Which Z12 codes can be used in a EUDAMED device record?

994 of the 1,123 codes listed under Z12 (Instruments for Functional Explorations and Therapeutic Interventions) are terminal and can be selected. The other 129 are branch headings that cannot.

EMDN Z12: Instruments for Functional Explorations and Therapeutic Interventions

Complete hierarchy for EMDN group Z12 in category Z (Medical Equipment and Related Accessories, Software and Consumables): 994 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.

Z12Instruments for Functional Explorations and Therapeutic Interventions
- Z1201General and Multidisciplinary Surgery Instruments
  - Z120101Arteriotomy Ablatorsterminal
  - Z120102Cryosurgery EquipmentMDR 3 classes · n=188MDD 2 classes · n=175terminal
    Registered in EUDAMED under MDR with this code, the 188 devices are split across classes (as of 8 Sep 2026).
    78 Class IIb (41.4%)
    59 Class IIa (31.3%)
    51 Class I (27.1%)
    Registered in EUDAMED under MDD with this code, the 175 devices are split across classes (as of 8 Sep 2026).
    158 Class IIa (90.2%)
    17 Class IIb (9.7%)
    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.
  - Z120103Dermotomy EquipmentMDD 100.0% Class IIa · n=30terminal
    Registered in EUDAMED under MDD with this code: 30 of 30 devices carry Class IIa on their registration (as of 8 Sep 2026).
    30 Class IIa (100.0%)
    Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
  - Z120104Self–transfusion Equipmentterminal
  - Z120105Surgical Medical AspiratorsMDR 4 classes · n=621MDD 98.3% Class IIa · n=368terminal
    Registered in EUDAMED under MDR with this code, the 621 devices are split across classes (as of 8 Sep 2026).
    509 Class IIa (81.9%)
    78 Class I (12.5%)
    26 Class IIb (4.1%)
    8 Class III (1.2%)
    Registered in EUDAMED under MDD with this code: 362 of 368 devices carry Class IIa on their registration (as of 8 Sep 2026).
    362 Class IIa (98.3%)
    6 Class IIb (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.
  - Z120106HydrodissectorsMDD 95.0% Class IIb · n=20terminal
    Registered in EUDAMED under MDD with this code: 19 of 20 devices carry Class IIb on their registration (as of 8 Sep 2026).
    19 Class IIb (95.0%)
    1 Class IIa (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.
  - Z120107Scialytic Lamp Lighting Systems
    - Z12010701Fixed Scialytic LampsMDR 100.0% Class I · n=4,213terminal
      Registered in EUDAMED under MDR with this code: 4,213 of 4,213 devices carry Class I on their registration (as of 8 Sep 2026).
      4,213 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.
    - Z12010702Mobile Scialytic LampsMDR 100.0% Class I · n=611terminal
      Registered in EUDAMED under MDR with this code: 611 of 611 devices carry Class I on their registration (as of 8 Sep 2026).
      611 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.
    - Z12010780Scialytic Lamp Lighting Systems - Hardware AccessoriesMDR 100.0% Class I · n=478terminal
      Registered in EUDAMED under MDR with this code: 478 of 478 devices carry Class I on their registration (as of 8 Sep 2026).
      478 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.
    - Z12010785Scialytic Lamp Lighting Systems - Consumablesterminal
    - Z12010799Scialytic Lamp Lighting Systems - OtherMDR 100.0% Class I · n=460terminal
      Registered in EUDAMED under MDR with this code: 460 of 460 devices carry Class I on their registration (as of 8 Sep 2026).
      460 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.
  - Z120108Instruments for Ultrasonic Surgery
    - Z12010801Ultrasonic ScalpelMDR 98.3% Class IIb · n=122terminal
      Registered in EUDAMED under MDR with this code: 120 of 122 devices carry Class IIb on their registration (as of 8 Sep 2026).
      120 Class IIb (98.3%)
      2 Class IIa (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.
    - Z12010880Instruments for Ultrasonic Surgery - Hardware AccessoriesMDR 3 classes · n=183terminal
      Registered in EUDAMED under MDR with this code, the 183 devices are split across classes (as of 8 Sep 2026).
      143 Class IIa (78.1%)
      21 Class I (11.4%)
      19 Class IIb (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.
    - Z12010882Instruments for Ultrasonic Surgery - Software Accessoriesterminal
    - Z12010885Instruments for Ultrasonic Surgery - ConsumablesMDR 4 classes · n=194terminal
      Registered in EUDAMED under MDR with this code, the 194 devices are split across classes (as of 8 Sep 2026).
      96 Class IIa (49.4%)
      48 Class III (24.7%)
      38 Class I (19.5%)
      12 Class IIb (6.1%)
      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.
    - Z12010892Instruments for Ultrasonic Surgery - Medical Device Softwareterminal
  - Z120109Electrosurgical Instruments
    - Z12010901Diathermocoagulatorsterminal
    - Z12010902Electrosurgical Units (Esu) for General UseMDR 98.4% Class IIb · n=194MDD 98.3% Class IIb · n=560terminal
      Registered in EUDAMED under MDR with this code: 191 of 194 devices carry Class IIb on their registration (as of 8 Sep 2026).
      191 Class IIb (98.4%)
      3 Class I (1.5%)
      Registered in EUDAMED under MDD with this code: 551 of 560 devices carry Class IIb on their registration (as of 8 Sep 2026).
      551 Class IIb (98.3%)
      9 Class IIa (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.
    - Z12010903Argon Electrosurgical Units (Esu)terminal
    - Z12010904Endoscopic Electrosurgical Units (Esu)MDR 3 classes · n=51terminal
      Registered in EUDAMED under MDR with this code, the 51 devices are split across classes (as of 8 Sep 2026).
      39 Class I (76.4%)
      8 Class IIa (15.6%)
      4 Class IIb (7.8%)
      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.
    - Z12010905Radiosurgical UnitsMDR 3 classes · n=38MDD 96.1% Class IIb · n=52terminal
      Registered in EUDAMED under MDR with this code, the 38 devices are split across classes (as of 8 Sep 2026).
      29 Class IIb (76.3%)
      8 Class I (21.0%)
      1 Class IIa (2.6%)
      Registered in EUDAMED under MDD with this code: 50 of 52 devices carry Class IIb on their registration (as of 8 Sep 2026).
      50 Class IIb (96.1%)
      2 Class IIa (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.
    - Z12010980Electrosurgery Instruments - Hardware AccessoriesMDR 3 classes · n=542terminal
      Registered in EUDAMED under MDR with this code, the 542 devices are split across classes (as of 8 Sep 2026).
      484 Class I (89.2%)
      55 Class IIb (10.1%)
      3 Class IIa (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.
    - Z12010982Electrosurgery Instruments - Software Accessoriesterminal
    - Z12010985Electrosurgery Instruments - ConsumablesMDR 3 classes · n=218MDD 2 classes · n=42terminal
      Registered in EUDAMED under MDR with this code, the 218 devices are split across classes (as of 8 Sep 2026).
      154 Class IIb (70.6%)
      60 Class IIa (27.5%)
      4 Class I (1.8%)
      Registered in EUDAMED under MDD with this code, the 42 devices are split across classes (as of 8 Sep 2026).
      38 Class IIb (90.4%)
      4 Class I (9.5%)
      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.
    - Z12010992Electrosurgery Instruments - Medical Device Softwareterminal
    - Z12010999Electrosurgery Instruments - OtherMDR 3 classes · n=23MDD 2 classes · n=33terminal
      Registered in EUDAMED under MDR with this code, the 23 devices are split across classes (as of 8 Sep 2026).
      11 Class IIb (47.8%)
      9 Class I (39.1%)
      3 Class IIa (13.0%)
      Registered in EUDAMED under MDD with this code, the 33 devices are split across classes (as of 8 Sep 2026).
      17 Class IIb (51.5%)
      16 Class I (48.4%)
      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.
  - Z120110Laser Surgery Instruments
    - Z12011001Excimer Surgical Laserterminal
    - Z12011002Carbon Monoxide Surgical Laserterminal
    - Z12011003Holmium Surgical LaserMDR 100.0% Class IIb · n=20MDD 100.0% Class IIb · n=84terminal
      Registered in EUDAMED under MDR with this code: 20 of 20 devices carry Class IIb on their registration (as of 8 Sep 2026).
      20 Class IIb (100.0%)
      Registered in EUDAMED under MDD with this code: 84 of 84 devices carry Class IIb on their registration (as of 8 Sep 2026).
      84 Class IIb (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - Z12011004Krypton Surgical Laserterminal
    - Z12011005Carbon Dioxide Surgical LaserMDR 100.0% Class IIb · n=44MDD 100.0% Class IIb · n=45terminal
      Registered in EUDAMED under MDR with this code: 44 of 44 devices carry Class IIb on their registration (as of 8 Sep 2026).
      44 Class IIb (100.0%)
      Registered in EUDAMED under MDD with this code: 45 of 45 devices carry Class IIb on their registration (as of 8 Sep 2026).
      45 Class IIb (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - Z12011006Diode–pumped Solid–state (Dpss) Surgical LaserMDD 100.0% Class IIb · n=59terminal
      Registered in EUDAMED under MDD with this code: 59 of 59 devices carry Class IIb on their registration (as of 8 Sep 2026).
      59 Class IIb (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - Z12011007Dye Surgical Laserterminal
    - Z12011008Helium/Neon Surgical Laserterminal
    - Z12011009Copper Vapour Surgical Laserterminal
    - Z12011010Argon/Krypton Surgical Laserterminal
    - Z12011011Ktp Surgical Laserterminal
    - Z12011012Dye/Alexandrite Surgical LaserMDD 2 classes · n=45terminal
      Registered in EUDAMED under MDD with this code, the 45 devices are split across classes (as of 8 Sep 2026).
      34 Class IIb (75.5%)
      11 Class IIa (24.4%)
      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.
    - Z12011013Argon Surgical Laserterminal
    - Z12011014Erbium Surgical LaserMDD 100.0% Class IIb · n=42terminal
      Registered in EUDAMED under MDD with this code: 42 of 42 devices carry Class IIb on their registration (as of 8 Sep 2026).
      42 Class IIb (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - Z12011015Ruby Surgical Laserterminal
    - Z12011016Diode Surgical LaserMDR 2 classes · n=173MDD 100.0% Class IIb · n=133terminal
      Registered in EUDAMED under MDR with this code, the 173 devices are split across classes (as of 8 Sep 2026).
      157 Class IIb (90.7%)
      16 Class IIa (9.2%)
      Registered in EUDAMED under MDD with this code: 133 of 133 devices carry Class IIb on their registration (as of 8 Sep 2026).
      133 Class IIb (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - Z12011017Neodymium Surgical LaserMDR 97.7% Class IIb · n=44MDD 100.0% Class IIb · n=61terminal
      Registered in EUDAMED under MDR with this code: 43 of 44 devices carry Class IIb on their registration (as of 8 Sep 2026).
