IVDR 100.0% Class B · n=50IVDD 100.0% IVD general · n=226terminal

          Registered in EUDAMED under IVDR with this code: 50 of 50 devices carry Class B on their registration (as of 8 Sep 2026).

          • 50 Class B (100.0%)

          Registered in EUDAMED under IVDD with this code: 226 of 226 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 226 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010202Bile AcidsIVDD 100.0% IVD general · n=92terminal

          Registered in EUDAMED under IVDD with this code: 92 of 92 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 92 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010203BilirubinIVDR 2 classes · n=75IVDD 100.0% IVD general · n=405terminal

          Registered in EUDAMED under IVDR with this code, the 75 devices are split across classes (as of 8 Sep 2026).

          • 43 Class B (57.3%)
          • 32 Class C (42.6%)

          Registered in EUDAMED under IVDD with this code: 405 of 405 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 405 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010204Urea/Blood Urea NitrogenIVDR 100.0% Class B · n=43IVDD 100.0% IVD general · n=208terminal

          Registered in EUDAMED under IVDR with this code: 43 of 43 devices carry Class B on their registration (as of 8 Sep 2026).

          • 43 Class B (100.0%)

          Registered in EUDAMED under IVDD with this code: 208 of 208 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 208 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010205CholesterolIVDR 100.0% Class B · n=56IVDD 100.0% IVD general · n=207terminal

          Registered in EUDAMED under IVDR with this code: 56 of 56 devices carry Class B on their registration (as of 8 Sep 2026).

          • 56 Class B (100.0%)

          Registered in EUDAMED under IVDD with this code: 207 of 207 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 207 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010206CopperIVDD 100.0% IVD general · n=53terminal

          Registered in EUDAMED under IVDD with this code: 53 of 53 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 53 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010207CreatinineIVDR 2 classes · n=70IVDD 100.0% IVD general · n=268terminal

          Registered in EUDAMED under IVDR with this code, the 70 devices are split across classes (as of 8 Sep 2026).

          • 52 Class B (74.2%)
          • 18 Class C (25.7%)

          Registered in EUDAMED under IVDD with this code: 268 of 268 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 268 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010208D-Xyloseterminal
        • W01010209Delta-Aminolaevulinic Acidterminal
        • W01010210FructosamineIVDD 100.0% IVD general · n=50terminal

          Registered in EUDAMED under IVDD with this code: 50 of 50 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 50 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010211Fructoseterminal
        • W01010212Galactoseterminal
        • W01010213GlucoseIVDR 3 classes · n=76IVDD 99.5% IVD general · n=239terminal

          Registered in EUDAMED under IVDR with this code, the 76 devices are split across classes (as of 8 Sep 2026).

          • 40 Class C (52.6%)
          • 23 Class B (30.2%)
          • 13 Class A (17.1%)

          Registered in EUDAMED under IVDD with this code: 238 of 239 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 238 IVD general (99.5%)
          • 1 Annex II List B (0.4%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010214Glycosylated/Glycated Haemoglobin (Cc)IVDR 3 classes · n=60IVDD 98.5% IVD general · n=274terminal

          Registered in EUDAMED under IVDR with this code, the 60 devices are split across classes (as of 8 Sep 2026).

          • 28 Class C (46.6%)
          • 23 Class A (38.3%)
          • 9 Class B (15.0%)

          Registered in EUDAMED under IVDD with this code: 270 of 274 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 270 IVD general (98.5%)
          • 4 Annex II List B (1.4%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010215High Density Lipoprotein CholesterolIVDR 100.0% Class B · n=50IVDD 100.0% IVD general · n=187terminal

          Registered in EUDAMED under IVDR with this code: 50 of 50 devices carry Class B on their registration (as of 8 Sep 2026).

          • 50 Class B (100.0%)

          Registered in EUDAMED under IVDD with this code: 187 of 187 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 187 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010216Iron (Cc)IVDR 100.0% Class B · n=47IVDD 100.0% IVD general · n=126terminal

          Registered in EUDAMED under IVDR with this code: 47 of 47 devices carry Class B on their registration (as of 8 Sep 2026).

          • 47 Class B (100.0%)

          Registered in EUDAMED under IVDD with this code: 126 of 126 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 126 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010217Iron Binding Capacity - Total (Cc)IVDD 100.0% IVD general · n=60terminal

          Registered in EUDAMED under IVDD with this code: 60 of 60 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 60 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010218LactateIVDD 100.0% IVD general · n=63terminal

          Registered in EUDAMED under IVDD with this code: 63 of 63 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 63 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010219Lecithinterminal
        • W01010220Lipoprotein, Chemical Determination/DetectionIVDD 100.0% IVD general · n=22terminal

          Registered in EUDAMED under IVDD with this code: 22 of 22 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 22 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010221Low Density Lipoprotein Cholesterol Including Sd-LdlIVDR 100.0% Class B · n=33IVDD 100.0% IVD general · n=122terminal

          Registered in EUDAMED under IVDR with this code: 33 of 33 devices carry Class B on their registration (as of 8 Sep 2026).

          • 33 Class B (100.0%)

          Registered in EUDAMED under IVDD with this code: 122 of 122 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 122 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010222Non Esterified Fatty AcidsIVDD 100.0% IVD general · n=27terminal

          Registered in EUDAMED under IVDD with this code: 27 of 27 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 27 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010223Oxalateterminal
      • W010106Clinical Chemistry - Rapid Tests & Poc
        • W01010601Blood Test Strips (Cc) - Rt & Poc
          • W0101060101Glucose Test StripsIVDR 2 classes · n=68IVDD 3 classes · n=446terminal

            Registered in EUDAMED under IVDR with this code, the 68 devices are split across classes (as of 8 Sep 2026).

            • 56 Class C (82.3%)
            • 12 Class B (17.6%)

            Registered in EUDAMED under IVDD with this code, the 446 devices are split across classes (as of 8 Sep 2026).

            • 361 Annex II List B (80.9%)
            • 56 IVD self-testing (12.5%)
            • 29 IVD general (6.5%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0101060102Cholesterol Test StripsIVDD 3 classes · n=40terminal

            Registered in EUDAMED under IVDD with this code, the 40 devices are split across classes (as of 8 Sep 2026).

            • 17 IVD general (42.5%)
            • 16 IVD self-testing (40.0%)
            • 7 Annex II List B (17.5%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0101060103Hdl Test StripsIVDD 2 classes · n=35terminal

            Registered in EUDAMED under IVDD with this code, the 35 devices are split across classes (as of 8 Sep 2026).

            • 32 IVD general (91.4%)
            • 3 IVD self-testing (8.5%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0101060104Lactate Test Stripsterminal
          • W0101060105Triglyceride Test Stripsterminal
          • W0101060106Urea Test StripsIVDD 96.8% IVD general · n=32terminal

            Registered in EUDAMED under IVDD with this code: 31 of 32 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 31 IVD general (96.8%)
            • 1 IVD self-testing (3.1%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0101060107Hba1c Test StripsIVDD 2 classes · n=112terminal

            Registered in EUDAMED under IVDD with this code, the 112 devices are split across classes (as of 8 Sep 2026).

            • 99 IVD general (88.3%)
            • 13 IVD self-testing (11.6%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0101060108Controls/Standards/Calibrators (Blood Test Strips)
            • W010106010801Blood Test Strips ControlsIVDR 95.4% Class C · n=22IVDD 3 classes · n=177terminal

              Registered in EUDAMED under IVDR with this code: 21 of 22 devices carry Class C on their registration (as of 8 Sep 2026).

              • 21 Class C (95.4%)
              • 1 Class B (4.5%)

              Registered in EUDAMED under IVDD with this code, the 177 devices are split across classes (as of 8 Sep 2026).

              • 103 Annex II List B (58.1%)
              • 47 IVD self-testing (26.5%)
              • 27 IVD general (15.2%)

              Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

            • W010106010802Blood Test Strips Calibrators and Standardsterminal
          • W0101060109Multiple Parameter Blood TestIVDD 96.5% IVD general · n=58terminal

            Registered in EUDAMED under IVDD with this code: 56 of 58 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 56 IVD general (96.5%)
            • 2 IVD self-testing (3.4%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0101060110Ketone Test Strips (β-Hydroxybutyrate Test Strips)IVDD 3 classes · n=29terminal

            Registered in EUDAMED under IVDD with this code, the 29 devices are split across classes (as of 8 Sep 2026).

            • 13 IVD self-testing (44.8%)
            • 12 IVD general (41.3%)
            • 4 Annex II List B (13.7%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0101060111Ldl Test StripsIVDD 100.0% IVD general · n=23terminal

            Registered in EUDAMED under IVDD with this code: 23 of 23 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 23 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0101060112Creatinine Analysis Test Stripsterminal
          • W0101060199Blood Test Strips (Cc) - Rapid Tests and "point of Care" - OtherIVDD 3 classes · n=96terminal

            Registered in EUDAMED under IVDD with this code, the 96 devices are split across classes (as of 8 Sep 2026).

            • 70 IVD general (72.9%)
            • 25 IVD self-testing (26.0%)
            • 1 Annex II List B (1.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010602Urine Testing (Cc) - Rt & Poc
          • W0101060201Urine Single Test Strips (Incl. Tablets)IVDR 98.5% Class B · n=69IVDD 2 classes · n=25terminal

            Registered in EUDAMED under IVDR with this code: 68 of 69 devices carry Class B on their registration (as of 8 Sep 2026).

            • 68 Class B (98.5%)
            • 1 Class C (1.4%)

            Registered in EUDAMED under IVDD with this code, the 25 devices are split across classes (as of 8 Sep 2026).

            • 23 IVD general (92.0%)
            • 2 IVD self-testing (8.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0101060203Urine Sediment Test Kit
            • W010106020301Urine Sediment Test Kit (Manual)terminal
            • W010106020302Urine Sediment Test Kit (Automated)terminal
          • W0101060204Urine Multi-Constituent Test Strips (Manual)IVDR 100.0% Class B · n=77IVDD 2 classes · n=428terminal

            Registered in EUDAMED under IVDR with this code: 77 of 77 devices carry Class B on their registration (as of 8 Sep 2026).

            • 77 Class B (100.0%)

            Registered in EUDAMED under IVDD with this code, the 428 devices are split across classes (as of 8 Sep 2026).

            • 254 IVD general (59.3%)
            • 174 IVD self-testing (40.6%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0101060205Urine Multi-Constituent Test Strips (Automated)IVDR 98.8% Class B · n=84IVDD 100.0% IVD general · n=442terminal

            Registered in EUDAMED under IVDR with this code: 83 of 84 devices carry Class B on their registration (as of 8 Sep 2026).

            • 83 Class B (98.8%)
            • 1 Class C (1.1%)

            Registered in EUDAMED under IVDD with this code: 442 of 442 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 442 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0101060206Urine Testing Controls Calibrators and Standards
            • W010106020601Urine Testing ControlsIVDR 96.5% Class B · n=29IVDD 100.0% IVD general · n=80terminal

              Registered in EUDAMED under IVDR with this code: 28 of 29 devices carry Class B on their registration (as of 8 Sep 2026).

              • 28 Class B (96.5%)
              • 1 Class A (3.4%)

              Registered in EUDAMED under IVDD with this code: 80 of 80 devices carry IVD general on their registration (as of 8 Sep 2026).

              • 80 IVD general (100.0%)

              Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

            • W010106020602Urine Testing Calibrators and StandardsIVDD 100.0% IVD general · n=27terminal

              Registered in EUDAMED under IVDD with this code: 27 of 27 devices carry IVD general on their registration (as of 8 Sep 2026).

              • 27 IVD general (100.0%)

              Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0101060299Urine Testing - OtherIVDR 2 classes · n=76IVDD 100.0% IVD general · n=41terminal

            Registered in EUDAMED under IVDR with this code, the 76 devices are split across classes (as of 8 Sep 2026).

            • 70 Class A (92.1%)
            • 6 Class C (7.8%)

            Registered in EUDAMED under IVDD with this code: 41 of 41 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 41 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010603Faeces Tests (Cc) - Rt & Poc
          • W0101060301Guaiac-Based Faecal Occult Blood (Cc)IVDD 2 classes · n=42terminal

            Registered in EUDAMED under IVDD with this code, the 42 devices are split across classes (as of 8 Sep 2026).

            • 37 IVD general (88.0%)
            • 5 IVD self-testing (11.9%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0101060302Albumin in Stool (Meconium)terminal
          • W0101060303Pancreas-Elastaseterminal
          • W0101060399Faeces Tests - Rapid Tests and "point of Care" - OtherIVDR 3 classes · n=113IVDD 100.0% IVD general · n=79terminal

            Registered in EUDAMED under IVDR with this code, the 113 devices are split across classes (as of 8 Sep 2026).

            • 101 Class C (89.3%)
            • 8 Class A (7.0%)
            • 4 Class B (3.5%)

            Registered in EUDAMED under IVDD with this code: 79 of 79 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 79 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010604Multiple Parameters Poc
          • W0101060401Multiple Enzymes &/or Substrates &/or Electrolytesterminal
          • W0101060402Multiple Parameters Poc Controls Calibrators and Standards
            • W010106040201Multiple Parameters Poc Controlsterminal
            • W010106040202Multiple Parameters Poc Calibrators and Standardsterminal
          • W0101060499Multiple Parameters Poc - OtherIVDD 100.0% IVD general · n=40terminal

            Registered in EUDAMED under IVDD with this code: 40 of 40 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 40 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010606Electrodes or Cassettes for Blood Gas Analysis Incl. Electrolytes / Metabolites - Poc
          • W0101060601Carbon Dioxide - Electrodes (Bg)IVDD 100.0% IVD general · n=21terminal

            Registered in EUDAMED under IVDD with this code: 21 of 21 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 21 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0101060602Ph - Electrodes (Bg)terminal
          • W0101060603Oxygen - Electrodes (Bg)terminal
          • W0101060604Ph/Po2/Pco2 - Electrodes (Bg)terminal
          • W0101060605Bg &/or Ise &/or Metabolites - Electrodes (Bg)IVDD 100.0% IVD general · n=110terminal

            Registered in EUDAMED under IVDD with this code: 110 of 110 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 110 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0101060606Blood Gas Buffers and Solutions - Electrodes or Cassetteterminal
          • W0101060607Blood Gas Controls - Electrodes or Cassetteterminal
          • W0101060608Blood Gas Calibrators and Standards Electrodes or Cassetteterminal
          • W0101060609Blood Gas Incl. Electrolytes / Metabolites - Unitary Use Cassetteterminal
          • W0101060610Blood Gas Incl. Electrolytes / Metabolites - Multi Use CassetteIVDR 100.0% Class C · n=89terminal

            Registered in EUDAMED under IVDR with this code: 89 of 89 devices carry Class C on their registration (as of 8 Sep 2026).

            • 89 Class C (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0101060699Blood Gas Electrodes or Cassette Poc - OtherIVDR 98.3% Class C · n=61terminal

            Registered in EUDAMED under IVDR with this code: 60 of 61 devices carry Class C on their registration (as of 8 Sep 2026).

            • 60 Class C (98.3%)
            • 1 Class A (1.6%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

        • W01010699Clin. Chem. Rt & Poc - OtherIVDD 3 classes · n=78terminal

          Registered in EUDAMED under IVDD with this code, the 78 devices are split across classes (as of 8 Sep 2026).

          • 68 IVD general (87.1%)
          • 8 IVD self-testing (10.2%)
          • 2 Annex II List B (2.5%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

      • W010107Electrodes and Biosensors - Laboratory
        • W01010701Electrolyte Electrodes
          • W0101070101Ammonia - Electrodesterminal
          • W0101070102Calcium - Electrodesterminal
          • W0101070103Chloride - Electrodesterminal
          • W0101070104Lithium - Electrodesterminal
          • W0101070105Magnesium - Electrodesterminal
          • W0101070106Potassium - Electrodesterminal
          • W0101070107Sodium - Electrodesterminal
          • W0101070108Carbon Dioxide (Bicarbonate) - Electrodes (Cc)terminal
          • W0101070199Electrolyte Electrodes - Otherterminal
        • W01010702Substrate Electrodes / Biosensors
          • W0101070201Creatinine - Electrodesterminal
          • W0101070202Glucose - Electrodesterminal
          • W0101070203Glycated Haemoglobin - Electrodesterminal
          • W0101070204Lactate - Electrodesterminal
          • W0101070205Urea - Electrodesterminal
          • W0101070206Bilirubin - Electrodesterminal
          • W0101070299Substrate - Electrodes / Biosensors - Otherterminal
        • W01010703Reference Material and Buffers (Electrolytes)
          • W0101070301Reference Electrodesterminal
          • W0101070302Electrolyte Electrode Buffers and SolutionsIVDR 100.0% Class A · n=66terminal

            Registered in EUDAMED under IVDR with this code: 66 of 66 devices carry Class A on their registration (as of 8 Sep 2026).

            • 66 Class A (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0101070303Substrate Electrode Buffers and Solutionsterminal
          • W0101070304Common Buffers and Solutions (Electrolytes)IVDR 100.0% Class A · n=82terminal

            Registered in EUDAMED under IVDR with this code: 82 of 82 devices carry Class A on their registration (as of 8 Sep 2026).

            • 82 Class A (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0101070399Reference Materials and Buffers (Electrolytes) - Otherterminal
      • W010108Multiple Parameter Electrodes/Biosensors
        • W01010801Multiple Enzymes Only - Electrodes/Biosensorsterminal
        • W01010802Multiple Substrates Only - Electrodes/Biosensorsterminal
        • W01010803Multiple Electrolytes Only - Electrodes/Biosensorsterminal
        • W01010804Multiple Blood Gas Only - Electrodes/Biosensorsterminal
        • W01010805Multiple Parameters (Mix of All) - Electrodes/Biosensorsterminal
        • W01010899Multiple Parameter - Electrodes/Biosensors - Otherterminal
      • W010109Urine Multiple Parameters Testing (Cc) - Lab Reagents
        • W01010901Urine Multi-Constituent Test Strips / Cassettes (Automated)IVDD 100.0% IVD general · n=31terminal

          Registered in EUDAMED under IVDD with this code: 31 of 31 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 31 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01010902Urine Sediment Test Kit (Automated)terminal
        • W01010999Multiple Parameters Urine Testing - OtherIVDR 2 classes · n=58IVDD 2 classes · n=31terminal

          Registered in EUDAMED under IVDR with this code, the 58 devices are split across classes (as of 8 Sep 2026).

          • 48 Class B (82.7%)
          • 10 Class A (17.2%)

          Registered in EUDAMED under IVDD with this code, the 31 devices are split across classes (as of 8 Sep 2026).

          • 28 IVD general (90.3%)
          • 3 IVD self-testing (9.6%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

      • W010190Other Clinical Chemistry
        • W01019001Buffers (Unassignable), Supplem. Reagents, Etc (Cc)IVDR 3 classes · n=464IVDD 96.7% IVD general · n=62terminal

          Registered in EUDAMED under IVDR with this code, the 464 devices are split across classes (as of 8 Sep 2026).

          • 429 Class A (92.4%)
          • 26 Class B (5.6%)
          • 9 Class C (1.9%)

          Registered in EUDAMED under IVDD with this code: 60 of 62 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 60 IVD general (96.7%)
          • 2 Annex II List B (3.2%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01019002Electrophoresis Media (Unassignable)terminal
        • W01019099Clinical Chemistry Reagents - OtherIVDR 3 classes · n=505IVDD 100.0% IVD general · n=322terminal

          Registered in EUDAMED under IVDR with this code, the 505 devices are split across classes (as of 8 Sep 2026).

          • 345 Class A (68.3%)
          • 130 Class B (25.7%)
          • 30 Class C (5.9%)

          Registered in EUDAMED under IVDD with this code: 322 of 322 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 322 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

    • W0102Immunochemistry (Immunology)
      • W010204Thyroid Function Hormones
        • W01020401Free TriiodothyronineIVDR 100.0% Class B · n=60IVDD 100.0% IVD general · n=213terminal

          Registered in EUDAMED under IVDR with this code: 60 of 60 devices carry Class B on their registration (as of 8 Sep 2026).

          • 60 Class B (100.0%)

          Registered in EUDAMED under IVDD with this code: 213 of 213 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 213 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01020402Free ThyroxineIVDR 100.0% Class B · n=62IVDD 100.0% IVD general · n=191terminal

          Registered in EUDAMED under IVDR with this code: 62 of 62 devices carry Class B on their registration (as of 8 Sep 2026).

          • 62 Class B (100.0%)

          Registered in EUDAMED under IVDD with this code: 191 of 191 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 191 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01020403Neonatal Thyroid Stimulating Hormoneterminal
        • W01020404Reverse Triiodothyronineterminal
        • W01020405TriiodothyronineIVDR 100.0% Class B · n=59IVDD 100.0% IVD general · n=184terminal

          Registered in EUDAMED under IVDR with this code: 59 of 59 devices carry Class B on their registration (as of 8 Sep 2026).

          • 59 Class B (100.0%)

          Registered in EUDAMED under IVDD with this code: 184 of 184 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 184 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01020406T- Uptaketerminal
        • W01020407ThyroxineIVDR 100.0% Class B · n=59IVDD 100.0% IVD general · n=182terminal

          Registered in EUDAMED under IVDR with this code: 59 of 59 devices carry Class B on their registration (as of 8 Sep 2026).

          • 59 Class B (100.0%)

          Registered in EUDAMED under IVDD with this code: 182 of 182 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 182 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01020408ThyroglobulinIVDR 2 classes · n=50IVDD 100.0% IVD general · n=81terminal

          Registered in EUDAMED under IVDR with this code, the 50 devices are split across classes (as of 8 Sep 2026).

          • 27 Class C (54.0%)
          • 23 Class B (46.0%)

          Registered in EUDAMED under IVDD with this code: 81 of 81 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 81 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01020409Thyroid Binding Globulinterminal
        • W01020410Thyroid Stimulating HormoneIVDR 98.7% Class B · n=82IVDD 100.0% IVD general · n=199terminal

          Registered in EUDAMED under IVDR with this code: 81 of 82 devices carry Class B on their registration (as of 8 Sep 2026).

          • 81 Class B (98.7%)
          • 1 Class A (1.2%)

          Registered in EUDAMED under IVDD with this code: 199 of 199 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 199 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01020411Neonatal Thyroxineterminal
        • W01020499Thyroid Hormones - OtherIVDD 100.0% IVD general · n=55terminal

          Registered in EUDAMED under IVDD with this code: 55 of 55 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 55 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

      • W010205Fertility / Pregnancy Hormones / Proteins
        • W01020501Fertility Function Hormones / Proteins
          • W0102050101Androstenedioneterminal
          • W0102050102Dehydro-Epiandrosterone Sulphate (Incl. Dhea)IVDR 2 classes · n=26IVDD 100.0% IVD general · n=41terminal

            Registered in EUDAMED under IVDR with this code, the 26 devices are split across classes (as of 8 Sep 2026).

            • 19 Class B (73.0%)
            • 7 Class C (26.9%)

            Registered in EUDAMED under IVDD with this code: 41 of 41 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 41 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102050103EstradiolIVDR 2 classes · n=66IVDD 100.0% IVD general · n=149terminal

            Registered in EUDAMED under IVDR with this code, the 66 devices are split across classes (as of 8 Sep 2026).

            • 60 Class B (90.9%)
            • 6 Class C (9.0%)

            Registered in EUDAMED under IVDD with this code: 149 of 149 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 149 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102050104Follicle Stimulating HormoneIVDR 100.0% Class B · n=49IVDD 98.3% IVD general · n=187terminal

            Registered in EUDAMED under IVDR with this code: 49 of 49 devices carry Class B on their registration (as of 8 Sep 2026).

            • 49 Class B (100.0%)

            Registered in EUDAMED under IVDD with this code: 184 of 187 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 184 IVD general (98.3%)
            • 3 IVD self-testing (1.6%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102050105Luteinising HormoneIVDR 100.0% Class B · n=83IVDD 98.4% IVD general · n=195terminal

            Registered in EUDAMED under IVDR with this code: 83 of 83 devices carry Class B on their registration (as of 8 Sep 2026).

            • 83 Class B (100.0%)

            Registered in EUDAMED under IVDD with this code: 192 of 195 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 192 IVD general (98.4%)
            • 3 IVD self-testing (1.5%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102050106ProgesteroneIVDR 100.0% Class B · n=66IVDD 99.4% IVD general · n=170terminal

            Registered in EUDAMED under IVDR with this code: 66 of 66 devices carry Class B on their registration (as of 8 Sep 2026).

            • 66 Class B (100.0%)

            Registered in EUDAMED under IVDD with this code: 169 of 170 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 169 IVD general (99.4%)
            • 1 IVD self-testing (0.5%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W010205010717 Oh ProgesteroneIVDD 100.0% IVD general · n=41terminal

            Registered in EUDAMED under IVDD with this code: 41 of 41 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 41 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102050108ProlactinIVDR 2 classes · n=55IVDD 100.0% IVD general · n=164terminal

            Registered in EUDAMED under IVDR with this code, the 55 devices are split across classes (as of 8 Sep 2026).

            • 50 Class B (90.9%)
            • 5 Class C (9.0%)

            Registered in EUDAMED under IVDD with this code: 164 of 164 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 164 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102050109Sex Hormone Binding GlobulinIVDR 100.0% Class B · n=30IVDD 100.0% IVD general · n=50terminal

            Registered in EUDAMED under IVDR with this code: 30 of 30 devices carry Class B on their registration (as of 8 Sep 2026).

            • 30 Class B (100.0%)

            Registered in EUDAMED under IVDD with this code: 50 of 50 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 50 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102050110Testosterone (with Dehydro and Free Testosterone)IVDR 100.0% Class B · n=74IVDD 100.0% IVD general · n=187terminal

            Registered in EUDAMED under IVDR with this code: 74 of 74 devices carry Class B on their registration (as of 8 Sep 2026).

            • 74 Class B (100.0%)

            Registered in EUDAMED under IVDD with this code: 187 of 187 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 187 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102050111Androsteroneterminal
          • W0102050112Androstanediol-Glucuronideterminal
          • W010205011411-Desoxycortisolterminal
          • W0102050115Corticosteron (R/M)terminal
          • W0102050199Fertility Function Hormones - OtherIVDD 100.0% IVD general · n=47terminal

            Registered in EUDAMED under IVDD with this code: 47 of 47 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 47 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01020502Pregnancy Testing Hormones / Proteins
          • W0102050201Alpha2-Pregnancy Associated Glycoproteinterminal
          • W0102050202Estriolterminal
          • W0102050203Unconjugated (Free) EstriolIVDD 2 classes · n=27terminal

            Registered in EUDAMED under IVDD with this code, the 27 devices are split across classes (as of 8 Sep 2026).

            • 23 IVD general (85.1%)
            • 4 Annex II List B (14.8%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102050204Estroneterminal
          • W0102050205Total Human Chorionic GonadotropinIVDR 2 classes · n=65IVDD 3 classes · n=125terminal

            Registered in EUDAMED under IVDR with this code, the 65 devices are split across classes (as of 8 Sep 2026).

            • 51 Class B (78.4%)
            • 14 Class C (21.5%)

            Registered in EUDAMED under IVDD with this code, the 125 devices are split across classes (as of 8 Sep 2026).

            • 95 IVD general (76.0%)
            • 26 IVD self-testing (20.8%)
            • 4 Annex II List B (3.2%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102050206B- Human Chorionic Gonadotropin (Incl. Subunit)IVDR 2 classes · n=38IVDD 98.0% IVD general · n=151terminal

            Registered in EUDAMED under IVDR with this code, the 38 devices are split across classes (as of 8 Sep 2026).

            • 33 Class B (86.8%)
            • 5 Class C (13.1%)

            Registered in EUDAMED under IVDD with this code: 148 of 151 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 148 IVD general (98.0%)
            • 3 IVD self-testing (1.9%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102050207Human Placental Lactogenterminal
          • W0102050208Pregnancy Specific B1 -Glycoproteinterminal
          • W0102050209Glycoprotein A Subunitterminal
          • W0102050210Pregnancy Associated Plasma Protein - A (Downs)IVDD 95.2% IVD general · n=42terminal

            Registered in EUDAMED under IVDD with this code: 40 of 42 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 40 IVD general (95.2%)
            • 2 Annex II List B (4.7%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102050211Placental Growth Factor (Pre-Eclampsia)IVDD 100.0% IVD general · n=37terminal

            Registered in EUDAMED under IVDD with this code: 37 of 37 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 37 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102050212Soluble Fms-Like Tyrosine Kinase-1IVDD 100.0% IVD general · n=40terminal

            Registered in EUDAMED under IVDD with this code: 40 of 40 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 40 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102050213Free Beta Hcg (Prenatal Screening)IVDD 2 classes · n=62terminal

            Registered in EUDAMED under IVDD with this code, the 62 devices are split across classes (as of 8 Sep 2026).

            • 58 IVD general (93.5%)
            • 4 Annex II List B (6.4%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102050214Inhibin A/B (Prenatal Screening)IVDD 2 classes · n=38terminal

            Registered in EUDAMED under IVDD with this code, the 38 devices are split across classes (as of 8 Sep 2026).

            • 36 IVD general (94.7%)
            • 2 Annex II List B (5.2%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102050215Anti-Mullerian HormoneIVDR 95.8% Class B · n=48IVDD 100.0% IVD general · n=142terminal

            Registered in EUDAMED under IVDR with this code: 46 of 48 devices carry Class B on their registration (as of 8 Sep 2026).

            • 46 Class B (95.8%)
            • 2 Class C (4.1%)

            Registered in EUDAMED under IVDD with this code: 142 of 142 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 142 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102050299Pregnancy Testing Hormones - OtherIVDD 2 classes · n=51terminal

            Registered in EUDAMED under IVDD with this code, the 51 devices are split across classes (as of 8 Sep 2026).

            • 31 IVD general (60.7%)
            • 20 Annex II List B (39.2%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

      • W010201Specific Proteins
        • W01020101Immunoglobulins (Except Ige)
          • W0102010101Immunoglobulin AIVDR 3 classes · n=38IVDD 100.0% IVD general · n=146terminal

            Registered in EUDAMED under IVDR with this code, the 38 devices are split across classes (as of 8 Sep 2026).

