EMDN W02: IVD Instruments

Complete hierarchy for EMDN group W02 in category W (In Vitro Diagnostic Medical Devices): 329 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.

  • W02IVD Instruments
    • W0201Chemistry / Immunochemistry Instruments
      • W020101Chemistry Instruments
        • W02010101Chemistry Analysers
          • W0201010101Chemistry Analysers - Low Routine (Random Access without Ise Mode Test/H <= 400)IVDR 100.0% Class A · n=320terminal

            Registered in EUDAMED under IVDR with this code: 320 of 320 devices carry Class A on their registration (as of 8 Sep 2026).

            • 320 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.

          • W0201010102Chemistry Analysers - Moderate Routine (Random Access without Ise Mode Test/H > 400 and <= 800)IVDR 100.0% Class A · n=92terminal

            Registered in EUDAMED under IVDR with this code: 92 of 92 devices carry Class A on their registration (as of 8 Sep 2026).

            • 92 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.

          • W0201010103Chemistry Analysers - Moderate to High Routine (Random Access without Ise Mode Test/H > 800 and <= 1.200)terminal
          • W0201010104Chemistry Analysers - High Routine (Random Access without Ise Mode Test/H > 1.200)terminal
          • W0201010105Chemistry Analysers - Low Routine (with Ise Mode Test/H <= 400)IVDR 100.0% Class A · n=77terminal

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

            • 77 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.

          • W0201010106Chemistry Analysers - Moderate Routine (with Ise Mode Test/H > 400 and <= 800)IVDR 100.0% Class A · n=80terminal

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

            • 80 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.

          • W0201010107Chemistry Analysers - Moderate to High Routine (with Ise Mode Test/H > 800 and <= 1.200)IVDR 100.0% Class A · n=51IVDD 100.0% IVD general · n=22terminal

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

            • 51 Class A (100.0%)

            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.

          • W0201010108Chemistry Analysers - High Routine (with Ise Mode Test/H > 1.200)terminal
          • W0201010180Chemistry Analysers - Hardware AccessoriesIVDR 100.0% Class A · n=40terminal

            Registered in EUDAMED under IVDR with this code: 40 of 40 devices carry Class A on their registration (as of 8 Sep 2026).

            • 40 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.

          • W0201010182Chemistry Analysers - Software AccessoriesIVDR 100.0% Class A · n=31terminal

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

            • 31 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.

          • W0201010185Chemistry Analysers - ConsumablesIVDR 100.0% Class A · n=182terminal

            Registered in EUDAMED under IVDR with this code: 182 of 182 devices carry Class A on their registration (as of 8 Sep 2026).

            • 182 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.

          • W0201010192Chemistry Analysers - IVD Medical Device Softwareterminal
        • W02010102Limited Panel Chemistry Analysers
          • W0201010201Urine Analysers
            • W020101020101Urine Strip ReadersIVDR 97.5% Class A · n=40terminal

              Registered in EUDAMED under IVDR with this code: 39 of 40 devices carry Class A on their registration (as of 8 Sep 2026).

              • 39 Class A (97.5%)
              • 1 Class 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.

            • W020101020102Semi-Automated Urine AnalysersIVDR 98.6% Class A · n=72terminal

              Registered in EUDAMED under IVDR with this code: 71 of 72 devices carry Class A on their registration (as of 8 Sep 2026).

              • 71 Class A (98.6%)
              • 1 Class C (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.

            • W020101020103Automated Urine AnalysersIVDR 2 classes · n=22IVDD 100.0% IVD general · n=39terminal

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

              • 17 Class A (77.2%)
              • 5 Class B (22.7%)

              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.

            • W020101020180Automated Urine Analysers - Hardware Accessoriesterminal
            • W020101020182Automated Urine Analysers - Software Accessoriesterminal
            • W020101020185Automated Urine Analysers - Consumablesterminal
            • W020101020192Automated Urine Analysers - IVD Medical Device Softwareterminal
          • W0201010202Urinary Sediment Devicesterminal
          • W0201010203Blood-Ammonia Checkersterminal
          • W0201010280Limited Panel Chemistry Analysers - Hardware Accessoriesterminal
          • W0201010282Limited Panel Chemistry Analysers - Software Accessoriesterminal
          • W0201010285Limited Panel Chemistry Analysers - Consumablesterminal
          • W0201010292Limited Panel Chemistry Analysers - IVD Medical Device Softwareterminal
          • W0201010299Limited Panel Chemistry Analysers - Otherterminal
        • W02010199Chemistry Instruments - OtherIVDR 100.0% Class A · n=79IVDD 3 classes · n=31terminal

          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%)

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

          • 23 Annex II List B (74.1%)
          • 5 IVD general (16.1%)
          • 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.

      • W020102Immunochemistry Instruments
        • W02010201Automated Immunochemistry Analysers
          • W0201020101Automated Immunochemistry Analysers - Low Routine (Throughput <= 100 Test/H)IVDR 100.0% Class A · n=233terminal

            Registered in EUDAMED under IVDR with this code: 233 of 233 devices carry Class A on their registration (as of 8 Sep 2026).

            • 233 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.

          • W0201020102Automated Immunochemistry Analysers - Moderate Routine (Throughput > 100 and <= 250 Test/H)IVDR 100.0% Class A · n=164terminal

            Registered in EUDAMED under IVDR with this code: 164 of 164 devices carry Class A on their registration (as of 8 Sep 2026).

            • 164 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.

          • W0201020103Automated Immunochemistry Analysers - Moderate to High Routine (Throughput > 250 and <= 700 Test/H)IVDR 100.0% Class A · n=68terminal

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

            • 68 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.

          • W0201020104Automated Immunochemistry Analysers - High Routine (Throughput > 700 Test/H)IVDR 100.0% Class A · n=42terminal

            Registered in EUDAMED under IVDR with this code: 42 of 42 devices carry Class A on their registration (as of 8 Sep 2026).

            • 42 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.