      43 Class IIb (97.7%)
      1 Class I (2.2%)
      Registered in EUDAMED under MDD with this code: 61 of 61 devices carry Class IIb on their registration (as of 8 Sep 2026).
      61 Class IIb (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - Z12011018Helium/Cadmium Surgical Laserterminal
    - Z12011019Multi–platform LaserMDR 96.4% Class IIb · n=140MDD 100.0% Class IIb · n=112terminal
      Registered in EUDAMED under MDR with this code: 135 of 140 devices carry Class IIb on their registration (as of 8 Sep 2026).
      135 Class IIb (96.4%)
      5 Class IIa (3.5%)
      Registered in EUDAMED under MDD with this code: 112 of 112 devices carry Class IIb on their registration (as of 8 Sep 2026).
      112 Class IIb (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - Z12011080Laser Surgery Instruments - Hardware AccessoriesMDR 3 classes · n=391MDD 2 classes · n=41terminal
      Registered in EUDAMED under MDR with this code, the 391 devices are split across classes (as of 8 Sep 2026).
      278 Class IIa (71.0%)
      59 Class I (15.0%)
      54 Class IIb (13.8%)
      Registered in EUDAMED under MDD with this code, the 41 devices are split across classes (as of 8 Sep 2026).
      32 Class IIb (78.0%)
      9 Class IIa (21.9%)
      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.
    - Z12011082Laser Surgery Instruments - Software Accessoriesterminal
    - Z12011085Laser Surgery Instruments - ConsumablesMDR 99.7% Class IIa · n=1,724MDD 98.8% Class IIa · n=89terminal
      Registered in EUDAMED under MDR with this code: 1,720 of 1,724 devices carry Class IIa on their registration (as of 8 Sep 2026).
      1,720 Class IIa (99.7%)
      4 Class I (0.2%)
      Registered in EUDAMED under MDD with this code: 88 of 89 devices carry Class IIa on their registration (as of 8 Sep 2026).
      88 Class IIa (98.8%)
      1 Class IIb (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.
    - Z12011092Laser Surgery Instruments - Medical Device Softwareterminal
    - Z12011099Laser Surgery Instruments - OtherMDR 3 classes · n=166MDD 3 classes · n=192terminal
      Registered in EUDAMED under MDR with this code, the 166 devices are split across classes (as of 8 Sep 2026).
      105 Class IIb (63.2%)
      46 Class IIa (27.7%)
      15 Class I (9.0%)
      Registered in EUDAMED under MDD with this code, the 192 devices are split across classes (as of 8 Sep 2026).
      177 Class IIa (92.1%)
      9 Class I (4.6%)
      6 Class IIb (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.
  - Z120111Instruments for Operative Microscopy
    - Z12011101Operative MicroscopesMDR 99.4% Class I · n=685terminal
      Registered in EUDAMED under MDR with this code: 681 of 685 devices carry Class I on their registration (as of 8 Sep 2026).
      681 Class I (99.4%)
      4 Class IIa (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.
    - Z12011180Instruments for Operative Microscopy - Hardware Accessories
      - Z1201118001Stands for Operative Microscopyterminal
      - Z1201118099Instruments for Operative Microscopy - Hardware Accessories - OtherMDR 100.0% Class I · n=526terminal
        Registered in EUDAMED under MDR with this code: 526 of 526 devices carry Class I on their registration (as of 8 Sep 2026).
        526 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.
    - Z12011182Instruments for Operative Microscopy - Software Accessoriesterminal
    - Z12011185Instruments for Operative Microscopy - Consumablesterminal
    - Z12011192Instruments for Operative Microscopy - Medical Device Softwareterminal
    - Z12011199Instruments for Operative Microscopy – Otherterminal
  - Z120112Patient Positioning Instruments
    - Z12011201Operating ChairsMDR 100.0% Class I · n=101terminal
      Registered in EUDAMED under MDR with this code: 101 of 101 devices carry Class I on their registration (as of 8 Sep 2026).
      101 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.
    - Z12011202Operating TablesMDR 100.0% Class I · n=1,729MDD 100.0% Class I · n=24terminal
      Registered in EUDAMED under MDR with this code: 1,729 of 1,729 devices carry Class I on their registration (as of 8 Sep 2026).
      1,729 Class I (100.0%)
      Registered in EUDAMED under MDD with this code: 24 of 24 devices carry Class I on their registration (as of 8 Sep 2026).
      24 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.
    - Z12011280Patient Positioning Instruments - Hardware AccessoriesMDR 100.0% Class I · n=2,713terminal
      Registered in EUDAMED under MDR with this code: 2,713 of 2,713 devices carry Class I on their registration (as of 8 Sep 2026).
      2,713 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.
    - Z12011285Patient Positioning Instruments - ConsumablesMDR 100.0% Class I · n=730MDD 100.0% Class I · n=32terminal
      Registered in EUDAMED under MDR with this code: 730 of 730 devices carry Class I on their registration (as of 8 Sep 2026).
      730 Class I (100.0%)
      Registered in EUDAMED under MDD with this code: 32 of 32 devices carry Class I on their registration (as of 8 Sep 2026).
      32 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.
    - Z12011299Patient Positioning Instruments – OtherMDR 99.9% Class I · n=2,258terminal
      Registered in EUDAMED under MDR with this code: 2,257 of 2,258 devices carry Class I on their registration (as of 8 Sep 2026).
      2,257 Class I (99.9%)
      1 Class IIb (<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.
  - Z120113Cleaning, Disinfection and Sterilisation Instruments
    - Z12011301Cleaning and Disinfection EquipmentMDR 3 classes · n=1,913MDD 2 classes · n=134terminal
      Registered in EUDAMED under MDR with this code, the 1,913 devices are split across classes (as of 8 Sep 2026).
      1,650 Class IIa (86.2%)
      149 Class IIb (7.7%)
      114 Class I (5.9%)
      Registered in EUDAMED under MDD with this code, the 134 devices are split across classes (as of 8 Sep 2026).
      116 Class IIb (86.5%)
      18 Class IIa (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.
    - Z12011302Ultrasonic Cleaning EquipmentMDR 99.6% Class I · n=578terminal
      Registered in EUDAMED under MDR with this code: 576 of 578 devices carry Class I on their registration (as of 8 Sep 2026).
      576 Class I (99.6%)
      2 Class IIb (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.
    - Z12011303Chemical Sterilisation Equipmentterminal
    - Z12011304Autoclaves with A Chamber Larger Than or Equal to 1 Standard Sterilisation UnitMDR 98.8% Class IIa · n=504MDD 99.0% Class IIb · n=530terminal
      Registered in EUDAMED under MDR with this code: 498 of 504 devices carry Class IIa on their registration (as of 8 Sep 2026).
      498 Class IIa (98.8%)
      3 Class I (0.5%)
      3 Class IIb (0.5%)
      Registered in EUDAMED under MDD with this code: 525 of 530 devices carry Class IIb on their registration (as of 8 Sep 2026).
      525 Class IIb (99.0%)
      5 Class IIa (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.
    - Z12011305Small Load Autoclaves with A Chamber Smaller Than 1 Standard Sterilisation UnitMDR 2 classes · n=539MDD 2 classes · n=104terminal
      Registered in EUDAMED under MDR with this code, the 539 devices are split across classes (as of 8 Sep 2026).
      363 Class IIb (67.3%)
      176 Class IIa (32.6%)
      Registered in EUDAMED under MDD with this code, the 104 devices are split across classes (as of 8 Sep 2026).
      98 Class IIb (94.2%)
      6 Class IIa (5.7%)
      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.
    - Z12011306Cleaning and Decontamination Systems for General and Multidisciplinary Surgery Instrumentsterminal
    - Z12011307Dry Air Sterilisersterminal
    - Z12011309Plasma SterilisersMDR 100.0% Class IIa · n=83MDD 100.0% Class IIb · n=36terminal
      Registered in EUDAMED under MDR with this code: 83 of 83 devices carry Class IIa on their registration (as of 8 Sep 2026).
      83 Class IIa (100.0%)
      Registered in EUDAMED under MDD with this code: 36 of 36 devices carry Class IIb on their registration (as of 8 Sep 2026).
      36 Class IIb (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - Z12011310Radiation Sterilisers
      - Z1201131001Radiation Sterilisers, X–rayterminal
      - Z1201131002Radiation Sterilisers, Gamma–rayterminal
      - Z1201131003Radiation Sterilisers, Microwaveterminal
      - Z1201131099Radiation Sterilisers - Otherterminal
    - Z12011311Endoscope WashersMDR 3 classes · n=35MDD 2 classes · n=58terminal
      Registered in EUDAMED under MDR with this code, the 35 devices are split across classes (as of 8 Sep 2026).
      17 Class I (48.5%)
      12 Class IIa (34.2%)
      6 Class IIb (17.1%)
      Registered in EUDAMED under MDD with this code, the 58 devices are split across classes (as of 8 Sep 2026).
      30 Class IIa (51.7%)
      28 Class IIb (48.2%)
      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.
    - Z12011312Endoscope Dryersterminal
    - Z12011313Endoscope Sterilisersterminal
    - Z12011314Endoscope Drying Cabinets and StorageMDR 100.0% Class I · n=103terminal
      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%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
    - Z12011380Cleaning, Disinfection and Sterilisation Instruments - Hardware AccessoriesMDR 95.7% Class I · n=593terminal
      Registered in EUDAMED under MDR with this code: 568 of 593 devices carry Class I on their registration (as of 8 Sep 2026).
      568 Class I (95.7%)
      19 Class IIa (3.2%)
      6 Class IIb (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.
    - Z12011382Cleaning, Disinfection and Sterilisation Instruments - Software Accessoriesterminal
    - Z12011385Cleaning, Disinfection and Sterilisation Instruments - ConsumablesMDR 3 classes · n=588terminal
      Registered in EUDAMED under MDR with this code, the 588 devices are split across classes (as of 8 Sep 2026).
      297 Class I (50.5%)
      277 Class IIa (47.1%)
      14 Class IIb (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.
    - Z12011392Cleaning, Disinfection and Sterilisation Instruments - Medical Device Softwareterminal
    - Z12011399Cleaning, Disinfection and Sterilisation Instruments - OtherMDR 100.0% Class I · n=1,918terminal
      Registered in EUDAMED under MDR with this code: 1,918 of 1,918 devices carry Class I on their registration (as of 8 Sep 2026).
      1,918 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.
  - Z120114Surgical Navigation Instruments
    - Z12011401Surgical Navigation SystemMDR 3 classes · n=128terminal
      Registered in EUDAMED under MDR with this code, the 128 devices are split across classes (as of 8 Sep 2026).