            • 29 Class B (76.3%)
            • 7 Class C (18.4%)
            • 2 Class A (5.2%)

            Registered in EUDAMED under IVDD with this code: 146 of 146 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 146 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102010102Immunoglobulin A Subclass Reagentsterminal
          • W0102010103Immunoglobulin Dterminal
          • W0102010104Immunoglobulin D Subclass Reagentsterminal
          • W0102010105Immunoglobulin GIVDR 3 classes · n=51IVDD 100.0% IVD general · n=204terminal

            Registered in EUDAMED under IVDR with this code, the 51 devices are split across classes (as of 8 Sep 2026).

            • 35 Class B (68.6%)
            • 12 Class C (23.5%)
            • 4 Class A (7.8%)

            Registered in EUDAMED under IVDD with this code: 204 of 204 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 204 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102010106Immunoglobulin G Subclass ReagentsIVDR 2 classes · n=33IVDD 100.0% IVD general · n=58terminal

            Registered in EUDAMED under IVDR with this code, the 33 devices are split across classes (as of 8 Sep 2026).

            • 29 Class B (87.8%)
            • 4 Class A (12.1%)

            Registered in EUDAMED under IVDD with this code: 58 of 58 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 58 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102010107Immunoglobulin MIVDR 3 classes · n=38IVDD 100.0% IVD general · n=138terminal

            Registered in EUDAMED under IVDR with this code, the 38 devices are split across classes (as of 8 Sep 2026).

            • 30 Class B (78.9%)
            • 7 Class C (18.4%)
            • 1 Class A (2.6%)

            Registered in EUDAMED under IVDD with this code: 138 of 138 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 138 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102010108Immunoglobulin M Subclass Reagentsterminal
          • W0102010109Kappa and Lambda ChainIVDR 3 classes · n=28IVDD 100.0% IVD general · n=53terminal

            Registered in EUDAMED under IVDR with this code, the 28 devices are split across classes (as of 8 Sep 2026).

            • 24 Class C (85.7%)
            • 2 Class A (7.1%)
            • 2 Class B (7.1%)

            Registered in EUDAMED under IVDD with this code: 53 of 53 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 53 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102010110Immunoelectrophoresis Kitsterminal
          • W0102010111Immunofixation Kitsterminal
          • W0102010112Anti Human Ig Polyvalent Antiseraterminal
          • W0102010113Human Anti-Mouse Antibodyterminal
          • W0102010114Buffers (Unassignable), Supplem. Reagents, Etc (Ig's)IVDR 3 classes · n=42terminal

            Registered in EUDAMED under IVDR with this code, the 42 devices are split across classes (as of 8 Sep 2026).

            • 39 Class A (92.8%)
            • 2 Class B (4.7%)
            • 1 Class C (2.3%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0102010199Immunoglobulins - Otherterminal
        • W01020102Complement Components
          • W0102010201Complement Component C1qIVDD 100.0% IVD general · n=31terminal

            Registered in EUDAMED under IVDD with this code: 31 of 31 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 31 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102010202Complement Component C1 Inhibitorterminal
          • W0102010203Complement Component C3/C3cIVDR 100.0% Class B · n=23IVDD 100.0% IVD general · n=138terminal

            Registered in EUDAMED under IVDR with this code: 23 of 23 devices carry Class B on their registration (as of 8 Sep 2026).

            • 23 Class B (100.0%)

            Registered in EUDAMED under IVDD with this code: 138 of 138 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 138 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102010204Complement Component for Bbterminal
          • W0102010205Complement Component C4IVDR 100.0% Class B · n=23IVDD 100.0% IVD general · n=138terminal

            Registered in EUDAMED under IVDR with this code: 23 of 23 devices carry Class B on their registration (as of 8 Sep 2026).

            • 23 Class B (100.0%)

            Registered in EUDAMED under IVDD with this code: 138 of 138 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 138 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102010206Complement Component C5aterminal
          • W0102010207Complement Component C59terminal
          • W0102010208Total Complement Activity (Ch50)terminal
          • W0102010299Complement Components - Otherterminal
        • W01020103Transport Proteins
          • W0102010301CeruloplasminIVDD 100.0% IVD general · n=43terminal

            Registered in EUDAMED under IVDD with this code: 43 of 43 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 43 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102010302HaptoglobinIVDD 100.0% IVD general · n=54terminal

            Registered in EUDAMED under IVDD with this code: 54 of 54 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 54 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102010303Hemopexinterminal
          • W0102010304Lactoferrinterminal
          • W0102010305Pre-Albumin / TransthyretinIVDD 100.0% IVD general · n=102terminal

            Registered in EUDAMED under IVDD with this code: 102 of 102 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 102 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102010306Retinol Binding ProteinIVDD 100.0% IVD general · n=86terminal

            Registered in EUDAMED under IVDD with this code: 86 of 86 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 86 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102010307TransferrinIVDR 100.0% Class B · n=34IVDD 100.0% IVD general · n=146terminal

            Registered in EUDAMED under IVDR with this code: 34 of 34 devices carry Class B on their registration (as of 8 Sep 2026).

            • 34 Class B (100.0%)

            Registered in EUDAMED under IVDD with this code: 146 of 146 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 146 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102010308Transcobalamin (S)terminal
          • W0102010309Albumin (Ic) Incl. UalbuminIVDR 2 classes · n=46IVDD 100.0% IVD general · n=168terminal

            Registered in EUDAMED under IVDR with this code, the 46 devices are split across classes (as of 8 Sep 2026).

            • 43 Class B (93.4%)
            • 3 Class C (6.5%)

            Registered in EUDAMED under IVDD with this code: 168 of 168 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 168 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102010399Transport Proteins - Otherterminal
        • W01020104Lipoproteins
          • W0102010401Apolipoprotein A IIVDR 100.0% Class B · n=20IVDD 100.0% IVD general · n=113terminal

            Registered in EUDAMED under IVDR with this code: 20 of 20 devices carry Class B on their registration (as of 8 Sep 2026).

            • 20 Class B (100.0%)

            Registered in EUDAMED under IVDD with this code: 113 of 113 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 113 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102010402Apolipoprotein A Iiterminal
          • W0102010403Apolipoprotein BIVDD 100.0% IVD general · n=114terminal

            Registered in EUDAMED under IVDD with this code: 114 of 114 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 114 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102010404Apolipoprotein E Sub-TypingIVDD 100.0% IVD general · n=26terminal

            Registered in EUDAMED under IVDD with this code: 26 of 26 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 26 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102010405Lipoprotein ( A )IVDR 100.0% Class B · n=22IVDD 100.0% IVD general · n=216terminal

            Registered in EUDAMED under IVDR with this code: 22 of 22 devices carry Class B on their registration (as of 8 Sep 2026).

            • 22 Class B (100.0%)

            Registered in EUDAMED under IVDD with this code: 216 of 216 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 216 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102010499Lipoproteins - OtherIVDD 100.0% IVD general · n=27terminal

            Registered in EUDAMED under IVDD with this code: 27 of 27 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 27 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01020190Other Specific Proteins
          • W0102019001A1-Acid Glycoprotein (Orosomucoid)IVDD 100.0% IVD general · n=63terminal

            Registered in EUDAMED under IVDD with this code: 63 of 63 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 63 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102019002A1-Antitrypsin (Protease Inhibitor)IVDD 100.0% IVD general · n=61terminal

            Registered in EUDAMED under IVDD with this code: 61 of 61 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 61 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102019003A2-MacroglobulinIVDD 100.0% IVD general · n=56terminal

            Registered in EUDAMED under IVDD with this code: 56 of 56 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 56 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102019004A1-MicroglobulinIVDD 100.0% IVD general · n=87terminal

            Registered in EUDAMED under IVDD with this code: 87 of 87 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 87 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102019005FibronectinIVDD 100.0% IVD general · n=48terminal

            Registered in EUDAMED under IVDD with this code: 48 of 48 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 48 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102019006Trypsin-A1-Antitrypsin (Elastase)terminal
          • W0102019007Immuno Reactive Trypsinterminal
          • W0102019008Cystatin CIVDD 100.0% IVD general · n=157terminal

            Registered in EUDAMED under IVDD with this code: 157 of 157 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 157 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102019009CalprotectinIVDR 2 classes · n=41IVDD 100.0% IVD general · n=118terminal

            Registered in EUDAMED under IVDR with this code, the 41 devices are split across classes (as of 8 Sep 2026).

            • 35 Class B (85.3%)
            • 6 Class A (14.6%)

            Registered in EUDAMED under IVDD with this code: 118 of 118 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 118 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102019010Adenosine DeaminaseIVDD 100.0% IVD general · n=35terminal

            Registered in EUDAMED under IVDD with this code: 35 of 35 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 35 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102019011Adrenomedullinterminal
          • W0102019012Amyloid Beta-Derived Diffusible Ligand (Beta-Amyloid Oligomer)terminal
          • W0102019013Beta-Amyloid (1-40)IVDD 95.0% IVD general · n=20terminal

            Registered in EUDAMED under IVDD with this code: 19 of 20 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 19 IVD general (95.0%)
            • 1 Annex II List B (5.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102019014Beta-Amyloid (1-42)IVDD 95.2% IVD general · n=21terminal

            Registered in EUDAMED under IVDD with this code: 20 of 21 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 20 IVD general (95.2%)
            • 1 Annex II List B (4.7%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102019015Total Tauterminal
          • W0102019016Human Tau (Htau)terminal
          • W0102019017Phosphorylated Tau (Ptau)IVDD 100.0% IVD general · n=32terminal

            Registered in EUDAMED under IVDD with this code: 32 of 32 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 32 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102019018Presepsin (Soluble Cd14 or Scd14)terminal
          • W0102019019Neurofilament Light Chain (Nfl)terminal
          • W0102019099Specific Proteins - OtherIVDR 3 classes · n=182IVDD 99.0% IVD general · n=409terminal

            Registered in EUDAMED under IVDR with this code, the 182 devices are split across classes (as of 8 Sep 2026).

            • 110 Class A (60.4%)
            • 44 Class B (24.1%)
            • 28 Class C (15.3%)

            Registered in EUDAMED under IVDD with this code: 405 of 409 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 405 IVD general (99.0%)
            • 3 IVD self-testing (0.7%)
            • 1 Annex II List B (0.2%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

      • W010202Allergy
        • W01020201Immunoglobulin E - TotalIVDR 3 classes · n=45IVDD 100.0% IVD general · n=175terminal

          Registered in EUDAMED under IVDR with this code, the 45 devices are split across classes (as of 8 Sep 2026).

          • 35 Class B (77.7%)
          • 6 Class C (13.3%)
          • 4 Class A (8.8%)

          Registered in EUDAMED under IVDD with this code: 175 of 175 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 175 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01020202Immunoglobulin E - Specific, Monotest/MonoresultIVDR 98.5% Class B · n=765IVDD 100.0% IVD general · n=749terminal

          Registered in EUDAMED under IVDR with this code: 754 of 765 devices carry Class B on their registration (as of 8 Sep 2026).

          • 754 Class B (98.5%)
          • 11 Class C (1.4%)

          Registered in EUDAMED under IVDD with this code: 749 of 749 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 749 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01020203Immunoglobulin E - Monotest/Monoresult - Multi AgIVDR 2 classes · n=30IVDD 100.0% IVD general · n=46terminal

          Registered in EUDAMED under IVDR with this code, the 30 devices are split across classes (as of 8 Sep 2026).

          • 24 Class B (80.0%)
          • 6 Class C (20.0%)

          Registered in EUDAMED under IVDD with this code: 46 of 46 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 46 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01020204Immunoglobulin E - Monotest/Pluriresult-Multi AgIVDR 2 classes · n=43IVDD 100.0% IVD general · n=75terminal

          Registered in EUDAMED under IVDR with this code, the 43 devices are split across classes (as of 8 Sep 2026).

          • 38 Class B (88.3%)
          • 5 Class C (11.6%)

          Registered in EUDAMED under IVDD with this code: 75 of 75 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 75 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01020205Immunoglobulin E - ScreenIVDR 98.0% Class A · n=359IVDD 100.0% IVD general · n=180terminal

          Registered in EUDAMED under IVDR with this code: 352 of 359 devices carry Class A on their registration (as of 8 Sep 2026).

          • 352 Class A (98.0%)
          • 6 Class C (1.6%)
          • 1 Class B (0.2%)

          Registered in EUDAMED under IVDD with this code: 180 of 180 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 180 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01020206Leukotriene Stimulation Testterminal
        • W01020207Allergene Specific Igaterminal
        • W01020208Allergene Specific IggIVDD 100.0% IVD general · n=71terminal

          Registered in EUDAMED under IVDD with this code: 71 of 71 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 71 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01020209Histamineterminal
        • W01020299Allergy Tests - OtherIVDD 100.0% IVD general · n=25terminal

          Registered in EUDAMED under IVDD with this code: 25 of 25 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 25 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

      • W010203Tumour Markers
        • W01020303Oncoproteins
          • W0102030301Her-2/Neuterminal
          • W0102030302P53terminal
          • W0102030399Other OncoproteinsIVDD 100.0% IVD general · n=27terminal

            Registered in EUDAMED under IVDD with this code: 27 of 27 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 27 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01020390Other Tumour Markers
          • W0102039001AlphafetoproteinIVDR 98.1% Class C · n=54IVDD 100.0% IVD general · n=173terminal

            Registered in EUDAMED under IVDR with this code: 53 of 54 devices carry Class C on their registration (as of 8 Sep 2026).

            • 53 Class C (98.1%)
            • 1 Class A (1.8%)

            Registered in EUDAMED under IVDD with this code: 173 of 173 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 173 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102039002Beta2-MicroglobulinIVDR 2 classes · n=22IVDD 100.0% IVD general · n=180terminal

            Registered in EUDAMED under IVDR with this code, the 22 devices are split across classes (as of 8 Sep 2026).

            • 16 Class B (72.7%)
            • 6 Class C (27.2%)

            Registered in EUDAMED under IVDD with this code: 180 of 180 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 180 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102039003Cathepsin-Dterminal
          • W01020390045 Hiaaterminal
          • W0102039005Human Placenta Like Alkaline Phosphataseterminal
          • W0102039006LamininIVDD 100.0% IVD general · n=23terminal

            Registered in EUDAMED under IVDD with this code: 23 of 23 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 23 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102039007Neuron Specific EnolaseIVDR 100.0% Class C · n=29IVDD 100.0% IVD general · n=74terminal

            Registered in EUDAMED under IVDR with this code: 29 of 29 devices carry Class C on their registration (as of 8 Sep 2026).

            • 29 Class C (100.0%)

            Registered in EUDAMED under IVDD with this code: 74 of 74 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 74 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102039008Thymidine Kinaseterminal
          • W0102039009Tissue Associated Proteinterminal
          • W0102039010Matrix-MetalloproteinasesIVDD 100.0% IVD general · n=25terminal

            Registered in EUDAMED under IVDD with this code: 25 of 25 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 25 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102039011Serotonineterminal
          • W0102039013Fecal Occult Blood (Ic)IVDR 3 classes · n=21IVDD 2 classes · n=59terminal

            Registered in EUDAMED under IVDR with this code, the 21 devices are split across classes (as of 8 Sep 2026).

            • 18 Class C (85.7%)
            • 2 Class B (9.5%)
            • 1 Class A (4.7%)

            Registered in EUDAMED under IVDD with this code, the 59 devices are split across classes (as of 8 Sep 2026).

            • 56 IVD general (94.9%)
            • 3 IVD self-testing (5.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102039014Chromogranin Aterminal
          • W0102039015Alpha Subunitterminal
          • W0102039017Protein Induced by Vitamin K Absence or Antagonist-Ii (Pivka-Ii)IVDR 100.0% Class C · n=27IVDD 100.0% IVD general · n=27terminal

            Registered in EUDAMED under IVDR with this code: 27 of 27 devices carry Class C on their registration (as of 8 Sep 2026).

            • 27 Class C (100.0%)

            Registered in EUDAMED under IVDD with this code: 27 of 27 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 27 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102039018Alpha-Fucosidaseterminal
          • W0102039019Soluble Mesothelin-Related Peptidesterminal
          • W0102039099Tumour Markers - OtherIVDR 100.0% Class C · n=51IVDD 100.0% IVD general · n=336terminal

            Registered in EUDAMED under IVDR with this code: 51 of 51 devices carry Class C on their registration (as of 8 Sep 2026).

            • 51 Class C (100.0%)

            Registered in EUDAMED under IVDD with this code: 336 of 336 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 336 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01020301Cancer Antigens
          • W0102030101Bladder Tumour Antigenterminal
          • W0102030102Cancer Antigen 15-3IVDR 100.0% Class C · n=47IVDD 100.0% IVD general · n=130terminal

            Registered in EUDAMED under IVDR with this code: 47 of 47 devices carry Class C on their registration (as of 8 Sep 2026).

            • 47 Class C (100.0%)

            Registered in EUDAMED under IVDD with this code: 130 of 130 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 130 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102030103Cancer Antigen 19-9IVDR 100.0% Class C · n=54IVDD 100.0% IVD general · n=108terminal

            Registered in EUDAMED under IVDR with this code: 54 of 54 devices carry Class C on their registration (as of 8 Sep 2026).

            • 54 Class C (100.0%)

            Registered in EUDAMED under IVDD with this code: 108 of 108 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 108 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102030104Cancer Antigen 50IVDR 100.0% Class C · n=20IVDD 100.0% IVD general · n=63terminal

            Registered in EUDAMED under IVDR with this code: 20 of 20 devices carry Class C on their registration (as of 8 Sep 2026).

            • 20 Class C (100.0%)

            Registered in EUDAMED under IVDD with this code: 63 of 63 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 63 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102030105Cancer Antigen 72-4IVDR 100.0% Class C · n=21IVDD 100.0% IVD general · n=78terminal

            Registered in EUDAMED under IVDR with this code: 21 of 21 devices carry Class C on their registration (as of 8 Sep 2026).

            • 21 Class C (100.0%)

            Registered in EUDAMED under IVDD with this code: 78 of 78 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 78 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102030106Cancer Antigen 125IVDR 100.0% Class C · n=61IVDD 100.0% IVD general · n=136terminal

            Registered in EUDAMED under IVDR with this code: 61 of 61 devices carry Class C on their registration (as of 8 Sep 2026).

            • 61 Class C (100.0%)

            Registered in EUDAMED under IVDD with this code: 136 of 136 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 136 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102030107Cancer Antigen 195terminal
          • W0102030108Cancer Antigen 242IVDD 100.0% IVD general · n=58terminal

            Registered in EUDAMED under IVDD with this code: 58 of 58 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 58 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102030109Cancer Antigen 549terminal
          • W0102030110Cancer Antigen 27.29terminal
          • W0102030111Cyfra 21-1IVDR 100.0% Class C · n=26IVDD 100.0% IVD general · n=64terminal

            Registered in EUDAMED under IVDR with this code: 26 of 26 devices carry Class C on their registration (as of 8 Sep 2026).

            • 26 Class C (100.0%)

            Registered in EUDAMED under IVDD with this code: 64 of 64 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 64 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102030112Carcinoembryonic AntigenIVDR 97.9% Class C · n=49IVDD 100.0% IVD general · n=191terminal

            Registered in EUDAMED under IVDR with this code: 48 of 49 devices carry Class C on their registration (as of 8 Sep 2026).

            • 48 Class C (97.9%)
            • 1 Class A (2.0%)

            Registered in EUDAMED under IVDD with this code: 191 of 191 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 191 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102030113Total Prostatic Specific AntigenIVDR 100.0% Class C · n=80IVDD 2 classes · n=40terminal

            Registered in EUDAMED under IVDR with this code: 80 of 80 devices carry Class C on their registration (as of 8 Sep 2026).

            • 80 Class C (100.0%)

            Registered in EUDAMED under IVDD with this code, the 40 devices are split across classes (as of 8 Sep 2026).

            • 23 IVD general (57.5%)
            • 17 Annex II List B (42.5%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102030114Free Prostatic Specific AntigenIVDR 100.0% Class C · n=57IVDD 2 classes · n=26terminal

            Registered in EUDAMED under IVDR with this code: 57 of 57 devices carry Class C on their registration (as of 8 Sep 2026).

            • 57 Class C (100.0%)

            Registered in EUDAMED under IVDD with this code, the 26 devices are split across classes (as of 8 Sep 2026).

            • 16 IVD general (61.5%)
            • 10 Annex II List B (38.4%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102030115Complexed Prostatic Specific Antigenterminal
          • W0102030116Squamous Cell Carcinoma AntigenIVDR 100.0% Class C · n=31IVDD 100.0% IVD general · n=76terminal

            Registered in EUDAMED under IVDR with this code: 31 of 31 devices carry Class C on their registration (as of 8 Sep 2026).

            • 31 Class C (100.0%)

            Registered in EUDAMED under IVDD with this code: 76 of 76 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 76 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102030117Tumor Polypeptide Antigen (Tpa - Incl. Tps)terminal
          • W0102030118Cancer Associated Serum Antigenterminal
          • W0102030119Human Epididymis Protein 4IVDR 100.0% Class C · n=26IVDD 100.0% IVD general · n=68terminal

            Registered in EUDAMED under IVDR with this code: 26 of 26 devices carry Class C on their registration (as of 8 Sep 2026).

            • 26 Class C (100.0%)

            Registered in EUDAMED under IVDD with this code: 68 of 68 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 68 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102030120Prostatic Acid Phosphatase (Ic)terminal
          • W0102030121Pro-Gastrin-Releasing PeptideIVDR 96.5% Class C · n=29IVDD 100.0% IVD general · n=60terminal

            Registered in EUDAMED under IVDR with this code: 28 of 29 devices carry Class C on their registration (as of 8 Sep 2026).

            • 28 Class C (96.5%)
            • 1 Class B (3.4%)

            Registered in EUDAMED under IVDD with this code: 60 of 60 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 60 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102030122Early Prostate Cancer Antigen - 2terminal
          • W0102030123Nuclear Matrix Protein 22terminal
          • W0102030124Cancer Antigen P16terminal
          • W0102030125Cancer Antigen P63terminal
          • W0102030126CytokeratinsIVDD 100.0% IVD general · n=23terminal

            Registered in EUDAMED under IVDD with this code: 23 of 23 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 23 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102030127(2)propsaterminal
          • W0102030199Cancer Antigens - OtherIVDR 100.0% Class C · n=24IVDD 100.0% IVD general · n=109terminal

            Registered in EUDAMED under IVDR with this code: 24 of 24 devices carry Class C on their registration (as of 8 Sep 2026).

            • 24 Class C (100.0%)

            Registered in EUDAMED under IVDD with this code: 109 of 109 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 109 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01020302Receptor Assays
          • W0102030201Estrogen Receptor Assaysterminal
          • W0102030202Progesterone Receptor Assaysterminal
          • W0102030299Receptor Assays - Otherterminal
      • W010206Individual and Specific Hormones / Proteins
        • W01020601Diabetes Assays (Hormones)
          • W0102060101C-PeptideIVDR 2 classes · n=35IVDD 100.0% IVD general · n=109terminal

            Registered in EUDAMED under IVDR with this code, the 35 devices are split across classes (as of 8 Sep 2026).

            • 18 Class B (51.4%)
            • 17 Class C (48.5%)

            Registered in EUDAMED under IVDD with this code: 109 of 109 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 109 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102060102Glucagonterminal
          • W0102060103InsulinIVDR 2 classes · n=38IVDD 100.0% IVD general · n=112terminal

            Registered in EUDAMED under IVDR with this code, the 38 devices are split across classes (as of 8 Sep 2026).

            • 20 Class B (52.6%)
            • 18 Class C (47.3%)

            Registered in EUDAMED under IVDD with this code: 112 of 112 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 112 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102060104Insulin AntibodyIVDD 100.0% IVD general · n=20terminal

            Registered in EUDAMED under IVDD with this code: 20 of 20 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 20 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102060105Gad Ii Antibodies and Other IcaIVDD 100.0% IVD general · n=29terminal

            Registered in EUDAMED under IVDD with this code: 29 of 29 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 29 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102060106Thyrosin Phosphatase Ia2 Antibodiesterminal
          • W0102060107Proinsulinterminal
          • W0102060108Islet Cell Abterminal
          • W0102060109Glycosylated/Glycated Haemoglobin (Ic)IVDD 100.0% IVD general · n=75terminal

            Registered in EUDAMED under IVDD with this code: 75 of 75 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 75 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102060199Diabetes Assays - OtherIVDD 100.0% IVD general · n=25terminal

            Registered in EUDAMED under IVDD with this code: 25 of 25 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 25 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01020602Renal Metabolism Assays
          • W0102060201AldosteroneIVDD 100.0% IVD general · n=51terminal

            Registered in EUDAMED under IVDD with this code: 51 of 51 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 51 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102060202Angiotensin I / IiIVDD 100.0% IVD general · n=56terminal

            Registered in EUDAMED under IVDD with this code: 56 of 56 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 56 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102060203CortisolIVDR 2 classes · n=43IVDD 99.0% IVD general · n=109terminal

            Registered in EUDAMED under IVDR with this code, the 43 devices are split across classes (as of 8 Sep 2026).

            • 22 Class B (51.1%)
            • 21 Class C (48.8%)

            Registered in EUDAMED under IVDD with this code: 108 of 109 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 108 IVD general (99.0%)
            • 1 Annex II List B (0.9%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102060204Renine (Plasma Renine Activity)IVDD 100.0% IVD general · n=40terminal

            Registered in EUDAMED under IVDD with this code: 40 of 40 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 40 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102060205Angiotensin Converting Enzyme (Ic)terminal
          • W0102060206Renine Directterminal
          • W0102060207Neutrophil Gelatinase Associated Lipocalin (Lipocalin 2)IVDD 100.0% IVD general · n=84terminal

            Registered in EUDAMED under IVDD with this code: 84 of 84 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 84 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102060208Tissue Inhibitor of Metalloproteinase-2 / Insuline-Like Growth Factor - Binding Protein-7terminal
          • W0102060299Renal Metabolism Tests - Otherterminal
        • W01020603Bone and Mineral Metabolism Assays
          • W0102060301CalcitoninIVDR 2 classes · n=22IVDD 100.0% IVD general · n=53terminal

            Registered in EUDAMED under IVDR with this code, the 22 devices are split across classes (as of 8 Sep 2026).

            • 13 Class B (59.0%)
            • 9 Class C (40.9%)

            Registered in EUDAMED under IVDD with this code: 53 of 53 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 53 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102060302Collagen Type I C-Terminal Propeptideterminal
          • W0102060303Collagen Type Iii C-Terminal Propeptideterminal
          • W0102060304Cross-Linked C-Telopeptidesterminal
          • W0102060305Cross-Linked N-Telopeptidesterminal
          • W0102060306Cyclic Adenosin Monophosphateterminal
          • W0102060307Deoxypyridinolineterminal
          • W01020603081.25-Dihydroxyvitamin Dterminal
          • W010206030925-Hydroxyvitamin DIVDR 100.0% Class B · n=71IVDD 2 classes · n=224terminal

            Registered in EUDAMED under IVDR with this code: 71 of 71 devices carry Class B on their registration (as of 8 Sep 2026).

            • 71 Class B (100.0%)

            Registered in EUDAMED under IVDD with this code, the 224 devices are split across classes (as of 8 Sep 2026).

            • 212 IVD general (94.6%)
            • 12 IVD self-testing (5.3%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102060310Hydroxyprolineterminal
          • W0102060311OsteocalcineIVDD 100.0% IVD general · n=51terminal

            Registered in EUDAMED under IVDD with this code: 51 of 51 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 51 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102060312Parathyroid Hormone IntactIVDR 100.0% Class B · n=43IVDD 100.0% IVD general · n=77terminal

            Registered in EUDAMED under IVDR with this code: 43 of 43 devices carry Class B on their registration (as of 8 Sep 2026).

            • 43 Class B (100.0%)

            Registered in EUDAMED under IVDD with this code: 77 of 77 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 77 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102060313Parathyroid Hormone (C-/N-Terminal, M-Regional)terminal
          • W0102060314Parathyroid Hormone Related Peptideterminal
          • W0102060315Pyridinolineterminal
          • W0102060316Tartrate-Resistant Acid Phosphatase 5bterminal
          • W0102060317Procollagen Type I N Terminal PropeptideIVDD 100.0% IVD general · n=21terminal

            Registered in EUDAMED under IVDD with this code: 21 of 21 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 21 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102060318Bone Alkaline Phosphatase (Ic)terminal
          • W0102060399Bone Metabolism Tests - Otherterminal
        • W01020604Endocrine Hormones and Peptides
          • W0102060401Adrenocorticotropic HormoneIVDR 2 classes · n=24IVDD 100.0% IVD general · n=56terminal

            Registered in EUDAMED under IVDR with this code, the 24 devices are split across classes (as of 8 Sep 2026).

            • 22 Class B (91.6%)
            • 2 Class C (8.3%)

            Registered in EUDAMED under IVDD with this code: 56 of 56 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 56 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102060402Human Growth HormoneIVDR 100.0% Class B · n=30IVDD 100.0% IVD general · n=80terminal

            Registered in EUDAMED under IVDR with this code: 30 of 30 devices carry Class B on their registration (as of 8 Sep 2026).

            • 30 Class B (100.0%)

            Registered in EUDAMED under IVDD with this code: 80 of 80 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 80 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102060403Insulin-Like Growth Factor I (Somatomedin C)IVDD 100.0% IVD general · n=33terminal

            Registered in EUDAMED under IVDD with this code: 33 of 33 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 33 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102060404Insulin-Like Growth Factor Iiterminal
          • W0102060405Insulin-Like Growth Factor Binding Protein 1IVDD 100.0% IVD general · n=47terminal

            Registered in EUDAMED under IVDD with this code: 47 of 47 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 47 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102060406Insulin-Like Growth Factor Binding Protein 3IVDD 100.0% IVD general · n=27terminal

            Registered in EUDAMED under IVDD with this code: 27 of 27 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 27 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102060407Vasointestinal Peptideterminal
          • W0102060408Vasopressinterminal
          • W0102060499Endocrine Hormones (Growth Factors) - OtherIVDD 100.0% IVD general · n=31terminal

            Registered in EUDAMED under IVDD with this code: 31 of 31 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 31 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01020605Neuroendocrine Function Assays
          • W0102060501Bombesinterminal
          • W0102060502B-Endorphinterminal
          • W010206050317-Hydroxy-Ketosteroneterminal
          • W010206050417-Ketogenic Steroidsterminal
          • W010206050517-Ketosteroidsterminal
          • W0102060506A-Melanocite Stimulating Hormonesterminal
          • W0102060507Neurotensinterminal
          • W0102060508Somatostatinterminal
          • W0102060509Substance Pterminal
          • W0102060599Neoendocrine Function Assays - Otherterminal
        • W01020606Multiple Hormones - Individual and Specific
          • W0102060601Adrenalin / Noradrenaline / Dopamineterminal
          • W0102060699Multiple Individual Hormones - Otherterminal
        • W01020690Various Individual and Specific Hormones
          • W0102069001GastrinIVDD 100.0% IVD general · n=80terminal

            Registered in EUDAMED under IVDD with this code: 80 of 80 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 80 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102069002Gonadotropin-Releasing Hormoneterminal
          • W0102069003Melatonineterminal
          • W0102069004Neopterineterminal
          • W0102069005Oxytocinterminal
          • W0102069006PepsinogenIVDR 2 classes · n=56IVDD 100.0% IVD general · n=230terminal

            Registered in EUDAMED under IVDR with this code, the 56 devices are split across classes (as of 8 Sep 2026).