          • W0201020180Automated Immunochemistry Analysers - Hardware AccessoriesIVDR 100.0% Class A · n=32terminal

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

            • 32 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.

          • W0201020182Automated Immunochemistry Analysers - Software AccessoriesIVDR 100.0% Class A · n=37terminal

            Registered in EUDAMED under IVDR with this code: 37 of 37 devices carry Class A on their registration (as of 8 Sep 2026).

            • 37 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.

          • W0201020185Automated Immunochemistry Analysers - ConsumablesIVDR 100.0% Class A · n=152terminal

            Registered in EUDAMED under IVDR with this code: 152 of 152 devices carry Class A on their registration (as of 8 Sep 2026).

            • 152 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.

          • W0201020192Automated Immunochemistry Analysers - IVD Medical Device Softwareterminal
        • W02010202Limited Panel Immunochemistry Analysers
          • W0201020201Immunochemistry ReadersIVDR 100.0% Class A · n=196terminal

            Registered in EUDAMED under IVDR with this code: 196 of 196 devices carry Class A on their registration (as of 8 Sep 2026).

            • 196 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.

          • W0201020202Beta Particles Countersterminal
          • W0201020203Gamma Countersterminal
          • W0201020204Nephelometersterminal
          • W0201020205Turbidimetersterminal
          • W0201020280Limited Panel Immunochemistry Analysers - Hardware Accessoriesterminal
          • W0201020282Limited Panel Immunochemistry Analysers - Software Accessoriesterminal
          • W0201020285Limited Panel Immunochemistry Analysers - ConsumablesIVDR 100.0% Class A · n=29terminal

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

            • 29 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.

          • W0201020292Limited Panel Immunochemistry Analysers - IVD Medical Device Softwareterminal
          • W0201020299Limited Panel Immunochemistry Analysers - OtherIVDR 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.

        • W02010299Immunochemistry Instruments - OtherIVDR 100.0% Class A · n=110terminal

          Registered in EUDAMED under IVDR with this code: 110 of 110 devices carry Class A on their registration (as of 8 Sep 2026).

          • 110 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.

      • W020103Integrated / Modular Chemistry / Immunochemistry Instruments
        • W02010301Mixed Panel Multiparameter Analysers
          • W0201030101Mixed Panel Multiparameter Analysers - Low Routine (Throughput <= 800 Test/H)IVDR 100.0% Class A · n=20terminal

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

            • 20 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.

          • W0201030102Mixed Panel Multiparameter Analysers - Moderate Routine (Throughput > 800 and <= 2000 Test/H)terminal
          • W0201030103Mixed Panel Multiparameter Analysers - High Routine (Throughput > 2000 Test/H)terminal
          • W0201030180Mixed Panel Multiparameter Analysers - Hardware Accessoriesterminal
          • W0201030182Mixed Panel Multiparameter Analysers - Software Accessoriesterminal
          • W0201030185Mixed Panel Multiparameter Analysers - Consumablesterminal
          • W0201030192Mixed Panel Multiparameter Analysers - IVD Medical Device Softwareterminal
        • W02010399Integrated / Modular Chemistry / Immunochemistry Instruments - OtherIVDR 100.0% Class A · n=37terminal

          Registered in EUDAMED under IVDR with this code: 37 of 37 devices carry Class A on their registration (as of 8 Sep 2026).

          • 37 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.

      • W020104Blood Gas Analysis / Electrolyte Instruments
        • W02010401Blood Gas Analysers
          • W0201040101Blood Gas Analysers - with Classic Profile (Ph, Po2, Pco2, Hct + Electrolytes)IVDR 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.

          • W0201040102Blood Gas Analysers - with Additional Parameters (Ph, Po2, Pco2, Hct + Metabolites + Electrolytes, Co-Oximeter Parameters and Coagulation Parameters)IVDR 100.0% Class A · n=44terminal

            Registered in EUDAMED under IVDR with this code: 44 of 44 devices carry Class A on their registration (as of 8 Sep 2026).

            • 44 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.

          • W0201040180Blood Gas Analysers - Hardware Accessoriesterminal
          • W0201040182Blood Gas Analysers - Software Accessoriesterminal
          • W0201040185Blood Gas Analysers - Consumablesterminal
          • W0201040192Blood Gas Analysers - IVD Medical Device Softwareterminal
        • W02010402Limited Panel Analysers for Blood Gas Analysis / Electrolytes
          • W0201040201Ion Selective Electrolyte AnalysersIVDR 98.4% Class A · n=66terminal

            Registered in EUDAMED under IVDR with this code: 65 of 66 devices carry Class A on their registration (as of 8 Sep 2026).

            • 65 Class A (98.4%)
            • 1 Class 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.

          • W0201040202Flame Photometersterminal
          • W0201040203Chloride Analysersterminal
          • W0201040280Limited Panel Analysers for Blood Gas Analysis / Electrolyte - Hardware Accessoriesterminal
          • W0201040282Limited Panel Analysers for Blood Gas Analysis / Electrolytes - Software Accessoriesterminal
          • W0201040285Limited Panel Analysers for Blood Gas Analysis / Electrolytes - Consumablesterminal
          • W0201040292Limited Panel Analysers for Blood Gas Analysis / Electrolytes - IVD Medical Device Softwareterminal
          • W0201040299Limited Panel Analysers for Blood Gas Analysis / Electrolytes - Otherterminal
        • W02010499Blood Gas Analysis / Electrolyte Instruments - Otherterminal
      • W020105Electrophoresis / Chromatography Instruments
        • W02010501Electrophoresis Instruments
          • W0201050101Automated Electrophoresis Systemsterminal
          • W0201050102Limited Panel Electrophoresis Analysers
            • W020105010201Semi-Automated Electrophoresis Systemsterminal
            • W020105010202Capillary Electrophoresis Systemsterminal
            • W020105010203Densitometersterminal
            • W020105010280Limited Panel Electrophoresis Analysers - Hardware Accessoriesterminal
            • W020105010282Limited Panel Electrophoresis Analysers - Software Accessoriesterminal
            • W020105010285Limited Panel Electrophoresis Analysers - Consumablesterminal
            • W020105010292Limited Panel Electrophoresis Analysers - IVD Medical Device Softwareterminal
            • W020105010299Limited Panel Electrophoresis Analysers - Otherterminal
          • W0201050190Various Electrophoresis Instruments
            • W020105019001Electrophoretic Gel Processorsterminal
            • W020105019002Gel Documentation Systemsterminal
            • W020105019080Various Electrophoresis Instruments - Hardware Accessoriesterminal
            • W020105019082Various Electrophoresis Instruments - Software Accessoriesterminal
            • W020105019085Various Electrophoresis Instruments - Consumablesterminal
            • W020105019092Various Electrophoresis Instruments - IVD Medical Device Softwareterminal
            • W020105019099Various Electrophoresis Instruments - OtherIVDR 100.0% Class A · n=57terminal