      73 Class I (57.0%)
      39 Class IIa (30.4%)
      16 Class IIb (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.
    - Z12011480Surgical Navigation Instruments - Hardware AccessoriesMDR 3 classes · n=469MDD 95.8% Class IIb · n=48terminal
      Registered in EUDAMED under MDR with this code, the 469 devices are split across classes (as of 8 Sep 2026).
      324 Class I (69.0%)
      139 Class IIa (29.6%)
      6 Class IIb (1.2%)
      Registered in EUDAMED under MDD with this code: 46 of 48 devices carry Class IIb on their registration (as of 8 Sep 2026).
      46 Class IIb (95.8%)
      2 Class IIa (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.
    - Z12011482Surgical Navigation Instruments - Software AccessoriesMDR 3 classes · n=32terminal
      Registered in EUDAMED under MDR with this code, the 32 devices are split across classes (as of 8 Sep 2026).
      15 Class IIa (46.8%)
      15 Class IIb (46.8%)
      2 Class I (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.
    - Z12011485Surgical Navigation Instruments - ConsumablesMDR 3 classes · n=99MDD 2 classes · n=24terminal
      Registered in EUDAMED under MDR with this code, the 99 devices are split across classes (as of 8 Sep 2026).
      54 Class I (54.5%)
      44 Class IIa (44.4%)
      1 Class III (1.0%)
      Registered in EUDAMED under MDD with this code, the 24 devices are split across classes (as of 8 Sep 2026).
      20 Class IIa (83.3%)
      4 Class I (16.6%)
      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.
    - Z12011492Surgical Navigation Instruments - Medical Device Softwareterminal
  - Z120190Various Instruments for General and Multidisciplinary Surgery
    - Z12019001Surgical Wire Application EquipmentMDR 100.0% Class I · n=111terminal
      Registered in EUDAMED under MDR with this code: 111 of 111 devices carry Class I on their registration (as of 8 Sep 2026).
      111 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.
    - Z12019002Equipment for the Transport of Organic Materialterminal
    - Z12019003Wound Treatment EquipmentMDR 3 classes · n=314MDD 3 classes · n=74terminal
      Registered in EUDAMED under MDR with this code, the 314 devices are split across classes (as of 8 Sep 2026).
      194 Class IIa (61.7%)
      73 Class I (23.2%)
      47 Class IIb (14.9%)
      Registered in EUDAMED under MDD with this code, the 74 devices are split across classes (as of 8 Sep 2026).
      45 Class IIb (60.8%)
      27 Class IIa (36.4%)
      2 Class III (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.
    - Z12019004Surgical Smoke Evacuation SystemsMDR 97.7% Class I · n=136terminal
      Registered in EUDAMED under MDR with this code: 133 of 136 devices carry Class I on their registration (as of 8 Sep 2026).
      133 Class I (97.7%)
      3 Class IIa (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.
    - Z12019005Dermographsterminal
    - Z12019006Photocoagulatorsterminal
    - Z12019007IrrigatorsMDR 3 classes · n=123terminal
      Registered in EUDAMED under MDR with this code, the 123 devices are split across classes (as of 8 Sep 2026).
      83 Class I (67.4%)
      39 Class IIa (31.7%)
      1 Class IIb (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.
    - Z12019008Blood HeatersMDR 2 classes · n=41MDD 96.6% Class IIb · n=60terminal
      Registered in EUDAMED under MDR with this code, the 41 devices are split across classes (as of 8 Sep 2026).
      33 Class IIa (80.4%)
      8 Class I (19.5%)
      Registered in EUDAMED under MDD with this code: 58 of 60 devices carry Class IIb on their registration (as of 8 Sep 2026).
      58 Class IIb (96.6%)
      2 Class IIa (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. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - Z12019009Thawing UnitsMDR 100.0% Class IIa · n=101terminal
      Registered in EUDAMED under MDR with this code: 101 of 101 devices carry Class IIa on their registration (as of 8 Sep 2026).
      101 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
    - Z12019010Patient Transfer SystemsMDR 100.0% Class I · n=112terminal
      Registered in EUDAMED under MDR with this code: 112 of 112 devices carry Class I on their registration (as of 8 Sep 2026).
      112 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.
    - Z12019080Various Instruments for General and Multidisciplinary Surgery - Hardware AccessoriesMDR 3 classes · n=228terminal
      Registered in EUDAMED under MDR with this code, the 228 devices are split across classes (as of 8 Sep 2026).
      196 Class I (85.9%)
      31 Class IIa (13.5%)
      1 Class IIb (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.
    - Z12019082Various Instruments for General and Multidisciplinary Surgery - Software Accessoriesterminal
    - Z12019085Various Instruments for General and Multidisciplinary Surgery - ConsumablesMDR 3 classes · n=61terminal
      Registered in EUDAMED under MDR with this code, the 61 devices are split across classes (as of 8 Sep 2026).
      37 Class IIa (60.6%)
      23 Class I (37.7%)
      1 Class IIb (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.
    - Z12019092Various Instruments for General and Multidisciplinary Surgery - Medical Device Softwareterminal
    - Z12019099Various Instruments for General and Multidisciplinary Surgery - OtherMDR 2 classes · n=749MDD 2 classes · n=29terminal
      Registered in EUDAMED under MDR with this code, the 749 devices are split across classes (as of 8 Sep 2026).
      554 Class I (73.9%)
      195 Class IIa (26.0%)
      Registered in EUDAMED under MDD with this code, the 29 devices are split across classes (as of 8 Sep 2026).
      27 Class IIa (93.1%)
      2 Class I (6.8%)
      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.
- Z1202Endoscopic and Minimally Invasive Surgery Instruments
  - Z120201Remote Control Robotic Endoscopic Surgery Instruments
    - Z12020101Robot-Assisted Endoscopic Surgery SystemsMDR 3 classes · n=126terminal
      Registered in EUDAMED under MDR with this code, the 126 devices are split across classes (as of 8 Sep 2026).
      64 Class IIb (50.7%)
      56 Class I (44.4%)
      6 Class IIa (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.
    - Z12020180Remote Control Robot-Assisted Endoscopic Surgery Instruments - Hardware Accessories
      - Z1202018001Robotic Arms for Videoendoscopyterminal
      - Z1202018002Command Consoles for Endoscopic Surgeryterminal
      - Z1202018099Remote Control Robot-Assisted Endoscopic Surgery Instruments - Hardware Accessories - OtherMDR 3 classes · n=125terminal
        Registered in EUDAMED under MDR with this code, the 125 devices are split across classes (as of 8 Sep 2026).
        103 Class I (82.4%)
        19 Class IIb (15.2%)
        3 Class IIa (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.
    - Z12020182Remote Control Robotic Endoscopic Surgery Instruments - Software Accessoriesterminal
    - Z12020185Remote Control Robot-Assisted Endoscopic Surgery Instruments - Consumablesterminal
    - Z12020192Remote Control Robot-Assisted Endoscopic Surgery Instruments - Medical Device Softwareterminal
    - Z12020199Remote Control Robot-Assisted Endoscopic Surgery Instruments - Otherterminal
  - Z120202Motorised Instruments for Endoscopic Surgery
    - Z12020201Motorised Systems for Endoscopic Surgeryterminal
    - Z12020280Motorised Instruments for Endoscopic Surgery - Hardware Accessoriesterminal
    - Z12020282Motorised Instruments for Endoscopic Surgery - Software Accessoriesterminal
    - Z12020285Motorised Instruments for Endoscopic Surgery - Consumablesterminal
    - Z12020292Motorised Instruments for Endoscopic Surgery - Medical Device Softwareterminal
  - Z120203Endoscopic Lithotripsy Instruments
    - Z12020301Electromechanical Endoscopic LithotriptersMDD 100.0% Class IIb · n=21terminal
      Registered in EUDAMED under MDD with this code: 21 of 21 devices carry Class IIb on their registration (as of 8 Sep 2026).
      21 Class IIb (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - Z12020302Ultrasonic Endoscopic Lithotriptersterminal
    - Z12020303Electrohydraulic Endoscopic Lithotriptersterminal
    - Z12020304Laser Endoscopic Lithotriptersterminal
    - Z12020380Endoscopic Lithotripsy Instruments - Hardware Accessoriesterminal
    - Z12020382Endoscopic Lithotripsy Instruments - Software Accessoriesterminal
    - Z12020385Endoscopic Lithotripsy Instruments - Consumablesterminal
    - Z12020392Endoscopic Lithotripsy Instruments - Medical Device Softwareterminal
  - Z120204Instruments for the Acquisition and Management of Endoscopic and Minimally Invasive Surgery Images
    - Z12020401Integrated Systems for the Acquisition and Management of Endoscopic and Minimally Invasive Surgery ImagesMDR 2 classes · n=450terminal
      Registered in EUDAMED under MDR with this code, the 450 devices are split across classes (as of 8 Sep 2026).
      383 Class I (85.1%)
      67 Class IIa (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.
    - Z12020402Light Sources for Endoscopy and Minimally Invasive SurgeryMDR 2 classes · n=431terminal
      Registered in EUDAMED under MDR with this code, the 431 devices are split across classes (as of 8 Sep 2026).
      316 Class I (73.3%)
      115 Class IIa (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.
    - Z12020403Modules for Endoscopic Imaging and Minimally Invasive SurgeryMDR 2 classes · n=35terminal
      Registered in EUDAMED under MDR with this code, the 35 devices are split across classes (as of 8 Sep 2026).
      28 Class I (80.0%)
      7 Class IIa (20.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
    - Z12020404Remote Control Units for Endoscopy and Minimally Invasive Surgeryterminal
    - Z12020405Surgical CamerasMDR 97.4% Class I · n=656terminal
      Registered in EUDAMED under MDR with this code: 639 of 656 devices carry Class I on their registration (as of 8 Sep 2026).
      639 Class I (97.4%)
      17 Class IIa (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.
    - Z12020406Video ProcessorsMDR 2 classes · n=493terminal
      Registered in EUDAMED under MDR with this code, the 493 devices are split across classes (as of 8 Sep 2026).
      373 Class I (75.6%)
      120 Class IIa (24.3%)
      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.
    - Z12020480Instruments for the Acquisition and Management of Endoscopic and Minimally Invasive Surgery Images - Hardware AccessoriesMDR 97.0% Class I · n=301terminal
      Registered in EUDAMED under MDR with this code: 292 of 301 devices carry Class I on their registration (as of 8 Sep 2026).
      292 Class I (97.0%)
      9 Class IIa (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.
    - Z12020482Instruments for the Acquisition and Management of Endoscopic and Minimally Invasive Surgery Images - Software Accessoriesterminal
    - Z12020485Instruments for the Acquisition and Management of Endoscopic and Minimally Invasive Surgery Images - ConsumablesMDR 100.0% Class I · n=23terminal
      Registered in EUDAMED under MDR with this code: 23 of 23 devices carry Class I on their registration (as of 8 Sep 2026).