            • 40 Class B (71.4%)
            • 16 Class C (28.5%)

            Registered in EUDAMED under IVDD with this code: 230 of 230 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 230 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102069007Prostaglandinterminal
          • W0102069008Serotonin-Uptake (Platelets)terminal
          • W0102069009Elastase (Pancreatic Polypeptide)terminal
          • W0102069010Adrenalinterminal
          • W0102069011Noradrenalinterminal
          • W0102069012Dopamineterminal
          • W0102069013ProcalcitoninIVDR 3 classes · n=75IVDD 100.0% IVD general · n=250terminal

            Registered in EUDAMED under IVDR with this code, the 75 devices are split across classes (as of 8 Sep 2026).

            • 53 Class C (70.6%)
            • 15 Class B (20.0%)
            • 7 Class A (9.3%)

            Registered in EUDAMED under IVDD with this code: 250 of 250 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 250 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102069014Leptinterminal
          • W0102069015Motilinterminal
          • W0102069016Cyclic Guanosine Monophosphateterminal
          • W0102069017Mid-Regional Proadrenomedullin (Mr-Proadm)terminal
          • W0102069099Individual and Specific Hormones - OtherIVDR 100.0% Class B · n=28IVDD 100.0% IVD general · n=25terminal

            Registered in EUDAMED under IVDR with this code: 28 of 28 devices carry Class B on their registration (as of 8 Sep 2026).

            • 28 Class B (100.0%)

            Registered in EUDAMED under IVDD with this code: 25 of 25 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 25 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

      • W010207Anemia Related / Vitamin Tests
        • W01020701Anemia
          • W0102070101Erythropoietinterminal
          • W0102070102FerritinIVDR 2 classes · n=98IVDD 95.1% IVD general · n=348terminal

            Registered in EUDAMED under IVDR with this code, the 98 devices are split across classes (as of 8 Sep 2026).

            • 80 Class B (81.6%)
            • 18 Class C (18.3%)

            Registered in EUDAMED under IVDD with this code: 331 of 348 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 331 IVD general (95.1%)
            • 17 IVD self-testing (4.8%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102070103FolateIVDR 100.0% Class B · n=46IVDD 100.0% IVD general · n=116terminal

            Registered in EUDAMED under IVDR with this code: 46 of 46 devices carry Class B on their registration (as of 8 Sep 2026).

            • 46 Class B (100.0%)

            Registered in EUDAMED under IVDD with this code: 116 of 116 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 116 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102070104Soluble Transferrin Receptorterminal
          • W0102070105Reticulocyte Haemoglobin Contentterminal
          • W0102070106Iron (Ic)terminal
          • W0102070107Iron Binding Capacity - Total (Ic)terminal
          • W0102070199Anemia - Otherterminal
        • W01020702Vitamines
          • W0102070201Vitamin B1terminal
          • W0102070202Vitamin B2terminal
          • W0102070203Vitamin B6terminal
          • W0102070204Vitamin B12IVDR 100.0% Class B · n=44IVDD 99.3% IVD general · n=148terminal

            Registered in EUDAMED under IVDR with this code: 44 of 44 devices carry Class B on their registration (as of 8 Sep 2026).

            • 44 Class B (100.0%)

            Registered in EUDAMED under IVDD with this code: 147 of 148 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 147 IVD general (99.3%)
            • 1 Annex II List B (0.6%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102070205Intrinsic Factor (Blocking Antibody)terminal
          • W0102070206Vitamin D (Cholecalciferol)IVDD 95.4% IVD general · n=44terminal

            Registered in EUDAMED under IVDD with this code: 42 of 44 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 42 IVD general (95.4%)
            • 2 IVD self-testing (4.5%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102070299Vitamin Tests - OtherIVDD 97.3% IVD general · n=38terminal

            Registered in EUDAMED under IVDD with this code: 37 of 38 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 37 IVD general (97.3%)
            • 1 Annex II List B (2.6%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01020703Multiple - Anemia Related / Vitamin Tests
          • W0102070301Vitamin B 12 / Folateterminal
          • W0102070399Multiple Anemia / Vitamin Tests - Otherterminal
      • W010208Therapeutic Drug Monitoring
        • W01020801Cardiovascular Tdm
          • W0102080101Digoxinterminal
          • W0102080102Digitoxinterminal
          • W0102080103Disopyramideterminal
          • W0102080104Flecainideterminal
          • W0102080105Lidocaineterminal
          • W0102080106N-Acetylprocainamideterminal
          • W0102080107Procainamideterminal
          • W0102080108Propranololterminal
          • W0102080109Quinidineterminal
          • W0102080199Cardiovascular Tdm - Otherterminal
        • W01020802Central Nervous Systems Tdm
          • W0102080201Carbamazepineterminal
          • W0102080202Ethosuximideterminal
          • W0102080203Free Carbamazepineterminal
          • W0102080204Free Phenytointerminal
          • W0102080205Free Primidoneterminal
          • W0102080206Free Valproic Acidterminal
          • W0102080207Phenobarbitalterminal
          • W0102080208Phenytointerminal
          • W0102080209Primidoneterminal
          • W0102080210Valproic Acidterminal
          • W0102080211Gabapentinterminal
          • W0102080212Lamotrigineterminal
          • W0102080213Topiramateterminal
          • W0102080214Zonisamideterminal
          • W0102080215Levetiracetamterminal
          • W0102080299Central Nervous System Tdm - Otherterminal
        • W01020803Antibiotic Tdm / Antivirus Tdm
          • W0102080301Amikacinterminal
          • W0102080303Chloramphenicolterminal
          • W0102080305Dibekacinterminal
          • W0102080307Gentamicinterminal
          • W0102080309Kanamycinterminal
          • W0102080311Netilmycinterminal
          • W0102080313Sisomycinterminal
          • W0102080315Streptomycinterminal
          • W0102080317Tobramycinterminal
          • W0102080319Vancomycinterminal
          • W0102080321Teicoplanineterminal
          • W0102080399Antibiotics Tdm - Otherterminal
        • W01020804Anti-Asthma Tdm
          • W0102080401Caffeineterminal
          • W0102080402Theophyllineterminal
          • W0102080499Anti-Asthma Tdm - Otherterminal
        • W01020805Anti-Neoplastic Tdm
          • W0102080501Methotrexateterminal
          • W0102080599Anti-Neoplastic Tdm - Otherterminal
        • W01020806Immunosuppressant Tdm
          • W0102080601Cyclosporine Totalterminal
          • W0102080602Cyclosporine Specificterminal
          • W0102080603Tacrolimusterminal
          • W0102080604Rapamycin (Sirolimus)terminal
          • W0102080605Mycophenolateterminal
          • W0102080606Everolimusterminal
          • W0102080699Immunosuppressant Tdm - Otherterminal
        • W01020807Autoimmune Disease Tdm
          • W0102080701Infliximabterminal
          • W0102080702Adalimumabterminal
          • W0102080703Etanercepterminal
          • W0102080704Rituximabterminal
          • W0102080799Autoimmune Disease Tdm - OtherIVDR 100.0% Class B · n=55IVDD 100.0% IVD general · n=51terminal

            Registered in EUDAMED under IVDR with this code: 55 of 55 devices carry Class B on their registration (as of 8 Sep 2026).

            • 55 Class B (100.0%)

            Registered in EUDAMED under IVDD with this code: 51 of 51 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 51 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01020899Therapeutic Drug Monitoring - OtherIVDR 2 classes · n=30IVDD 100.0% IVD general · n=49terminal

          Registered in EUDAMED under IVDR with this code, the 30 devices are split across classes (as of 8 Sep 2026).

          • 27 Class C (90.0%)
          • 3 Class B (10.0%)

          Registered in EUDAMED under IVDD with this code: 49 of 49 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 49 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

      • W010209Drugs of Abuse / Toxicology
        • W01020901Drugs of Abuse
          • W0102090101Amphetamines GroupIVDD 100.0% IVD general · n=26terminal

            Registered in EUDAMED under IVDD with this code: 26 of 26 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 26 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102090102Amphetamine/Methamphetamine SpecificIVDD 100.0% IVD general · n=31terminal

            Registered in EUDAMED under IVDD with this code: 31 of 31 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 31 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102090103BarbituratesIVDD 100.0% IVD general · n=22terminal

            Registered in EUDAMED under IVDD with this code: 22 of 22 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 22 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102090104BenzodiazepinesIVDD 100.0% IVD general · n=39terminal

            Registered in EUDAMED under IVDD with this code: 39 of 39 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 39 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102090105CannabinoidsIVDD 100.0% IVD general · n=86terminal

            Registered in EUDAMED under IVDD with this code: 86 of 86 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 86 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102090106Cocaine + Cocaine MetabolitesIVDD 100.0% IVD general · n=33terminal

            Registered in EUDAMED under IVDD with this code: 33 of 33 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 33 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102090107Codeineterminal
          • W0102090108CotinineIVDD 100.0% IVD general · n=25terminal

            Registered in EUDAMED under IVDD with this code: 25 of 25 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 25 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102090109Lysergic Acid Diethylamideterminal
          • W0102090110MethadoneIVDD 100.0% IVD general · n=34terminal

            Registered in EUDAMED under IVDD with this code: 34 of 34 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 34 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102090111Methaqualoneterminal
          • W0102090112MorphinesIVDD 100.0% IVD general · n=42terminal

            Registered in EUDAMED under IVDD with this code: 42 of 42 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 42 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102090113OpiatesIVDD 100.0% IVD general · n=67terminal

            Registered in EUDAMED under IVDD with this code: 67 of 67 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 67 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102090114PhencyclidineIVDD 100.0% IVD general · n=25terminal

            Registered in EUDAMED under IVDD with this code: 25 of 25 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 25 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102090115PropoxypheneIVDD 100.0% IVD general · n=24terminal

            Registered in EUDAMED under IVDD with this code: 24 of 24 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 24 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W01020901166-Acethylmorphiumterminal
          • W0102090117BuprenorphineIVDD 100.0% IVD general · n=50terminal

            Registered in EUDAMED under IVDD with this code: 50 of 50 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 50 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102090118Dextromethorphanterminal
          • W0102090119Mdma (Ecstasy)IVDD 100.0% IVD general · n=22terminal

            Registered in EUDAMED under IVDD with this code: 22 of 22 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 22 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102090120Eddp Specific (Methadone Metabolites)terminal
          • W0102090121Tramadolterminal
          • W0102090122Fentanylterminal
          • W0102090123OxycodineIVDD 100.0% IVD general · n=41terminal

            Registered in EUDAMED under IVDD with this code: 41 of 41 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 41 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102090199Drugs of Abuse - OtherIVDR 98.3% Class B · n=59IVDD 100.0% IVD general · n=434terminal

            Registered in EUDAMED under IVDR with this code: 58 of 59 devices carry Class B on their registration (as of 8 Sep 2026).

            • 58 Class B (98.3%)
            • 1 Class C (1.6%)

            Registered in EUDAMED under IVDD with this code: 434 of 434 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 434 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01020902Toxicology
          • W0102090201Acetaminophene (Paracetamol)terminal
          • W01020902025-Aminolevulinate Dehydrataseterminal
          • W0102090203Amitriptylineterminal
          • W0102090204Catecholaminesterminal
          • W0102090205Desipramineterminal
          • W0102090206Doxepin Plus Metabolitesterminal
          • W0102090207Ethanol (Alcohol)IVDR 2 classes · n=29IVDD 100.0% IVD general · n=74terminal

            Registered in EUDAMED under IVDR with this code, the 29 devices are split across classes (as of 8 Sep 2026).

            • 21 Class A (72.4%)
            • 8 Class B (27.5%)

            Registered in EUDAMED under IVDD with this code: 74 of 74 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 74 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102090208Hippuric Acidterminal
          • W0102090209Imipramineterminal
          • W0102090210Nortriptylineterminal
          • W0102090211Phenolsterminal
          • W0102090212Protoporphyrin Ixterminal
          • W0102090213Salicylateterminal
          • W0102090214Trichloroacetic Acidterminal
          • W0102090215Tricyclic Antidepressants (Total)terminal
          • W0102090216Uro/Coproporphyrinsterminal
          • W0102090217Vanillylmandelic Acidterminal
          • W0102090218Homovanillic Acidterminal
          • W0102090220Ethyl Glucuronideterminal
          • W0102090299Toxicology - OtherIVDD 100.0% IVD general · n=71terminal

            Registered in EUDAMED under IVDD with this code: 71 of 71 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 71 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

      • W010210Markers for Auto-Immune Diseases
        • W01021001Autoimmune Connective Tissue Diseases
          • W0102100101Ana ScreeningIVDR 98.3% Class B · n=61IVDD 100.0% IVD general · n=107terminal

            Registered in EUDAMED under IVDR with this code: 60 of 61 devices carry Class B on their registration (as of 8 Sep 2026).

            • 60 Class B (98.3%)
            • 1 Class A (1.6%)

            Registered in EUDAMED under IVDD with this code: 107 of 107 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 107 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102100102Ena ScreeningIVDD 100.0% IVD general · n=25terminal

            Registered in EUDAMED under IVDD with this code: 25 of 25 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 25 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102100105Ds DNA - AntibodiesIVDD 100.0% IVD general · n=75terminal

            Registered in EUDAMED under IVDD with this code: 75 of 75 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 75 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102100106Ss DNA - Antibodiesterminal
          • W0102100107Histones (H1, H2a, H3, H4,…hn)IVDD 100.0% IVD general · n=29terminal

            Registered in EUDAMED under IVDD with this code: 29 of 29 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 29 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102100108Jo-1IVDR 100.0% Class B · n=36IVDD 100.0% IVD general · n=35terminal

            Registered in EUDAMED under IVDR with this code: 36 of 36 devices carry Class B on their registration (as of 8 Sep 2026).

            • 36 Class B (100.0%)

            Registered in EUDAMED under IVDD with this code: 35 of 35 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 35 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102100109Pm-Scl - AntibodiesIVDD 100.0% IVD general · n=20terminal

            Registered in EUDAMED under IVDD with this code: 20 of 20 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 20 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102100110Scl-70IVDD 100.0% IVD general · n=27terminal

            Registered in EUDAMED under IVDD with this code: 27 of 27 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 27 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102100111SmIVDD 100.0% IVD general · n=24terminal

            Registered in EUDAMED under IVDD with this code: 24 of 24 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 24 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102100112Ss-AIVDR 100.0% Class B · n=25IVDD 100.0% IVD general · n=35terminal

            Registered in EUDAMED under IVDR with this code: 25 of 25 devices carry Class B on their registration (as of 8 Sep 2026).

            • 25 Class B (100.0%)

            Registered in EUDAMED under IVDD with this code: 35 of 35 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 35 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102100113Ss-BIVDD 100.0% IVD general · n=21terminal

            Registered in EUDAMED under IVDD with this code: 21 of 21 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 21 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102100114U1-Snrnp - AntibodiesIVDD 100.0% IVD general · n=25terminal

            Registered in EUDAMED under IVDD with this code: 25 of 25 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 25 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102100115Anti-Centromere Antibodiesterminal
          • W0102100117Nucleosome Antibodiesterminal
          • W0102100118Ribosomal Phosphoprotein Antibodiesterminal
          • W0102100199Autoimmune Connective Tissue Diseases Testing - OtherIVDR 100.0% Class B · n=35IVDD 100.0% IVD general · n=135terminal

            Registered in EUDAMED under IVDR with this code: 35 of 35 devices carry Class B on their registration (as of 8 Sep 2026).

            • 35 Class B (100.0%)

            Registered in EUDAMED under IVDD with this code: 135 of 135 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 135 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01021002Neuro-Auto-Immune Disease
          • W0102100201Anti-Ganglioside-Antibodies Totalterminal
          • W0102100202Anti-Gm1terminal
          • W0102100203Asialo-Gm1terminal
          • W0102100204Anti-Gd1bterminal
          • W0102100205Gal (ß1-3)terminal
          • W0102100206Galnacterminal
          • W0102100207Anti-Mag (Myelin Associated Glycoprotein)terminal
          • W0102100208Anti-Car (Cancer Associated Retinopathy)terminal
          • W0102100209Anti-Hu Antibodyterminal
          • W0102100210Anti-Yo Antibodyterminal
          • W0102100211Anti-Ri Antibodyterminal
          • W0102100212Anti-Gq1bterminal
          • W0102100299Neuro-Auto-Immune Disease - Otherterminal
        • W01021003Thyroid-Auto-Immune Disease
          • W0102100301Thyroid Peroxidase (Incl. Microsomal) AntibodiesIVDR 100.0% Class B · n=42IVDD 100.0% IVD general · n=91terminal

            Registered in EUDAMED under IVDR with this code: 42 of 42 devices carry Class B on their registration (as of 8 Sep 2026).

            • 42 Class B (100.0%)

            Registered in EUDAMED under IVDD with this code: 91 of 91 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 91 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102100302Tsh Receptor AntibodiesIVDD 100.0% IVD general · n=50terminal

            Registered in EUDAMED under IVDD with this code: 50 of 50 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 50 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102100303Thyroglobulin AutoantibodyIVDR 97.8% Class B · n=46IVDD 100.0% IVD general · n=83terminal

            Registered in EUDAMED under IVDR with this code: 45 of 46 devices carry Class B on their registration (as of 8 Sep 2026).

            • 45 Class B (97.8%)
            • 1 Class C (2.1%)

            Registered in EUDAMED under IVDD with this code: 83 of 83 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 83 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102100304Thyroid Stimulating Immunoglobulinterminal
          • W0102100399Thyroid-Auto-Immune Disease - Otherterminal
        • W01021004Vasculitis
          • W0102100401Anca ScreeningIVDD 100.0% IVD general · n=21terminal

            Registered in EUDAMED under IVDD with this code: 21 of 21 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 21 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102100402Mpo Ancaterminal
          • W0102100403Pr3 Ancaterminal
          • W0102100499Vasculitis - OtherIVDD 100.0% IVD general · n=22terminal

            Registered in EUDAMED under IVDD with this code: 22 of 22 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 22 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01021005Anti-Phospholipid Syndrom
          • W0102100501Anti-Cardiolipin AntibodiesIVDR 2 classes · n=42IVDD 100.0% IVD general · n=91terminal

            Registered in EUDAMED under IVDR with this code, the 42 devices are split across classes (as of 8 Sep 2026).

            • 26 Class B (61.9%)
            • 16 Class C (38.0%)

            Registered in EUDAMED under IVDD with this code: 91 of 91 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 91 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102100502Anti-Phosphatidylserin Antibodiesterminal
          • W0102100503Anti-B2-Glycoprotein I AntibodiesIVDR 2 classes · n=44IVDD 100.0% IVD general · n=89terminal

            Registered in EUDAMED under IVDR with this code, the 44 devices are split across classes (as of 8 Sep 2026).

            • 28 Class B (63.6%)
            • 16 Class C (36.3%)

            Registered in EUDAMED under IVDD with this code: 89 of 89 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 89 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102100504Apls Screening (or Anti-Cardiolipin / Anti-B2-Glycoprotein Combitest)terminal
          • W0102100599Anti-Phospholip Syndrome - OtherIVDD 100.0% IVD general · n=34terminal

            Registered in EUDAMED under IVDD with this code: 34 of 34 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 34 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01021006Celiac Disease
          • W0102100601Tissue Transglutaminase AntibodiesIVDD 98.4% IVD general · n=65terminal

            Registered in EUDAMED under IVDD with this code: 64 of 65 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 64 IVD general (98.4%)
            • 1 IVD self-testing (1.5%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102100602Tissue Transglutaminase/ Gliadin Antibodies Combitestterminal
          • W0102100603Antibodies to Endomysial Autoantigenesterminal
          • W0102100604Gliadin AntibodiesIVDD 2 classes · n=37terminal

            Registered in EUDAMED under IVDD with this code, the 37 devices are split across classes (as of 8 Sep 2026).

            • 29 IVD general (78.3%)
            • 8 IVD self-testing (21.6%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102100699Celiac Disease - OtherIVDD 95.0% IVD general · n=20terminal

            Registered in EUDAMED under IVDD with this code: 19 of 20 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 19 IVD general (95.0%)
            • 1 IVD self-testing (5.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01021007Autoimmune Hepatitis
          • W0102100701Hepatitis Autoantibody Screeningterminal
          • W0102100702Anti-Mitochondrial Antibodiesterminal
          • W0102100703Lkm1 and Related Proteins AntibodiesIVDR 100.0% Class B · n=24terminal

            Registered in EUDAMED under IVDR with this code: 24 of 24 devices carry Class B on their registration (as of 8 Sep 2026).

            • 24 Class B (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0102100704Anti-Actin Antibodiesterminal
          • W0102100705Parietal Cell Antibodiesterminal
          • W0102100706Sp 100 Antibodiesterminal
          • W0102100707Antibodies to Soluble Liver Antigenesterminal
          • W0102100799Autoimmune Hepatitis - OtherIVDD 100.0% IVD general · n=36terminal

            Registered in EUDAMED under IVDD with this code: 36 of 36 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 36 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01021008Inflamatory Bowel Disease (Ibd)
          • W0102100801Saccharomyces Cerevisiae Antibodiesterminal
          • W0102100802Perinuclear Anti-Neutrophil Cytoplasmic Antibodiesterminal
          • W0102100899Others Inflamatory Bowel Diseaseterminal
        • W01021090Various Auto-Immune Disease
          • W0102109005Complement Activationterminal
          • W0102109007Goodpasture Antibodiesterminal
          • W0102109013Sperm Antibodiesterminal
          • W0102109014Antibodies to Glomerular Basal MembraneIVDD 100.0% IVD general · n=20terminal

            Registered in EUDAMED under IVDD with this code: 20 of 20 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 20 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102109022Acetylcholin Receptor Antibodiesterminal
          • W0102109023Ldl Antibodiesterminal
          • W0102109099Auto-Immune Disease Tests - OtherIVDR 2 classes · n=70IVDD 100.0% IVD general · n=235terminal

            Registered in EUDAMED under IVDR with this code, the 70 devices are split across classes (as of 8 Sep 2026).

            • 46 Class B (65.7%)
            • 24 Class A (34.2%)

            Registered in EUDAMED under IVDD with this code: 235 of 235 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 235 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

      • W010217Traumatic Brain Injury
        • W01021701Glial Fibrillary Acidic Protein / Ubiquitin C-Terminal Hydrolase-L1terminal
        • W01021702Protein S-100 BIVDD 100.0% IVD general · n=30terminal

          Registered in EUDAMED under IVDD with this code: 30 of 30 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 30 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01021799Other Traumatic Brain Injury Markersterminal
      • W010290Other Immunochemistry
        • W01029001Antisera (Monovalent and Polyvalent)IVDR 100.0% Class A · n=50IVDD 100.0% IVD general · n=334terminal

          Registered in EUDAMED under IVDR with this code: 50 of 50 devices carry Class A on their registration (as of 8 Sep 2026).

          • 50 Class A (100.0%)

          Registered in EUDAMED under IVDD with this code: 334 of 334 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 334 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01029002Amanitin ( Organic Poisons )terminal
        • W01029003Buffers (Unassignable), Supplem. Reagents, Etc (Ic)IVDR 96.8% Class A · n=734terminal

          Registered in EUDAMED under IVDR with this code: 711 of 734 devices carry Class A on their registration (as of 8 Sep 2026).

          • 711 Class A (96.8%)
          • 19 Class B (2.5%)
          • 4 Class C (0.5%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

        • W01029004Coated Tubes and Beads (Unassignable) (Ic)terminal
        • W01029099Immunochemistry Reagents - OtherIVDR 95.2% Class A · n=250IVDD 97.8% IVD general · n=367terminal

          Registered in EUDAMED under IVDR with this code: 238 of 250 devices carry Class A on their registration (as of 8 Sep 2026).

          • 238 Class A (95.2%)
          • 11 Class B (4.4%)
          • 1 Class C (0.4%)

          Registered in EUDAMED under IVDD with this code: 359 of 367 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 359 IVD general (97.8%)
          • 7 IVD self-testing (1.9%)
          • 1 Annex II List B (0.2%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

      • W010211Rheumatoid - Inflammatory Diseases Markers
        • W01021101Anti-Streptococcal Deoxyribonuclease B (Anti-Dnaase B)terminal
        • W01021102Anti - Streptococcal Hyaluronidaseterminal
        • W01021103Anti-Streptokinaseterminal
        • W01021104Anti-Streptolysin O (Quantitative)IVDR 100.0% Class B · n=24IVDD 100.0% IVD general · n=201terminal

          Registered in EUDAMED under IVDR with this code: 24 of 24 devices carry Class B on their registration (as of 8 Sep 2026).

          • 24 Class B (100.0%)

          Registered in EUDAMED under IVDD with this code: 201 of 201 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 201 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01021105Anti-Streptolysin O Reaction Time / Titre (Qualitative)IVDD 100.0% IVD general · n=50terminal

          Registered in EUDAMED under IVDD with this code: 50 of 50 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 50 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01021106Anti-Staphylolysin (Quantitative)terminal
        • W01021107Anti-Staphylolysin Reaction Time / Titre (Qualitative)terminal
        • W01021108Circulating Immune Complexesterminal
        • W01021109C-Reactive ProteinIVDR 2 classes · n=102IVDD 100.0% IVD general · n=534terminal

          Registered in EUDAMED under IVDR with this code, the 102 devices are split across classes (as of 8 Sep 2026).

          • 67 Class C (65.6%)
          • 35 Class B (34.3%)

          Registered in EUDAMED under IVDD with this code: 534 of 534 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 534 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01021110Rheumatoid FactorsIVDR 98.4% Class B · n=66IVDD 100.0% IVD general · n=379terminal

          Registered in EUDAMED under IVDR with this code: 65 of 66 devices carry Class B on their registration (as of 8 Sep 2026).

          • 65 Class B (98.4%)
          • 1 Class C (1.5%)

          Registered in EUDAMED under IVDD with this code: 379 of 379 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 379 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01021111Anti-Streptococcal Screeningterminal
        • W01021112Anti-Cyclic Citrullinated PeptideIVDR 100.0% Class B · n=29IVDD 100.0% IVD general · n=122terminal

          Registered in EUDAMED under IVDR with this code: 29 of 29 devices carry Class B on their registration (as of 8 Sep 2026).

          • 29 Class B (100.0%)

          Registered in EUDAMED under IVDD with this code: 122 of 122 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 122 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01021199Rheumatoid / Inflammatory Disease Markers - OtherIVDR 2 classes · n=80IVDD 100.0% IVD general · n=218terminal

          Registered in EUDAMED under IVDR with this code, the 80 devices are split across classes (as of 8 Sep 2026).

          • 58 Class B (72.5%)
          • 22 Class C (27.5%)

          Registered in EUDAMED under IVDD with this code: 218 of 218 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 218 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

      • W010212Specific Organ Function Assays
        • W01021201Liver Function (Immunochemistry)
          • W0102120101Megxterminal
          • W0102120102Carbo Hydrate Deficient Transferrinterminal
          • W0102120103Hyaluronic AcidIVDD 100.0% IVD general · n=28terminal

            Registered in EUDAMED under IVDD with this code: 28 of 28 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 28 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102120104Procollagen Iii Amino Terminal PeptideIVDD 100.0% IVD general · n=22terminal

            Registered in EUDAMED under IVDD with this code: 22 of 22 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 22 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102120105Tissue Inhibitor of Metalloproteinase 1terminal
          • W0102120199Liver Function - OtherIVDR 96.1% Class B · n=26IVDD 100.0% IVD general · n=38terminal

            Registered in EUDAMED under IVDR with this code: 25 of 26 devices carry Class B on their registration (as of 8 Sep 2026).

            • 25 Class B (96.1%)
            • 1 Class C (3.8%)

            Registered in EUDAMED under IVDD with this code: 38 of 38 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 38 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01021299Organ Function Assays - Otherterminal
      • W010213Cardiac Markers
        • W01021301Bnp / Probnp (Including Other Natriuric Peptides)IVDR 97.4% Class C · n=119IVDD 100.0% IVD general · n=309terminal

          Registered in EUDAMED under IVDR with this code: 116 of 119 devices carry Class C on their registration (as of 8 Sep 2026).

          • 116 Class C (97.4%)
          • 3 Class B (2.5%)

          Registered in EUDAMED under IVDD with this code: 309 of 309 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 309 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01021302Heart-Type Fatty Acid Binding ProteinIVDD 100.0% IVD general · n=88terminal

          Registered in EUDAMED under IVDD with this code: 88 of 88 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 88 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01021303Glycogen Phosphorylase Bbterminal
        • W01021304MyoglobinIVDR 96.8% Class C · n=63IVDD 100.0% IVD general · n=206terminal

          Registered in EUDAMED under IVDR with this code: 61 of 63 devices carry Class C on their registration (as of 8 Sep 2026).

          • 61 Class C (96.8%)
          • 2 Class B (3.1%)

          Registered in EUDAMED under IVDD with this code: 206 of 206 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 206 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01021305Myosin Light Chainterminal
        • W01021306Troponin I/TIVDR 100.0% Class C · n=102IVDD 100.0% IVD general · n=402terminal

          Registered in EUDAMED under IVDR with this code: 102 of 102 devices carry Class C on their registration (as of 8 Sep 2026).

          • 102 Class C (100.0%)

          Registered in EUDAMED under IVDD with this code: 402 of 402 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 402 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01021307HomocysteineIVDD 100.0% IVD general · n=79terminal

          Registered in EUDAMED under IVDD with this code: 79 of 79 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 79 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01021308High-Sensitivity C-.reactive ProteinIVDR 100.0% Class C · n=28IVDD 100.0% IVD general · n=95terminal

          Registered in EUDAMED under IVDR with this code: 28 of 28 devices carry Class C on their registration (as of 8 Sep 2026).