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

              • 57 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.

        • W02010502Chromatography Instruments (Hplc)
          • W0201050201High Performance Liquid Chromatography SystemsIVDR 100.0% Class A · n=62IVDD 100.0% IVD general · n=27terminal

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

            • 62 Class A (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.

          • W0201050280High Performance Liquid Chromatography Systems - Hardware Accessoriesterminal
          • W0201050282High Performance Liquid Chromatography Systems - Software Accessoriesterminal
          • W0201050285High Performance Liquid Chromatography Systems - Consumablesterminal
          • W0201050292High Performance Liquid Chromatography Systems - IVD Medical Device Softwareterminal
          • W0201050299High Performance Liquid Chromatography Systems - Otherterminal
      • W020106Chemistry / Immunochemistry Rapid Tests + Poc Tests
        • W02010601Diabetes Monitoring
          • W0201060101Glycosilated Hemoglobin DevicesIVDR 3 classes · n=62IVDD 2 classes · n=32terminal

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

            • 55 Class A (88.7%)
            • 5 Class B (8.0%)
            • 2 Class C (3.2%)

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

            • 26 IVD general (81.2%)
            • 6 IVD self-testing (18.7%)

            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.

          • W0201060102Blood Glucose MetersIVDR 2 classes · n=82IVDD 3 classes · n=361terminal

            Registered in EUDAMED under IVDR with this code, the 82 devices are split across classes (as of 8 Sep 2026).

            • 65 Class C (79.2%)
            • 17 Class A (20.7%)

            Registered in EUDAMED under IVDD with this code, the 361 devices are split across classes (as of 8 Sep 2026).

            • 284 Annex II List B (78.6%)
            • 53 IVD self-testing (14.6%)
            • 24 IVD general (6.6%)

            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.

          • W0201060190Various Diabetes Monitoring Instruments
            • W020106019080Various Diabetes Monitoring Instruments - Hardware Accessoriesterminal
            • W020106019082Various Diabetes Monitoring Instruments - Software Accessoriesterminal
            • W020106019085Various Diabetes Monitoring Instruments - Consumablesterminal
            • W020106019092Various Diabetes Monitoring Instruments - IVD Medical Device Softwareterminal
            • W020106019099Various Diabetes Monitoring Instruments - Otherterminal
        • W02010690Various Rapid Test Chemistry / Immunochemistry Instruments ("point of Care" and/or Emergency)
          • W0201069001Cardiac Marker Portable Analysersterminal
          • W0201069002Blood Gas Portable Analysersterminal
          • W0201069003Alcohol Analysersterminal
          • W0201069004Bilirubinometersterminal
          • W0201069005Hemoximetersterminal
          • W0201069080Various Rapid Test Chemistry / Immunochemistry Instruments - Hardware Accessoriesterminal
          • W0201069082Various Rapid Test Chemistry / Immunochemistry Instruments - Software Accessoriesterminal
          • W0201069085Various Rapid Test Chemistry / Immunochemistry Instruments - Consumablesterminal
          • W0201069092Various Rapid Test Chemistry / Immunochemistry Instruments - IVD Medical Device Softwareterminal
          • W0201069099Various Rapid Test Chemistry / Immunochemistry Instruments - OtherIVDR 99.1% Class A · n=237IVDD 3 classes · n=84terminal

            Registered in EUDAMED under IVDR with this code: 235 of 237 devices carry Class A on their registration (as of 8 Sep 2026).

            • 235 Class A (99.1%)
            • 1 Class B (0.4%)
            • 1 Class C (0.4%)

            Registered in EUDAMED under IVDD with this code, the 84 devices are split across classes (as of 8 Sep 2026).

            • 38 IVD general (45.2%)
            • 27 Annex II List B (32.1%)
            • 19 IVD self-testing (22.6%)

            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.

      • W020107Urinalysis (Ur) - Laboratory Analysers
        • W02010701Urinalysis (Ur) - Laboratory Analysers- InstrumentsIVDR 100.0% Class A · n=90terminal

          Registered in EUDAMED under IVDR with this code: 90 of 90 devices carry Class A on their registration (as of 8 Sep 2026).

          • 90 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.

        • W02010780Urinalysis (Ur) - Laboratory Analysers - Hardware Accessoriesterminal
        • W02010782Urinalysis (Ur) - Laboratory Analysers - Software Accessoriesterminal
        • W02010785Urinalysis (Ur) - Laboratory Analysers - ConsumablesIVDR 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.

        • W02010792Urinalysis (Ur) - Laboratory Analysers- IVD Medical Device Softwareterminal
    • W0202Hematology / Histology / Cytology Instruments
      • W020201Haematology / Cell Counting
        • W02020101Automated 5 Part Differential Hematology Analysers
          • W0202010101Automated Whole Blood Hematology Analysers - Low Routine (Throughput <= 100 Samples/Hr)IVDR 2 classes · n=277IVDD 100.0% IVD general · n=129terminal

            Registered in EUDAMED under IVDR with this code, the 277 devices are split across classes (as of 8 Sep 2026).