      23 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.
    - Z12020492Instruments for the Acquisition and Management of Endoscopic and Minimally Invasive Surgery Images - Medical Device SoftwareMDR 96.6% Class I · n=30terminal
      Registered in EUDAMED under MDR with this code: 29 of 30 devices carry Class I on their registration (as of 8 Sep 2026).
      29 Class I (96.6%)
      1 Class IIa (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.
    - Z12020499Instruments for the Acquisition and Management of Endoscopic and Minimally Invasive Surgery Images – OtherMDR 100.0% Class I · n=78terminal
      Registered in EUDAMED under MDR with this code: 78 of 78 devices carry Class I on their registration (as of 8 Sep 2026).
      78 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.
  - Z120205Upper Gastrointestinal Tract Endoscopy Instruments
    - Z12020501CholedocoscopesMDR 100.0% Class IIa · n=84terminal
      Registered in EUDAMED under MDR with this code: 84 of 84 devices carry Class IIa on their registration (as of 8 Sep 2026).
      84 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
    - Z12020502Duodenoscopesterminal
    - Z12020503Echo–gastroscopesterminal
    - Z12020504Oesophagoscopesterminal
    - Z12020505Gastroduodenoscopesterminal
    - Z12020506Gastroscopesterminal
    - Z12020507Video CholedocoscopesMDR 100.0% Class IIa · n=65terminal
      Registered in EUDAMED under MDR with this code: 65 of 65 devices carry Class IIa on their registration (as of 8 Sep 2026).
      65 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
    - Z12020508Video Duodenoscopesterminal
    - Z12020509Video Oesophagoscopesterminal
    - Z12020510Video GastroduodenoscopesMDR 100.0% Class IIa · n=20terminal
      Registered in EUDAMED under MDR with this code: 20 of 20 devices carry Class IIa on their registration (as of 8 Sep 2026).
      20 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
    - Z12020511Video GastroscopesMDR 100.0% Class IIa · n=79MDD 100.0% Class IIa · n=21terminal
      Registered in EUDAMED under MDR with this code: 79 of 79 devices carry Class IIa on their registration (as of 8 Sep 2026).
      79 Class IIa (100.0%)
      Registered in EUDAMED under MDD with this code: 21 of 21 devices carry Class IIa on their registration (as of 8 Sep 2026).
      21 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - Z12020580Upper Gastrointestinal Tract Endoscopy Instruments - Hardware Accessoriesterminal
    - Z12020582Upper Gastrointestinal Tract Endoscopy Instruments - Software Accessoriesterminal
    - Z12020585Upper Gastrointestinal Tract Endoscopy Instruments - Consumablesterminal
    - Z12020592Upper Gastrointestinal Tract Endoscopy Instruments - Medical Device Softwareterminal
    - Z12020599Upper Gastrointestinal Tract Endoscopy Instruments - Otherterminal
  - Z120206Lower Gastrointestinal Tract Endoscopy Instruments
    - Z12020601ColonoscopesMDR 100.0% Class IIa · n=71terminal
      Registered in EUDAMED under MDR with this code: 71 of 71 devices carry Class IIa on their registration (as of 8 Sep 2026).
      71 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
    - Z12020602Sigmoidoscopesterminal
    - Z12020603ProctoscopesMDR 100.0% Class I · n=56terminal
      Registered in EUDAMED under MDR with this code: 56 of 56 devices carry Class I on their registration (as of 8 Sep 2026).
      56 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.
    - Z12020604Ultrasonic Proctoscopesterminal
    - Z12020605Rectoscopesterminal
    - Z12020606Video ColonoscopesMDR 100.0% Class IIa · n=160MDD 100.0% Class IIa · n=47terminal
      Registered in EUDAMED under MDR with this code: 160 of 160 devices carry Class IIa on their registration (as of 8 Sep 2026).
      160 Class IIa (100.0%)
      Registered in EUDAMED under MDD with this code: 47 of 47 devices carry Class IIa on their registration (as of 8 Sep 2026).
      47 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - Z12020607Video Enteroscopesterminal
    - Z12020608Video Sigmoidoscopesterminal
    - Z12020680Lower Gastrointestinal Tract Endoscopy Instruments - Hardware Accessoriesterminal
    - Z12020682Lower Gastrointestinal Tract Endoscopy Instruments - Software Accessoriesterminal
    - Z12020685Lower Gastrointestinal Tract Endoscopy Instruments - ConsumablesMDR 97.1% Class I · n=107MDD 2 classes · n=115terminal
      Registered in EUDAMED under MDR with this code: 104 of 107 devices carry Class I on their registration (as of 8 Sep 2026).
      104 Class I (97.1%)
      3 Class IIa (2.8%)
      Registered in EUDAMED under MDD with this code, the 115 devices are split across classes (as of 8 Sep 2026).
      76 Class IIa (66.0%)
      39 Class I (33.9%)
      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.
    - Z12020692Lower Gastrointestinal Tract Endoscopy Instruments - Medical Device Softwareterminal
    - Z12020699Lower Gastrointestinal Tract Endoscopy Instruments - Otherterminal
  - Z120207Genitourinary Endoscopy Instruments
    - Z12020701CystoscopesMDR 2 classes · n=427MDD 100.0% Class IIa · n=110terminal
      Registered in EUDAMED under MDR with this code, the 427 devices are split across classes (as of 8 Sep 2026).
      390 Class IIa (91.3%)
      37 Class I (8.6%)
      Registered in EUDAMED under MDD with this code: 110 of 110 devices carry Class IIa on their registration (as of 8 Sep 2026).
      110 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - Z12020702CystourethroscopesMDR 2 classes · n=73terminal
      Registered in EUDAMED under MDR with this code, the 73 devices are split across classes (as of 8 Sep 2026).
      41 Class I (56.1%)
      32 Class IIa (43.8%)
      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.
    - Z12020703ColposcopesMDR 98.5% Class I · n=135terminal
      Registered in EUDAMED under MDR with this code: 133 of 135 devices carry Class I on their registration (as of 8 Sep 2026).
      133 Class I (98.5%)
      2 Class IIa (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.
    - Z12020704HysteroscopesMDR 98.9% Class IIa · n=465MDD 100.0% Class IIa · n=35terminal
      Registered in EUDAMED under MDR with this code: 460 of 465 devices carry Class IIa on their registration (as of 8 Sep 2026).
      460 Class IIa (98.9%)
      5 Class I (1.0%)
      Registered in EUDAMED under MDD with this code: 35 of 35 devices carry Class IIa on their registration (as of 8 Sep 2026).
      35 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - Z12020705NephroscopesMDR 100.0% Class IIa · n=39MDD 100.0% Class IIa · n=48terminal
      Registered in EUDAMED under MDR with this code: 39 of 39 devices carry Class IIa on their registration (as of 8 Sep 2026).
      39 Class IIa (100.0%)
      Registered in EUDAMED under MDD with this code: 48 of 48 devices carry Class IIa on their registration (as of 8 Sep 2026).
      48 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - Z12020706Pelviscopesterminal
    - Z12020707ResectoscopesMDR 96.4% Class IIa · n=28MDD 96.8% Class IIa · n=63terminal
      Registered in EUDAMED under MDR with this code: 27 of 28 devices carry Class IIa on their registration (as of 8 Sep 2026).
      27 Class IIa (96.4%)
      1 Class I (3.5%)
      Registered in EUDAMED under MDD with this code: 61 of 63 devices carry Class IIa on their registration (as of 8 Sep 2026).
      61 Class IIa (96.8%)
      1 Class I (1.5%)
      1 Class IIb (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.
    - Z12020708Video Colposcopy Instruments
      - Z1202070801Video Colposcopy Systemsterminal
      - Z1202070880Video Colposcopy Instruments - Hardware Accessoriesterminal
      - Z1202070882Video Colposcopy Instruments - Software Accessoriesterminal
      - Z1202070885Video Colposcopy Instruments - Consumablesterminal
      - Z1202070892Video Colposcopy Instruments - Medical Device Softwareterminal
    - Z12020709UteroscopesMDR 100.0% Class IIa · n=69terminal
      Registered in EUDAMED under MDR with this code: 69 of 69 devices carry Class IIa on their registration (as of 8 Sep 2026).
      69 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
    - Z12020710Vaginoscopesterminal
    - Z12020711Video CystourethroscopesMDR 100.0% Class IIa · n=50terminal
      Registered in EUDAMED under MDR with this code: 50 of 50 devices carry Class IIa on their registration (as of 8 Sep 2026).
      50 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
    - Z12020712Video HysteroscopesMDR 100.0% Class IIa · n=20terminal
      Registered in EUDAMED under MDR with this code: 20 of 20 devices carry Class IIa on their registration (as of 8 Sep 2026).
      20 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
    - Z12020713UreterorenoscopesMDR 95.2% Class IIa · n=396MDD 100.0% Class IIa · n=53terminal
      Registered in EUDAMED under MDR with this code: 377 of 396 devices carry Class IIa on their registration (as of 8 Sep 2026).
      377 Class IIa (95.2%)
      19 Class I (4.7%)
      Registered in EUDAMED under MDD with this code: 53 of 53 devices carry Class IIa on their registration (as of 8 Sep 2026).
      53 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - Z12020780Genitourinary Endoscopy Instruments - Hardware AccessoriesMDR 2 classes · n=167terminal
      Registered in EUDAMED under MDR with this code, the 167 devices are split across classes (as of 8 Sep 2026).
      156 Class I (93.4%)
      11 Class IIa (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.
    - Z12020782Genitourinary Endoscopy Instruments - Software Accessoriesterminal
    - Z12020785Genitourinary Endoscopy Instruments - Consumablesterminal
    - Z12020792Genitourinary Endoscopy Instruments - Medical Device Softwareterminal
    - Z12020799Genitourinary Endoscopy Instruments – OtherMDR 2 classes · n=24terminal
      Registered in EUDAMED under MDR with this code, the 24 devices are split across classes (as of 8 Sep 2026).
      19 Class IIa (79.1%)
      5 Class I (20.8%)
      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.
  - Z120208Pulmonary Endoscopic Instruments
    - Z12020801BronchoscopesMDR 2 classes · n=226MDD 2 classes · n=32terminal
      Registered in EUDAMED under MDR with this code, the 226 devices are split across classes (as of 8 Sep 2026).
      201 Class IIa (88.9%)
      25 Class I (11.0%)
      Registered in EUDAMED under MDD with this code, the 32 devices are split across classes (as of 8 Sep 2026).
      16 Class I (50.0%)
      16 Class IIa (50.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - Z12020802Video BronchoscopesMDR 95.6% Class IIa · n=389MDD 100.0% Class IIa · n=41terminal
      Registered in EUDAMED under MDR with this code: 372 of 389 devices carry Class IIa on their registration (as of 8 Sep 2026).