          • 28 Class C (100.0%)

          Registered in EUDAMED under IVDD with this code: 95 of 95 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 95 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01021309Ischemia Modified Albuminterminal
        • W01021310MyeloperoxidaseIVDD 100.0% IVD general · n=33terminal

          Registered in EUDAMED under IVDD with this code: 33 of 33 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 33 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01021311Creatine Kinase - Mb Mass (Ic)IVDR 2 classes · n=47IVDD 100.0% IVD general · n=139terminal

          Registered in EUDAMED under IVDR with this code, the 47 devices are split across classes (as of 8 Sep 2026).

          • 44 Class C (93.6%)
          • 3 Class B (6.3%)

          Registered in EUDAMED under IVDD with this code: 139 of 139 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 139 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01021312Lipoprotein-Associated Phospholipase A2IVDD 100.0% IVD general · n=106terminal

          Registered in EUDAMED under IVDD with this code: 106 of 106 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 106 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01021313Galectin-3terminal
        • W01021314St2IVDD 100.0% IVD general · n=70terminal

          Registered in EUDAMED under IVDD with this code: 70 of 70 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 70 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01021315Copeptinterminal
        • W01021316Mid-Regional Pro Atrial Natriuretic Peptide (Mr-Proanp)terminal
        • W01021399Cardiac Markers - OtherIVDD 100.0% IVD general · n=59terminal

          Registered in EUDAMED under IVDD with this code: 59 of 59 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 59 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

      • W010214Multiple Parameters - Immunochemistry
        • W01021499Multiple Immunochemistry Reagents - OtherIVDD 100.0% IVD general · n=113terminal

          Registered in EUDAMED under IVDD with this code: 113 of 113 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 113 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

      • W010215Immunochemistry Controls/Standards/Calibrators
        • W01021520Controls - Immunochemistry
          • W0102152001Tdm/Drug ControlsIVDR 2 classes · n=44IVDD 100.0% IVD general · n=76terminal

            Registered in EUDAMED under IVDR with this code, the 44 devices are split across classes (as of 8 Sep 2026).

            • 26 Class B (59.0%)
            • 18 Class C (40.9%)

            Registered in EUDAMED under IVDD with this code: 76 of 76 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 76 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102152002Hormone ControlsIVDR 2 classes · n=132IVDD 100.0% IVD general · n=201terminal

            Registered in EUDAMED under IVDR with this code, the 132 devices are split across classes (as of 8 Sep 2026).

            • 102 Class B (77.2%)
            • 30 Class C (22.7%)

            Registered in EUDAMED under IVDD with this code: 201 of 201 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 201 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102152003Specific Protein ControlsIVDR 2 classes · n=151IVDD 99.6% IVD general · n=284terminal

            Registered in EUDAMED under IVDR with this code, the 151 devices are split across classes (as of 8 Sep 2026).

            • 82 Class B (54.3%)
            • 69 Class C (45.6%)

            Registered in EUDAMED under IVDD with this code: 283 of 284 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 283 IVD general (99.6%)
            • 1 Annex II List B (0.3%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102152004Cardiac Marker ControlsIVDR 2 classes · n=105IVDD 100.0% IVD general · n=165terminal

            Registered in EUDAMED under IVDR with this code, the 105 devices are split across classes (as of 8 Sep 2026).

            • 96 Class C (91.4%)
            • 9 Class B (8.5%)

            Registered in EUDAMED under IVDD with this code: 165 of 165 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 165 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102152005Tumour Marker ControlsIVDR 98.9% Class C · n=189IVDD 2 classes · n=106terminal

            Registered in EUDAMED under IVDR with this code: 187 of 189 devices carry Class C on their registration (as of 8 Sep 2026).

            • 187 Class C (98.9%)
            • 2 Class B (1.0%)

            Registered in EUDAMED under IVDD with this code, the 106 devices are split across classes (as of 8 Sep 2026).

            • 91 IVD general (85.8%)
            • 15 Annex II List B (14.1%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102152006Anaemia Related/Vitamin ControlsIVDR 97.5% Class B · n=41IVDD 100.0% IVD general · n=79terminal

            Registered in EUDAMED under IVDR with this code: 40 of 41 devices carry Class B on their registration (as of 8 Sep 2026).

            • 40 Class B (97.5%)
            • 1 Class C (2.4%)

            Registered in EUDAMED under IVDD with this code: 79 of 79 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 79 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102152008Controls for Individual and Specific HormonesIVDR 2 classes · n=65IVDD 100.0% IVD general · n=83terminal

            Registered in EUDAMED under IVDR with this code, the 65 devices are split across classes (as of 8 Sep 2026).

            • 52 Class B (80.0%)
            • 13 Class C (20.0%)

            Registered in EUDAMED under IVDD with this code: 83 of 83 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 83 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102152009Controls for Narcotics / ToxicologyIVDR 96.8% Class B · n=32IVDD 100.0% IVD general · n=44terminal

            Registered in EUDAMED under IVDR with this code: 31 of 32 devices carry Class B on their registration (as of 8 Sep 2026).

            • 31 Class B (96.8%)
            • 1 Class C (3.1%)

            Registered in EUDAMED under IVDD with this code: 44 of 44 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 44 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102152010Controls for RheumatologyIVDD 100.0% IVD general · n=43terminal

            Registered in EUDAMED under IVDD with this code: 43 of 43 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 43 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102152011Controls for AutoimmunityIVDR 3 classes · n=151IVDD 100.0% IVD general · n=184terminal

            Registered in EUDAMED under IVDR with this code, the 151 devices are split across classes (as of 8 Sep 2026).

            • 136 Class B (90.0%)
            • 8 Class A (5.2%)
            • 7 Class C (4.6%)

            Registered in EUDAMED under IVDD with this code: 184 of 184 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 184 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102152099Controls- Immunochemistry - OtherIVDR 3 classes · n=188IVDD 98.4% IVD general · n=196terminal

            Registered in EUDAMED under IVDR with this code, the 188 devices are split across classes (as of 8 Sep 2026).

            • 95 Class C (50.5%)
            • 82 Class B (43.6%)
            • 11 Class A (5.8%)

            Registered in EUDAMED under IVDD with this code: 193 of 196 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 193 IVD general (98.4%)
            • 2 Annex II List A (1.0%)
            • 1 Annex II List B (0.5%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01021521Multicomponent Immunochemistry ControlsIVDR 2 classes · n=149IVDD 2 classes · n=212terminal

          Registered in EUDAMED under IVDR with this code, the 149 devices are split across classes (as of 8 Sep 2026).

          • 107 Class C (71.8%)
          • 42 Class B (28.1%)

          Registered in EUDAMED under IVDD with this code, the 212 devices are split across classes (as of 8 Sep 2026).

          • 183 IVD general (86.3%)
          • 29 Annex II List B (13.6%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01021522Standards and Calibrators Immunochemistry
          • W0102152201Tdm/Drug Standards and CalibratorsIVDR 3 classes · n=48IVDD 100.0% IVD general · n=21terminal

            Registered in EUDAMED under IVDR with this code, the 48 devices are split across classes (as of 8 Sep 2026).

            • 39 Class C (81.2%)
            • 7 Class B (14.5%)
            • 2 Class A (4.1%)

            Registered in EUDAMED under IVDD with this code: 21 of 21 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 21 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102152202Hormone Standards and CalibratorsIVDR 2 classes · n=74IVDD 100.0% IVD general · n=53terminal

            Registered in EUDAMED under IVDR with this code, the 74 devices are split across classes (as of 8 Sep 2026).

            • 50 Class B (67.5%)
            • 24 Class C (32.4%)

            Registered in EUDAMED under IVDD with this code: 53 of 53 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 53 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102152203Specific Protein Standards and CalibratorsIVDR 2 classes · n=135IVDD 100.0% IVD general · n=131terminal

            Registered in EUDAMED under IVDR with this code, the 135 devices are split across classes (as of 8 Sep 2026).

            • 93 Class B (68.8%)
            • 42 Class C (31.1%)

            Registered in EUDAMED under IVDD with this code: 131 of 131 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 131 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102152204Cardiac Marker Standards and CalibratorsIVDR 95.5% Class C · n=45terminal

            Registered in EUDAMED under IVDR with this code: 43 of 45 devices carry Class C on their registration (as of 8 Sep 2026).

            • 43 Class C (95.5%)
            • 2 Class B (4.4%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0102152205Tumour Marker Standards and CalibratorsIVDR 97.7% Class C · n=135terminal

            Registered in EUDAMED under IVDR with this code: 132 of 135 devices carry Class C on their registration (as of 8 Sep 2026).

            • 132 Class C (97.7%)
            • 3 Class B (2.2%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0102152206Anaemia Related/Vitamin Standards and CalibratorsIVDR 2 classes · n=49terminal

            Registered in EUDAMED under IVDR with this code, the 49 devices are split across classes (as of 8 Sep 2026).

            • 43 Class B (87.7%)
            • 6 Class C (12.2%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0102152208Standards and Calibrators for Individual and Specific Hormones /ProteinsIVDR 3 classes · n=68terminal

            Registered in EUDAMED under IVDR with this code, the 68 devices are split across classes (as of 8 Sep 2026).

            • 56 Class B (82.3%)
            • 10 Class C (14.7%)
            • 2 Class A (2.9%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0102152209Drugs of Abuse / Toxicology Standards and CalibratorsIVDR 98.6% Class B · n=75IVDD 100.0% IVD general · n=91terminal

            Registered in EUDAMED under IVDR with this code: 74 of 75 devices carry Class B on their registration (as of 8 Sep 2026).

            • 74 Class B (98.6%)
            • 1 Class C (1.3%)

            Registered in EUDAMED under IVDD with this code: 91 of 91 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 91 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102152210Standards and Calibrators for RheumatologyIVDD 100.0% IVD general · n=25terminal

            Registered in EUDAMED under IVDD with this code: 25 of 25 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 25 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102152211Standards and Calibrators for AutoimmunityIVDR 3 classes · n=57IVDD 100.0% IVD general · n=40terminal

            Registered in EUDAMED under IVDR with this code, the 57 devices are split across classes (as of 8 Sep 2026).

            • 35 Class B (61.4%)
            • 13 Class A (22.8%)
            • 9 Class C (15.7%)

            Registered in EUDAMED under IVDD with this code: 40 of 40 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 40 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102152299Standards and Calibrators - Immunochemistry - OtherIVDR 3 classes · n=159IVDD 3 classes · n=65terminal

            Registered in EUDAMED under IVDR with this code, the 159 devices are split across classes (as of 8 Sep 2026).

            • 87 Class B (54.7%)
            • 64 Class C (40.2%)
            • 8 Class A (5.0%)

            Registered in EUDAMED under IVDD with this code, the 65 devices are split across classes (as of 8 Sep 2026).

            • 56 IVD general (86.1%)
            • 6 Annex II List A (9.2%)
            • 3 Annex II List B (4.6%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

      • W010216Immunochemistry - Rapid Tests & Point of Care
        • W01021609Individual and Specific Hormones/Proteins Rt & Poc
          • W0102160901Lipocalin-2 Granulocyte Gelatinase Associated - Rt & Pocterminal
          • W0102160902Parathyroid Hormone - Rt & Pocterminal
          • W0102160903Thyroid-Stimulating Hormone - Rt & PocIVDD 2 classes · n=49terminal

            Registered in EUDAMED under IVDD with this code, the 49 devices are split across classes (as of 8 Sep 2026).

            • 42 IVD general (85.7%)
            • 7 IVD self-testing (14.2%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102160999Individual and Specific Hormones/Proteins Rt & Poc - OtherIVDD 100.0% IVD general · n=113terminal

            Registered in EUDAMED under IVDD with this code: 113 of 113 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 113 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01021699Rapid Tests & Point of Care - Immunochemistry - OtherIVDD 2 classes · n=379terminal

          Registered in EUDAMED under IVDD with this code, the 379 devices are split across classes (as of 8 Sep 2026).

          • 332 IVD general (87.5%)
          • 47 IVD self-testing (12.4%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01021601Specific Proteins Rt & Poc
          • W0102160101Albumin Incl. Ualbumin Rt & PocIVDD 2 classes · n=74terminal

            Registered in EUDAMED under IVDD with this code, the 74 devices are split across classes (as of 8 Sep 2026).

            • 70 IVD general (94.5%)
            • 4 IVD self-testing (5.4%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102160102Glycosylated/Glycated Haemoglobin (Ic) Rt & PocIVDD 100.0% IVD general · n=40terminal

            Registered in EUDAMED under IVDD with this code: 40 of 40 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 40 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102160199Specific Proteins Rt & Poc - OtherIVDR 98.6% Class C · n=73IVDD 99.3% IVD general · n=160terminal

            Registered in EUDAMED under IVDR with this code: 72 of 73 devices carry Class C on their registration (as of 8 Sep 2026).

            • 72 Class C (98.6%)
            • 1 Class B (1.3%)

            Registered in EUDAMED under IVDD with this code: 159 of 160 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 159 IVD general (99.3%)
            • 1 IVD self-testing (0.6%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01021602Tumour Markers Rt & Poc
          • W0102160201Bta - Rt & Pocterminal
          • W0102160202Psa - Rt & PocIVDR 100.0% Class C · n=20IVDD 2 classes · n=32terminal

            Registered in EUDAMED under IVDR with this code: 20 of 20 devices carry Class C on their registration (as of 8 Sep 2026).

            • 20 Class C (100.0%)

            Registered in EUDAMED under IVDD with this code, the 32 devices are split across classes (as of 8 Sep 2026).

            • 24 Annex II List B (75.0%)
            • 8 IVD general (25.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102160203Fecal Occult Blood - Rt & PocIVDD 2 classes · n=132terminal

            Registered in EUDAMED under IVDD with this code, the 132 devices are split across classes (as of 8 Sep 2026).

            • 122 IVD general (92.4%)
            • 10 IVD self-testing (7.5%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102160299Tumour Marker Rt & Poc - OtherIVDD 96.8% IVD general · n=64terminal

            Registered in EUDAMED under IVDD with this code: 62 of 64 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 62 IVD general (96.8%)
            • 1 Annex II List B (1.5%)
            • 1 IVD self-testing (1.5%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01021603Fertility / Pregnancy Rt & Poc
          • W0102160301Fsh - Rt & PocIVDD 2 classes · n=88terminal

            Registered in EUDAMED under IVDD with this code, the 88 devices are split across classes (as of 8 Sep 2026).

            • 67 IVD general (76.1%)
            • 21 IVD self-testing (23.8%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102160302Hcg - Rt & PocIVDR 100.0% Class B · n=267IVDD 2 classes · n=689terminal

            Registered in EUDAMED under IVDR with this code: 267 of 267 devices carry Class B on their registration (as of 8 Sep 2026).

            • 267 Class B (100.0%)

            Registered in EUDAMED under IVDD with this code, the 689 devices are split across classes (as of 8 Sep 2026).

            • 427 IVD self-testing (61.9%)
            • 262 IVD general (38.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102160303Hpl - Rt & Pocterminal
          • W0102160304Lh - Rt & PocIVDR 100.0% Class B · n=55IVDD 2 classes · n=357terminal

            Registered in EUDAMED under IVDR with this code: 55 of 55 devices carry Class B on their registration (as of 8 Sep 2026).

            • 55 Class B (100.0%)

            Registered in EUDAMED under IVDD with this code, the 357 devices are split across classes (as of 8 Sep 2026).

            • 234 IVD self-testing (65.5%)
            • 123 IVD general (34.4%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102160399Fertility/Pregnancy Rt & Poc - OtherIVDD 2 classes · n=192terminal

            Registered in EUDAMED under IVDD with this code, the 192 devices are split across classes (as of 8 Sep 2026).

            • 165 IVD general (85.9%)
            • 27 IVD self-testing (14.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01021604Therapeutic Drug Monitoring (Tdm) Rt & Poc
          • W0102160401Theophylline - Rt & Pocterminal
          • W0102160499Tdm Rt & Poc - Otherterminal
        • W01021605Drugs of Abuse/Toxicology Rt & Poc
          • W0102160501Amphetamines - Rt & PocIVDD 97.3% IVD general · n=76terminal

            Registered in EUDAMED under IVDD with this code: 74 of 76 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 74 IVD general (97.3%)
            • 2 IVD self-testing (2.6%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102160502Amphetamine/Methamphetamine Specific (+ecstasy) - Rt & PocIVDD 97.7% IVD general · n=89terminal

            Registered in EUDAMED under IVDD with this code: 87 of 89 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 87 IVD general (97.7%)
            • 2 IVD self-testing (2.2%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102160503Barbiturates - Rt & PocIVDD 98.2% IVD general · n=57terminal

            Registered in EUDAMED under IVDD with this code: 56 of 57 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 56 IVD general (98.2%)
            • 1 IVD self-testing (1.7%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102160504Benzodiazepines - Rt & PocIVDD 98.6% IVD general · n=72terminal

            Registered in EUDAMED under IVDD with this code: 71 of 72 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 71 IVD general (98.6%)
            • 1 IVD self-testing (1.3%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102160505Cannabinoids - Rt & PocIVDD 95.5% IVD general · n=134terminal

            Registered in EUDAMED under IVDD with this code: 128 of 134 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 128 IVD general (95.5%)
            • 6 IVD self-testing (4.4%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102160506Cocaine + Cocaine Metabolites - Rt & PocIVDD 96.0% IVD general · n=76terminal

            Registered in EUDAMED under IVDD with this code: 73 of 76 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 73 IVD general (96.0%)
            • 3 IVD self-testing (3.9%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102160507Methadone Incl. Eddp - Rt & PocIVDD 97.6% IVD general · n=84terminal

            Registered in EUDAMED under IVDD with this code: 82 of 84 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 82 IVD general (97.6%)
            • 2 IVD self-testing (2.3%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102160508Opiates - Rt & PocIVDD 99.0% IVD general · n=109terminal

            Registered in EUDAMED under IVDD with this code: 108 of 109 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 108 IVD general (99.0%)
            • 1 IVD self-testing (0.9%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102160509Phencyclidine - Rt & PocIVDD 97.2% IVD general · n=37terminal

            Registered in EUDAMED under IVDD with this code: 36 of 37 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 36 IVD general (97.2%)
            • 1 IVD self-testing (2.7%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102160510Tricyclic Antidepressants - Rt & PocIVDD 96.1% IVD general · n=26terminal

            Registered in EUDAMED under IVDD with this code: 25 of 26 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 25 IVD general (96.1%)
            • 1 IVD self-testing (3.8%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102160511Multiple Drugs of Abuse/Toxicology Rt & PocIVDR 100.0% Class B · n=714IVDD 99.7% IVD general · n=2,218terminal

            Registered in EUDAMED under IVDR with this code: 714 of 714 devices carry Class B on their registration (as of 8 Sep 2026).

            • 714 Class B (100.0%)

            Registered in EUDAMED under IVDD with this code: 2,213 of 2,218 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 2,213 IVD general (99.7%)
            • 5 IVD self-testing (0.2%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102160599Drugs of Abuse/Toxicology Rt & Poc - OtherIVDD 99.7% IVD general · n=1,296terminal

            Registered in EUDAMED under IVDD with this code: 1,293 of 1,296 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 1,293 IVD general (99.7%)
            • 3 IVD self-testing (0.2%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01021606Rheumatoid / Inflammatory Disease Rt & Poc
          • W0102160601C-Reactive Protein - Rt & PocIVDR 3 classes · n=30IVDD 100.0% IVD general · n=141terminal

            Registered in EUDAMED under IVDR with this code, the 30 devices are split across classes (as of 8 Sep 2026).

            • 19 Class B (63.3%)
            • 8 Class A (26.6%)
            • 3 Class C (10.0%)

            Registered in EUDAMED under IVDD with this code: 141 of 141 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 141 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102160699Rheumatoid / Inflammatory Disease Rt & Poc - OtherIVDD 98.7% IVD general · n=78terminal

            Registered in EUDAMED under IVDD with this code: 77 of 78 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 77 IVD general (98.7%)
            • 1 IVD self-testing (1.2%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01021607Cardiac Markers - Rt & Poc
          • W0102160701Creatine Kinase - Mb Mass - Rt & PocIVDD 100.0% IVD general · n=51terminal

            Registered in EUDAMED under IVDD with this code: 51 of 51 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 51 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102160702Myoglobin - Rt & PocIVDD 100.0% IVD general · n=52terminal

            Registered in EUDAMED under IVDD with this code: 52 of 52 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 52 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102160703Troponin I/T - Rt & PocIVDD 100.0% IVD general · n=141terminal

            Registered in EUDAMED under IVDD with this code: 141 of 141 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 141 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102160704Bnp / Probnp - Rt & Poc (Including Other Natriuric Peptides)IVDD 100.0% IVD general · n=81terminal

            Registered in EUDAMED under IVDD with this code: 81 of 81 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 81 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102160705Heart-Type Fatty Acid-Binding Protein - Rt & PocIVDD 100.0% IVD general · n=51terminal

            Registered in EUDAMED under IVDD with this code: 51 of 51 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 51 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102160706Multiple Cardiac Markers - Rt & PocIVDD 100.0% IVD general · n=78terminal

            Registered in EUDAMED under IVDD with this code: 78 of 78 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 78 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102160799Cardiac Markers - Rt & Poc - OtherIVDD 100.0% IVD general · n=38terminal

            Registered in EUDAMED under IVDD with this code: 38 of 38 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 38 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01021608Controls / Standards / Calibrators Immunochem - Rt & Poc
          • W0102160801Controls Immunochem - Rt & PocIVDR 97.2% Class C · n=37IVDD 99.1% IVD general · n=228terminal

            Registered in EUDAMED under IVDR with this code: 36 of 37 devices carry Class C on their registration (as of 8 Sep 2026).

            • 36 Class C (97.2%)
            • 1 Class A (2.7%)

            Registered in EUDAMED under IVDD with this code: 226 of 228 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 226 IVD general (99.1%)
            • 2 IVD self-testing (0.8%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0102160802Standards and Calibrators Immunochem - Rt & Pocterminal
    • W0103Haematology / Haemostasis / Immunohaematology / Histology / Cytology
      • W010301Haematology Reagents
        • W01030101Reagents for (Automated) Haematology Analyzer
          • W0103010102Specific Reticulocyte Reagentsterminal
          • W0103010103Complete Cell CountIVDR 100.0% Class A · n=58terminal

            Registered in EUDAMED under IVDR with this code: 58 of 58 devices carry Class A on their registration (as of 8 Sep 2026).

            • 58 Class A (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0103010104Small Cell Countterminal
          • W0103010105Cbc-Reagents (Cleaning-/Diluting-/Lysing-/Sheath-Fluids)IVDR 100.0% Class A · n=1,595IVDD 100.0% IVD general · n=92terminal

            Registered in EUDAMED under IVDR with this code: 1,595 of 1,595 devices carry Class A on their registration (as of 8 Sep 2026).

            • 1,595 Class A (100.0%)

            Registered in EUDAMED under IVDD with this code: 92 of 92 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 92 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0103010199Reagents for (Automated) Haematology Analyzer - OtherIVDR 99.0% Class A · n=108IVDD 100.0% IVD general · n=28terminal

            Registered in EUDAMED under IVDR with this code: 107 of 108 devices carry Class A on their registration (as of 8 Sep 2026).

            • 107 Class A (99.0%)
            • 1 Class B (0.9%)

            Registered in EUDAMED under IVDD with this code: 28 of 28 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 28 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01030102Haemoglobin (Types) Testing
          • W0103010201Haemoglobin Determinations (Total Hb)IVDD 95.1% IVD general · n=41terminal

            Registered in EUDAMED under IVDD with this code: 39 of 41 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 39 IVD general (95.1%)
            • 1 Annex II List B (2.4%)
            • 1 IVD self-testing (2.4%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0103010202Haemoglobin Subtypes Hba2, Hbc, Hbf, Hbs, Etc.(Excl. Hba1)IVDD 100.0% IVD general · n=41terminal

            Registered in EUDAMED under IVDD with this code: 41 of 41 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 41 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0103010299Other Haemoglobin (Types) Testing - OtherIVDR 2 classes · n=64terminal

            Registered in EUDAMED under IVDR with this code, the 64 devices are split across classes (as of 8 Sep 2026).

            • 60 Class A (93.7%)
            • 4 Class C (6.2%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

        • W01030103Cellular Stains for Microscopy
          • W0103010301Histo / Cyto StainsIVDR 100.0% Class A · n=643terminal

            Registered in EUDAMED under IVDR with this code: 643 of 643 devices carry Class A on their registration (as of 8 Sep 2026).

            • 643 Class A (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0103010302Romanowsky StainsIVDR 96.8% Class A · n=258terminal

            Registered in EUDAMED under IVDR with this code: 250 of 258 devices carry Class A on their registration (as of 8 Sep 2026).

            • 250 Class A (96.8%)
            • 8 Class B (3.1%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0103010399Haematology Stains for Microscopy - OtherIVDR 100.0% Class A · n=82terminal

            Registered in EUDAMED under IVDR with this code: 82 of 82 devices carry Class A on their registration (as of 8 Sep 2026).

            • 82 Class A (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

        • W01030105Haematology Controls and Calibrators
          • W0103010501Normal Blood ControlsIVDR 2 classes · n=36IVDD 100.0% IVD general · n=24terminal

            Registered in EUDAMED under IVDR with this code, the 36 devices are split across classes (as of 8 Sep 2026).

            • 30 Class B (83.3%)
            • 6 Class A (16.6%)

            Registered in EUDAMED under IVDD with this code: 24 of 24 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 24 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0103010502Abnormal Blood ControlsIVDR 2 classes · n=29IVDD 100.0% IVD general · n=27terminal

            Registered in EUDAMED under IVDR with this code, the 29 devices are split across classes (as of 8 Sep 2026).

            • 23 Class B (79.3%)
            • 6 Class A (20.6%)

            Registered in EUDAMED under IVDD with this code: 27 of 27 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 27 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0103010503Multilevel Blood ControlsIVDR 96.4% Class B · n=198IVDD 100.0% IVD general · n=223terminal

            Registered in EUDAMED under IVDR with this code: 191 of 198 devices carry Class B on their registration (as of 8 Sep 2026).

            • 191 Class B (96.4%)
            • 4 Class A (2.0%)
            • 3 Class C (1.5%)

            Registered in EUDAMED under IVDD with this code: 223 of 223 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 223 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0103010504Haemoglobin ControlsIVDD 3 classes · n=43terminal

            Registered in EUDAMED under IVDD with this code, the 43 devices are split across classes (as of 8 Sep 2026).

            • 40 IVD general (93.0%)
            • 2 IVD self-testing (4.6%)
            • 1 Annex II List B (2.3%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0103010505Platelet Controlsterminal
          • W0103010506Reticulocyte ControlsIVDR 95.4% Class B · n=22IVDD 100.0% IVD general · n=31terminal

            Registered in EUDAMED under IVDR with this code: 21 of 22 devices carry Class B on their registration (as of 8 Sep 2026).

            • 21 Class B (95.4%)
            • 1 Class C (4.5%)

            Registered in EUDAMED under IVDD with this code: 31 of 31 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 31 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0103010507Whole Blood CalibratorsIVDR 3 classes · n=45IVDD 100.0% IVD general · n=54terminal

            Registered in EUDAMED under IVDR with this code, the 45 devices are split across classes (as of 8 Sep 2026).

            • 41 Class B (91.1%)
            • 2 Class A (4.4%)
            • 2 Class C (4.4%)

            Registered in EUDAMED under IVDD with this code: 54 of 54 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 54 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0103010599Haematology Controls - OtherIVDR 3 classes · n=78IVDD 100.0% IVD general · n=152terminal

            Registered in EUDAMED under IVDR with this code, the 78 devices are split across classes (as of 8 Sep 2026).

            • 68 Class B (87.1%)
            • 8 Class A (10.2%)
            • 2 Class C (2.5%)

            Registered in EUDAMED under IVDD with this code: 152 of 152 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 152 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01030106Haematology Tests - Rt & Poc
          • W0103010601Haemoglobin (Hb)IVDD 2 classes · n=33terminal

            Registered in EUDAMED under IVDD with this code, the 33 devices are split across classes (as of 8 Sep 2026).

            • 29 IVD general (87.8%)
            • 4 IVD self-testing (12.1%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0103010602Erythrocytes (Ery)terminal
          • W0103010603Haematocrit (Hct)terminal
          • W0103010604White Blood Cells (Wbc)terminal
          • W0103010605Plateletsterminal
          • W0103010606Haematology Controls - Rt & Pocterminal
          • W0103010607Haematology Standards and Calibrators - Rt & Pocterminal
          • W0103010699Haematology Rapid Tests & Point of Care - Otherterminal
        • W01030107Erythrocyte Sedimentation Rate (Esr) Testterminal
        • W01030190Other Haematology Reagents
          • W0103019001Cellular Enzyme Determination Reagents (G-6-Pdh, Pyruvate Kinase)terminal
        • W01030199Haematology Reagents - OtherIVDR 100.0% Class A · n=116terminal

          Registered in EUDAMED under IVDR with this code: 116 of 116 devices carry Class A on their registration (as of 8 Sep 2026).

          • 116 Class A (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

      • W010302Haemostasis Reagents (Coagulation)
        • W01030201General Coagulation Tests
          • W0103020101Prothrombin Time ( Quick Test )IVDR 100.0% Class C · n=51IVDD 96.0% IVD general · n=126terminal

            Registered in EUDAMED under IVDR with this code: 51 of 51 devices carry Class C on their registration (as of 8 Sep 2026).

            • 51 Class C (100.0%)

            Registered in EUDAMED under IVDD with this code: 121 of 126 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 121 IVD general (96.0%)
            • 5 IVD self-testing (3.9%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0103020102Activated Partial Thromboplastin TimeIVDR 97.8% Class C · n=47IVDD 100.0% IVD general · n=96terminal

            Registered in EUDAMED under IVDR with this code: 46 of 47 devices carry Class C on their registration (as of 8 Sep 2026).

            • 46 Class C (97.8%)
            • 1 Class A (2.1%)

            Registered in EUDAMED under IVDD with this code: 96 of 96 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 96 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0103020103Thrombin Time / Reptilase / Batroxobin TimeIVDD 100.0% IVD general · n=56terminal

            Registered in EUDAMED under IVDD with this code: 56 of 56 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 56 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0103020104Activated Clotting Timeterminal
          • W0103020199General Coagulation Tests - OtherIVDR 2 classes · n=32IVDD 100.0% IVD general · n=46terminal

            Registered in EUDAMED under IVDR with this code, the 32 devices are split across classes (as of 8 Sep 2026).