            • 184 Class B (66.4%)
            • 93 Class A (33.5%)

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

            • 129 IVD general (100.0%)

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

          • W0202010102Automated Whole Blood Hematology Analysers - Moderate Routine (Throughput > 100 and <= 120 Samples/Hr)IVDR 96.5% Class B · n=29terminal

            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%)

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

          • W0202010103Automated Whole Blood Hematology Analysers - High Routine (Throughput > 120 Samples/Hr)terminal
          • W0202010180Automated Whole Blood Hematology Analysers - Hardware Accessoriesterminal
          • W0202010182Automated Whole Blood Hematology Analysers - Software Accessoriesterminal
          • W0202010185Automated Whole Blood Hematology Analysers - ConsumablesIVDR 2 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 A (88.8%)
            • 3 Class B (11.1%)

            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.

          • W0202010192Automated Whole Blood Hematology Analysers - IVD Medical Device Softwareterminal
        • W02020102Limited Panel Cell Counting Analysers
          • W0202010201Automated 3 Part Hematology AnalysersIVDR 2 classes · n=87IVDD 100.0% IVD general · n=59terminal

            Registered in EUDAMED under IVDR with this code, the 87 devices are split across classes (as of 8 Sep 2026).

            • 49 Class A (56.3%)
            • 38 Class B (43.6%)

            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.

          • W0202010202Semi-Automated Hematology Analysersterminal
          • W0202010280Limited Panel Cell Counting Analysers - Hardware Accessoriesterminal
          • W0202010282Limited Panel Cell Counting Analysers - Software Accessoriesterminal
          • W0202010285Limited Panel Cell Counting Analysers - Consumablesterminal
          • W0202010292Limited Panel Cell Counting Analysers - IVD Medical Device Softwareterminal
          • W0202010299Limited Panel Cell Counting Analysers - Otherterminal
        • W02020199Cell Counting Instruments - OtherIVDR 2 classes · n=67IVDD 2 classes · n=22terminal

          Registered in EUDAMED under IVDR with this code, the 67 devices are split across classes (as of 8 Sep 2026).

          • 63 Class A (94.0%)
          • 4 Class B (5.9%)

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

          • 17 IVD general (77.2%)
          • 5 IVD self-testing (22.7%)

          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.

      • W020202Hemostasis
        • W02020201Coagulometers
          • W0202020101Semi-Automated CoagulometersIVDR 100.0% Class A · n=99terminal

            Registered in EUDAMED under IVDR with this code: 99 of 99 devices carry Class A on their registration (as of 8 Sep 2026).

            • 99 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.

          • W0202020102Automated CoagulometersIVDR 100.0% Class A · n=157terminal

            Registered in EUDAMED under IVDR with this code: 157 of 157 devices carry Class A on their registration (as of 8 Sep 2026).

            • 157 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.

          • W0202020180Coagulometers - Hardware AccessoriesIVDR 100.0% Class A · n=147terminal

            Registered in EUDAMED under IVDR with this code: 147 of 147 devices carry Class A on their registration (as of 8 Sep 2026).

            • 147 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.

          • W0202020182Coagulometers - Software Accessoriesterminal
          • W0202020185Coagulometers - ConsumablesIVDR 100.0% Class A · n=86terminal

            Registered in EUDAMED under IVDR with this code: 86 of 86 devices carry Class A on their registration (as of 8 Sep 2026).

            • 86 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.

          • W0202020192Coagulometers - IVD Medical Device Softwareterminal
        • W02020290Various Hemostasis Instruments
          • W0202029001Thrombelastographsterminal
          • W0202029080Various Hemostasis Instruments - Hardware Accessoriesterminal
          • W0202029082Various Hemostasis Instruments - Software Accessoriesterminal
          • W0202029085Various Hemostasis Instruments - Consumablesterminal
          • W0202029092Various Hemostasis Instruments - IVD Medical Device Softwareterminal
          • W0202029099Various Hemostasis Instruments - OtherIVDR 100.0% Class A · n=38terminal

            Registered in EUDAMED under IVDR with this code: 38 of 38 devices carry Class A on their registration (as of 8 Sep 2026).

            • 38 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.

      • W020203Blood Grouping Instruments
        • W02020301Blood Grouping Analysers
          • W0202030101Blood Grouping Analysers - Manual or Semi-Automatedterminal
          • W0202030102Automated Blood Grouping AnalysersIVDR 100.0% Class A · n=60terminal

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

            • 60 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.

          • W0202030180Blood Grouping Analysers - Hardware Accessoriesterminal
          • W0202030182Blood Grouping Analysers - Software Accessoriesterminal
          • W0202030185Blood Grouping Analysers - Consumablesterminal
          • W0202030192Blood Grouping Analysers - IVD Medical Device Softwareterminal
        • W02020302Limited Panel Blood Grouping Analysers
          • W0202030201Immunohematology Readersterminal
          • W0202030202Transilluminatorsterminal
          • W0202030203Limited Panel Blood Grouping Analysers - Otherterminal
          • W0202030280Limited Panel Blood Grouping Analysers - Hardware Accessoriesterminal
          • W0202030282Limited Panel Blood Grouping Analysers - Software Accessoriesterminal
          • W0202030285Limited Panel Blood Grouping Analysers - Consumablesterminal
          • W0202030292Limited Panel Blood Grouping Analysers - IVD Medical Device Softwareterminal
        • W02020399Blood Grouping Instruments - Otherterminal
      • W020204Flow Cytometry Instruments
        • W02020401Cytoflowmeters
          • W0202040101Cytoflowmeters - Low Routineterminal
          • W0202040102Cytoflowmeters - Moderate Routineterminal
          • W0202040103Cytoflowmeters - High RoutineIVDR 100.0% Class A · n=72terminal

            Registered in EUDAMED under IVDR with this code: 72 of 72 devices carry Class A on their registration (as of 8 Sep 2026).

            • 72 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.