      372 Class IIa (95.6%)
      17 Class I (4.3%)
      Registered in EUDAMED under MDD with this code: 41 of 41 devices carry Class IIa on their registration (as of 8 Sep 2026).
      41 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - Z12020880Pulmonary Endoscopic Instruments - Hardware Accessoriesterminal
    - Z12020882Pulmonary Endoscopic Instruments - Software Accessoriesterminal
    - Z12020885Pulmonary Endoscopic Instruments - ConsumablesMDR 2 classes · n=25terminal
      Registered in EUDAMED under MDR with this code, the 25 devices are split across classes (as of 8 Sep 2026).
      16 Class I (64.0%)
      9 Class IIa (36.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
    - Z12020892Pulmonary Endoscopic Instruments - Medical Device Softwareterminal
    - Z12020899Pulmonary Endoscopic Instruments - Otherterminal
  - Z120209Neuroendoscopy Instruments
    - Z12020901Encephaloscopesterminal
    - Z12020902Neuroscopesterminal
    - Z12020903SpinoscopesMDR 100.0% Class IIa · n=52terminal
      Registered in EUDAMED under MDR with this code: 52 of 52 devices carry Class IIa on their registration (as of 8 Sep 2026).
      52 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
    - Z12020980Neuroendoscopy Instruments - Hardware Accessoriesterminal
    - Z12020982Neuroendoscopy Instruments - Software Accessoriesterminal
    - Z12020985Neuroendoscopy Instruments - Consumablesterminal
    - Z12020992Neuroendoscopy Instruments - Medical Device Softwareterminal
    - Z12020999Neuroendoscopy Instruments - Otherterminal
  - Z120210ENT Endoscopy Instruments
    - Z12021001Pharyngoscopesterminal
    - Z12021002Video Pharyngoscopesterminal
    - Z12021003LaryngoscopesMDR 97.5% Class I · n=3,058MDD 2 classes · n=149terminal
      Registered in EUDAMED under MDR with this code: 2,984 of 3,058 devices carry Class I on their registration (as of 8 Sep 2026).
      2,984 Class I (97.5%)
      74 Class IIa (2.4%)
      Registered in EUDAMED under MDD with this code, the 149 devices are split across classes (as of 8 Sep 2026).
      125 Class I (83.8%)
      24 Class IIa (16.1%)
      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.
    - Z12021004Video LaryngoscopesMDR 2 classes · n=336MDD 2 classes · n=41terminal
      Registered in EUDAMED under MDR with this code, the 336 devices are split across classes (as of 8 Sep 2026).
      315 Class I (93.7%)
      21 Class IIa (6.2%)
      Registered in EUDAMED under MDD with this code, the 41 devices are split across classes (as of 8 Sep 2026).
      36 Class IIa (87.8%)
      5 Class I (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.
    - Z12021005Nasal Pharyngo/LaryngoscopesMDR 2 classes · n=26terminal
      Registered in EUDAMED under MDR with this code, the 26 devices are split across classes (as of 8 Sep 2026).
      21 Class I (80.7%)
      5 Class IIa (19.2%)
      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.
    - Z12021006Video Nasopharyngo/LaryngoscopesMDR 2 classes · n=184terminal
      Registered in EUDAMED under MDR with this code, the 184 devices are split across classes (as of 8 Sep 2026).
      155 Class I (84.2%)
      29 Class IIa (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.
    - Z12021007Middle Ear OtoscopesMDR 2 classes · n=421terminal
      Registered in EUDAMED under MDR with this code, the 421 devices are split across classes (as of 8 Sep 2026).
      367 Class I (87.1%)
      54 Class IIa (12.8%)
      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.
    - Z12021008RhinoscopesMDR 2 classes · n=396MDD 100.0% Class I · n=20terminal
      Registered in EUDAMED under MDR with this code, the 396 devices are split across classes (as of 8 Sep 2026).
      236 Class IIa (59.5%)
      160 Class I (40.4%)
      Registered in EUDAMED under MDD with this code: 20 of 20 devices carry Class I on their registration (as of 8 Sep 2026).
      20 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.
    - Z12021009Direct Outpatient Video-OtoscopesMDR 100.0% Class I · n=54terminal
      Registered in EUDAMED under MDR with this code: 54 of 54 devices carry Class I on their registration (as of 8 Sep 2026).
      54 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.
    - Z12021010Laryngostroboscopesterminal
    - Z12021011Motorised Rhinoscopy Surgery Instruments
      - Z1202101101Motorised Rhinoscopy Surgery Systemsterminal
      - Z1202101180Motorised Rhinoscopy Surgery Instruments - Hardware Accessoriesterminal
      - Z1202101182Motorised Rhinoscopy Surgery Instruments - Software Accessoriesterminal
      - Z1202101185Motorised Rhinoscopy Surgery Instruments - Consumablesterminal
      - Z1202101192Motorised Rhinoscopy Surgery Instruments - Medical Device Softwareterminal
    - Z12021080ENT Endoscopy Instruments - Hardware AccessoriesMDR 97.9% Class I · n=48terminal
      Registered in EUDAMED under MDR with this code: 47 of 48 devices carry Class I on their registration (as of 8 Sep 2026).
      47 Class I (97.9%)
      1 Class IIa (2.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
    - Z12021082ENT Endoscopy Instruments - Software Accessoriesterminal
    - Z12021085ENT Endoscopy Instruments - ConsumablesMDR 100.0% Class I · n=32terminal
      Registered in EUDAMED under MDR with this code: 32 of 32 devices carry Class I on their registration (as of 8 Sep 2026).
      32 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.
    - Z12021092ENT Endoscopy Instruments - Medical Device Softwareterminal
    - Z12021099ENT Endoscopy Instruments - OtherMDR 98.9% Class I · n=94terminal
      Registered in EUDAMED under MDR with this code: 93 of 94 devices carry Class I on their registration (as of 8 Sep 2026).
      93 Class I (98.9%)
      1 Class IIa (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.
  - Z120211Orthopaedic Endoscopy Instruments
    - Z12021101ArthroscopesMDR 98.1% Class IIa · n=321MDD 100.0% Class IIa · n=98terminal
      Registered in EUDAMED under MDR with this code: 315 of 321 devices carry Class IIa on their registration (as of 8 Sep 2026).
      315 Class IIa (98.1%)
      6 Class I (1.8%)
      Registered in EUDAMED under MDD with this code: 98 of 98 devices carry Class IIa on their registration (as of 8 Sep 2026).
      98 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - Z12021102Motorised Arthroscopic Surgery Instruments
      - Z1202110201Motorised Arthroscopic Surgery SystemsMDR 2 classes · n=39terminal
        Registered in EUDAMED under MDR with this code, the 39 devices are split across classes (as of 8 Sep 2026).
        32 Class I (82.0%)
        7 Class IIa (17.9%)
        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.
      - Z1202110280Motorised Arthroscopic Surgery Instruments - Hardware Accessoriesterminal
      - Z1202110282Motorised Arthroscopic Surgery Instruments - Software Accessoriesterminal
      - Z1202110285Motorised Arthroscopic Surgery Instruments - Consumablesterminal
      - Z1202110292Motorised Arthroscopic Surgery Instruments - Medical Device Softwareterminal
    - Z12021180Orthopaedic Endoscopy Instruments - Hardware Accessoriesterminal
    - Z12021182Orthopaedic Endoscopy Instruments - Software Accessoriesterminal
    - Z12021185Orthopaedic Endoscopy Instruments - Consumablesterminal
    - Z12021192Orthopaedic Endoscopy Instruments - Medical Device Softwareterminal
    - Z12021199Orthopaedic Endoscopy Instruments - OtherMDR 2 classes · n=120MDD 3 classes · n=71terminal
      Registered in EUDAMED under MDR with this code, the 120 devices are split across classes (as of 8 Sep 2026).
      79 Class I (65.8%)
      41 Class IIa (34.1%)
      Registered in EUDAMED under MDD with this code, the 71 devices are split across classes (as of 8 Sep 2026).
      32 Class I (45.0%)
      32 Class IIb (45.0%)
      7 Class IIa (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.
  - Z120212Endoscopic Capsules Instruments
    - Z12021201Endoscopic CapsulesMDD 100.0% Class IIa · n=33terminal
      Registered in EUDAMED under MDD with this code: 33 of 33 devices carry Class IIa on their registration (as of 8 Sep 2026).
      33 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - Z12021202Endoscopic Capsule Signal Receiversterminal
    - Z12021280Endoscopic Capsule Signal Receivers - Hardware Accessoriesterminal
    - Z12021282Endoscopic Capsule Signal Receivers - Software Accessoriesterminal
    - Z12021285Endoscopic Capsule Signal Receivers - Consumablesterminal
    - Z12021292Endoscopic Capsule Signal Receivers - Medical Device Softwareterminal
  - Z120290Various Instruments for Endoscopy and Mini-Invasive Surgery
    - Z12029001Amnioscopesterminal
    - Z12029002Angioscopesterminal
    - Z12029003Endoscope Transport CartsMDR 100.0% Class I · n=87terminal
      Registered in EUDAMED under MDR with this code: 87 of 87 devices carry Class I on their registration (as of 8 Sep 2026).
      87 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.
    - Z12029004Lacrimal Duct Endoscopesterminal
    - Z12029005Mammary Duct Endoscopesterminal
    - Z12029006Fibroscopes for Intubationterminal
    - Z12029007Infra–red Surgical Illuminatorsterminal
    - Z12029008Gas InflatorsMDR 3 classes · n=53MDD 3 classes · n=23terminal
      Registered in EUDAMED under MDR with this code, the 53 devices are split across classes (as of 8 Sep 2026).
      34 Class IIa (64.1%)
      18 Class IIb (33.9%)
      1 Class I (1.8%)
      Registered in EUDAMED under MDD with this code, the 23 devices are split across classes (as of 8 Sep 2026).
      11 Class IIb (47.8%)
      7 Class I (30.4%)
      5 Class IIa (21.7%)
      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.
    - Z12029009LaparoscopesMDR 2 classes · n=310MDD 100.0% Class IIa · n=88terminal
      Registered in EUDAMED under MDR with this code, the 310 devices are split across classes (as of 8 Sep 2026).
      294 Class IIa (94.8%)
      16 Class I (5.1%)
      Registered in EUDAMED under MDD with this code: 88 of 88 devices carry Class IIa on their registration (as of 8 Sep 2026).
      88 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - Z12029011Optical Heatersterminal
    - Z12029012Endoscopic Phlebotomy Systems with Transilluminationterminal
    - Z12029014Gas Pre–heating Unitsterminal
    - Z12029015Lens Cleaning UnitsMDR 2 classes · n=116terminal
      Registered in EUDAMED under MDR with this code, the 116 devices are split across classes (as of 8 Sep 2026).