            • 30 Class C (93.7%)
            • 2 Class A (6.2%)

            Registered in EUDAMED under IVDD with this code: 46 of 46 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 46 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01030202Coagulation Factors
          • W0103020201Fibrinogen Assays (Factor I)IVDR 2 classes · n=34IVDD 100.0% IVD general · n=111terminal

            Registered in EUDAMED under IVDR with this code, the 34 devices are split across classes (as of 8 Sep 2026).

            • 26 Class C (76.4%)
            • 8 Class B (23.5%)

            Registered in EUDAMED under IVDD with this code: 111 of 111 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 111 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0103020202Coagulation Factor Ii ( Prothrombin )terminal
          • W0103020203Coagulation Factor Ii A ( Thrombin )terminal
          • W0103020204Coagulation Factor Vterminal
          • W0103020205Coagulation Factor Viiterminal
          • W0103020206Coagulation Factor Vii Aterminal
          • W0103020207Coagulation Factor Viiiterminal
          • W0103020208Coagulation Factor Ixterminal
          • W0103020209Coagulation Factor Xterminal
          • W0103020210Coagulation Factor Xiterminal
          • W0103020211Coagulation Factor Xiiterminal
          • W0103020212Coagulation Factor Xii Aterminal
          • W0103020213Coagulation Factor Xiiiterminal
          • W0103020214Coagulation Factor Hmw-Kininogen (Fitzgerald)terminal
          • W0103020215Coagulation Factor Von Willebrand (Ag)terminal
          • W0103020216Prekallikrein / Kallikrein (Fletcher Factor)terminal
          • W0103020217Coagulation Factor Von Willebrand Activity / Ristocetin Cofactor Activity (Rco)terminal
          • W0103020218Coagulation Factor Von Willebrand Collagen Binding Assay (Cba)terminal
          • W0103020299Coagulation Factors - Otherterminal
        • W01030203Special Coagulation Tests
          • W0103020301Fibrin Sensitivity Monomerterminal
          • W0103020302Fibrinopeptide Aterminal
          • W0103020303Standard Heparinterminal
          • W0103020304Hirudin Testterminal
          • W0103020305Plasmin - A2 - Antiplasmin ComplexIVDD 100.0% IVD general · n=25terminal

            Registered in EUDAMED under IVDD with this code: 25 of 25 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 25 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0103020306Prothrombin Fragment 1 + 2terminal
          • W0103020307Thrombin-Antithrombin Iii-ComplexIVDD 100.0% IVD general · n=35terminal

            Registered in EUDAMED under IVDD with this code: 35 of 35 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 35 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0103020308Low Molecular Weight Heparinterminal
          • W0103020309Anti Xa Activity for Heparin and Doacterminal
          • W0103020310Anti Iia Activity Fot Doacterminal
          • W0103020311Adamts13 (Activity, Ag, Ab, Inhibitor) Specific Von Willebrand Factor (Vwf) - Cleaving Proteaseterminal
          • W0103020399Special Coagulation Tests - OtherIVDD 100.0% IVD general · n=20terminal

            Registered in EUDAMED under IVDD with this code: 20 of 20 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 20 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01030204Platelet Factors
          • W0103020401Aggregation ReagentsIVDD 100.0% IVD general · n=33terminal

            Registered in EUDAMED under IVDD with this code: 33 of 33 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 33 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0103020402Platelet Factor 4terminal
          • W0103020403Prostacyclinterminal
          • W0103020404Thromboxaneterminal
          • W0103020405ß-Thromboglobulinterminal
          • W0103020406Screening for Primary Hemostasisterminal
          • W0103020407P2y12 Receptorterminal
          • W0103020499Primary Hemostasis/Platelet Factors - Otherterminal
        • W01030205Fibrinolysis
          • W0103020501A2-Antiplasminterminal
          • W0103020502Fibrinogen Degradation ProductsIVDD 100.0% IVD general · n=86terminal

            Registered in EUDAMED under IVDD with this code: 86 of 86 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 86 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0103020503D-DimerIVDR 3 classes · n=86IVDD 100.0% IVD general · n=285terminal

            Registered in EUDAMED under IVDR with this code, the 86 devices are split across classes (as of 8 Sep 2026).

            • 81 Class C (94.1%)
            • 3 Class A (3.4%)
            • 2 Class B (2.3%)

            Registered in EUDAMED under IVDD with this code: 285 of 285 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 285 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0103020504Plasminterminal
          • W0103020505Plasminogenterminal
          • W0103020506Plasminogen Activator-InhibitorsIVDD 100.0% IVD general · n=26terminal

            Registered in EUDAMED under IVDD with this code: 26 of 26 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 26 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0103020507Tissue Plasminogen Activatorterminal
          • W0103020508Urokinase Plasminogen Activatorterminal
          • W0103020509Thrombin Activating Fibrinolysis Inhibitorterminal
          • W0103020599Fibrinolysis Tests - Otherterminal
        • W01030206Coagulation Inhibitors/Thrombophilia Markers
          • W0103020601Anti-Phospholipid Antibodiesterminal
          • W0103020602AntithrombinIVDR 2 classes · n=31IVDD 100.0% IVD general · n=48terminal

            Registered in EUDAMED under IVDR with this code, the 31 devices are split across classes (as of 8 Sep 2026).

            • 26 Class C (83.8%)
            • 5 Class B (16.1%)

            Registered in EUDAMED under IVDD with this code: 48 of 48 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 48 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0103020603Coagulation Factor Viii Inhibitorterminal
          • W0103020604Coagulation Factor Ix Inhibitorterminal
          • W0103020605Coagulation Factor X Inhibitorterminal
          • W0103020606Lupus AnticoagulantIVDD 100.0% IVD general · n=24terminal

            Registered in EUDAMED under IVDD with this code: 24 of 24 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 24 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0103020607Protein Cterminal
          • W0103020608Protein S Activityterminal
          • W0103020609Heparin Cofactor Ii - Tissue Factor Pathway Inhibitorterminal
          • W0103020610Apc Resistanceterminal
          • W0103020611Pro C Globalterminal
          • W0103020612Free Protein S Antigenterminal
          • W0103020613Total Protein S Antigenterminal
          • W0103020614Homocysteineterminal
          • W0103020615Coagulation Inhibitors/Thrombophilia Markers for Heparin Induced Thrombocytopenia Test (Hit)terminal
          • W0103020699Coagulation Inhibitors - OtherIVDD 100.0% IVD general · n=23terminal

            Registered in EUDAMED under IVDD with this code: 23 of 23 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 23 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01030207Haemostasis Calibrators/Controls
          • W0103020701Calibration Plasma for HaemostasisIVDR 2 classes · n=80IVDD 100.0% IVD general · n=78terminal

            Registered in EUDAMED under IVDR with this code, the 80 devices are split across classes (as of 8 Sep 2026).

            • 74 Class C (92.5%)
            • 6 Class B (7.5%)

            Registered in EUDAMED under IVDD with this code: 78 of 78 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 78 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0103020702Control Plasma for HaemostasisIVDR 2 classes · n=181IVDD 100.0% IVD general · n=176terminal

            Registered in EUDAMED under IVDR with this code, the 181 devices are split across classes (as of 8 Sep 2026).

            • 163 Class C (90.0%)
            • 18 Class B (9.9%)

            Registered in EUDAMED under IVDD with this code: 176 of 176 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 176 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0103020799Haemostasis Controls - OtherIVDR 100.0% Class C · n=37IVDD 100.0% IVD general · n=58terminal

            Registered in EUDAMED under IVDR with this code: 37 of 37 devices carry Class C on their registration (as of 8 Sep 2026).

            • 37 Class C (100.0%)

            Registered in EUDAMED under IVDD with this code: 58 of 58 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 58 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01030208Haemostasis Rapid Tests - Rt & Poc
          • W0103020801Prothrombin Time Rt & Pocterminal
          • W0103020802Activated Partial Thromboplastin Time - Rt & Pocterminal
          • W0103020803D-Dimer - Rt & PocIVDD 100.0% IVD general · n=57terminal

            Registered in EUDAMED under IVDD with this code: 57 of 57 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 57 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0103020804Activated Clotting Time Rt & Pocterminal
          • W0103020805Controls/ Standards / Calibrators for Rt & Poc
            • W010302080501Hemostasis Controls Rt & PocIVDD 100.0% IVD general · n=26terminal

              Registered in EUDAMED under IVDD with this code: 26 of 26 devices carry IVD general on their registration (as of 8 Sep 2026).

              • 26 IVD general (100.0%)

              Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

            • W010302080502Haemostasis Standards and Calibrators Rt & Pocterminal
          • W0103020806Heparin Induced Thrombocytopenia Test (Hit) Rt & Pocterminal
          • W0103020899Haemostasis Rt & Poc - Otherterminal
        • W01030209Auxiliary Reagents and Supplements (Haemostasis)
          • W0103020901Calcium ChlorideIVDR 100.0% Class A · n=22terminal

            Registered in EUDAMED under IVDR with this code: 22 of 22 devices carry Class A on their registration (as of 8 Sep 2026).

            • 22 Class A (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0103020902Citrateterminal
          • W0103020903Buffers (Haemostasis)IVDR 100.0% Class A · n=54terminal

            Registered in EUDAMED under IVDR with this code: 54 of 54 devices carry Class A on their registration (as of 8 Sep 2026).

            • 54 Class A (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0103020904Coated Tubes (Citrate, Heparin Etc.)terminal
          • W0103020999Auxiliary Reagents (Haemostasis) - OtherIVDR 100.0% Class A · n=55terminal

            Registered in EUDAMED under IVDR with this code: 55 of 55 devices carry Class A on their registration (as of 8 Sep 2026).

            • 55 Class A (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

        • W01030299Haemostasis Reagents - OtherIVDR 3 classes · n=27terminal

          Registered in EUDAMED under IVDR with this code, the 27 devices are split across classes (as of 8 Sep 2026).

          • 19 Class A (70.3%)
          • 7 Class C (25.9%)
          • 1 Class B (3.7%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

      • W010303Immunohaematology (Blood Grouping)
        • W01030301Abo Typing
          • W0103030101Abo Grouping Cellsterminal
          • W0103030102Abo Seraterminal
          • W0103030199Abo Typing Tests - OtherIVDD 95.4% Annex II List A · n=22terminal

            Registered in EUDAMED under IVDD with this code: 21 of 22 devices carry Annex II List A on their registration (as of 8 Sep 2026).

            • 21 Annex II List A (95.4%)
            • 1 IVD general (4.5%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01030302Rhesus Typing
          • W0103030201Rhesus DIVDD 100.0% Annex II List A · n=28terminal

            Registered in EUDAMED under IVDD with this code: 28 of 28 devices carry Annex II List A on their registration (as of 8 Sep 2026).

            • 28 Annex II List A (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0103030202Rhesus PhenotypesIVDR 95.8% Class D · n=72IVDD 96.8% Annex II List A · n=32terminal

            Registered in EUDAMED under IVDR with this code: 69 of 72 devices carry Class D on their registration (as of 8 Sep 2026).

            • 69 Class D (95.8%)
            • 3 Class C (4.1%)

            Registered in EUDAMED under IVDD with this code: 31 of 32 devices carry Annex II List A on their registration (as of 8 Sep 2026).

            • 31 Annex II List A (96.8%)
            • 1 IVD general (3.1%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0103030299Rhesus Typing Assays Otherterminal
        • W01030303Antibody Detection (Immunohaematology)
          • W0103030301Antibody 1 Cell Screeningterminal
          • W0103030302Antibody 2 Cell Screeningterminal
          • W0103030303Antibody Identification Cell Panelsterminal
          • W0103030304Polyspecific Antihuman Serumterminal
          • W0103030305Monospecific Antihuman Serumterminal
          • W0103030306Enhancement Media (E.g. Bovine Albumin, Liss, Peg)IVDR 100.0% Class A · n=33terminal

            Registered in EUDAMED under IVDR with this code: 33 of 33 devices carry Class A on their registration (as of 8 Sep 2026).

            • 33 Class A (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0103030307Enzymes (E.g. Bromelin / Papain, Etc.)terminal
          • W0103030308Antibody 3 Cell Screeningterminal
          • W0103030399Antibody Detection (Immunohaematology) - OtherIVDD 2 classes · n=23terminal

            Registered in EUDAMED under IVDD with this code, the 23 devices are split across classes (as of 8 Sep 2026).

            • 16 IVD general (69.5%)
            • 7 Annex II List B (30.4%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01030304Immunohaematology Controls
          • W0103030401Coombs Control Cellsterminal
          • W0103030402Control Kits (Immunohaematology)terminal
          • W0103030499Immunohaematology Controls - Otherterminal
        • W01030305Other Antigen Typing
          • W0103030501Other Antigen Typing ReagentsIVDR 3 classes · n=51IVDD 4 classes · n=92terminal

            Registered in EUDAMED under IVDR with this code, the 51 devices are split across classes (as of 8 Sep 2026).

            • 30 Class C (58.8%)
            • 16 Class D (31.3%)
            • 5 Class A (9.8%)

            Registered in EUDAMED under IVDD with this code, the 92 devices are split across classes (as of 8 Sep 2026).

            • 60 IVD general (65.2%)
            • 24 Annex II List B (26.0%)
            • 7 Annex II List A (7.6%)
            • 1 IVD self-testing (1.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01030309Combined Abo Typing + Rhesus Typing
          • W0103030901Combined Abo Typing + Rhesus DIVDD 3 classes · n=26terminal

            Registered in EUDAMED under IVDD with this code, the 26 devices are split across classes (as of 8 Sep 2026).

            • 21 Annex II List A (80.7%)
            • 4 IVD self-testing (15.3%)
            • 1 IVD general (3.8%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0103030902Combined Abo Typing + Rhesus Phenotypesterminal
          • W0103030999Combined Abo Typing + Rhesus Typing Test - OtherIVDD 100.0% Annex II List A · n=28terminal

            Registered in EUDAMED under IVDD with this code: 28 of 28 devices carry Annex II List A on their registration (as of 8 Sep 2026).

            • 28 Annex II List A (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01030399Immunohaematology (Blood Grouping) Tests - OtherIVDR 3 classes · n=46terminal

          Registered in EUDAMED under IVDR with this code, the 46 devices are split across classes (as of 8 Sep 2026).

          • 25 Class C (54.3%)
          • 20 Class A (43.4%)
          • 1 Class B (2.1%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

      • W010304Tissue Typing Reagents
        • W01030401Complement for Hla Testingterminal
        • W01030402Hla Antibody Screeningterminal
        • W01030403Hla Antigen TypingIVDR 2 classes · n=40IVDD 2 classes · n=178terminal

          Registered in EUDAMED under IVDR with this code, the 40 devices are split across classes (as of 8 Sep 2026).

          • 35 Class C (87.5%)
          • 5 Class A (12.5%)

          Registered in EUDAMED under IVDD with this code, the 178 devices are split across classes (as of 8 Sep 2026).

          • 135 Annex II List B (75.8%)
          • 43 IVD general (24.1%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01030404Hla Control Cellsterminal
        • W01030405Lymphocyte Separation Mediaterminal
        • W01030406Lymphocyte Stabilizing Mediaterminal
        • W01030499Tissue Typing Reagents - OtherIVDR 2 classes · n=36IVDD 3 classes · n=34terminal

          Registered in EUDAMED under IVDR with this code, the 36 devices are split across classes (as of 8 Sep 2026).

          • 34 Class C (94.4%)
          • 2 Class A (5.5%)

          Registered in EUDAMED under IVDD with this code, the 34 devices are split across classes (as of 8 Sep 2026).

          • 17 IVD general (50.0%)
          • 16 Annex II List B (47.0%)
          • 1 Annex II List A (2.9%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

      • W010306Cytokines (Lymphokines) / Immunomodulators
        • W01030601Interferons (α, β, ɣ…)terminal
        • W01030602Soluble Antigens / Receptorsterminal
        • W01030603Tumour Necrosis Factors (Tnfα,tnfβ, ...)IVDD 100.0% IVD general · n=24terminal

          Registered in EUDAMED under IVDD with this code: 24 of 24 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 24 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01030604Tumour Necrosis Factors Receptors (Tnf-R I,tnf-R Ii)terminal
        • W01030605Colony Stimulating Factors (G-Csf,m-Csf,gm-Csf)terminal
        • W01030606Other Interleukins (Except for Il-6)IVDD 100.0% IVD general · n=182terminal

          Registered in EUDAMED under IVDD with this code: 182 of 182 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 182 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01030607Interleukins Receptors (Il-2r,il6r ...)IVDD 100.0% IVD general · n=30terminal

          Registered in EUDAMED under IVDD with this code: 30 of 30 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 30 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01030608Cytokines Calibrators/Controlsterminal
        • W01030609Interleukin 6 (Il-6)IVDR 3 classes · n=64IVDD 100.0% IVD general · n=153terminal

          Registered in EUDAMED under IVDR with this code, the 64 devices are split across classes (as of 8 Sep 2026).

          • 35 Class B (54.6%)
          • 18 Class C (28.1%)
          • 11 Class A (17.1%)

          Registered in EUDAMED under IVDD with this code: 153 of 153 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 153 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01030699Lymphokines /Immunmodulators - OtherIVDD 100.0% IVD general · n=92terminal

          Registered in EUDAMED under IVDD with this code: 92 of 92 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 92 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

      • W010307Histology/Cytology Reagents
        • W01030701Chromosome Culture Kits / Reagentsterminal
        • W01030702Cytochemical Staining ReagentsIVDR 2 classes · n=92terminal

          Registered in EUDAMED under IVDR with this code, the 92 devices are split across classes (as of 8 Sep 2026).

          • 87 Class A (94.5%)
          • 5 Class B (5.4%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

        • W01030703DNA in Situ Hybridisation ReagentsIVDR 2 classes · n=265IVDD 100.0% IVD general · n=240terminal

          Registered in EUDAMED under IVDR with this code, the 265 devices are split across classes (as of 8 Sep 2026).

          • 240 Class C (90.5%)
          • 25 Class A (9.4%)

          Registered in EUDAMED under IVDD with this code: 240 of 240 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 240 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01030704Embedding Media (Histology/Cytology)IVDR 100.0% Class A · n=237terminal

          Registered in EUDAMED under IVDR with this code: 237 of 237 devices carry Class A on their registration (as of 8 Sep 2026).

          • 237 Class A (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

        • W01030705Fixing Reagents (Histology/Cytology)IVDR 2 classes · n=1,327terminal

          Registered in EUDAMED under IVDR with this code, the 1,327 devices are split across classes (as of 8 Sep 2026).

          • 974 Class A (73.3%)
          • 353 Class C (26.6%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

        • W01030706Mounting Media (Histology/Cytology)IVDR 99.8% Class A · n=552terminal

          Registered in EUDAMED under IVDR with this code: 551 of 552 devices carry Class A on their registration (as of 8 Sep 2026).

          • 551 Class A (99.8%)
          • 1 Class C (0.1%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

        • W01030707Stain Powders (Histology/Cytology)IVDR 100.0% Class A · n=108terminal

          Registered in EUDAMED under IVDR with this code: 108 of 108 devices carry Class A on their registration (as of 8 Sep 2026).

          • 108 Class A (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

        • W01030708Stain Solutions (Histology/Cytology)IVDR 99.9% Class A · n=2,792terminal

          Registered in EUDAMED under IVDR with this code: 2,791 of 2,792 devices carry Class A on their registration (as of 8 Sep 2026).

          • 2,791 Class A (99.9%)
          • 1 Class C (<0.1%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

        • W01030709Primary Antisera for ImmunohistologyIVDR 97.4% Class C · n=1,159IVDD 100.0% IVD general · n=8,723terminal

          Registered in EUDAMED under IVDR with this code: 1,130 of 1,159 devices carry Class C on their registration (as of 8 Sep 2026).

          • 1,130 Class C (97.4%)
          • 27 Class B (2.3%)
          • 2 Class A (0.1%)

          Registered in EUDAMED under IVDD with this code: 8,723 of 8,723 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 8,723 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01030710Secondary Antisera for ImmunohistologyIVDR 100.0% Class A · n=84terminal

          Registered in EUDAMED under IVDR with this code: 84 of 84 devices carry Class A on their registration (as of 8 Sep 2026).

          • 84 Class A (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

        • W01030711Immunohistology KitsIVDR 99.7% Class A · n=385IVDD 100.0% IVD general · n=76terminal

          Registered in EUDAMED under IVDR with this code: 384 of 385 devices carry Class A on their registration (as of 8 Sep 2026).

          • 384 Class A (99.7%)
          • 1 Class C (0.2%)

          Registered in EUDAMED under IVDD with this code: 76 of 76 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 76 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01030799Histology / Cytology Reagents - OtherIVDR 99.9% Class A · n=1,524IVDD 100.0% IVD general · n=31terminal

          Registered in EUDAMED under IVDR with this code: 1,523 of 1,524 devices carry Class A on their registration (as of 8 Sep 2026).

          • 1,523 Class A (99.9%)
          • 1 Class B (<0.1%)

          Registered in EUDAMED under IVDD with this code: 31 of 31 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 31 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

      • W010308Monoclonal Antibodies / Flow Cytometry
        • W01030801Monoclonal Antibodies for Cell Surface Antigens
          • W0103080101Antibodies for B and T-Cell SubtypingIVDR 99.1% Class C · n=116terminal

            Registered in EUDAMED under IVDR with this code: 115 of 116 devices carry Class C on their registration (as of 8 Sep 2026).

            • 115 Class C (99.1%)
            • 1 Class B (0.8%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0103080102Antibodies for Hla Class Ii Determinantsterminal
          • W0103080103Antibodies for Lymphoma Typing (Except B-&t-Cell Typing)terminal
          • W0103080104Antibodies for Recognizing Cell Surface Receptorsterminal
          • W0103080105Antibodies for Subtyping of Leukemia (Except B-&t-Cell Typing)IVDD 100.0% IVD general · n=25terminal

            Registered in EUDAMED under IVDD with this code: 25 of 25 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 25 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0103080106Antibodies for Lymphocyte SubtypingIVDD 100.0% IVD general · n=74terminal

            Registered in EUDAMED under IVDD with this code: 74 of 74 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 74 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0103080199Monoclonal Antibodies for Cell Surface Antigens - OtherIVDR 2 classes · n=473IVDD 100.0% IVD general · n=149terminal

            Registered in EUDAMED under IVDR with this code, the 473 devices are split across classes (as of 8 Sep 2026).

            • 366 Class C (77.3%)
            • 107 Class A (22.6%)

            Registered in EUDAMED under IVDD with this code: 149 of 149 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 149 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01030802Monoclonal Antibodies for Cytoplasmatic Antigens
          • W0103080201Monoclonal Antibodies for Recognizing Enzymesterminal
          • W0103080202Iga, Igd, Igm, Igg, IgeIVDD 100.0% IVD general · n=76terminal

            Registered in EUDAMED under IVDD with this code: 76 of 76 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 76 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0103080203Monoclonal Antibodies for Detecting Cells Exspressing Kappa or Lambda Light Chainsterminal
          • W0103080204Proliferation Markersterminal
          • W0103080299Monoclonal Antibodies for Cytoplasmatic Antigens - Otherterminal
        • W01030803Stem Cell Enumeration Reagentsterminal
        • W01030804Flow Cytometry Controls
          • W0103080401Setup Beadsterminal
          • W0103080402Leucocyte Controlsterminal
          • W0103080403Lymphocyte Subtyping Controlsterminal
          • W0103080404Stem Cell Enumeration Controlsterminal
          • W0103080499Flow Cytometry Controls - OtherIVDR 2 classes · n=20terminal

            Registered in EUDAMED under IVDR with this code, the 20 devices are split across classes (as of 8 Sep 2026).

            • 15 Class B (75.0%)
            • 5 Class C (25.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

        • W01030805Auxiliary & Supplemental Reagents for Flow Cytometry
          • W0103080501Cell Staining Reagents for Cell Nuclear Stainingterminal
          • W0103080502Cell Staining Reagents for Detecting Reticulocytesterminal
          • W0103080599Auxiliary & Supplemental Reagents for Flow Cytometry - OtherIVDR 2 classes · n=27terminal

            Registered in EUDAMED under IVDR with this code, the 27 devices are split across classes (as of 8 Sep 2026).

            • 25 Class A (92.5%)
            • 2 Class C (7.4%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

        • W01030806Other Reagents for Flow Cytometry
          • W0103080699Reagents for Flow Cytometry - OtherIVDR 3 classes · n=45IVDD 100.0% IVD general · n=81terminal

            Registered in EUDAMED under IVDR with this code, the 45 devices are split across classes (as of 8 Sep 2026).

            • 40 Class A (88.8%)
            • 4 Class C (8.8%)
            • 1 Class B (2.2%)

            Registered in EUDAMED under IVDD with this code: 81 of 81 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 81 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

      • W010399Haematology / Haemostasis / Immunohaematology / Histology / Cytology Reagents - OtherIVDR 98.7% Class A · n=155terminal

        Registered in EUDAMED under IVDR with this code: 153 of 155 devices carry Class A on their registration (as of 8 Sep 2026).

        • 153 Class A (98.7%)
        • 2 Class C (1.2%)

        Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

    • W0104Microbiology (Culture)
      • W010401Bacteriology - Culture Media
        • W01040101Dehydrated Culture Media (Dcm - Bacteriology))
          • W0104010101Dehydrated Culture Media (Dcm)IVDR 99.6% Class A · n=2,061terminal

            Registered in EUDAMED under IVDR with this code: 2,054 of 2,061 devices carry Class A on their registration (as of 8 Sep 2026).

            • 2,054 Class A (99.6%)
            • 5 Class C (0.2%)
            • 2 Class B (<0.1%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0104010103Raw Materials (Agar, Peptones, …)terminal
          • W0104010104Additives for Dcm (Growth Supplements, Selective Agents, ...)IVDR 99.0% Class A · n=212terminal

            Registered in EUDAMED under IVDR with this code: 210 of 212 devices carry Class A on their registration (as of 8 Sep 2026).

            • 210 Class A (99.0%)
            • 1 Class B (0.4%)
            • 1 Class C (0.4%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0104010199Dcm - Otherterminal
        • W01040102Prepared Media in Tubes (Bacteriology)
          • W0104010203Transport MediaIVDR 100.0% Class A · n=183terminal

            Registered in EUDAMED under IVDR with this code: 183 of 183 devices carry Class A on their registration (as of 8 Sep 2026).

            • 183 Class A (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0104010204Sample Transport for Na TestingIVDR 100.0% Class A · n=79terminal

            Registered in EUDAMED under IVDR with this code: 79 of 79 devices carry Class A on their registration (as of 8 Sep 2026).

            • 79 Class A (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0104010206Media in Tubes (Solid & Liquid)IVDR 99.4% Class A · n=1,382terminal

            Registered in EUDAMED under IVDR with this code: 1,374 of 1,382 devices carry Class A on their registration (as of 8 Sep 2026).

            • 1,374 Class A (99.4%)
            • 8 Class C (0.5%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0104010299Media in Tubes - OtherIVDR 100.0% Class A · n=213terminal

            Registered in EUDAMED under IVDR with this code: 213 of 213 devices carry Class A on their registration (as of 8 Sep 2026).

            • 213 Class A (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

        • W01040103Prepared Media in Bottles (Bacteriology)
          • W0104010306Culture Media in BottlesIVDR 99.1% Class A · n=1,096terminal

            Registered in EUDAMED under IVDR with this code: 1,087 of 1,096 devices carry Class A on their registration (as of 8 Sep 2026).

            • 1,087 Class A (99.1%)
            • 6 Class C (0.5%)
            • 3 Class B (0.2%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

        • W01040104Prepared Media in Plates (Bacteriology)
          • W0104010402Chromogenic Id Media (Plates)IVDR 3 classes · n=216terminal

            Registered in EUDAMED under IVDR with this code, the 216 devices are split across classes (as of 8 Sep 2026).

            • 200 Class A (92.5%)
            • 8 Class B (3.7%)
            • 8 Class C (3.7%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0104010403Susceptibility Test Media (Plates)IVDR 3 classes · n=121terminal

            Registered in EUDAMED under IVDR with this code, the 121 devices are split across classes (as of 8 Sep 2026).

            • 100 Class A (82.6%)
            • 20 Class B (16.5%)
            • 1 Class C (0.8%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0104010404Chromogenic Resistance Marker Media (Plates) - Mrsa, Vre, Esbl …IVDR 2 classes · n=53terminal

            Registered in EUDAMED under IVDR with this code, the 53 devices are split across classes (as of 8 Sep 2026).

            • 48 Class A (90.5%)
            • 5 Class C (9.4%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0104010405Non-Chromogenic Media (Plates)IVDR 98.5% Class A · n=1,233terminal

            Registered in EUDAMED under IVDR with this code: 1,215 of 1,233 devices carry Class A on their registration (as of 8 Sep 2026).

            • 1,215 Class A (98.5%)
            • 13 Class B (1.0%)
            • 5 Class C (0.4%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0104010407Bi-Plates - Including Non-Chromogenic & Chromogenic Media CombinationIVDR 3 classes · n=144terminal

            Registered in EUDAMED under IVDR with this code, the 144 devices are split across classes (as of 8 Sep 2026).

            • 135 Class A (93.7%)
            • 5 Class B (3.4%)
            • 4 Class C (2.7%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0104010499Prepared Media in Plates - OtherIVDR 98.8% Class A · n=336terminal

            Registered in EUDAMED under IVDR with this code: 332 of 336 devices carry Class A on their registration (as of 8 Sep 2026).

            • 332 Class A (98.8%)
            • 4 Class B (1.1%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

        • W01040105Blood Culture - Manual & Automated
          • W0104010501Bottles for Manual Blood CultureIVDR 97.5% Class A · n=41terminal

            Registered in EUDAMED under IVDR with this code: 40 of 41 devices carry Class A on their registration (as of 8 Sep 2026).

            • 40 Class A (97.5%)
            • 1 Class C (2.4%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0104010504Bottles for Automated Blood CultureIVDR 2 classes · n=86terminal

            Registered in EUDAMED under IVDR with this code, the 86 devices are split across classes (as of 8 Sep 2026).