          • W0202040180Cytoflowmeters - Hardware Accessoriesterminal
          • W0202040182Cytoflowmeters - Software AccessoriesIVDR 100.0% Class A · n=21terminal

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

            • 21 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.

          • W0202040185Cytoflowmeters - Consumablesterminal
          • W0202040192Cytoflowmeters - IVD Medical Device Softwareterminal
        • W02020499Flow Cytometry Instruments - OtherIVDR 100.0% Class A · n=98terminal

          Registered in EUDAMED under IVDR with this code: 98 of 98 devices carry Class A on their registration (as of 8 Sep 2026).

          • 98 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.

      • W020205Histology / Cytology
        • W02020501Histological Samples Analysersterminal
        • W02020502Cervical Screening Systemsterminal
        • W02020503Laboratory Instruments for Microscopic Investigations
          • W0202050301Electron MicroscopesIVDR 100.0% Class A · n=141terminal

            Registered in EUDAMED under IVDR with this code: 141 of 141 devices carry Class A on their registration (as of 8 Sep 2026).

            • 141 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.

          • W0202050302Laser Scanning MicroscopesIVDR 100.0% Class A · n=23terminal

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

            • 23 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.

          • W0202050303Optical Laboratory MicroscopesIVDR 100.0% Class A · n=203terminal

            Registered in EUDAMED under IVDR with this code: 203 of 203 devices carry Class A on their registration (as of 8 Sep 2026).

            • 203 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.

          • W0202050304Digital Laboratory MicroscopesIVDR 100.0% Class A · n=128terminal

            Registered in EUDAMED under IVDR with this code: 128 of 128 devices carry Class A on their registration (as of 8 Sep 2026).

            • 128 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.

          • W0202050380Laboratory Instruments for Microscopic Investigations - Hardware AccessoriesIVDR 100.0% Class A · n=47terminal

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

            • 47 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.

          • W0202050382Laboratory Instruments for Microscopic Investigations - Software AccessoriesIVDR 100.0% Class A · n=25terminal

            Registered in EUDAMED under IVDR with this code: 25 of 25 devices carry Class A on their registration (as of 8 Sep 2026).

            • 25 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.

          • W0202050385Laboratory Instruments for Microscopic Investigations - ConsumablesIVDR 100.0% Class A · n=896terminal

            Registered in EUDAMED under IVDR with this code: 896 of 896 devices carry Class A on their registration (as of 8 Sep 2026).

            • 896 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.

          • W0202050392Laboratory Instruments for Microscopic Investigations - IVD Medical Device SoftwareIVDR 2 classes · n=31terminal

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

            • 17 Class C (54.8%)
            • 14 Class A (45.1%)

            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.

        • W02020590Various Processing Instruments for Hystology / Cytology
          • W0202059001Immunohistochemistry Processorsterminal
          • W0202059002Automated Slide StainersIVDR 100.0% Class A · n=222terminal

            Registered in EUDAMED under IVDR with this code: 222 of 222 devices carry Class A on their registration (as of 8 Sep 2026).

            • 222 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.

          • W0202059003Cryostat MicrotomesIVDR 100.0% Class A · n=106terminal

            Registered in EUDAMED under IVDR with this code: 106 of 106 devices carry Class A on their registration (as of 8 Sep 2026).

            • 106 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.

          • W0202059004Tissue Embedding ProcessorsIVDR 100.0% Class A · n=57terminal

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

            • 57 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.

          • W0202059005MicrotomesIVDR 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.

          • W0202059006Laser Microdissection Systemsterminal
          • W0202059007Micromanipulatorsterminal
          • W0202059008Automated CoverslippersIVDR 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.

          • W0202059009Paraffin Dispensersterminal
          • W0202059010Tissue ProcessorsIVDR 100.0% Class A · n=139terminal

            Registered in EUDAMED under IVDR with this code: 139 of 139 devices carry Class A on their registration (as of 8 Sep 2026).

            • 139 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.

          • W0202059011Sample Preparation Units for Chromosomic Analysisterminal
          • W0202059012Cooling Paraffin PlatesIVDR 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.

          • W0202059013Heated Forcepsterminal
          • W0202059014Solvent Distillersterminal
          • W0202059015Cutting Station for Histological SamplesIVDR 100.0% Class A · n=20terminal

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

            • 20 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.

          • W0202059016Automated Dewaxing Systemsterminal
          • W0202059017Cassette / Slide PrintersIVDR 100.0% Class A · n=63terminal

            Registered in EUDAMED under IVDR with this code: 63 of 63 devices carry Class A on their registration (as of 8 Sep 2026).

            • 63 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.

          • W0202059080Various Processing Instruments for Hystology / Cytology - Hardware AccessoriesIVDR 100.0% Class A · n=42terminal

            Registered in EUDAMED under IVDR with this code: 42 of 42 devices carry Class A on their registration (as of 8 Sep 2026).

            • 42 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.

          • W0202059082Various Processing Instruments for Hystology / Cytology - Software Accessoriesterminal
          • W0202059085Various Processing Instruments for Hystology / Cytology - ConsumablesIVDR 100.0% Class A · n=107terminal

            Registered in EUDAMED under IVDR with this code: 107 of 107 devices carry Class A on their registration (as of 8 Sep 2026).

            • 107 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.

          • W0202059092Various Processing Instruments for Hystology / Cytology - IVD Medical Device Softwareterminal
          • W0202059099Various Processing Instruments for Hystology / Cytology - OtherIVDR 100.0% Class A · n=121terminal

            Registered in EUDAMED under IVDR with this code: 121 of 121 devices carry Class A on their registration (as of 8 Sep 2026).

            • 121 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.