      110 Class I (94.8%)
      6 Class IIa (5.1%)
      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.
    - Z12029016Video LaparoscopesMDR 98.7% Class IIa · n=78terminal
      Registered in EUDAMED under MDR with this code: 77 of 78 devices carry Class IIa on their registration (as of 8 Sep 2026).
      77 Class IIa (98.7%)
      1 Class I (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.
    - Z12029017Thoracoscopesterminal
    - Z12029080Various Instruments for Endoscopy and Mini-Invasive Surgery - Hardware AccessoriesMDR 3 classes · n=330terminal
      Registered in EUDAMED under MDR with this code, the 330 devices are split across classes (as of 8 Sep 2026).
      313 Class I (94.8%)
      14 Class IIa (4.2%)
      3 Class IIb (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.
    - Z12029082Various Instruments for Endoscopy and Mini-Invasive Surgery - Software Accessoriesterminal
    - Z12029085Various Instruments for Endoscopy and Mini-Invasive Surgery - ConsumablesMDR 3 classes · n=518MDD 3 classes · n=31terminal
      Registered in EUDAMED under MDR with this code, the 518 devices are split across classes (as of 8 Sep 2026).
      482 Class I (93.0%)
      20 Class IIb (3.8%)
      16 Class IIa (3.0%)
      Registered in EUDAMED under MDD with this code, the 31 devices are split across classes (as of 8 Sep 2026).
      22 Class IIa (70.9%)
      6 Class IIb (19.3%)
      3 Class I (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.
    - Z12029092Various Instruments for Endoscopy and Mini-Invasive Surgery - Medical Device Softwareterminal
    - Z12029099Various Instruments for Endoscopy and Mini–invasive Surgery – OtherMDR 3 classes · n=682MDD 2 classes · n=26terminal
      Registered in EUDAMED under MDR with this code, the 682 devices are split across classes (as of 8 Sep 2026).
      391 Class I (57.3%)
      290 Class IIa (42.5%)
      1 Class IIb (0.1%)
      Registered in EUDAMED under MDD with this code, the 26 devices are split across classes (as of 8 Sep 2026).
      20 Class IIa (76.9%)
      6 Class I (23.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
- Z1203Instruments to Support and Monitor Vital Signs
  - Z120301Anaesthesia and Pulmonary Ventilation Support Instruments
    - Z12030101Anaesthesia Systems
      - Z1203010101Anaesthesia DevicesMDR 2 classes · n=133MDD 97.6% Class IIb · n=127terminal
        Registered in EUDAMED under MDR with this code, the 133 devices are split across classes (as of 8 Sep 2026).
        126 Class IIb (94.7%)
        7 Class IIa (5.2%)
        Registered in EUDAMED under MDD with this code: 124 of 127 devices carry Class IIb on their registration (as of 8 Sep 2026).
        124 Class IIb (97.6%)
        3 Class IIa (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.
      - Z1203010180Anaesthesia Systems - Hardware AccessoriesMDR 98.1% Class IIb · n=222MDD 2 classes · n=86terminal
        Registered in EUDAMED under MDR with this code: 218 of 222 devices carry Class IIb on their registration (as of 8 Sep 2026).
        218 Class IIb (98.1%)
        2 Class I (0.9%)
        2 Class IIa (0.9%)
        Registered in EUDAMED under MDD with this code, the 86 devices are split across classes (as of 8 Sep 2026).
        76 Class IIb (88.3%)
        10 Class IIa (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.
      - Z1203010182Anaesthesia Systems - Software Accessoriesterminal
      - Z1203010185Anaesthesia Systems - Consumablesterminal
      - Z1203010192Anaesthesia Systems - Medical Device Softwareterminal
      - Z1203010199Anaesthesia Systems - Otherterminal
    - Z12030102Continuous Positive Pressure EquipmentMDR 3 classes · n=545MDD 2 classes · n=374terminal
      Registered in EUDAMED under MDR with this code, the 545 devices are split across classes (as of 8 Sep 2026).
      438 Class IIa (80.3%)
      100 Class I (18.3%)
      7 Class IIb (1.2%)
      Registered in EUDAMED under MDD with this code, the 374 devices are split across classes (as of 8 Sep 2026).
      321 Class IIa (85.8%)
      53 Class IIb (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.
    - Z12030103Pulmonary Ventilators for Non–hospital UseMDR 3 classes · n=21MDD 2 classes · n=388terminal
      Registered in EUDAMED under MDR with this code, the 21 devices are split across classes (as of 8 Sep 2026).
      16 Class IIb (76.1%)
      4 Class IIa (19.0%)
      1 Class I (4.7%)
      Registered in EUDAMED under MDD with this code, the 388 devices are split across classes (as of 8 Sep 2026).
      203 Class IIb (52.3%)
      185 Class IIa (47.6%)
      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.
    - Z12030104Portable Pulmonary VentilatorsMDR 2 classes · n=57MDD 2 classes · n=132terminal
      Registered in EUDAMED under MDR with this code, the 57 devices are split across classes (as of 8 Sep 2026).
      49 Class IIb (85.9%)
      8 Class IIa (14.0%)
      Registered in EUDAMED under MDD with this code, the 132 devices are split across classes (as of 8 Sep 2026).
      118 Class IIb (89.3%)
      14 Class IIa (10.6%)
      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.
    - Z12030105Pulmonary Ventilators for Hospital Use
      - Z1203010501High–frequency Pulmonary Ventilatorsterminal
      - Z1203010502Adult Pulmonary VentilatorsMDD 2 classes · n=26terminal
        Registered in EUDAMED under MDD with this code, the 26 devices are split across classes (as of 8 Sep 2026).
        24 Class IIa (92.3%)
        2 Class IIb (7.6%)
        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.
      - Z1203010503Neonatal/Paediatric Pulmonary VentilatorsMDR 100.0% Class IIb · n=25MDD 98.8% Class IIb · n=89terminal
        Registered in EUDAMED under MDR with this code: 25 of 25 devices carry Class IIb on their registration (as of 8 Sep 2026).
        25 Class IIb (100.0%)
        Registered in EUDAMED under MDD with this code: 88 of 89 devices carry Class IIb on their registration (as of 8 Sep 2026).
        88 Class IIb (98.8%)
        1 Class IIa (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.
      - Z1203010504Adult and Paediatric/Neonatal Pulmonary VentilatorsMDR 2 classes · n=151MDD 95.7% Class IIb · n=94terminal
        Registered in EUDAMED under MDR with this code, the 151 devices are split across classes (as of 8 Sep 2026).
        119 Class IIb (78.8%)
        32 Class IIa (21.1%)
        Registered in EUDAMED under MDD with this code: 90 of 94 devices carry Class IIb on their registration (as of 8 Sep 2026).
        90 Class IIb (95.7%)
        4 Class IIa (4.2%)
        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.
      - Z1203010580Pulmonary Ventilators for Hospital Use - Hardware Accessoriesterminal
      - Z1203010582Pulmonary Ventilators for Hospital Use - Software Accessoriesterminal
      - Z1203010585Pulmonary Ventilators for Hospital Use - ConsumablesMDR 3 classes · n=32terminal
        Registered in EUDAMED under MDR with this code, the 32 devices are split across classes (as of 8 Sep 2026).
        23 Class IIa (71.8%)
        6 Class I (18.7%)
        3 Class IIb (9.3%)
        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.
      - Z1203010592Pulmonary Ventilators for Hospital Use - Medical Device Softwareterminal
      - Z1203010599Pulmonary Ventilators for Hospital Use - Otherterminal
    - Z12030190Various Instruments for Anaesthesia and Pulmonary Ventilation Support
      - Z1203019001Neuromuscular Relaxation Monitoring EquipmentMDR 2 classes · n=43terminal
        Registered in EUDAMED under MDR with this code, the 43 devices are split across classes (as of 8 Sep 2026).
        30 Class IIa (69.7%)
        13 Class I (30.2%)
        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.
      - Z1203019002Nitric Oxide DispensersMDR 3 classes · n=78terminal
        Registered in EUDAMED under MDR with this code, the 78 devices are split across classes (as of 8 Sep 2026).
        70 Class IIb (89.7%)
        5 Class IIa (6.4%)
        3 Class I (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.
      - Z1203019003Ventilation Monitorsterminal
      - Z1203019004Iron Lungsterminal
      - Z1203019005Oxygen Therapy Tentsterminal
      - Z1203019080Various Instruments for Anaesthesia and Pulmonary Ventilation Support - Hardware AccessoriesMDR 3 classes · n=253MDD 3 classes · n=114terminal
        Registered in EUDAMED under MDR with this code, the 253 devices are split across classes (as of 8 Sep 2026).
        135 Class I (53.3%)
        63 Class IIb (24.9%)
        55 Class IIa (21.7%)
        Registered in EUDAMED under MDD with this code, the 114 devices are split across classes (as of 8 Sep 2026).
        66 Class IIb (57.8%)
        41 Class IIa (35.9%)
        7 Class I (6.1%)
        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.
      - Z1203019082Various Instruments for Anaesthesia and Pulmonary Ventilation Support - Software Accessoriesterminal
      - Z1203019085Various Instruments for Anaesthesia and Pulmonary Ventilation Support - ConsumablesMDR 2 classes · n=56terminal
        Registered in EUDAMED under MDR with this code, the 56 devices are split across classes (as of 8 Sep 2026).
        51 Class I (91.0%)
        5 Class IIa (8.9%)
        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.
      - Z1203019092Various Instruments for Anaesthesia and Pulmonary Ventilation Support - Medical Device Softwareterminal
      - Z1203019099Various Instruments for Anaesthesia and Pulmonary Ventilation Support – OtherMDR 3 classes · n=38MDD 3 classes · n=57terminal
        Registered in EUDAMED under MDR with this code, the 38 devices are split across classes (as of 8 Sep 2026).
        22 Class I (57.8%)
        13 Class IIa (34.2%)
        3 Class IIb (7.8%)
        Registered in EUDAMED under MDD with this code, the 57 devices are split across classes (as of 8 Sep 2026).
        46 Class IIa (80.7%)
        10 Class IIb (17.5%)
        1 Class I (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.
  - Z120302Vital Signs Monitoring Instruments
    - Z12030201Central Information Computing SystemsMDR 3 classes · n=123terminal
      Registered in EUDAMED under MDR with this code, the 123 devices are split across classes (as of 8 Sep 2026).
      85 Class IIb (69.1%)
      24 Class I (19.5%)
      14 Class IIa (11.3%)
      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.
    - Z12030202Multi–parameter Patient Monitors
      - Z1203020201Multi–parameter Patient Bedside MonitorsMDR 3 classes · n=731MDD 98.1% Class IIb · n=499terminal
        Registered in EUDAMED under MDR with this code, the 731 devices are split across classes (as of 8 Sep 2026).