            • 80 Class A (93.0%)
            • 6 Class C (6.9%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0104010599Manual Blood Cultures - (Concentrators, Antibotic Inactivators,etc.) - Otherterminal
        • W01040106Mycobacteria Culture (Manual & Automated)
          • W0104010603Automated Mycobacteria Media (Bottles)terminal
          • W0104010604Manual Mycobacteria Media (Tubes & Bottles)IVDR 96.0% Class A · n=51terminal

            Registered in EUDAMED under IVDR with this code: 49 of 51 devices carry Class A on their registration (as of 8 Sep 2026).

            • 49 Class A (96.0%)
            • 2 Class C (3.9%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0104010699Media for Mycobacteria Cultures - Manual & Automated (for Ast Drugs, Supplements) - Otherterminal
        • W01040107Urine Screening (Bacteriology)
          • W0104010701Urine Screening Reagents - Automatedterminal
          • W0104010702Urine Screening Manual - Strips, Etc.)terminal
          • W0104010703Urine Screening Manual (Dipslides Etc.)terminal
          • W0104010799Urine Screening (Bacteriology) - Otherterminal
        • W01040108Stains, Buffers (Bacteriology)
          • W0104010804StainsIVDR 100.0% Class A · n=584terminal

            Registered in EUDAMED under IVDR with this code: 584 of 584 devices carry Class A on their registration (as of 8 Sep 2026).

            • 584 Class A (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0104010805BuffersIVDR 100.0% Class A · n=26terminal

            Registered in EUDAMED under IVDR with this code: 26 of 26 devices carry Class A on their registration (as of 8 Sep 2026).

            • 26 Class A (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0104010899Buffers, Stains - OtherIVDR 100.0% Class A · n=135terminal

            Registered in EUDAMED under IVDR with this code: 135 of 135 devices carry Class A on their registration (as of 8 Sep 2026).

            • 135 Class A (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

        • W01040109Environmental Generating Systems
          • W0104010901Gas Generating Kitsterminal
          • W0104010999Environmental Generating Systems - Otherterminal
      • W010403Mycology
        • W01040301Dehydrated Culture Media (Mycology)
          • W0104030101Dcm for Yeasts and Fungiterminal
          • W0104030199Dcm (Mycology) - Otherterminal
        • W01040302Prepared Media in Plates (Mycology)
          • W0104030201Ppm for Yeasts and FungiIVDR 100.0% Class A · n=93terminal

            Registered in EUDAMED under IVDR with this code: 93 of 93 devices carry Class A on their registration (as of 8 Sep 2026).

            • 93 Class A (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0104030202Chromogenic Media for Yeasts and Fungiterminal
          • W0104030299Prepared Media in Plates (Mycology) - OtherIVDR 100.0% Class A · n=28terminal

            Registered in EUDAMED under IVDR with this code: 28 of 28 devices carry Class A on their registration (as of 8 Sep 2026).

            • 28 Class A (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

        • W01040303Tubes and Bottled Media for Yeasts and Fungi
          • W0104030301Tubes for Yeasts and FungiIVDR 100.0% Class A · n=61terminal

            Registered in EUDAMED under IVDR with this code: 61 of 61 devices carry Class A on their registration (as of 8 Sep 2026).

            • 61 Class A (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0104030302Dip Slides (Mycology)terminal
          • W0104030303Bottled Media for Yeasts and FungiIVDR 95.4% Class A · n=22terminal

            Registered in EUDAMED under IVDR with this code: 21 of 22 devices carry Class A on their registration (as of 8 Sep 2026).

            • 21 Class A (95.4%)
            • 1 Class C (4.5%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0104030399Tubes Media for Yeasts and Fungi - Otherterminal
        • W01040304Identification (Mycology)
          • W0104030403Identification Systems for Yeasts and Fungi - Automatedterminal
          • W0104030404Identification Systems for Yeasts and Fungi / Na Reagentsterminal
          • W0104030405Identification Systems for Yeasts and Fungi - ManualIVDR 2 classes · n=22terminal

            Registered in EUDAMED under IVDR with this code, the 22 devices are split across classes (as of 8 Sep 2026).

            • 19 Class A (86.3%)
            • 3 Class B (13.6%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0104030499Identification Systems for Yeast and Fungi - Otherterminal
        • W01040305Serological Identification (Mycology)
          • W0104030501Serological Identification of Yeasts and Fungiterminal
          • W0104030599Serological Identification Systems of Yeast and Fungi - Otherterminal
        • W01040306Susceptibility Testing (Mycology)
          • W0104030601Susceptibility Testing Systems for Yeasts and Fungi
            • W010403060101Susceptibility Testing Systems for Yeasts and Fungi - Manualterminal
            • W010403060102Susceptibility Testing Systems for Yeasts and Fungi - Automatedterminal
            • W010403060199Susceptibility Testing Systems for Yeasts and Fungi - Otherterminal
      • W010404Tissue Culture for Virology
        • W01040401Cells for Tissue Cultureterminal
        • W01040402Media for Tissue Cultureterminal
        • W01040403Serum for Tissue Cultureterminal
        • W01040404Other Tissue Culture Additives and Solutionsterminal
        • W01040499Viral Culture Reagents - Otherterminal
      • W010405Parasitology ( Microbiology )
        • W01040501Parasitology Reagents
          • W0104050101Parasitology Extraction Reagentsterminal
          • W0104050102Parasitology StainsIVDR 2 classes · n=27terminal

            Registered in EUDAMED under IVDR with this code, the 27 devices are split across classes (as of 8 Sep 2026).

            • 25 Class A (92.5%)
            • 2 Class B (7.4%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0104050199Parasitology Reagents - OtherIVDR 100.0% Class A · n=61terminal

            Registered in EUDAMED under IVDR with this code: 61 of 61 devices carry Class A on their registration (as of 8 Sep 2026).

            • 61 Class A (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

        • W01040502Detection and Identification (Parasitology)
          • W0104050201Pneumocystis Jirovecii (Pneumocystis Carinii)terminal
          • W0104050202Plasmodium Falciparumterminal
          • W0104050203Cryptosporidiumterminal
          • W0104050299Detection and Identification (Parasitology) - Otherterminal
      • W010406Controls/Standards/Calibrators - Microbiology
        • W01040601Qc Strains BacteriologyIVDR 100.0% Class B · n=2,217terminal

          Registered in EUDAMED under IVDR with this code: 2,217 of 2,217 devices carry Class B on their registration (as of 8 Sep 2026).

          • 2,217 Class B (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

        • W01040699Controls, Standards, Calibrators, Microbiology - OtherIVDR 2 classes · n=410IVDD 100.0% IVD general · n=36terminal

          Registered in EUDAMED under IVDR with this code, the 410 devices are split across classes (as of 8 Sep 2026).

          • 371 Class B (90.4%)
          • 39 Class A (9.5%)

          Registered in EUDAMED under IVDD with this code: 36 of 36 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 36 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

      • W010407Microbiology Rt & Pocterminal
      • W010408Bacteriology - Identification and Susceptibility Testing
        • W01040801Biochemical Identification and Susceptibility Testing - Automated
          • W0104080101Gram Negative Identification - Automatedterminal
          • W0104080103Gram Positive Identification - Automatedterminal
          • W0104080105Anaerobic and Other Pathogenic Germs Identification - Automatedterminal
          • W0104080107Gram Negative Susceptibility Testing - AutomatedIVDR 2 classes · n=149terminal

            Registered in EUDAMED under IVDR with this code, the 149 devices are split across classes (as of 8 Sep 2026).

            • 132 Class B (88.5%)
            • 17 Class C (11.4%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0104080108Gram Positive Susceptibility Testing - AutomatedIVDR 2 classes · n=32terminal

            Registered in EUDAMED under IVDR with this code, the 32 devices are split across classes (as of 8 Sep 2026).

            • 20 Class B (62.5%)
            • 12 Class C (37.5%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0104080109Combined Susceptibility and Identification Systems Gram Negatives - AutomatedIVDR 2 classes · n=32terminal

            Registered in EUDAMED under IVDR with this code, the 32 devices are split across classes (as of 8 Sep 2026).

            • 28 Class B (87.5%)
            • 4 Class C (12.5%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0104080110Combined Susceptibility and Identification Systems Gram Positives - Automatedterminal
          • W0104080111Anaerobes and Fastidious Suscept Testing - Automatedterminal
          • W0104080112Other Automated Identification Testing (Incl. Consumables...)terminal
          • W0104080113Other Automated Susceptibility Testing (Incl Consumables...)IVDR 2 classes · n=43terminal

            Registered in EUDAMED under IVDR with this code, the 43 devices are split across classes (as of 8 Sep 2026).

            • 28 Class B (65.1%)
            • 15 Class A (34.8%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

        • W01040802Biochemical Identification - Manual
          • W0104080201Gram Negative - Manual Identificationterminal
          • W0104080203Gram Positive - Manual Identificationterminal
          • W0104080207Mycoplasma / Ureaplasma - (Incl. Combined Id-Ast)terminal
          • W0104080208Single Tests (Discs, Strips, Droppers...)IVDR 3 classes · n=43IVDD 100.0% IVD general · n=42terminal

            Registered in EUDAMED under IVDR with this code, the 43 devices are split across classes (as of 8 Sep 2026).

            • 25 Class A (58.1%)
            • 17 Class B (39.5%)
            • 1 Class C (2.3%)

            Registered in EUDAMED under IVDD with this code: 42 of 42 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 42 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0104080209Manual Identification Kits - Anaerobes, Pathogens - Otherterminal
          • W0104080299Manual Identification - OtherIVDR 2 classes · n=200terminal

            Registered in EUDAMED under IVDR with this code, the 200 devices are split across classes (as of 8 Sep 2026).

            • 182 Class A (91.0%)
            • 18 Class B (9.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

        • W01040803Immunological Identification by Culture
          • W0104080301Serotyping (E.coli, Salmonella, Shigella, Etc)IVDR 2 classes · n=435IVDD 100.0% IVD general · n=50terminal

            Registered in EUDAMED under IVDR with this code, the 435 devices are split across classes (as of 8 Sep 2026).

            • 331 Class A (76.0%)
            • 104 Class B (23.9%)

            Registered in EUDAMED under IVDD with this code: 50 of 50 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 50 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0104080302Streptococci Grouping Slide Teststerminal
          • W0104080303Staphylococci Slide Teststerminal
          • W0104080304Meningitis Slide Teststerminal
          • W0104080399Immunological Identification - Otherterminal
        • W01040805Manual Susceptibility Testing
          • W0104080501Mic Systems - Dilution Methods (Incl. E-Test)IVDR 99.1% Class B · n=238IVDD 100.0% IVD general · n=54terminal

            Registered in EUDAMED under IVDR with this code: 236 of 238 devices carry Class B on their registration (as of 8 Sep 2026).

            • 236 Class B (99.1%)
            • 2 Class C (0.8%)

            Registered in EUDAMED under IVDD with this code: 54 of 54 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 54 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0104080502Impregnated Disks, Multi-Disks & TabletsIVDR 2 classes · n=741IVDD 100.0% IVD general · n=53terminal

            Registered in EUDAMED under IVDR with this code, the 741 devices are split across classes (as of 8 Sep 2026).

            • 622 Class B (83.9%)
            • 119 Class A (16.0%)

            Registered in EUDAMED under IVDD with this code: 53 of 53 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 53 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0104080503Manual Antimicrobial Suceptibility Testing (Ast)- Strips / Cassettes/GalleriesIVDD 100.0% IVD general · n=35terminal

            Registered in EUDAMED under IVDD with this code: 35 of 35 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 35 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0104080504Targeted Resistance Tests - Mrsaterminal
          • W0104080505Targeted Resistance Tests - Esblterminal
          • W0104080506Targeted Resistance Tests - CarbapenemaseIVDD 100.0% IVD general · n=26terminal

            Registered in EUDAMED under IVDD with this code: 26 of 26 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 26 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0104080590Targeted Resistance Tests - OtherIVDR 3 classes · n=27terminal

            Registered in EUDAMED under IVDR with this code, the 27 devices are split across classes (as of 8 Sep 2026).

            • 24 Class C (88.8%)
            • 2 Class B (7.4%)
            • 1 Class A (3.7%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0104080599Manual Susceptibility Testing - OtherIVDR 2 classes · n=23terminal

            Registered in EUDAMED under IVDR with this code, the 23 devices are split across classes (as of 8 Sep 2026).

            • 15 Class B (65.2%)
            • 8 Class A (34.7%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

        • W01040806Nucleic Acid Identification (Bacteriology)
          • W0104080601Nucleic Acid Identification - Manual / Automated Bacteria Spp / SsppIVDR 100.0% Class A · n=46terminal

            Registered in EUDAMED under IVDR with this code: 46 of 46 devices carry Class A on their registration (as of 8 Sep 2026).

            • 46 Class A (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0104080602Nucleic Acid Identification - Manual / Automated Mrsa and/or Mssaterminal
          • W0104080604Nucleic Acid Identification - Manual / Automated Vreterminal
          • W0104080605Nucleic Acid Identification - Manual / Automated Esblterminal
          • W0104080606Nucleic Acid Identification - Manual / Automated Carbapenemaseterminal
          • W0104080607Nucleic Acid Identification - Manual / Automated Other Resistance Markersterminal
          • W0104080608Nucleic Acid Identification - Manual / Automated Esbl / Carbapenemase Combinedterminal
          • W0104080699Nucleic Acid Identification (Bacteriology) Manual / Automated - OtherIVDR 2 classes · n=124terminal

            Registered in EUDAMED under IVDR with this code, the 124 devices are split across classes (as of 8 Sep 2026).

            • 115 Class A (92.7%)
            • 9 Class C (7.2%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

      • W010499Microbiology Tests - OtherIVDR 100.0% Class A · n=97terminal

        Registered in EUDAMED under IVDR with this code: 97 of 97 devices carry Class A on their registration (as of 8 Sep 2026).

        • 97 Class A (100.0%)

        Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

    • W0105Infectious Diseases
      • W010501Bacteriology (Infect. Immunology/Nat)
        • W01050101Chlamydia
          • W0105010107Chlamydia Trachomatis Antigen DetectionIVDD 3 classes · n=20terminal

            Registered in EUDAMED under IVDD with this code, the 20 devices are split across classes (as of 8 Sep 2026).

            • 15 Annex II List B (75.0%)
            • 4 IVD general (20.0%)
            • 1 IVD self-testing (5.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105010108Chlamydia Trachomatis Antibody Assays Totalterminal
          • W0105010109Chlamydia Trachomatis Antibody Igaterminal
          • W0105010110Chlamydia Trachomatis Antibody Iggterminal
          • W0105010111Chlamydia Trachomatis Antibody Igmterminal
          • W0105010112Chlamydia Pneumoniae Antigen Detectionterminal
          • W0105010113Chlamydia Pneumoniae Antibody Assays Totalterminal
          • W0105010114Chlamydia Pneumoniae Antibody Igaterminal
          • W0105010115Chlamydia Pneumoniae Antibody Iggterminal
          • W0105010116Chlamydia Pneumoniae Antibody Igmterminal
          • W0105010117Chlamydia Trachomatis Detection by Na Reagentsterminal
          • W0105010118Chlamydia Pneumoniae Detection by Na Reagentsterminal
          • W0105010199Chlamydia Reagents - Otherterminal
        • W01050102Gonococci (Neisseria Gonorrhoeae)
          • W0105010201Gonococcal Antigen DetectionIVDD 100.0% IVD general · n=26terminal

            Registered in EUDAMED under IVDD with this code: 26 of 26 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 26 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105010202Gonococcal Antibody Assays Totalterminal
          • W0105010203Gonococcal Detection by Na ReagentsIVDR 98.0% Class C · n=50IVDD 100.0% IVD general · n=39terminal

            Registered in EUDAMED under IVDR with this code: 49 of 50 devices carry Class C on their registration (as of 8 Sep 2026).

            • 49 Class C (98.0%)
            • 1 Class B (2.0%)

            Registered in EUDAMED under IVDD with this code: 39 of 39 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 39 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105010299Gonococci Reagents - Otherterminal
        • W01050103Syphilis (Treponema Pallidum)
          • W0105010301Syphilis Antigen Detectionterminal
          • W0105010302Syphilis Antibody Assays TotalIVDR 96.6% Class C · n=30IVDD 100.0% IVD general · n=88terminal

            Registered in EUDAMED under IVDR with this code: 29 of 30 devices carry Class C on their registration (as of 8 Sep 2026).

            • 29 Class C (96.6%)
            • 1 Class B (3.3%)

            Registered in EUDAMED under IVDD with this code: 88 of 88 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 88 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105010303Syphilis Antibody Iggterminal
          • W0105010304Syphilis Antibody Igmterminal
          • W0105010305Syphilis Detection by Na Reagentsterminal
          • W0105010306Syphilis, Reagin Antibodiesterminal
          • W0105010399Syphilis Reagents OtherIVDD 100.0% IVD general · n=41terminal

            Registered in EUDAMED under IVDD with this code: 41 of 41 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 41 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01050104Helicobacter Pylori
          • W0105010401H. Pylori Antigen DetectionIVDR 100.0% Class B · n=30IVDD 100.0% IVD general · n=98terminal

            Registered in EUDAMED under IVDR with this code: 30 of 30 devices carry Class B on their registration (as of 8 Sep 2026).

            • 30 Class B (100.0%)

            Registered in EUDAMED under IVDD with this code: 98 of 98 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 98 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105010402H. Pylori Antibody AssaysIVDR 2 classes · n=24IVDD 99.0% IVD general · n=106terminal

            Registered in EUDAMED under IVDR with this code, the 24 devices are split across classes (as of 8 Sep 2026).

            • 20 Class B (83.3%)
            • 4 Class C (16.6%)

            Registered in EUDAMED under IVDD with this code: 105 of 106 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 105 IVD general (99.0%)
            • 1 IVD self-testing (0.9%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105010403H. Pylori Detection by Na ReagentsIVDR 100.0% Class B · n=25IVDD 100.0% IVD general · n=28terminal

            Registered in EUDAMED under IVDR with this code: 25 of 25 devices carry Class B on their registration (as of 8 Sep 2026).

            • 25 Class B (100.0%)

            Registered in EUDAMED under IVDD with this code: 28 of 28 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 28 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105010499H. Pylori Reagents - OtherIVDD 100.0% IVD general · n=34terminal

            Registered in EUDAMED under IVDD with this code: 34 of 34 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 34 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01050105Legionella
          • W0105010501Legionella Antigen Detectionterminal
          • W0105010502Legionella Antibody Assaysterminal
          • W0105010503Legionella Detection by Na ReagentsIVDD 100.0% IVD general · n=23terminal

            Registered in EUDAMED under IVDD with this code: 23 of 23 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 23 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105010599Legionella Reagents - Otherterminal
        • W01050106Lyme Borreliosis
          • W0105010601Lyme Antigen Detectionterminal
          • W0105010602Lyme Antibody Totalterminal
          • W0105010603Lyme Antibody Iggterminal
          • W0105010604Lyme Antibody Igmterminal
          • W0105010605Lyme Detection by Na Reagentsterminal
          • W0105010699Lyme Borreliosis Reagents - Otherterminal
        • W01050107Mycobacteria Genus + Species
          • W0105010701Mycobacterial Antigen Detectionterminal
          • W0105010702Mycobacterial Antibody Assaysterminal
          • W0105010703Mycobacterial Detection by Na ReagentsIVDR 100.0% Class C · n=38IVDD 98.9% IVD general · n=194terminal

            Registered in EUDAMED under IVDR with this code: 38 of 38 devices carry Class C on their registration (as of 8 Sep 2026).

            • 38 Class C (100.0%)

            Registered in EUDAMED under IVDD with this code: 192 of 194 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 192 IVD general (98.9%)
            • 2 Annex II List B (1.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105010704Tb-Igra (Interferon-Gamma-Release Assay)terminal
          • W0105010799Mycobacteria Reagents - OtherIVDR 2 classes · n=42IVDD 100.0% IVD general · n=32terminal

            Registered in EUDAMED under IVDR with this code, the 42 devices are split across classes (as of 8 Sep 2026).

            • 27 Class A (64.2%)
            • 15 Class C (35.7%)

            Registered in EUDAMED under IVDD with this code: 32 of 32 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 32 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01050108Mycoplasma / Ureaplasma
          • W0105010801Mycoplasma Antigen Detectionterminal
          • W0105010802Mycoplasma Antibody AssaysIVDR 2 classes · n=24IVDD 100.0% IVD general · n=74terminal

            Registered in EUDAMED under IVDR with this code, the 24 devices are split across classes (as of 8 Sep 2026).

            • 15 Class B (62.5%)
            • 9 Class C (37.5%)

            Registered in EUDAMED under IVDD with this code: 74 of 74 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 74 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105010803Mycoplasma / Ureaplasma Detection by Na Reagents
            • W010501080301Mycoplasma Pneumoniae Detection by Na Reagentsterminal
            • W010501080302Urogenital Mycoplasma Detection by Na ReagentsIVDR 2 classes · n=42IVDD 100.0% IVD general · n=24terminal

              Registered in EUDAMED under IVDR with this code, the 42 devices are split across classes (as of 8 Sep 2026).

              • 24 Class B (57.1%)
              • 18 Class C (42.8%)

              Registered in EUDAMED under IVDD with this code: 24 of 24 devices carry IVD general on their registration (as of 8 Sep 2026).

              • 24 IVD general (100.0%)

              Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

            • W010501080303Ureaplasma Detection by Na Reagentsterminal
            • W010501080304Mycoplasma / Ureaplasma Detection by Na Reagentsterminal
          • W0105010899Mycoplasma / Ureaplasma Reagents - Otherterminal
        • W01050109Pseudomonas Aeruginosa
          • W0105010901Pseudomonas Aeruginosa Antibody Iggterminal
          • W0105010902Pseudomonas Detection by Na Reagentsterminal
          • W0105010999Pseudomonas Aeruginosa Reagents - Otherterminal
        • W01050110Salmonella
          • W0105011001Salmonella Antigen DetectionIVDD 100.0% IVD general · n=51terminal

            Registered in EUDAMED under IVDD with this code: 51 of 51 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 51 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105011002Salmonella Antibody AssaysIVDD 100.0% IVD general · n=136terminal

            Registered in EUDAMED under IVDD with this code: 136 of 136 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 136 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105011003Salmonella Detection by Na ReagentsIVDD 100.0% IVD general · n=53terminal

            Registered in EUDAMED under IVDD with this code: 53 of 53 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 53 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105011099Salmonella Reagents - Otherterminal
        • W01050111Streptococci
          • W0105011101Streptococcal Direct Antigen DetectionIVDR 2 classes · n=32IVDD 100.0% IVD general · n=25terminal

            Registered in EUDAMED under IVDR with this code, the 32 devices are split across classes (as of 8 Sep 2026).

            • 29 Class C (90.6%)
            • 3 Class A (9.3%)

            Registered in EUDAMED under IVDD with this code: 25 of 25 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 25 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105011102Streptococcal Detection by Na ReagentsIVDD 96.4% IVD general · n=28terminal

            Registered in EUDAMED under IVDD with this code: 27 of 28 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 27 IVD general (96.4%)
            • 1 Annex II List B (3.5%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105011103Strep. A Detection by Na ReagentsIVDR 100.0% Class B · n=24IVDD 100.0% IVD general · n=26terminal

            Registered in EUDAMED under IVDR with this code: 24 of 24 devices carry Class B on their registration (as of 8 Sep 2026).

            • 24 Class B (100.0%)

            Registered in EUDAMED under IVDD with this code: 26 of 26 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 26 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105011104Strep. B Detection by Na ReagentsIVDD 100.0% IVD general · n=36terminal

            Registered in EUDAMED under IVDD with this code: 36 of 36 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 36 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105011105Strep. Pneumoniae Detection by Na Reagentsterminal
          • W0105011199Streptococcal Reagents - OtherIVDR 3 classes · n=31terminal

            Registered in EUDAMED under IVDR with this code, the 31 devices are split across classes (as of 8 Sep 2026).

            • 16 Class B (51.6%)
            • 14 Class C (45.1%)
            • 1 Class A (3.2%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

        • W01050112Staphylococci
          • W0105011201Staphylococcal Direct Antigen Detectionterminal
          • W0105011202Staphylotoxinterminal
          • W0105011203Staphylococcal Detection by Na ReagentsIVDD 96.8% IVD general · n=32terminal

            Registered in EUDAMED under IVDD with this code: 31 of 32 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 31 IVD general (96.8%)
            • 1 Annex II List B (3.1%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105011299Staphylococci Reagents - Otherterminal
        • W01050113Listeria
          • W0105011301Listeria Antigen Detectionterminal
          • W0105011302Listeria Antibody Assaysterminal
          • W0105011303Listeria Monocytogenes Direct Antigen Detectionterminal
          • W0105011304Listeria Monocytogenes Antibody Assaysterminal
          • W0105011305Listeria Detection by Na Reagentsterminal
          • W0105011399Listeria Reagents - Otherterminal
        • W01050114Campylobacter
          • W0105011401Campylobacter Direct Antigen Detectionterminal
          • W0105011402Campylobacter Detection by Na Reagentsterminal
          • W0105011499Campylobacter Reagents - Otherterminal
        • W01050115Escherichia Coli
          • W0105011501E. Coli Direct Antigen Detectionterminal
          • W0105011502E. Coli Toxinterminal
          • W0105011503E. Coli Detection by Na ReagentsIVDD 100.0% IVD general · n=32terminal

            Registered in EUDAMED under IVDD with this code: 32 of 32 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 32 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105011599E. Coli Reagents - Otherterminal
        • W01050116Other Bacteriology - Na Reagents
          • W0105011601Brucella - Na Reagentsterminal
          • W0105011603Coxiella Burnetii (Q Fever) - Na Reagentsterminal
          • W0105011604Leptospira - Na Reagentsterminal
          • W0105011605Rickettsia - Na Reagentsterminal
          • W0105011606Yersinia - Na Reagentsterminal
          • W0105011607Bordetella Pertussis / Parapertussis - Na ReagentsIVDR 2 classes · n=31IVDD 100.0% IVD general · n=38terminal

            Registered in EUDAMED under IVDR with this code, the 31 devices are split across classes (as of 8 Sep 2026).

            • 27 Class B (87.0%)
            • 4 Class C (12.9%)

            Registered in EUDAMED under IVDD with this code: 38 of 38 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 38 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105011608Diphtheria (Corynebacterium D.) - Na Reagentsterminal
          • W0105011609Tetanus (Clostridium T.) - Na Reagentsterminal
          • W0105011610Haemophilus Influenzae - Na Reagentsterminal
          • W0105011611Neisseria Meningitidis - Na Reagentsterminal
          • W0105011612Proteus - Na Reagentsterminal
          • W0105011613Pseudomonas - Na Reagentsterminal
          • W0105011614Shigella - Na Reagentsterminal
          • W0105011699Bacteriology - Na Reagents - OtherIVDD 98.2% IVD general · n=114terminal

            Registered in EUDAMED under IVDD with this code: 112 of 114 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 112 IVD general (98.2%)
            • 2 Annex II List B (1.7%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01050117Other Bacteriology Immunoassays
          • W0105011701BrucellaIVDD 100.0% IVD general · n=75terminal

            Registered in EUDAMED under IVDD with this code: 75 of 75 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 75 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105011703Coxiella Burnetii (Q Fever)terminal
          • W0105011704Leptospiraterminal
          • W0105011705Rickettsiaterminal
          • W0105011706Yersiniaterminal
          • W0105011707Bordetella Pertussis / Parapertussisterminal
          • W0105011708Diphtheria (Corynebacterium D.)terminal
          • W0105011709Tetanus (Clostridium T.)IVDD 100.0% IVD general · n=23terminal

            Registered in EUDAMED under IVDD with this code: 23 of 23 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 23 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105011710Haemophilus Influenzaeterminal
          • W0105011711Neisseria MeningitidisIVDD 100.0% IVD general · n=24terminal

            Registered in EUDAMED under IVDD with this code: 24 of 24 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 24 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105011712Proteusterminal
          • W0105011713Pseudomonasterminal
          • W0105011714Shigellaterminal
          • W0105011799Bacteriology Immunoassay - OtherIVDD 100.0% IVD general · n=82terminal

            Registered in EUDAMED under IVDD with this code: 82 of 82 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 82 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01050118Clostridium Difficile
          • W0105011801C.difficile Gdh Detectionterminal
          • W0105011802C.difficile Toxin A/B DetectionIVDD 100.0% IVD general · n=21terminal

            Registered in EUDAMED under IVDD with this code: 21 of 21 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 21 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105011803C.difficile Gdh and Toxin A/B Combined Detectionterminal
          • W0105011804C.difficile by Na ReagentsIVDR 100.0% Class B · n=58IVDD 100.0% IVD general · n=32terminal

            Registered in EUDAMED under IVDR with this code: 58 of 58 devices carry Class B on their registration (as of 8 Sep 2026).

            • 58 Class B (100.0%)

            Registered in EUDAMED under IVDD with this code: 32 of 32 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 32 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105011899C.difficile Reagents - Otherterminal
      • W010502Hepatitis Viruses (Infect. Immunology/Nat)
        • W01050201Hepatitis A Virus
          • W0105020101Hav Antigen Confirmatoryterminal
          • W0105020102Hav Antibody (Total)terminal
          • W0105020103Hav Antibody Iggterminal
          • W0105020104Hav Antibody IgmIVDR 2 classes · n=20IVDD 100.0% IVD general · n=22terminal

            Registered in EUDAMED under IVDR with this code, the 20 devices are split across classes (as of 8 Sep 2026).