      • W020206Rapid Test Hematology / Histology / Cytology Instruments
        • W02020601Rapid Test Cell Count Instrumentsterminal
        • W02020602Rapid Test Hemostasis Instrumentsterminal
        • W02020680Rapid Test Hematology / Histology / Cytology Instruments - Hardware Accessoriesterminal
        • W02020682Rapid Test Hematology / Histology / Cytology Instruments - Software Accessoriesterminal
        • W02020685Rapid Test Hematology / Histology / Cytology Instruments - Consumablesterminal
        • W02020692Rapid Test Hematology / Histology / Cytology Instruments - IVD Medical Device Softwareterminal
        • W02020699Rapid Test Hematology / Histology / Cytology Instruments - OtherIVDR 100.0% Class A · n=36terminal

          Registered in EUDAMED under IVDR with this code: 36 of 36 devices carry Class A on their registration (as of 8 Sep 2026).

          • 36 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.

      • W020290Various Hematology / Histology /Cytology Instruments
        • W02029001Erythrocyte Sedimentation Rate DevicesIVDR 96.6% Class A · n=59terminal

          Registered in EUDAMED under IVDR with this code: 57 of 59 devices carry Class A on their registration (as of 8 Sep 2026).

          • 57 Class A (96.6%)
          • 2 Class B (3.3%)

          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.

        • W02029002Blood Photodynamic Treatment Unitsterminal
        • W02029003Automated Blood Component Extractorsterminal
        • W02029005Cytofluorometric Preparation Unitsterminal
        • W02029006Apheresis Unitsterminal
        • W02029007Immunomagnetic Cellular Separation Systemsterminal
        • W02029008Tubing Weldersterminal
        • W02029009Blood Bag Pressesterminal
        • W02029010Bag Sealersterminal
        • W02029080Various Hematology / Histology / Cytology Instruments - Hardware AccessoriesIVDR 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.

        • W02029082Various Hematology / Histology / Cytology Instruments - Software Accessoriesterminal
        • W02029085Various Hematology / Histology / Cytology Instruments - ConsumablesIVDR 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.

        • W02029092Various Hematology / Histology / Cytology Instruments - IVD Medical Device SoftwareIVDR 2 classes · n=45terminal

          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%)
          • 5 Class C (11.1%)

          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.

        • W02029099Various Hematology / Histology / Cytology Instruments - OtherIVDR 2 classes · n=48IVDD 95.6% IVD general · n=23terminal

          Registered in EUDAMED under IVDR with this code, the 48 devices are split across classes (as of 8 Sep 2026).

          • 45 Class A (93.7%)
          • 3 Class B (6.2%)

          Registered in EUDAMED under IVDD with this code: 22 of 23 devices carry IVD general on their registration (as of 8 Sep 2026).

          • 22 IVD general (95.6%)
          • 1 IVD self-testing (4.3%)

          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.

    • W0203Microbiology Instruments (Cultures)
      • W020301Microbiology Susceptibility / Identification
        • W02030101Antibiotic Susceptibility Analysers
          • W0203010180Antibiotic Susceptibility Analysers - Hardware AccessoriesIVDR 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.

          • W0203010182Antibiotic Susceptibility Analysers - Software Accessoriesterminal
          • W0203010185Antibiotic Susceptibility Analysers - ConsumablesIVDR 2 classes · n=126IVDD 100.0% IVD general · n=67terminal

            Registered in EUDAMED under IVDR with this code, the 126 devices are split across classes (as of 8 Sep 2026).

            • 73 Class B (57.9%)
            • 53 Class A (42.0%)

            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.

          • W0203010192Antibiotic Susceptibility Analysers - IVD Medical Device Softwareterminal
        • W02030199Antibiotic Susceptibility Analysers - Otherterminal
      • W020302Blood Cultures and Mycobacteria
        • W02030201Automated Blood Culture AnalysersIVDR 100.0% Class A · n=69terminal

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

          • 69 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.

        • W02030299Instruments for Blood Cultures and Mycobacteria - Otherterminal
      • W020303Mass - Spectrometry SystemIVDR 2 classes · n=38terminal

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

        • 32 Class A (84.2%)
        • 6 Class C (15.7%)

        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.

      • W020304Microbiology Gram Stainerterminal
      • W020305Plates Streaking Equipment (Streaker/ Incubator/ Reader)terminal
      • W020306Urinary Screening Systemterminal
      • W020390Various Microbiology Instruments
        • W02039001Colony Countersterminal
        • W02039002Carbon Dioxide Incubatorsterminal
        • W02039003Petri Dish Fillersterminal
        • W02039004Automated Slide Preparation Unitsterminal
        • W02039005Culture Medium Preparation Unitsterminal
        • W02039006DNA Thermal CyclersIVDR 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.

        • W02039080Various Microbiology Instruments - Hardware AccessoriesIVDR 100.0% Class A · n=24terminal

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

          • 24 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.

        • W02039082Various Microbiology Instruments - Software Accessoriesterminal
        • W02039085Various Microbiology Instruments - ConsumablesIVDR 100.0% Class A · n=27terminal

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

          • 27 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.

        • W02039092Various Microbiology Instruments - IVD Medical Device Softwareterminal
        • W02039099Various Microbiology Instruments - OtherIVDR 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.

    • W0204Infectious Immunology Instrumentsterminal
    • W0205Nucleic Acid Testing Instruments
      • W020501Nucleic Acid Testing Instruments Except Micro-Arrays
        • W02050101Nucleic Acid Hybridization UnitsIVDR 100.0% Class A · n=21terminal

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

          • 21 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.

        • W02050102Eukaryotic Cell Bioreactorsterminal
        • W02050103Blotting Systemsterminal
        • W02050104Karyotype Processing Automated Systemsterminal
        • W02050105Electroporation Devicesterminal
        • W02050106DNA Genomic Preparation DevicesIVDR 100.0% Class A · n=111terminal

          Registered in EUDAMED under IVDR with this code: 111 of 111 devices carry Class A on their registration (as of 8 Sep 2026).

          • 111 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.

        • W02050107Micro-Array Scannersterminal
        • W02050108Genetic System ReadersIVDR 100.0% Class A · n=27terminal

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

          • 27 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.