        577 Class IIb (78.9%)
        152 Class I (20.7%)
        2 Class IIa (0.2%)
        Registered in EUDAMED under MDD with this code: 490 of 499 devices carry Class IIb on their registration (as of 8 Sep 2026).
        490 Class IIb (98.1%)
        9 Class IIa (1.8%)
        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.
      - Z1203020202Transportable/Portable Multi–parameter Patient MonitorsMDR 3 classes · n=300MDD 2 classes · n=143terminal
        Registered in EUDAMED under MDR with this code, the 300 devices are split across classes (as of 8 Sep 2026).
        119 Class IIb (39.6%)
        104 Class I (34.6%)
        77 Class IIa (25.6%)
        Registered in EUDAMED under MDD with this code, the 143 devices are split across classes (as of 8 Sep 2026).
        116 Class IIb (81.1%)
        27 Class IIa (18.8%)
        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.
      - Z1203020280Multi-Parameter Monitors - Hardware AccessoriesMDR 3 classes · n=1,385MDD 2 classes · n=81terminal
        Registered in EUDAMED under MDR with this code, the 1,385 devices are split across classes (as of 8 Sep 2026).
        1,092 Class I (78.8%)
        168 Class IIb (12.1%)
        125 Class IIa (9.0%)
        Registered in EUDAMED under MDD with this code, the 81 devices are split across classes (as of 8 Sep 2026).
        55 Class IIb (67.9%)
        26 Class IIa (32.0%)
        Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
      - Z1203020282Multi-Parameter Monitors - Software AccessoriesMDR 3 classes · n=33terminal
        Registered in EUDAMED under MDR with this code, the 33 devices are split across classes (as of 8 Sep 2026).
        18 Class IIb (54.5%)
        12 Class I (36.3%)
        3 Class IIa (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.
      - Z1203020285Multi-Parameter Monitors - ConsumablesMDR 98.4% Class I · n=2,789MDD 3 classes · n=46terminal
        Registered in EUDAMED under MDR with this code: 2,747 of 2,789 devices carry Class I on their registration (as of 8 Sep 2026).
        2,747 Class I (98.4%)
        33 Class IIb (1.1%)
        9 Class IIa (0.3%)
        Registered in EUDAMED under MDD with this code, the 46 devices are split across classes (as of 8 Sep 2026).
        22 Class IIa (47.8%)
        12 Class I (26.0%)
        12 Class IIb (26.0%)
        Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
      - Z1203020292Multi-Parameter Monitors - Medical Device SoftwareMDR 3 classes · n=28terminal
        Registered in EUDAMED under MDR with this code, the 28 devices are split across classes (as of 8 Sep 2026).
        15 Class IIb (53.5%)
        11 Class IIa (39.2%)
        2 Class I (7.1%)
        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.
      - Z1203020299Multi–parameter Monitors - OtherMDR 3 classes · n=275MDD 3 classes · n=71terminal
        Registered in EUDAMED under MDR with this code, the 275 devices are split across classes (as of 8 Sep 2026).
        199 Class I (72.3%)
        59 Class IIb (21.4%)
        17 Class IIa (6.1%)
        Registered in EUDAMED under MDD with this code, the 71 devices are split across classes (as of 8 Sep 2026).
        34 Class IIa (47.8%)
        28 Class IIb (39.4%)
        9 Class I (12.6%)
        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.
    - Z12030203Blood Pressure Monitoring Instruments
      - Z1203020301Invasive Blood Pressure Monitoring InstrumentsMDR 3 classes · n=1,523MDD 2 classes · n=122terminal
        Registered in EUDAMED under MDR with this code, the 1,523 devices are split across classes (as of 8 Sep 2026).
        929 Class IIb (60.9%)
        386 Class I (25.3%)
        208 Class IIa (13.6%)
        Registered in EUDAMED under MDD with this code, the 122 devices are split across classes (as of 8 Sep 2026).
        95 Class IIb (77.8%)
        27 Class IIa (22.1%)
        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.
      - Z1203020302Non–invasive Blood Pressure Monitoring InstrumentsMDR 3 classes · n=3,045MDD 95.6% Class IIa · n=254terminal
        Registered in EUDAMED under MDR with this code, the 3,045 devices are split across classes (as of 8 Sep 2026).
        2,261 Class I (74.2%)
        775 Class IIa (25.4%)
        9 Class IIb (0.2%)
        Registered in EUDAMED under MDD with this code: 243 of 254 devices carry Class IIa on their registration (as of 8 Sep 2026).
        243 Class IIa (95.6%)
        6 Class IIb (2.3%)
        5 Class I (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.
    - Z12030204Gaseous Exchange Monitoring Instruments
      - Z1203020401Carbon Dioxide AnalysersMDR 3 classes · n=34terminal
        Registered in EUDAMED under MDR with this code, the 34 devices are split across classes (as of 8 Sep 2026).
        28 Class IIb (82.3%)
        4 Class I (11.7%)
        2 Class IIa (5.8%)
        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.
      - Z1203020402Carbon Monoxide Analysersterminal
      - Z1203020403Oxygen Analysersterminal
      - Z1203020404Metabolism Equipmentterminal
      - Z1203020405Transcutaneous Po2/Pco2 MonitorsMDR 97.7% Class I · n=44terminal
        Registered in EUDAMED under MDR with this code: 43 of 44 devices carry Class I on their registration (as of 8 Sep 2026).
        43 Class I (97.7%)
        1 Class IIa (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.
      - Z1203020406Cerebral Oximetersterminal
      - Z1203020407Subcutaneous Oximetersterminal
      - Z1203020408Pulse OximetersMDR 3 classes · n=599MDD 2 classes · n=380terminal
        Registered in EUDAMED under MDR with this code, the 599 devices are split across classes (as of 8 Sep 2026).
        542 Class IIa (90.4%)
        56 Class IIb (9.3%)
        1 Class I (0.1%)
        Registered in EUDAMED under MDD with this code, the 380 devices are split across classes (as of 8 Sep 2026).
        222 Class IIb (58.4%)
        158 Class IIa (41.5%)
        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.
      - Z1203020480Gaseous Exchange Monitoring Instruments - Hardware AccessoriesMDD 100.0% Class IIa · n=93terminal
        Registered in EUDAMED under MDD with this code: 93 of 93 devices carry Class IIa on their registration (as of 8 Sep 2026).
        93 Class IIa (100.0%)
        Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
      - Z1203020482Gaseous Exchange Monitoring Instruments - Software Accessoriesterminal
      - Z1203020485Gaseous Exchange Monitoring Instruments - ConsumablesMDR 2 classes · n=134MDD 100.0% Class IIa · n=56terminal
        Registered in EUDAMED under MDR with this code, the 134 devices are split across classes (as of 8 Sep 2026).
        70 Class I (52.2%)
        64 Class IIa (47.7%)
        Registered in EUDAMED under MDD with this code: 56 of 56 devices carry Class IIa on their registration (as of 8 Sep 2026).
        56 Class IIa (100.0%)
        Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
      - Z1203020492Gaseous Exchange Monitoring Instruments - Medical Device Softwareterminal
      - Z1203020499Gaseous Exchange Monitoring Instruments – OtherMDR 3 classes · n=21terminal
        Registered in EUDAMED under MDR with this code, the 21 devices are split across classes (as of 8 Sep 2026).
        13 Class IIb (61.9%)
        7 Class IIa (33.3%)
        1 Class I (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.
    - Z12030205Non–invasive Blood Pressure Gauges
      - Z1203020501Non–invasive Oscillometric Blood Pressure GaugesMDR 97.1% Class IIa · n=1,018MDD 100.0% Class IIa · n=205terminal
        Registered in EUDAMED under MDR with this code: 989 of 1,018 devices carry Class IIa on their registration (as of 8 Sep 2026).
        989 Class IIa (97.1%)
        29 Class I (2.8%)
        Registered in EUDAMED under MDD with this code: 205 of 205 devices carry Class IIa on their registration (as of 8 Sep 2026).
        205 Class IIa (100.0%)
        Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
      - Z1203020599Non-Invasive Blood Pressure Gauges - OtherMDR 98.6% Class I · n=1,348terminal
        Registered in EUDAMED under MDR with this code: 1,330 of 1,348 devices carry Class I on their registration (as of 8 Sep 2026).
        1,330 Class I (98.6%)
        18 Class IIa (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.
    - Z12030206Vital Signs Telemetry Instruments (ECG, Nipb, Etco2, Spo2, Respiration,...)
      - Z1203020601Complete Vital Signs Telemetry SystemsMDR 2 classes · n=34MDD 100.0% Class IIb · n=26terminal
        Registered in EUDAMED under MDR with this code, the 34 devices are split across classes (as of 8 Sep 2026).
        27 Class IIb (79.4%)
        7 Class IIa (20.5%)
        Registered in EUDAMED under MDD with this code: 26 of 26 devices carry Class IIb on their registration (as of 8 Sep 2026).
        26 Class IIb (100.0%)
        Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
      - Z1203020602Vital Signs Telemetry Receiversterminal
      - Z1203020603Vital Signs Telemetry Transmitterterminal
      - Z1203020680Vital Signs Telemetry Instruments - Hardware AccessoriesMDR 97.8% Class I · n=47terminal
        Registered in EUDAMED under MDR with this code: 46 of 47 devices carry Class I on their registration (as of 8 Sep 2026).
        46 Class I (97.8%)
        1 Class IIb (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.
      - Z1203020682Vital Signs Telemetry Instruments - Software Accessoriesterminal
      - Z1203020685Vital Signs Telemetry Instruments - Consumablesterminal
      - Z1203020692Vital Signs Telemetry Instruments - Medical Device SoftwareMDR 2 classes · n=33terminal
        Registered in EUDAMED under MDR with this code, the 33 devices are split across classes (as of 8 Sep 2026).
        31 Class IIa (93.9%)
        2 Class IIb (6.0%)
        Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
    - Z12030280Vital Signs Monitoring Instruments - Hardware AccessoriesMDR 96.3% Class I · n=626MDD 3 classes · n=38terminal
      Registered in EUDAMED under MDR with this code: 603 of 626 devices carry Class I on their registration (as of 8 Sep 2026).
      603 Class I (96.3%)
      14 Class IIb (2.2%)
      9 Class IIa (1.4%)
      Registered in EUDAMED under MDD with this code, the 38 devices are split across classes (as of 8 Sep 2026).
      28 Class IIb (73.6%)
      6 Class I (15.7%)
      4 Class IIa (10.5%)
      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.
    - Z12030282Vital Signs Monitoring Instruments - Software Accessoriesterminal
    - Z12030285Vital Signs Monitoring Instruments - ConsumablesMDR 97.7% Class I · n=3,447MDD 97.0% Class IIb · n=778terminal
      Registered in EUDAMED under MDR with this code: 3,369 of 3,447 devices carry Class I on their registration (as of 8 Sep 2026).