            • 18 Class B (90.0%)
            • 2 Class C (10.0%)

            Registered in EUDAMED under IVDD with this code: 22 of 22 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 22 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105020105Hepatitis A Virus - Na ReagentsIVDD 100.0% IVD general · n=20terminal

            Registered in EUDAMED under IVDD with this code: 20 of 20 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 20 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105020199Hav Reagents - Otherterminal
        • W01050202Hepatitis B Virus
          • W0105020201Hepatitis B Surface Antigenterminal
          • W0105020202Hepatitis B Surface Antigen - Confirmatoryterminal
          • W0105020203Hepatitis B Surface Antibody (Total)terminal
          • W0105020204Hepatitis B Surface Antibody Iggterminal
          • W0105020205Hepatitis B Surface Antibody Igmterminal
          • W0105020206Hepatitis B Core Antigenterminal
          • W0105020207Hepatitis B Core Antigen - Confirmatoryterminal
          • W0105020208Hepatitis B Core Antibody (Total)terminal
          • W0105020209Hepatitis B Core Antibody Iggterminal
          • W0105020210Hepatitis B Core Antibody Igmterminal
          • W0105020211Hepatitis B Antigenterminal
          • W0105020212Hepatitis B Antigen - Confirmatoryterminal
          • W0105020213Hepatitis B Antibody (Total)terminal
          • W0105020214Hepatitis B Antibody Iggterminal
          • W0105020215Hepatitis B Antibody Igmterminal
          • W0105020216Hepatitis B Virus - Na Reagentsterminal
          • W0105020217Hepatitis B Surface Antigen - Quantitativeterminal
          • W0105020218Hepatitis B Virus - Genotyping - Na Reagentsterminal
          • W0105020299Hbv Reagents - Otherterminal
        • W01050203Hepatitis C Virus
          • W0105020301Hcv Antigenterminal
          • W0105020302Hcv Antigen - Confirmatoryterminal
          • W0105020303Hcv Antibody (Total)terminal
          • W0105020304Hcv Antibody Iggterminal
          • W0105020305Hcv Antibody Igmterminal
          • W0105020306Hcv Antibody - Confirmatoryterminal
          • W0105020307Hepatitis C Virus - Na ReagentsIVDD 2 classes · n=21terminal

            Registered in EUDAMED under IVDD with this code, the 21 devices are split across classes (as of 8 Sep 2026).

            • 12 Annex II List A (57.1%)
            • 9 IVD general (42.8%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105020308Hepatitis C Virus (Hcv) Antigen/Antibody Combo Testterminal
          • W0105020309Hepatitis C Virus (Hcv) Genotyping - Na Reagentsterminal
          • W0105020399Hcv Reagents - Otherterminal
        • W01050204Hepatitis Delta Virus
          • W0105020401Hepatitis Delta Antigenterminal
          • W0105020402Hepatitis Delta Antigen - Confirmatoryterminal
          • W0105020403Hepatitis Delta Antibody (Total)terminal
          • W0105020404Hepatitis Delta Antibody Iggterminal
          • W0105020405Hepatitis Delta Antibody Igmterminal
          • W0105020406Hepatitis Delta Virus - Na Reagentsterminal
          • W0105020499Hdv Reagents - Otherterminal
        • W01050205Hepatitis E Virus
          • W0105020501Hev Antigenterminal
          • W0105020502Hev Antigen - Confirmatoryterminal
          • W0105020503Hev Antibody (Total)terminal
          • W0105020504Hev Antibody Iggterminal
          • W0105020505Hev Antibody IgmIVDD 100.0% IVD general · n=28terminal

            Registered in EUDAMED under IVDD with this code: 28 of 28 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 28 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105020506Hev Antibody - Confirmatoryterminal
          • W0105020507Hepatitis E Virus - Na Reagentsterminal
          • W0105020599Hev Reagents - Otherterminal
        • W01050206Hepatitis G Virus
          • W0105020601Hgv Antigenterminal
          • W0105020602Hgv Antigen - Confirmatoryterminal
          • W0105020603Hgv Antibody (Total)terminal
          • W0105020604Hgv Antibody Iggterminal
          • W0105020605Hgv Antibody Igmterminal
          • W0105020606Hepatitis G Virus - Na Reagentsterminal
          • W0105020699Hgv Reagents - Otherterminal
        • W01050207Hepatitis X Virus
          • W0105020701Hxv Antigenterminal
          • W0105020702Hxv Antigen - Confirmatoryterminal
          • W0105020703Hxv Antibody (Total)terminal
          • W0105020704Hxv Antibody Iggterminal
          • W0105020705Hxv Antibody Igmterminal
          • W0105020706Hepatitis X Virus - Na Reagentsterminal
          • W0105020799Hxv Reagents - Otherterminal
        • W01050290Other Hepatitis Viruses
          • W0105029099Hepatitis Viruses Reagents - Otherterminal
      • W010503Retroviruses (Infect. Immunology/Nat)
        • W01050301HIV 1
          • W0105030101HIV 1 Antigenterminal
          • W0105030102HIV 1 Antigen - Confirmatoryterminal
          • W0105030103HIV 1 Antibody (Total)terminal
          • W0105030104HIV 1 Antibody Iggterminal
          • W0105030105HIV 1 Antibody Igmterminal
          • W0105030106HIV 1 Antibody - Confirmatoryterminal
          • W0105030107HIV 1 - Na Reagentsterminal
          • W0105030108HIV 1 Genotyping - Na Reagentsterminal
          • W0105030199HIV 1 Reagents - Otherterminal
        • W01050302HIV 2
          • W0105030201HIV 2 Antigenterminal
          • W0105030202HIV 2 Antibodyterminal
          • W0105030203HIV 2 Antibody - Confirmatoryterminal
          • W0105030204HIV 2 - Na Reagentsterminal
          • W0105030205HIV 2 Genotyping - Na Reagentsterminal
          • W0105030299HIV 2 Reagents - Otherterminal
        • W01050303HIV P24
          • W0105030301HIV P24 Antigenterminal
          • W0105030302HIV P24 Antibodyterminal
          • W0105030303HIV P24 - Na Reagentsterminal
          • W0105030399HIV P24 Reagents - Otherterminal
        • W01050304HIV - Multiple ( 1 / 2 )
          • W0105030401HIV Multiple Antigenterminal
          • W0105030402HIV Multiple AntibodyIVDD 100.0% Annex II List A · n=52terminal

            Registered in EUDAMED under IVDD with this code: 52 of 52 devices carry Annex II List A on their registration (as of 8 Sep 2026).

            • 52 Annex II List A (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105030403HIV Multiple Antibody - Confirmatoryterminal
          • W0105030404HIV Multiple Ag/Ab Combi Testterminal
          • W0105030405HIV Multiple - Na Reagentsterminal
          • W0105030499HIV Multiple (1/2) Reagents - Otherterminal
        • W01050305Htlv I
          • W0105030501Htlv I Antigenterminal
          • W0105030502Htlv I Antibodyterminal
          • W0105030503Htlv I Antibody - Confirmatoryterminal
          • W0105030504Htlv I - Na Reagentsterminal
          • W0105030599Htlv I Reagents - Otherterminal
        • W01050306Htlv Ii
          • W0105030601Htlv Ii Antigenterminal
          • W0105030602Htlv Ii Antibodyterminal
          • W0105030603Htlv Ii Antibody - Confirmatoryterminal
          • W0105030604Htlv Ii - Na Reagentsterminal
          • W0105030699Htlv Ii Reagents - Otherterminal
        • W01050307Htlv Multiple
          • W0105030701Htlv Multiple Antigenterminal
          • W0105030702Htlv Multiple Antibodyterminal
          • W0105030703Htlv Multiple Antibody - Confirmatoryterminal
          • W0105030704Htlv Multiple - Na Reagentsterminal
          • W0105030799Htlv Multiple Reagents - Otherterminal
      • W010504Other Virology Tests (Infect. Immunology/Nat)
        • W01050406Other Virology Antigen/Antibody Detection
          • W0105040601AdenovirusIVDD 100.0% IVD general · n=69terminal

            Registered in EUDAMED under IVDD with this code: 69 of 69 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 69 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105040602EnterovirusIVDD 100.0% IVD general · n=25terminal

            Registered in EUDAMED under IVDD with this code: 25 of 25 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 25 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105040604Influenza & Para InfluenzaIVDR 2 classes · n=45IVDD 99.0% IVD general · n=101terminal

            Registered in EUDAMED under IVDR with this code, the 45 devices are split across classes (as of 8 Sep 2026).

            • 37 Class B (82.2%)
            • 8 Class C (17.7%)

            Registered in EUDAMED under IVDD with this code: 100 of 101 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 100 IVD general (99.0%)
            • 1 IVD self-testing (0.9%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105040605Respiratory Syncytial Virus (Rsv)IVDD 100.0% IVD general · n=35terminal

            Registered in EUDAMED under IVDD with this code: 35 of 35 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 35 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105040606RotavirusIVDD 100.0% IVD general · n=44terminal

            Registered in EUDAMED under IVDD with this code: 44 of 44 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 44 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105040609Parvovirus B 19IVDD 100.0% IVD general · n=22terminal

            Registered in EUDAMED under IVDD with this code: 22 of 22 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 22 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105040611Dengue VirusIVDR 2 classes · n=28IVDD 100.0% IVD general · n=80terminal

            Registered in EUDAMED under IVDR with this code, the 28 devices are split across classes (as of 8 Sep 2026).

            • 20 Class C (71.4%)
            • 8 Class B (28.5%)

            Registered in EUDAMED under IVDD with this code: 80 of 80 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 80 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105040612Fsme VirusIVDD 100.0% IVD general · n=22terminal

            Registered in EUDAMED under IVDD with this code: 22 of 22 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 22 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105040613Lcm Virusterminal
          • W0105040614Hantavirus / Bunyavirusterminal
          • W0105040615Avian Influenzaterminal
          • W0105040616NorovirusIVDD 100.0% IVD general · n=25terminal

            Registered in EUDAMED under IVDD with this code: 25 of 25 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 25 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105040617Human Metapneumovirusterminal
          • W0105040618Bocavirusterminal
          • W0105040620Rhinovirusterminal
          • W0105040621Parechovirusterminal
          • W0105040622Bk Virusterminal
          • W0105040623Jc Virusterminal
          • W0105040624Hhv-6,7,8terminal
          • W0105040625Chikungunya VirusIVDD 100.0% IVD general · n=50terminal

            Registered in EUDAMED under IVDD with this code: 50 of 50 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 50 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105040626West Nile Virusterminal
          • W0105040627Ebola (Filovirus)terminal
          • W0105040628Crimean–congo Hemorrhagic Fever (Cchf)terminal
          • W0105040629Astrovirusterminal
          • W0105040630Zika VirusIVDD 100.0% IVD general · n=51terminal

            Registered in EUDAMED under IVDD with this code: 51 of 51 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 51 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105040699Viral Antigen/Antibody Detection - OtherIVDR 3 classes · n=33IVDD 99.5% IVD general · n=244terminal

            Registered in EUDAMED under IVDR with this code, the 33 devices are split across classes (as of 8 Sep 2026).

            • 21 Class A (63.6%)
            • 9 Class B (27.2%)
            • 3 Class C (9.0%)

            Registered in EUDAMED under IVDD with this code: 243 of 244 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 243 IVD general (99.5%)
            • 1 IVD self-testing (0.4%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01050401Rubella Virus
          • W0105040101Rubella Virus Antibodies - Totalterminal
          • W0105040102Rubella Virus Iggterminal
          • W0105040103Rubella Virus IgmIVDR 100.0% Class C · n=20terminal

            Registered in EUDAMED under IVDR with this code: 20 of 20 devices carry Class C on their registration (as of 8 Sep 2026).

            • 20 Class C (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0105040104Rubella - Na Reagentsterminal
          • W0105040199Rubella Virus Reagents - Otherterminal
        • W01050402Cytomegalovirus
          • W0105040201Cmv Antigenterminal
          • W0105040202Cmv Antibodies - Totalterminal
          • W0105040203Cmv IggIVDD 100.0% Annex II List B · n=23terminal

            Registered in EUDAMED under IVDD with this code: 23 of 23 devices carry Annex II List B on their registration (as of 8 Sep 2026).

            • 23 Annex II List B (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105040204Cmv IgmIVDR 100.0% Class C · n=24terminal

            Registered in EUDAMED under IVDR with this code: 24 of 24 devices carry Class C on their registration (as of 8 Sep 2026).

            • 24 Class C (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0105040205Cmv - Na ReagentsIVDR 100.0% Class C · n=29terminal

            Registered in EUDAMED under IVDR with this code: 29 of 29 devices carry Class C on their registration (as of 8 Sep 2026).

            • 29 Class C (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0105040206Cmv Igg - Avidityterminal
          • W0105040299Cmv Reagents - Otherterminal
        • W01050403Herpes Simplex Virus
          • W0105040301Hsv Antigenterminal
          • W0105040302Hsv 1+2 Antibodies - Totalterminal
          • W0105040303Hsv 1+2 IggIVDD 100.0% IVD general · n=30terminal

            Registered in EUDAMED under IVDD with this code: 30 of 30 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 30 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105040304Hsv 1+2 IgmIVDD 100.0% IVD general · n=36terminal

            Registered in EUDAMED under IVDD with this code: 36 of 36 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 36 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105040305Hsv 1 Antibodies - Totalterminal
          • W0105040306Hsv 1 IggIVDD 100.0% IVD general · n=30terminal

            Registered in EUDAMED under IVDD with this code: 30 of 30 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 30 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105040307Hsv 1 IgmIVDD 100.0% IVD general · n=22terminal

            Registered in EUDAMED under IVDD with this code: 22 of 22 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 22 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105040308Hsv 2 Antibodies - Totalterminal
          • W0105040309Hsv 2 IggIVDD 100.0% IVD general · n=31terminal

            Registered in EUDAMED under IVDD with this code: 31 of 31 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 31 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105040310Hsv 2 IgmIVDD 100.0% IVD general · n=21terminal

            Registered in EUDAMED under IVDD with this code: 21 of 21 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 21 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105040311Hsv - Na ReagentsIVDR 100.0% Class C · n=26IVDD 100.0% IVD general · n=75terminal

            Registered in EUDAMED under IVDR with this code: 26 of 26 devices carry Class C on their registration (as of 8 Sep 2026).

            • 26 Class C (100.0%)

            Registered in EUDAMED under IVDD with this code: 75 of 75 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 75 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105040399Hsv Reagents - Otherterminal
        • W01050404Epstein Barr Virus
          • W0105040401Ebv Antibodies
            • W010504040101Ebv Antibodies - Totalterminal
            • W010504040102Ebv Igg - Totalterminal
            • W010504040103Ebv Igm - Totalterminal
            • W010504040104Ebv Vca Igmterminal
            • W010504040105Ebv Vca IggIVDD 100.0% IVD general · n=33terminal

              Registered in EUDAMED under IVDD with this code: 33 of 33 devices carry IVD general on their registration (as of 8 Sep 2026).

              • 33 IVD general (100.0%)

              Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

            • W010504040106Ebv Ebna IggIVDD 100.0% IVD general · n=22terminal

              Registered in EUDAMED under IVDD with this code: 22 of 22 devices carry IVD general on their registration (as of 8 Sep 2026).

              • 22 IVD general (100.0%)

              Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

            • W010504040107Ebv Ea Igmterminal
            • W010504040108Ebv Ea Iggterminal
            • W010504040199Ebv Antibodies - OtherIVDD 100.0% IVD general · n=29terminal

              Registered in EUDAMED under IVDD with this code: 29 of 29 devices carry IVD general on their registration (as of 8 Sep 2026).

              • 29 IVD general (100.0%)

              Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105040403Ebv - Na ReagentsIVDR 100.0% Class C · n=26IVDD 100.0% IVD general · n=57terminal

            Registered in EUDAMED under IVDR with this code: 26 of 26 devices carry Class C on their registration (as of 8 Sep 2026).

            • 26 Class C (100.0%)

            Registered in EUDAMED under IVDD with this code: 57 of 57 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 57 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105040499Ebv Reagents - Otherterminal
        • W01050405Other Virology - Na Reagents
          • W0105040517Human Metapneumovirus - Na Reagentsterminal
          • W0105040518Bocavirus - Na Reagentsterminal
          • W0105040520Rhinovirus - Na Reagentsterminal
          • W0105040521Parechovirus - Na Reagentsterminal
          • W0105040522Bk Virus - Na ReagentsIVDR 100.0% Class C · n=20IVDD 100.0% IVD general · n=32terminal

            Registered in EUDAMED under IVDR with this code: 20 of 20 devices carry Class C on their registration (as of 8 Sep 2026).

            • 20 Class C (100.0%)

            Registered in EUDAMED under IVDD with this code: 32 of 32 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 32 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105040523Jc Virus - Na ReagentsIVDD 100.0% IVD general · n=22terminal

            Registered in EUDAMED under IVDD with this code: 22 of 22 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 22 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105040524Hhv-6,7,8 - Na ReagentsIVDR 100.0% Class C · n=45IVDD 100.0% IVD general · n=50terminal

            Registered in EUDAMED under IVDR with this code: 45 of 45 devices carry Class C on their registration (as of 8 Sep 2026).

            • 45 Class C (100.0%)

            Registered in EUDAMED under IVDD with this code: 50 of 50 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 50 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105040525Chikungunya Virus - Na ReagentsIVDR 100.0% Class C · n=24terminal

            Registered in EUDAMED under IVDR with this code: 24 of 24 devices carry Class C on their registration (as of 8 Sep 2026).

            • 24 Class C (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0105040526West Nile Virus - Na Reagentterminal
          • W0105040528Ebola (Filovirus) - Na Reagentsterminal
          • W0105040529Crimean–congo Hemorrhagic Fever (Cchf) - Na Reagentsterminal
          • W0105040530Astrovirus - Na Reagentsterminal
          • W0105040531Zika Virus - Na Reagentsterminal
          • W0105040532Monkeypox Virus / Mpox - Na ReagentIVDD 100.0% IVD general · n=21terminal

            Registered in EUDAMED under IVDD with this code: 21 of 21 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 21 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105040599Virology - Na Reagents - OtherIVDR 3 classes · n=155IVDD 100.0% IVD general · n=292terminal

            Registered in EUDAMED under IVDR with this code, the 155 devices are split across classes (as of 8 Sep 2026).

            • 75 Class C (48.3%)
            • 56 Class A (36.1%)
            • 24 Class B (15.4%)

            Registered in EUDAMED under IVDD with this code: 292 of 292 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 292 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105040501Adenovirus - Na ReagentsIVDR 100.0% Class C · n=36IVDD 100.0% IVD general · n=59terminal

            Registered in EUDAMED under IVDR with this code: 36 of 36 devices carry Class C on their registration (as of 8 Sep 2026).

            • 36 Class C (100.0%)

            Registered in EUDAMED under IVDD with this code: 59 of 59 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 59 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105040502Enterovirus - Na ReagentsIVDD 100.0% IVD general · n=61terminal

            Registered in EUDAMED under IVDD with this code: 61 of 61 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 61 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105040504Influenza & Para Influenza - Na ReagentsIVDR 100.0% Class B · n=63IVDD 100.0% IVD general · n=87terminal

            Registered in EUDAMED under IVDR with this code: 63 of 63 devices carry Class B on their registration (as of 8 Sep 2026).

            • 63 Class B (100.0%)

            Registered in EUDAMED under IVDD with this code: 87 of 87 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 87 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105040505Respiratory Syncytial Virus (Rsv) - Na ReagentsIVDR 100.0% Class B · n=29IVDD 100.0% IVD general · n=27terminal

            Registered in EUDAMED under IVDR with this code: 29 of 29 devices carry Class B on their registration (as of 8 Sep 2026).

            • 29 Class B (100.0%)

            Registered in EUDAMED under IVDD with this code: 27 of 27 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 27 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105040506Rotavirus - Na ReagentsIVDD 100.0% IVD general · n=23terminal

            Registered in EUDAMED under IVDD with this code: 23 of 23 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 23 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105040509Parvovirus B 19 - Na Reagentsterminal
          • W0105040511Dengue Virus - Na ReagentsIVDD 98.3% IVD general · n=62terminal

            Registered in EUDAMED under IVDD with this code: 61 of 62 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 61 IVD general (98.3%)
            • 1 Annex II List B (1.6%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105040512Fsme Virus - Na Reagentsterminal
          • W0105040513Lcm Virus - Na Reagentsterminal
          • W0105040514Hantavirus / Bunyavirus - Na Reagentsterminal
          • W0105040515Avian Influenza - Na ReagentsIVDD 100.0% IVD general · n=26terminal

            Registered in EUDAMED under IVDD with this code: 26 of 26 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 26 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105040516Norovirus - Na ReagentsIVDR 100.0% Class B · n=21IVDD 97.6% IVD general · n=42terminal

            Registered in EUDAMED under IVDR with this code: 21 of 21 devices carry Class B on their registration (as of 8 Sep 2026).

            • 21 Class B (100.0%)

            Registered in EUDAMED under IVDD with this code: 41 of 42 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 41 IVD general (97.6%)
            • 1 Annex II List B (2.3%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01050407Measles Virus
          • W0105040701Measles Virus Antibodies - Totalterminal
          • W0105040702Measles Virus Iggterminal
          • W0105040703Measles Virus Igmterminal
          • W0105040704Measles - Na Reagentsterminal
          • W0105040799Measles Virus Reagents - Otherterminal
        • W01050408Mumps / Parotitis Virus
          • W0105040801Mumps / Parotitis Virus Antibodies - Totalterminal
          • W0105040802Mumps / Parotitis Virus Iggterminal
          • W0105040803Mumps / Parotitis Virus Igmterminal
          • W0105040804Mumps / Parotitis - Na Reagentsterminal
          • W0105040899Mumps / Parotitis Virus Reagents - Otherterminal
        • W01050409Varicella Zoster Virus
          • W0105040901Varicella Zoster Virus Antibodies - Totalterminal
          • W0105040902Varicella Zoster Virus Iggterminal
          • W0105040903Varicella Zoster Virus Igmterminal
          • W0105040904Varicella Zoster - Na Reagentsterminal
          • W0105040999Varicella Zoster Virus Reagents - Otherterminal
        • W01050410Human Papilloma Virus
          • W0105041001Hpv Antigen / AntibodiesIVDD 100.0% IVD general · n=22terminal

            Registered in EUDAMED under IVDD with this code: 22 of 22 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 22 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105041002Screening High-Risk Hpv - Na ReagentsIVDR 100.0% Class C · n=28IVDD 100.0% IVD general · n=66terminal

            Registered in EUDAMED under IVDR with this code: 28 of 28 devices carry Class C on their registration (as of 8 Sep 2026).

            • 28 Class C (100.0%)

            Registered in EUDAMED under IVDD with this code: 66 of 66 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 66 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105041003Partial Genotyping High-Risk Hpv - Na ReagentsIVDR 2 classes · n=30IVDD 100.0% IVD general · n=112terminal

            Registered in EUDAMED under IVDR with this code, the 30 devices are split across classes (as of 8 Sep 2026).

            • 27 Class C (90.0%)
            • 3 Class A (10.0%)

            Registered in EUDAMED under IVDD with this code: 112 of 112 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 112 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105041004Full Genotyping High-Risk + Low-Risk Hpv - Na ReagentsIVDR 100.0% Class C · n=24IVDD 99.0% IVD general · n=104terminal

            Registered in EUDAMED under IVDR with this code: 24 of 24 devices carry Class C on their registration (as of 8 Sep 2026).

            • 24 Class C (100.0%)

            Registered in EUDAMED under IVDD with this code: 103 of 104 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 103 IVD general (99.0%)
            • 1 Annex II List B (0.9%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105041005Other Hpv - Na ReagentsIVDD 100.0% IVD general · n=51terminal

            Registered in EUDAMED under IVDD with this code: 51 of 51 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 51 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105041099Hpv Reagents - OtherIVDR 100.0% Class A · n=30terminal

            Registered in EUDAMED under IVDR with this code: 30 of 30 devices carry Class A on their registration (as of 8 Sep 2026).

            • 30 Class A (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

        • W01050411Coronavirus
          • W0105041101Coronavirus AgIVDD 96.3% IVD general · n=356terminal

            Registered in EUDAMED under IVDD with this code: 343 of 356 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 343 IVD general (96.3%)
            • 13 IVD self-testing (3.6%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105041102Coronavirus Antibodies - Totalterminal
          • W0105041103Coronavirus IggIVDD 100.0% IVD general · n=22terminal

            Registered in EUDAMED under IVDD with this code: 22 of 22 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 22 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105041104Coronavirus Igmterminal
          • W0105041105Coronavirus Igaterminal
          • W0105041106Coronavirus - Na ReagentsIVDR 100.0% Class B · n=46IVDD 100.0% IVD general · n=125terminal

            Registered in EUDAMED under IVDR with this code: 46 of 46 devices carry Class B on their registration (as of 8 Sep 2026).

            • 46 Class B (100.0%)

            Registered in EUDAMED under IVDD with this code: 125 of 125 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 125 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105041199Other Coronavirus ReagentsIVDD 100.0% IVD general · n=27terminal

            Registered in EUDAMED under IVDD with this code: 27 of 27 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 27 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01050499Virology Reagents - OtherIVDD 100.0% IVD general · n=49terminal

          Registered in EUDAMED under IVDD with this code: 49 of 49 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 49 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

      • W010505Parasitology (Infect. Immunology/Nat)
        • W01050501Toxoplasma
          • W0105050101Toxoplasma Antibody (Total)terminal
          • W0105050102Toxoplasma Antibody IggIVDR 100.0% Class C · n=26IVDD 100.0% Annex II List B · n=24terminal

            Registered in EUDAMED under IVDR with this code: 26 of 26 devices carry Class C on their registration (as of 8 Sep 2026).

            • 26 Class C (100.0%)

            Registered in EUDAMED under IVDD with this code: 24 of 24 devices carry Annex II List B on their registration (as of 8 Sep 2026).

            • 24 Annex II List B (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105050103Toxoplasma Antibody IgmIVDR 100.0% Class C · n=28IVDD 100.0% Annex II List B · n=22terminal

            Registered in EUDAMED under IVDR with this code: 28 of 28 devices carry Class C on their registration (as of 8 Sep 2026).

            • 28 Class C (100.0%)

            Registered in EUDAMED under IVDD with this code: 22 of 22 devices carry Annex II List B on their registration (as of 8 Sep 2026).

            • 22 Annex II List B (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105050104Toxoplasma Antibody Igg - Avidityterminal
          • W0105050105Toxoplasma - Na ReagentsIVDR 100.0% Class C · n=27terminal

            Registered in EUDAMED under IVDR with this code: 27 of 27 devices carry Class C on their registration (as of 8 Sep 2026).

            • 27 Class C (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0105050199Toxoplasma Reagents - Otherterminal
        • W01050502Miscellaneous Parasitology Immunoassay
          • W0105050201Entamoeba HistolyticaIVDD 100.0% IVD general · n=22terminal

            Registered in EUDAMED under IVDD with this code: 22 of 22 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 22 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105050202ChagasIVDD 100.0% IVD general · n=33terminal

            Registered in EUDAMED under IVDD with this code: 33 of 33 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 33 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105050203Distomatosisterminal
          • W0105050204Echinococcusterminal
          • W0105050205LeishmaniaIVDD 100.0% IVD general · n=26terminal

            Registered in EUDAMED under IVDD with this code: 26 of 26 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 26 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105050206Schistosomaterminal
          • W0105050207Cryptosporidiumterminal
          • W0105050208Giardia LambliaIVDD 100.0% IVD general · n=21terminal

            Registered in EUDAMED under IVDD with this code: 21 of 21 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 21 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105050209Plasmodium (Malaria)IVDD 100.0% IVD general · n=81terminal

            Registered in EUDAMED under IVDD with this code: 81 of 81 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 81 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105050210Trichomonasterminal
          • W0105050299Parasitology - OtherIVDD 100.0% IVD general · n=46terminal

            Registered in EUDAMED under IVDD with this code: 46 of 46 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 46 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01050503Miscellaneous Parasitology - Na Reagents
          • W0105050301Entamoeba Histolytica - Na Reagentsterminal
          • W0105050302Chagas - Na ReagentsIVDR 100.0% Class C · n=24terminal

            Registered in EUDAMED under IVDR with this code: 24 of 24 devices carry Class C on their registration (as of 8 Sep 2026).

            • 24 Class C (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0105050303Distomatosis - Na Reagentsterminal
          • W0105050304Echinococcus - Na Reagentsterminal
          • W0105050305Leishmania - Na Reagentsterminal
          • W0105050306Schistosoma - Na Reagentsterminal
          • W0105050307Cryptosporidium - Na Reagentsterminal
          • W0105050308Giardia Lamblia - Na Reagentsterminal
          • W0105050309Plasmodium (Malaria) - Na Reagentsterminal
          • W0105050310Trichomonas - Na Reagentsterminal
          • W0105050399Other Parasitology - Na ReagentsIVDR 2 classes · n=85terminal

            Registered in EUDAMED under IVDR with this code, the 85 devices are split across classes (as of 8 Sep 2026).

            • 79 Class B (92.9%)
            • 6 Class C (7.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

      • W010506Mycology (Infect. Immunology/Nat)
        • W01050603Mycology Immunoassays
          • W0105060301AspergillusIVDD 100.0% IVD general · n=54terminal

            Registered in EUDAMED under IVDD with this code: 54 of 54 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 54 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105060302Candida AlbicansIVDD 100.0% IVD general · n=45terminal

            Registered in EUDAMED under IVDD with this code: 45 of 45 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 45 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105060303CryptococcusIVDD 100.0% IVD general · n=33terminal

            Registered in EUDAMED under IVDD with this code: 33 of 33 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 33 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105060304Beta-D-Glucan (Pan-Fungal Markers)terminal
          • W0105060399Mycology Immunoassays - OtherIVDD 100.0% IVD general · n=25terminal

            Registered in EUDAMED under IVDD with this code: 25 of 25 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 25 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01050604Mycology - Na Reagents
          • W0105060401Aspergillus - Na ReagentsIVDD 100.0% IVD general · n=34terminal

            Registered in EUDAMED under IVDD with this code: 34 of 34 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 34 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105060402Candida Albicans - Na ReagentsIVDD 95.4% IVD general · n=22terminal

            Registered in EUDAMED under IVDD with this code: 21 of 22 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 21 IVD general (95.4%)
            • 1 Annex II List B (4.5%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105060403Cryptococcus - Na Reagentsterminal
          • W0105060404Candida Auris - Na ReagentsIVDR 96.1% Class C · n=26IVDD 100.0% IVD general · n=25terminal

            Registered in EUDAMED under IVDR with this code: 25 of 26 devices carry Class C on their registration (as of 8 Sep 2026).

            • 25 Class C (96.1%)
            • 1 Class B (3.8%)

            Registered in EUDAMED under IVDD with this code: 25 of 25 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 25 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105060405Pneumocystis - Na Reagentsterminal
          • W0105060499Mycology Na Reagents - OtherIVDD 100.0% IVD general · n=47terminal

            Registered in EUDAMED under IVDD with this code: 47 of 47 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 47 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

      • W010507Multiple Parameters - (Infect. Immunology/Nat)
        • W01050702Multiple Bacteria / Fungi Panels
          • W0105070201Gram+ - Gram- - Fungi - Multiplex Na ReagentsIVDR 100.0% Class C · n=26IVDD 98.0% IVD general · n=52terminal

            Registered in EUDAMED under IVDR with this code: 26 of 26 devices carry Class C on their registration (as of 8 Sep 2026).