        • W02050109Cell Washersterminal
        • W02050110Microinjectorsterminal
        • W02050111Epithelial Voltohmmetersterminal
        • W02050112Genic Expression Monitoring Systemsterminal
        • W02050113Peptide Synthesizersterminal
        • W02050114Molecular Biology Scannersterminal
        • W02050115DNA SynthesizersIVDR 100.0% Class A · n=31terminal

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

          • 31 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.

        • W02050116Nucleic Acid Testing Integrated Extraction /Amplification /Detection SystemsIVDR 99.5% Class A · n=486terminal

          Registered in EUDAMED under IVDR with this code: 484 of 486 devices carry Class A on their registration (as of 8 Sep 2026).

          • 484 Class A (99.5%)
          • 2 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.

        • W02050180Nucleic Acid Testing Instruments Except Micro-Arrays - Hardware Accessoriesterminal
        • W02050182Nucleic Acid Testing Instruments Except Micro-Arrays - Software AccessoriesIVDR 98.3% Class A · n=60terminal

          Registered in EUDAMED under IVDR with this code: 59 of 60 devices carry Class A on their registration (as of 8 Sep 2026).

          • 59 Class A (98.3%)
          • 1 Class C (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.

        • W02050185Nucleic Acid Testing Instruments Except Micro-Arrays - ConsumablesIVDR 100.0% Class A · n=81terminal

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

          • 81 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.

        • W02050192Nucleic Acid Testing Instruments Except Micro-Arrays - IVD Medical Device SoftwareIVDR 3 classes · n=48IVDD 2 classes · n=39terminal

          Registered in EUDAMED under IVDR with this code, the 48 devices are split across classes (as of 8 Sep 2026).

          • 34 Class C (70.8%)
          • 11 Class A (22.9%)
          • 3 Class B (6.2%)

          Registered in EUDAMED under IVDD with this code, the 39 devices are split across classes (as of 8 Sep 2026).

          • 35 IVD general (89.7%)
          • 4 Annex II List B (10.2%)

          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.

        • W02050199Nucleic Acid Testing Instruments Except Micro-Arrays - OtherIVDR 100.0% Class A · n=107terminal

          Registered in EUDAMED under IVDR with this code: 107 of 107 devices carry Class A on their registration (as of 8 Sep 2026).

          • 107 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.

      • W020502Micro-Array Instruments
        • W02050201Micro-Array Analysersterminal
        • W02050202Micro-Arrays Preparation Unitsterminal
        • W02050280Micro-Array Instruments - Hardware Accessoriesterminal
        • W02050282Micro-Array Instruments - Software Accessoriesterminal
        • W02050285Micro-Array Instruments - Consumablesterminal
        • W02050292Micro-Array Instruments - IVD Medical Device Softwareterminal
        • W02050299Micro-Array Instruments - Otherterminal
      • W020503Nucleic Acid Testing Instruments - Rapid and Point of Care Tests
        • W02050301Nucleic Acid Testing Apparatuses - Rapid and Point of Care TestsIVDR 100.0% Class A · n=71terminal

          Registered in EUDAMED under IVDR with this code: 71 of 71 devices carry Class A on their registration (as of 8 Sep 2026).

          • 71 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.

        • W02050380Nucleic Acid Testing Instruments - Rapid and Point of Care Tests - Hardware Accessoriesterminal
        • W02050382Nucleic Acid Testing Instruments- Rapid and Point of Care Tests - Software Accessoriesterminal
        • W02050385Nucleic Acid Testing Instruments - Rapid and Point of Care Tests - Consumablesterminal
        • W02050392Nucleic Acid Testing Instruments - Rapid and Point of Care Tests - IVD Medical Device Softwareterminal
        • W02050399Nucleic Acid Testing Instruments - Rapid and Point of Care Tests - Otherterminal
    • W0206Sample Processing Systems
      • W020601Robotic Sample Processing Systems
        • W02060101Automated Systems for the Management of Pre and Post-AnalysisIVDR 100.0% Class A · n=146terminal

          Registered in EUDAMED under IVDR with this code: 146 of 146 devices carry Class A on their registration (as of 8 Sep 2026).

          • 146 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.

        • W02060102Automated Sample Transport SystemsIVDR 100.0% Class A · n=101terminal

          Registered in EUDAMED under IVDR with this code: 101 of 101 devices carry Class A on their registration (as of 8 Sep 2026).

          • 101 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.

        • W02060180Robotic Sample Processing Systems - Hardware AccessoriesIVDR 100.0% Class A · n=20terminal

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

          • 20 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.

        • W02060182Robotic Sample Processing Systems - Software Accessoriesterminal
        • W02060185Robotic Sample Processing Systems - ConsumablesIVDR 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.

        • W02060192Robotic Sample Processing Systems - IVD Medical Device Softwareterminal
        • W02060199Robotic Sample Processing Systems - OtherIVDR 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.

      • W020602Post-Analysis Sample Archiving Systems
        • W02060201Post-Analysis Sample Archiving Systems - Instrumentsterminal
        • W02060280Post-Analysis Sample Archiving Systems - Hardware Accessoriesterminal
        • W02060282Post-Analysis Sample Archiving Systems - Software Accessoriesterminal
        • W02060285Post-Analysis Sample Archiving Systems - Consumablesterminal
        • W02060292Post-Analysis Sample Archiving Systems - IVD Medical Device Softwareterminal
        • W02060299Post-Analysis Sample Archiving Systems - Otherterminal
      • W020690Various Sample Processing Instruments
        • W02069001AutosamplersIVDR 100.0% Class A · n=23terminal

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

          • 23 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.

        • W02069002Test Tube ApparatusesIVDD 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.

        • W02069003CentrifugesMDR 2 classes · n=69IVDR 100.0% Class A · n=968terminal

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

          • 63 Class I (91.3%)
          • 6 Class IIa (8.6%)

          Registered in EUDAMED under IVDR with this code: 968 of 968 devices carry Class A on their registration (as of 8 Sep 2026).

          • 968 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.