            • 26 Class C (100.0%)

            Registered in EUDAMED under IVDD with this code: 51 of 52 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 51 IVD general (98.0%)
            • 1 Annex II List B (1.9%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105070202Blood Stream Infection/Sepsis (Bacteria & Fungi) - Multiplex Na ReagentsIVDD 100.0% IVD general · n=75terminal

            Registered in EUDAMED under IVDD with this code: 75 of 75 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 75 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105070203Gram+ - Gram- - Fungi - Multiplex AssaysIVDD 100.0% IVD general · n=35terminal

            Registered in EUDAMED under IVDD with this code: 35 of 35 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 35 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01050703Multiple Viruses Panels
          • W0105070301Hbv / Hcv / HIV Combination - Multiplex Na Reagentsterminal
          • W0105070302Other Virus Combinations - Multiplex Na ReagentsIVDR 2 classes · n=71IVDD 100.0% IVD general · n=65terminal

            Registered in EUDAMED under IVDR with this code, the 71 devices are split across classes (as of 8 Sep 2026).

            • 55 Class C (77.4%)
            • 16 Class B (22.5%)

            Registered in EUDAMED under IVDD with this code: 65 of 65 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 65 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105070303Immunosuppressed / Transplantation Monitoring - Multiplex Na Reagentsterminal
          • W0105070304Influenza & Para Influenza / Respiratory Syncytial Virus (Rsv) / Sars-Cov - Multiplex Na ReagentsIVDR 2 classes · n=23IVDD 100.0% IVD general · n=116terminal

            Registered in EUDAMED under IVDR with this code, the 23 devices are split across classes (as of 8 Sep 2026).

            • 21 Class B (91.3%)
            • 2 Class C (8.6%)

            Registered in EUDAMED under IVDD with this code: 116 of 116 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 116 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105070399Multiple Viruses - Multiplex Assays - OtherIVDR 2 classes · n=21IVDD 3 classes · n=134terminal

            Registered in EUDAMED under IVDR with this code, the 21 devices are split across classes (as of 8 Sep 2026).

            • 11 Class C (52.3%)
            • 10 Class B (47.6%)

            Registered in EUDAMED under IVDD with this code, the 134 devices are split across classes (as of 8 Sep 2026).

            • 117 IVD general (87.3%)
            • 14 Annex II List B (10.4%)
            • 3 IVD self-testing (2.2%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01050704Multiple Parasites PanelsIVDD 100.0% IVD general · n=26terminal

          Registered in EUDAMED under IVDD with this code: 26 of 26 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 26 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01050705Multiple Panels for Infections - Various
          • W0105070501Stis / Stds (C.trachomatis, N.gonorrhoeae ,m.genitalium, T.vaginalis, Ureaplasma Spp….) Combination - Multiplex Na ReagentsIVDR 100.0% Class C · n=171IVDD 2 classes · n=238terminal

            Registered in EUDAMED under IVDR with this code: 171 of 171 devices carry Class C on their registration (as of 8 Sep 2026).

            • 171 Class C (100.0%)

            Registered in EUDAMED under IVDD with this code, the 238 devices are split across classes (as of 8 Sep 2026).

            • 206 IVD general (86.5%)
            • 32 Annex II List B (13.4%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105070502Other Multiple Infectious - Multiplex Na ReagentsIVDR 2 classes · n=28IVDD 96.4% IVD general · n=85terminal

            Registered in EUDAMED under IVDR with this code, the 28 devices are split across classes (as of 8 Sep 2026).

            • 26 Class C (92.8%)
            • 2 Class B (7.1%)

            Registered in EUDAMED under IVDD with this code: 82 of 85 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 82 IVD general (96.4%)
            • 3 Annex II List B (3.5%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105070503Respiratory Tract Infections - Multiplex Na ReagentsIVDR 3 classes · n=226IVDD 3 classes · n=359terminal

            Registered in EUDAMED under IVDR with this code, the 226 devices are split across classes (as of 8 Sep 2026).

            • 125 Class B (55.3%)
            • 99 Class C (43.8%)
            • 2 Class A (0.8%)

            Registered in EUDAMED under IVDD with this code, the 359 devices are split across classes (as of 8 Sep 2026).

            • 335 IVD general (93.3%)
            • 23 Annex II List B (6.4%)
            • 1 Annex II List A (0.2%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105070504Gastrointestinal Infections - Multiplex Na ReagentsIVDR 2 classes · n=103IVDD 100.0% IVD general · n=193terminal

            Registered in EUDAMED under IVDR with this code, the 103 devices are split across classes (as of 8 Sep 2026).

            • 58 Class B (56.3%)
            • 45 Class C (43.6%)

            Registered in EUDAMED under IVDD with this code: 193 of 193 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 193 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105070505Meningitis / Encephalitis Infections - Multiplex Na ReagentsIVDR 100.0% Class C · n=51IVDD 97.2% IVD general · n=110terminal

            Registered in EUDAMED under IVDR with this code: 51 of 51 devices carry Class C on their registration (as of 8 Sep 2026).

            • 51 Class C (100.0%)

            Registered in EUDAMED under IVDD with this code: 107 of 110 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 107 IVD general (97.2%)
            • 3 Annex II List B (2.7%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105070506Tropical Fever - Multiplex Na ReagentsIVDD 100.0% IVD general · n=31terminal

            Registered in EUDAMED under IVDD with this code: 31 of 31 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 31 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105070507Tick Borne Diseases - Multiplex Na Reagentsterminal
          • W0105070599Multiple Infectious - Multiplex Assays - OtherIVDD 3 classes · n=93terminal

            Registered in EUDAMED under IVDD with this code, the 93 devices are split across classes (as of 8 Sep 2026).

            • 85 IVD general (91.3%)
            • 7 IVD self-testing (7.5%)
            • 1 Annex II List B (1.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01050799Multiple Viruses - OtherIVDD 100.0% IVD general · n=20terminal

          Registered in EUDAMED under IVDD with this code: 20 of 20 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 20 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

      • W010508Controls/Standards/Calibrators - (Infect. Immunology/Nat)
        • W01050808Controls - Infect. Immunology
          • W0105080801Bacteriology Controls - Inf.imm.IVDR 2 classes · n=56IVDD 2 classes · n=29terminal

            Registered in EUDAMED under IVDR with this code, the 56 devices are split across classes (as of 8 Sep 2026).

            • 37 Class B (66.0%)
            • 19 Class C (33.9%)

            Registered in EUDAMED under IVDD with this code, the 29 devices are split across classes (as of 8 Sep 2026).

            • 26 IVD general (89.6%)
            • 3 Annex II List B (10.3%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105080802Hepatitis Virus Controls - Inf.imm.IVDR 3 classes · n=49IVDD 100.0% IVD general · n=22terminal

            Registered in EUDAMED under IVDR with this code, the 49 devices are split across classes (as of 8 Sep 2026).

            • 19 Class B (38.7%)
            • 17 Class C (34.6%)
            • 13 Class D (26.5%)

            Registered in EUDAMED under IVDD with this code: 22 of 22 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 22 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105080803Retrovirus Controls - Inf.imm.terminal
          • W0105080804Other Virology Controls - Inf.imm.IVDR 2 classes · n=122IVDD 2 classes · n=57terminal

            Registered in EUDAMED under IVDR with this code, the 122 devices are split across classes (as of 8 Sep 2026).

            • 73 Class B (59.8%)
            • 49 Class C (40.1%)

            Registered in EUDAMED under IVDD with this code, the 57 devices are split across classes (as of 8 Sep 2026).

            • 47 IVD general (82.4%)
            • 10 Annex II List B (17.5%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105080805Parasitology Controls - Inf.imm.IVDR 2 classes · n=34terminal

            Registered in EUDAMED under IVDR with this code, the 34 devices are split across classes (as of 8 Sep 2026).

            • 30 Class C (88.2%)
            • 4 Class B (11.7%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0105080806Mycology Controls - Inf.imm.terminal
          • W0105080807Multiconstituent Controls - Inf.imm.IVDR 2 classes · n=105IVDD 2 classes · n=36terminal

            Registered in EUDAMED under IVDR with this code, the 105 devices are split across classes (as of 8 Sep 2026).

            • 83 Class B (79.0%)
            • 22 Class C (20.9%)

            Registered in EUDAMED under IVDD with this code, the 36 devices are split across classes (as of 8 Sep 2026).

            • 28 IVD general (77.7%)
            • 8 Annex II List B (22.2%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105080808All Infectious Diseases Controls - NatIVDR 3 classes · n=129IVDD 98.7% IVD general · n=77terminal

            Registered in EUDAMED under IVDR with this code, the 129 devices are split across classes (as of 8 Sep 2026).

            • 104 Class B (80.6%)
            • 24 Class C (18.6%)
            • 1 Class A (0.7%)

            Registered in EUDAMED under IVDD with this code: 76 of 77 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 76 IVD general (98.7%)
            • 1 Annex II List A (1.2%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105080899Controls - Inf. Immunology - OtherIVDR 3 classes · n=32IVDD 3 classes · n=50terminal

            Registered in EUDAMED under IVDR with this code, the 32 devices are split across classes (as of 8 Sep 2026).

            • 27 Class B (84.3%)
            • 3 Class C (9.3%)
            • 2 Class A (6.2%)

            Registered in EUDAMED under IVDD with this code, the 50 devices are split across classes (as of 8 Sep 2026).

            • 31 IVD general (62.0%)
            • 12 Annex II List A (24.0%)
            • 7 Annex II List B (14.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01050809Standards and Calibrators - Infect. Immunology/Nat
          • W0105080901Bacteriology Standards and Calibrators - Inf.imm.terminal
          • W0105080902Hepatitis Virus Standards and Calibrators - Inf.imm.terminal
          • W0105080903Retrovirus Standards and Calibrators - Inf.imm.terminal
          • W0105080904Other Virology Standards and Calibrators - Inf.imm.terminal
          • W0105080905Parasitology Standards and Calibrators - Inf.imm.terminal
          • W0105080906Mycology Standards and Calibrators - Inf.imm.terminal
          • W0105080907Multiconstituent Standards and Calibrators - Inf.imm.terminal
          • W0105080908Standards and Calibrators for All Infections/ Natterminal
          • W0105080999Standards and Calibrators - Inf. Immunology - Otherterminal
      • W010509Infectious Immunology - Rapid Tests & Point of Care
        • W01050901Bacteriology - Rt & Poc
          • W0105090101Chlamydia Ag - Rt & PocIVDR 100.0% Class C · n=30terminal

            Registered in EUDAMED under IVDR with this code: 30 of 30 devices carry Class C on their registration (as of 8 Sep 2026).

            • 30 Class C (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0105090102H. Pylori - Rt & PocIVDR 2 classes · n=45IVDD 2 classes · n=193terminal

            Registered in EUDAMED under IVDR with this code, the 45 devices are split across classes (as of 8 Sep 2026).

            • 33 Class B (73.3%)
            • 12 Class C (26.6%)

            Registered in EUDAMED under IVDD with this code, the 193 devices are split across classes (as of 8 Sep 2026).

            • 174 IVD general (90.1%)
            • 19 IVD self-testing (9.8%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105090103Strep. A - Rt & PocIVDR 2 classes · n=59IVDD 97.5% IVD general · n=122terminal

            Registered in EUDAMED under IVDR with this code, the 59 devices are split across classes (as of 8 Sep 2026).

            • 39 Class C (66.1%)
            • 20 Class B (33.8%)

            Registered in EUDAMED under IVDD with this code: 119 of 122 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 119 IVD general (97.5%)
            • 3 IVD self-testing (2.4%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105090104Strep. B - Rt & PocIVDD 100.0% IVD general · n=24terminal

            Registered in EUDAMED under IVDD with this code: 24 of 24 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 24 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105090105Syphilis - Rt & PocIVDR 100.0% Class C · n=36IVDD 100.0% IVD general · n=108terminal

            Registered in EUDAMED under IVDR with this code: 36 of 36 devices carry Class C on their registration (as of 8 Sep 2026).

            • 36 Class C (100.0%)

            Registered in EUDAMED under IVDD with this code: 108 of 108 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 108 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105090106Clost. Diff. Incl Gdh and/or Toxin A and B - Rt & PocIVDR 100.0% Class B · n=24IVDD 100.0% IVD general · n=54terminal

            Registered in EUDAMED under IVDR with this code: 24 of 24 devices carry Class B on their registration (as of 8 Sep 2026).

            • 24 Class B (100.0%)

            Registered in EUDAMED under IVDD with this code: 54 of 54 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 54 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105090107Meningitis Causitive Agents - Rt & Pocterminal
          • W0105090108Legionella - Rt & PocIVDD 100.0% IVD general · n=24terminal

            Registered in EUDAMED under IVDD with this code: 24 of 24 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 24 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105090109Strep. Pneumoniae - Rt & Pocterminal
          • W0105090199Bacteriology - Rt & Poc - OtherIVDR 3 classes · n=26IVDD 98.0% IVD general · n=463terminal

            Registered in EUDAMED under IVDR with this code, the 26 devices are split across classes (as of 8 Sep 2026).

            • 15 Class C (57.6%)
            • 10 Class B (38.4%)
            • 1 Class A (3.8%)

            Registered in EUDAMED under IVDD with this code: 454 of 463 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 454 IVD general (98.0%)
            • 9 Annex II List B (1.9%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01050902Hepatitis Viruses - Rt & Poc
          • W0105090201Hbsag - Rt & PocIVDD 100.0% Annex II List A · n=26terminal

            Registered in EUDAMED under IVDD with this code: 26 of 26 devices carry Annex II List A on their registration (as of 8 Sep 2026).

            • 26 Annex II List A (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105090202Hcv Antibody -Rt & PocIVDD 100.0% Annex II List A · n=27terminal

            Registered in EUDAMED under IVDD with this code: 27 of 27 devices carry Annex II List A on their registration (as of 8 Sep 2026).

            • 27 Annex II List A (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105090299Hepatitis Viruses - Rt & Poc - OtherIVDD 2 classes · n=46terminal

            Registered in EUDAMED under IVDD with this code, the 46 devices are split across classes (as of 8 Sep 2026).

            • 38 IVD general (82.6%)
            • 8 Annex II List A (17.3%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01050903Retroviruses Rt & Poc
          • W0105090301HIV 1 - Rt & Pocterminal
          • W0105090302HIV 1 / 2 - Rt & PocIVDR 100.0% Class D · n=31IVDD 100.0% Annex II List A · n=47terminal

            Registered in EUDAMED under IVDR with this code: 31 of 31 devices carry Class D on their registration (as of 8 Sep 2026).

            • 31 Class D (100.0%)

            Registered in EUDAMED under IVDD with this code: 47 of 47 devices carry Annex II List A on their registration (as of 8 Sep 2026).

            • 47 Annex II List A (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105090303HIV Ag/Ab Combi - Rt & Pocterminal
          • W0105090399Retroviruses - Rt & Poc - Otherterminal
        • W01050904Parasitology Rt & Poc
          • W0105090401Plasmodium (Malaria) - Rt & PocIVDR 100.0% Class C · n=34IVDD 99.5% IVD general · n=216terminal

            Registered in EUDAMED under IVDR with this code: 34 of 34 devices carry Class C on their registration (as of 8 Sep 2026).

            • 34 Class C (100.0%)

            Registered in EUDAMED under IVDD with this code: 215 of 216 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 215 IVD general (99.5%)
            • 1 Annex II List B (0.4%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105090499Parasites - Rt & Poc - OtherIVDR 100.0% Class B · n=20IVDD 97.0% IVD general · n=102terminal

            Registered in EUDAMED under IVDR with this code: 20 of 20 devices carry Class B on their registration (as of 8 Sep 2026).

            • 20 Class B (100.0%)

            Registered in EUDAMED under IVDD with this code: 99 of 102 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 99 IVD general (97.0%)
            • 3 Annex II List B (2.9%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01050905Coronavirus Rt & Poc
          • W0105090501Coronavirus Antigen (Ag) - Rt & PocIVDD 2 classes · n=143terminal

            Registered in EUDAMED under IVDD with this code, the 143 devices are split across classes (as of 8 Sep 2026).

            • 109 IVD general (76.2%)
            • 34 IVD self-testing (23.7%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105090502Coronavirus Antibody (Ab) - Rt & PocIVDD 100.0% IVD general · n=36terminal

            Registered in EUDAMED under IVDD with this code: 36 of 36 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 36 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105090599Other Coronavirus - Rt & Pocterminal
        • W01050906Multiple Pathogens - Rt & Poc
          • W0105090601Coronavirus / Influenza - Rt & PocIVDD 2 classes · n=99terminal

            Registered in EUDAMED under IVDD with this code, the 99 devices are split across classes (as of 8 Sep 2026).

            • 77 IVD general (77.7%)
            • 22 IVD self-testing (22.2%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105090699Other Multiple Pathogens - Rt & PocIVDR 2 classes · n=76IVDD 100.0% IVD general · n=326terminal

            Registered in EUDAMED under IVDR with this code, the 76 devices are split across classes (as of 8 Sep 2026).

            • 68 Class B (89.4%)
            • 8 Class C (10.5%)

            Registered in EUDAMED under IVDD with this code: 326 of 326 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 326 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01050940Controls, Standards and Calibrators Infectious Immunology - Rt & Poc
          • W0105094001Controls Infectious Immunology - Rt & PocIVDD 98.8% IVD general · n=263terminal

            Registered in EUDAMED under IVDD with this code: 260 of 263 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 260 IVD general (98.8%)
            • 3 Annex II List A (1.1%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105094002Standards and Calibrators Infectious Immunology - Rt & Pocterminal
        • W01050990Other Virology Rt & Poc
          • W0105099001Cmv - Rt & Pocterminal
          • W0105099002Rsv - Rt & PocIVDD 100.0% IVD general · n=53terminal

            Registered in EUDAMED under IVDD with this code: 53 of 53 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 53 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105099003Mononucleosis (Ebv) - Rt & PocIVDD 100.0% IVD general · n=37terminal

            Registered in EUDAMED under IVDD with this code: 37 of 37 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 37 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105099004Influenza A and /or B - Rt & PocIVDR 2 classes · n=34IVDD 96.2% IVD general · n=187terminal

            Registered in EUDAMED under IVDR with this code, the 34 devices are split across classes (as of 8 Sep 2026).

            • 19 Class B (55.8%)
            • 15 Class C (44.1%)

            Registered in EUDAMED under IVDD with this code: 180 of 187 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 180 IVD general (96.2%)
            • 7 IVD self-testing (3.7%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105099006Vzv - Rt & Pocterminal
          • W0105099007Dengue - Rt & PocIVDR 2 classes · n=50IVDD 100.0% IVD general · n=209terminal

            Registered in EUDAMED under IVDR with this code, the 50 devices are split across classes (as of 8 Sep 2026).

            • 31 Class C (62.0%)
            • 19 Class B (38.0%)

            Registered in EUDAMED under IVDD with this code: 209 of 209 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 209 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105099008Monkeypox Virus / Mpox Rt & PocIVDD 100.0% IVD general · n=67terminal

            Registered in EUDAMED under IVDD with this code: 67 of 67 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 67 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105099099Virology - Rt & Poc - OtherIVDR 2 classes · n=153IVDD 3 classes · n=812terminal

            Registered in EUDAMED under IVDR with this code, the 153 devices are split across classes (as of 8 Sep 2026).

            • 103 Class B (67.3%)
            • 50 Class C (32.6%)

            Registered in EUDAMED under IVDD with this code, the 812 devices are split across classes (as of 8 Sep 2026).

            • 707 IVD general (87.0%)
            • 104 IVD self-testing (12.8%)
            • 1 Annex II List B (0.1%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

      • W010590Other Infectious Immunology/Nat
        • W01059001Infectious Immunology
          • W0105900101Reagents for DNA and/or RNA Extraction and Preparation: Bacteria and/or VirusIVDR 100.0% Class A · n=1,866IVDD 100.0% IVD general · n=94terminal

            Registered in EUDAMED under IVDR with this code: 1,866 of 1,866 devices carry Class A on their registration (as of 8 Sep 2026).

            • 1,866 Class A (100.0%)

            Registered in EUDAMED under IVDD with this code: 94 of 94 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 94 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105900102Reagents for DNA and/or RNA Amplification and/or Detection: Bacteria and/or VirusIVDR 2 classes · n=61IVDD 100.0% IVD general · n=176terminal

            Registered in EUDAMED under IVDR with this code, the 61 devices are split across classes (as of 8 Sep 2026).

            • 43 Class A (70.4%)
            • 18 Class C (29.5%)

            Registered in EUDAMED under IVDD with this code: 176 of 176 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 176 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0105900103Supplemental Na ReagentsIVDR 100.0% Class A · n=85terminal

            Registered in EUDAMED under IVDR with this code: 85 of 85 devices carry Class A on their registration (as of 8 Sep 2026).

            • 85 Class A (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

        • W01059002Other Infectious Immunology Reagents
          • W0105900201Buffers (Unassignable ), Supplem. Reagents, EtcIVDR 98.9% Class A · n=91terminal

            Registered in EUDAMED under IVDR with this code: 90 of 91 devices carry Class A on their registration (as of 8 Sep 2026).

            • 90 Class A (98.9%)
            • 1 Class C (1.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0105900299Infectious Immunology - OtherIVDD 3 classes · n=24terminal

            Registered in EUDAMED under IVDD with this code, the 24 devices are split across classes (as of 8 Sep 2026).

            • 22 IVD general (91.6%)
            • 1 Annex II List B (4.1%)
            • 1 IVD self-testing (4.1%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

    • W0106Genetic Testing
      • W010601Inborn Gene or Chromosome Alterations
        • W01060101Monogenetic Disorders
          • W0106010101Cystic FibrosisIVDD 100.0% IVD general · n=25terminal

            Registered in EUDAMED under IVDD with this code: 25 of 25 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 25 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0106010102Duchenne Muscular Dystrophyterminal
          • W0106010103Factor V LeidenIVDD 95.0% IVD general · n=20terminal

            Registered in EUDAMED under IVDD with this code: 19 of 20 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 19 IVD general (95.0%)
            • 1 Annex II List B (5.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0106010104Fragile X Syndrometerminal
          • W0106010105Haemochromatosisterminal
          • W0106010106Haemophiliaterminal
          • W0106010107Huntington Choreaterminal
          • W0106010108Polycystic Kidney Diseaseterminal
          • W0106010109Sickle Cell Anemiaterminal
          • W0106010110Tay Sachs Diseaseterminal
          • W0106010111ThalassaemiaIVDD 100.0% IVD general · n=39terminal

            Registered in EUDAMED under IVDD with this code: 39 of 39 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 39 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0106010112Friedreich's Ataxiaterminal
          • W0106010113Spinocerebellar Ataxins Type 1,2,3,6,7,8terminal
          • W0106010114Prothrombin MutationIVDD 100.0% IVD general · n=20terminal

            Registered in EUDAMED under IVDD with this code: 20 of 20 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 20 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0106010115Combined Factor Ii / Factor V Leidenterminal
          • W0106010116Other Thrombophilia Mutations (Proc, Pros1, Mthfr, Serpinc1, Sepine1, F11, F12, F13, Other F2/F5)IVDD 100.0% IVD general · n=23terminal

            Registered in EUDAMED under IVDD with this code: 23 of 23 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 23 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0106010117Other Hemophilia Mutations (Vwf, F8, F9)terminal
          • W0106010118Myotonic Dystrophy Type 1 or Steinert's Diseaseterminal
          • W0106010199Monogenetic Disorders Tests - OtherIVDR 100.0% Class C · n=116IVDD 100.0% IVD general · n=101terminal

            Registered in EUDAMED under IVDR with this code: 116 of 116 devices carry Class C on their registration (as of 8 Sep 2026).

            • 116 Class C (100.0%)

            Registered in EUDAMED under IVDD with this code: 101 of 101 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 101 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01060102Polygenetic Disorders
          • W0106010201Alzheimer's Diseaseterminal
          • W0106010202Asthmaterminal
          • W0106010203Atherosclerosisterminal
          • W0106010204Diabetesterminal
          • W0106010205Hypertensionterminal
          • W0106010206Multiple Sclerosisterminal
          • W0106010207Osteoporosisterminal
          • W0106010299Polygenetic Disorders Tests - OtherIVDD 100.0% IVD general · n=38terminal

            Registered in EUDAMED under IVDD with this code: 38 of 38 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 38 IVD general (100.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01060103Chromosomal Disorders
          • W0106010301Down's Syndrometerminal
          • W0106010302Edwards Syndrometerminal
          • W0106010303Klinefelter Syndrometerminal
          • W0106010304Pätau Syndrometerminal
          • W0106010305Turner Syndrometerminal
          • W0106010306Multiple Detection of Chromosomal Disorders Teststerminal
          • W0106010399Chromosomal Disorders Tests - OtherIVDR 96.4% Class C · n=28IVDD 97.4% IVD general · n=78terminal

            Registered in EUDAMED under IVDR with this code: 27 of 28 devices carry Class C on their registration (as of 8 Sep 2026).

            • 27 Class C (96.4%)
            • 1 Class A (3.5%)

            Registered in EUDAMED under IVDD with this code: 76 of 78 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 76 IVD general (97.4%)
            • 2 Annex II List B (2.5%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01060104Polymorphisms
          • W0106010401Hla-TypingIVDR 100.0% Class C · n=28IVDD 2 classes · n=47terminal

            Registered in EUDAMED under IVDR with this code: 28 of 28 devices carry Class C on their registration (as of 8 Sep 2026).

            • 28 Class C (100.0%)

            Registered in EUDAMED under IVDD with this code, the 47 devices are split across classes (as of 8 Sep 2026).

            • 28 Annex II List B (59.5%)
            • 19 IVD general (40.4%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

          • W0106010402Lactose Intolerance (Polymorphisms)terminal
          • W0106010499Polymorphism Tests - OtherIVDR 3 classes · n=27IVDD 99.0% IVD general · n=207terminal

            Registered in EUDAMED under IVDR with this code, the 27 devices are split across classes (as of 8 Sep 2026).

            • 24 Class C (88.8%)
            • 2 Class D (7.4%)
            • 1 Class A (3.7%)

            Registered in EUDAMED under IVDD with this code: 205 of 207 devices carry IVD general on their registration (as of 8 Sep 2026).

            • 205 IVD general (99.0%)
            • 2 Annex II List B (0.9%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

      • W010602Acquired Gene or Chromosome Alterations
        • W01060201P53terminal
        • W01060202K-Rasterminal
        • W01060203Brca 1+2terminal
        • W01060204Retterminal
        • W01060205C-Mycterminal
        • W01060206Hnpccterminal
        • W01060207Apcterminal
        • W01060208T (9;22)IVDD 100.0% IVD general · n=32terminal

          Registered in EUDAMED under IVDD with this code: 32 of 32 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 32 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W01060209T (8;14)terminal
        • W01060210T (14;18)terminal
        • W01060211Inv (16)terminal
        • W01060212Telomeraseterminal
        • W01060213Her-2/Neu (Breast Cancer)terminal
        • W01060214Colorectal Cancer (Msi-H / Dmmr)terminal
        • W01060215Bladder Cancer Detection / Monitoringterminal
        • W01060299Tests for Acquired Genetic or Chromosomal Alterations - OtherIVDR 2 classes · n=264IVDD 100.0% IVD general · n=505terminal

          Registered in EUDAMED under IVDR with this code, the 264 devices are split across classes (as of 8 Sep 2026).

          • 243 Class C (92.0%)
          • 21 Class A (7.9%)

          Registered in EUDAMED under IVDD with this code: 505 of 505 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 505 IVD general (100.0%)

          Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

      • W010603Multiple Parameters - Genetic Testing
        • W01060301Pharmacogenomics
          • W0106030101Cyp 450 - Individual TestIVDR 2 classes · n=25terminal

            Registered in EUDAMED under IVDR with this code, the 25 devices are split across classes (as of 8 Sep 2026).

            • 15 Class C (60.0%)
            • 10 Class A (40.0%)

            Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

          • W0106030102Cyp 450 - Multiple Tests on Micro-Arraysterminal
          • W0106030103Cyp2c9terminal
          • W0106030104Cyp2c19terminal
          • W0106030105Vkorc1terminal
      • W010699Genetic Tests - OtherIVDR 2 classes · n=671IVDD 98.9% IVD general · n=396terminal

        Registered in EUDAMED under IVDR with this code, the 671 devices are split across classes (as of 8 Sep 2026).

        • 616 Class A (91.8%)
        • 55 Class C (8.1%)

        Registered in EUDAMED under IVDD with this code: 392 of 396 devices carry IVD general on their registration (as of 8 Sep 2026).

        • 392 IVD general (98.9%)
        • 4 Annex II List B (1.0%)

        Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

How W01 is structured

1,512
terminal codes, selectable in a device record
247
branch headings, not selectable
1,309
name a specific device type
13%
fallback entries: Other and Accessories

The Reagents branch runs 5 levels deep. 247 entries below are branch headings that group other codes rather than naming a device, so a classification has to resolve all the way down to one of the 1,512 codes marked terminal.

203 terminal codes are “- Other” entries, 13% of the branch. An “- Other” code is the residual slot for devices its siblings do not name, so it is worth ruling out every specific sibling before settling on one.

The largest sub-branch is W0102 (Immunochemistry (Immunology)), holding 536 of the 1,512 terminal codes.

Frequently asked questions

Which W01 codes can be used in a EUDAMED device record?
1,512 of the 1,759 codes listed under W01 (Reagents) are terminal and can be selected. The other 247 are branch headings that cannot.
How deep is the W01 hierarchy?
The W01 branch runs 5 levels below the group code. Its largest sub-branch is W0102 (Immunochemistry (Immunology)), which holds 536 of the 1,512 terminal codes.
How many W01 codes are catch-all entries?
203 terminal codes under W01 are "- Other" entries, 13% of the branch. The remaining 1,309 name a specific device type.

Not sure which level to stop at, or which of two plausible codes to submit? The guide to choosing an EMDN code walks the decision level by level, with a worked example and the mistakes that get a EUDAMED registration rejected.

Classifying more than a handful of devices?

EUDAMate maps your device list against all 6,773 terminal EMDN codes with confidence-scored suggestions you review and confirm. Start with a free Readiness Check on your own data.

Run a free Readiness Check

Other groups in category W

W02IVD InstrumentsW05IVD Generic Use Consumables

Source: European Commission, EMDN v2026 official release. Terminal codes are the only codes accepted in a EUDAMED device record. EMDN is a nomenclature, not a risk classification. MDR/IVDR class is determined separately.