        • W02069004CytocentrifugesIVDR 100.0% Class A · n=39terminal

          Registered in EUDAMED under IVDR with this code: 39 of 39 devices carry Class A on their registration (as of 8 Sep 2026).

          • 39 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.

        • W02069005Refrigerated CentrifugesMDR 100.0% Class IIa · n=22IVDR 100.0% Class A · n=205terminal

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

          • 22 Class IIa (100.0%)

          Registered in EUDAMED under IVDR with this code: 205 of 205 devices carry Class A on their registration (as of 8 Sep 2026).

          • 205 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.

        • W02069006Ultracentrifugesterminal
        • W02069080Various Sample Processing Instruments - Hardware AccessoriesIVDR 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.

        • W02069082Various Sample Processing Instruments - Software AccessoriesIVDR 100.0% Class A · n=56terminal

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

          • 56 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.

        • W02069085Various Sample Processing Instruments - ConsumablesIVDR 100.0% Class A · n=118terminal

          Registered in EUDAMED under IVDR with this code: 118 of 118 devices carry Class A on their registration (as of 8 Sep 2026).

          • 118 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.

        • W02069092Various Sample Processing Instruments - IVD Medical Device SoftwareIVDD 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.

        • W02069099Various Sample Processing Instruments - OtherIVDR 100.0% Class A · n=461terminal

          Registered in EUDAMED under IVDR with this code: 461 of 461 devices carry Class A on their registration (as of 8 Sep 2026).

          • 461 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.

    • W0207General Purpose IVD Instruments
      • W020701Scales
        • W02070101Analytical Scalesterminal
        • W02070102Technical Scalesterminal
        • W02070103Blood Scalesterminal
      • W020702Cryogenics / FrozenMDR 2 classes · n=60terminal

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

        • 38 Class IIa (63.3%)
        • 22 Class I (36.6%)

        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.

      • W020703Biological Hoods and Cabinets
        • W02070301Biological HoodsMDR 100.0% Class I · n=31terminal

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

          • 31 Class I (100.0%)

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

        • W02070302Fume HoodsIVDR 100.0% Class A · n=24terminal

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

          • 24 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.

        • W02070303Laminar Airflow Hoodsterminal
        • W02070304Chemical Filtration Air ClosetsMDD 100.0% Class I · n=34terminal

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

          • 34 Class I (100.0%)

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

      • W020704Shakers and Homogenizers
        • W02070401Laboratory Shakersterminal
        • W02070402Grinding Millsterminal
        • W02070403Homogenizersterminal
        • W02070404Blood Bag Mixersterminal
      • W020790Various General Purpose IVD Instruments
        • W02079001Thermostatic Water Bathsterminal
        • W02079002Dilutersterminal
        • W02079003Dispensersterminal
        • W02079004Evaporatorsterminal
        • W02079006Bunsen Burnersterminal
        • W02079007Freeze Dryersterminal
        • W02079008Heating Mantlesterminal
        • W02079009Ph Metersterminal
        • W02079011Melting Point Devicesterminal
        • W02079012Laboratory Hotplatesterminal
        • W02079013Laboratory Refractometersterminal
        • W02079014Labware Dryersterminal
        • W02079015Laboratory Titratorsterminal
        • W02079016Viscosimetersterminal
        • W02079017Osmometersterminal
        • W02079080Various General Purpose IVD Instruments - Hardware AccessoriesIVDR 100.0% Class A · n=81terminal

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

          • 81 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.

        • W02079082Various General Purpose IVD Instruments - Software Accessoriesterminal
        • W02079085Various General Purpose IVD Instruments - ConsumablesIVDR 100.0% Class A · n=25terminal

          Registered in EUDAMED under IVDR with this code: 25 of 25 devices carry Class A on their registration (as of 8 Sep 2026).

          • 25 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.

        • W02079092Various General Purpose IVD Instruments - IVD Medical Device SoftwareIVDR 3 classes · n=76IVDD 2 classes · n=24terminal

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

          • 58 Class A (76.3%)
          • 17 Class C (22.3%)
          • 1 Class B (1.3%)

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

          • 21 IVD general (87.5%)
          • 3 Annex II List B (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. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

        • W02079099Various General Purpose IVD Instruments - OtherIVDR 100.0% Class A · n=94terminal

          Registered in EUDAMED under IVDR with this code: 94 of 94 devices carry Class A on their registration (as of 8 Sep 2026).

          • 94 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.

    • W0299IVD Instruments - OtherMDR 100.0% Class I · n=103IVDR 99.8% Class A · n=576IVDD 100.0% IVD general · n=30terminal

      Registered in EUDAMED under MDR with this code: 103 of 103 devices carry Class I on their registration (as of 8 Sep 2026).

      • 103 Class I (100.0%)

      Registered in EUDAMED under IVDR with this code: 575 of 576 devices carry Class A on their registration (as of 8 Sep 2026).

      • 575 Class A (99.8%)
      • 1 Class B (0.1%)

      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.

How W02 is structured

329
terminal codes, selectable in a device record
58
branch headings, not selectable
264
name a specific device type
20%
fallback entries: Other and Accessories

The IVD Instruments branch runs 5 levels deep. 58 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 329 codes marked terminal.

31 terminal codes are “- Other” entries and 34 are “- Accessories” entries, 20% 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 W0201 (Chemistry / Immunochemistry Instruments), holding 113 of the 329 terminal codes.

Frequently asked questions

Which W02 codes can be used in a EUDAMED device record?
329 of the 387 codes listed under W02 (IVD Instruments) are terminal and can be selected. The other 58 are branch headings that cannot.
How deep is the W02 hierarchy?
The W02 branch runs 5 levels below the group code. Its largest sub-branch is W0201 (Chemistry / Immunochemistry Instruments), which holds 113 of the 329 terminal codes.
How many W02 codes are catch-all entries?
31 terminal codes under W02 are "- Other" entries and 34 are "- Accessories" entries, 20% of the branch. The remaining 264 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

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.