      3,369 Class I (97.7%)
      61 Class IIb (1.7%)
      17 Class IIa (0.4%)
      Registered in EUDAMED under MDD with this code: 755 of 778 devices carry Class IIb on their registration (as of 8 Sep 2026).
      755 Class IIb (97.0%)
      23 Class IIa (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.
    - Z12030292Vital Signs Monitoring Instruments - Medical Device SoftwareMDR 3 classes · n=50terminal
      Registered in EUDAMED under MDR with this code, the 50 devices are split across classes (as of 8 Sep 2026).
      27 Class IIa (54.0%)
      15 Class I (30.0%)
      8 Class IIb (16.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
    - Z12030299Vital Signs Monitoring Instruments - OtherMDR 3 classes · n=403MDD 2 classes · n=34terminal
      Registered in EUDAMED under MDR with this code, the 403 devices are split across classes (as of 8 Sep 2026).
      326 Class I (80.8%)
      72 Class IIb (17.8%)
      5 Class IIa (1.2%)
      Registered in EUDAMED under MDD with this code, the 34 devices are split across classes (as of 8 Sep 2026).
      27 Class IIb (79.4%)
      7 Class IIa (20.5%)
      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.
  - Z120303Infusion Instruments
    - Z12030301Infusion PumpsMDR 2 classes · n=127MDD 3 classes · n=80terminal
      Registered in EUDAMED under MDR with this code, the 127 devices are split across classes (as of 8 Sep 2026).
      117 Class IIb (92.1%)
      10 Class IIa (7.8%)
      Registered in EUDAMED under MDD with this code, the 80 devices are split across classes (as of 8 Sep 2026).
      66 Class IIb (82.5%)
      9 Class IIa (11.2%)
      5 Class I (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. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - Z12030302Syringe PumpsMDR 95.1% Class IIb · n=103MDD 96.7% Class IIb · n=62terminal
      Registered in EUDAMED under MDR with this code: 98 of 103 devices carry Class IIb on their registration (as of 8 Sep 2026).
      98 Class IIb (95.1%)
      4 Class IIa (3.8%)
      1 Class I (0.9%)
      Registered in EUDAMED under MDD with this code: 60 of 62 devices carry Class IIb on their registration (as of 8 Sep 2026).
      60 Class IIb (96.7%)
      1 Class I (1.6%)
      1 Class IIa (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.
    - Z12030303Enteral Feeding PumpsMDR 100.0% Class IIa · n=32MDD 2 classes · n=20terminal
      Registered in EUDAMED under MDR with this code: 32 of 32 devices carry Class IIa on their registration (as of 8 Sep 2026).
      32 Class IIa (100.0%)
      Registered in EUDAMED under MDD with this code, the 20 devices are split across classes (as of 8 Sep 2026).
      18 Class IIa (90.0%)
      2 Class IIb (10.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - Z12030304Infusion Regulatorsterminal
    - Z12030305Infusion HeatersMDR 2 classes · n=49MDD 3 classes · n=34terminal
      Registered in EUDAMED under MDR with this code, the 49 devices are split across classes (as of 8 Sep 2026).
      42 Class I (85.7%)
      7 Class IIa (14.2%)
      Registered in EUDAMED under MDD with this code, the 34 devices are split across classes (as of 8 Sep 2026).
      26 Class I (76.4%)
      5 Class IIa (14.7%)
      3 Class IIb (8.8%)
      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.
    - Z12030306Infusion and Syringe Pump Control SystemsMDR 2 classes · n=32terminal
      Registered in EUDAMED under MDR with this code, the 32 devices are split across classes (as of 8 Sep 2026).
      23 Class IIb (71.8%)
      9 Class I (28.1%)
      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.
    - Z12030380Infusion Instruments - Hardware AccessoriesMDR 3 classes · n=808terminal
      Registered in EUDAMED under MDR with this code, the 808 devices are split across classes (as of 8 Sep 2026).
      762 Class I (94.3%)
      45 Class IIb (5.5%)
      1 Class IIa (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.
    - Z12030382Infusion Instruments - Software Accessoriesterminal
    - Z12030385Infusion Instruments - ConsumablesMDR 2 classes · n=94MDD 100.0% Class IIa · n=71terminal
      Registered in EUDAMED under MDR with this code, the 94 devices are split across classes (as of 8 Sep 2026).
      85 Class IIa (90.4%)
      9 Class I (9.5%)
      Registered in EUDAMED under MDD with this code: 71 of 71 devices carry Class IIa on their registration (as of 8 Sep 2026).
      71 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - Z12030392Infusion Instruments - Medical Device Softwareterminal
    - Z12030399Infusion Instruments - OtherMDR 3 classes · n=118terminal
      Registered in EUDAMED under MDR with this code, the 118 devices are split across classes (as of 8 Sep 2026).
      111 Class I (94.0%)
      4 Class IIa (3.3%)
      3 Class IIb (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.
  - Z120304Cardiac CompressorsMDR 2 classes · n=34terminal
    Registered in EUDAMED under MDR with this code, the 34 devices are split across classes (as of 8 Sep 2026).
    22 Class IIb (64.7%)
    12 Class I (35.2%)
    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.
  - Z120305Defibrillators
    - Z12030501Semi-Automatic DefibrillatorsMDR 100.0% Class III · n=188MDD 2 classes · n=107terminal
      Registered in EUDAMED under MDR with this code: 188 of 188 devices carry Class III on their registration (as of 8 Sep 2026).
      188 Class III (100.0%)
      Registered in EUDAMED under MDD with this code, the 107 devices are split across classes (as of 8 Sep 2026).
      66 Class IIb (61.6%)
      41 Class III (38.3%)
      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.
    - Z12030502Manual DefibrillatorsMDD 98.3% Class IIb · n=61terminal
      Registered in EUDAMED under MDD with this code: 60 of 61 devices carry Class IIb on their registration (as of 8 Sep 2026).
      60 Class IIb (98.3%)
      1 Class III (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.
    - Z12030503Automatic DefibrillatorsMDR 100.0% Class III · n=166MDD 2 classes · n=84terminal
      Registered in EUDAMED under MDR with this code: 166 of 166 devices carry Class III on their registration (as of 8 Sep 2026).
      166 Class III (100.0%)
      Registered in EUDAMED under MDD with this code, the 84 devices are split across classes (as of 8 Sep 2026).
      44 Class IIb (52.3%)
      40 Class III (47.6%)
      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.
    - Z12030580Defibrillators - Hardware AccessoriesMDR 100.0% Class I · n=60MDD 2 classes · n=27terminal
      Registered in EUDAMED under MDR with this code: 60 of 60 devices carry Class I on their registration (as of 8 Sep 2026).
      60 Class I (100.0%)
      Registered in EUDAMED under MDD with this code, the 27 devices are split across classes (as of 8 Sep 2026).
      24 Class IIb (88.8%)
      3 Class III (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. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - Z12030582Defibrillators - Software Accessoriesterminal
    - Z12030585Defibrillators - ConsumablesMDR 98.0% Class I · n=51terminal
      Registered in EUDAMED under MDR with this code: 50 of 51 devices carry Class I on their registration (as of 8 Sep 2026).
      50 Class I (98.0%)
      1 Class IIb (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.
    - Z12030592Defibrillators - Medical Device Softwareterminal
    - Z12030599Defibrillators - Otherterminal
  - Z120308Hyperbaric ChambersMDD 100.0% Class IIb · n=51terminal
    Registered in EUDAMED under MDD with this code: 51 of 51 devices carry Class IIb on their registration (as of 8 Sep 2026).
    51 Class IIb (100.0%)
    Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
  - Z120309Medical/Medicinal Gas Pipeline Systems and Related AccessoriesMDR 3 classes · n=13,837MDD 3 classes · n=5,753terminal
    Registered in EUDAMED under MDR with this code, the 13,837 devices are split across classes (as of 8 Sep 2026).
    8,599 Class IIb (62.1%)
    5,076 Class IIa (36.6%)
    162 Class I (1.1%)
    Registered in EUDAMED under MDD with this code, the 5,753 devices are split across classes (as of 8 Sep 2026).
    4,186 Class IIb (72.7%)
    1,531 Class IIa (26.6%)
    36 Class I (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.
  - Z120390Various Instruments to Support and Monitor Vital Signs
    - Z12039001Intracranial Pressure Measuring Systemsterminal
    - Z12039002Intra Compartmental Pressure Monitor Systemsterminal
    - Z12039080Various Instruments to Support and Monitor Vital Signs - Hardware Accessoriesterminal
    - Z12039082Various Instruments to Support and Monitor Vital Signs - Software Accessoriesterminal
    - Z12039085Various Instruments to Support and Monitor Vital Signs - Consumablesterminal
    - Z12039092Various Instruments to Support and Monitor Vital Signs - Medical Device SoftwareMDR 3 classes · n=37terminal
      Registered in EUDAMED under MDR with this code, the 37 devices are split across classes (as of 8 Sep 2026).
      30 Class IIa (81.0%)
      4 Class IIb (10.8%)
      3 Class I (8.1%)
      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.
    - Z12039099Various Instruments to Support and Monitor Vital Signs – OtherMDR 3 classes · n=29terminal
      Registered in EUDAMED under MDR with this code, the 29 devices are split across classes (as of 8 Sep 2026).
      24 Class I (82.7%)
      4 Class IIb (13.7%)
      1 Class IIa (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.
- Z1204General Medicine Instruments
  - Z120401General Medicine Diagnosis and Monitoring Instruments
    - Z12040101Algesimetersterminal
    - Z12040102Equipment for Analysis of the Physiological Parameters of the Skinterminal
    - Z12040103Hepatic Functionality Equipmentterminal
    - Z12040104Equipment for Diagnosis of the Bioelectric Functional StateMDR 100.0% Class IIa · n=20terminal
      Registered in EUDAMED under MDR with this code: 20 of 20 devices carry Class IIa on their registration (as of 8 Sep 2026).
      20 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
    - Z12040105Perception Threshold EquipmentMDR 100.0% Class I · n=45terminal
      Registered in EUDAMED under MDR with this code: 45 of 45 devices carry Class I on their registration (as of 8 Sep 2026).
      45 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.
    - Z12040106Electrocellular Tomography Equipmentterminal
    - Z12040107Capillariscopesterminal
    - Z12040108DermatoscopesMDR 100.0% Class I · n=252terminal
      Registered in EUDAMED under MDR with this code: 252 of 252 devices carry Class I on their registration (as of 8 Sep 2026).
      252 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.
    - Z12040109Dermohygrometersterminal
    - Z12040110Electrogustometersterminal
    - Z12040111Blood Flow MetersMDR 2 classes · n=88terminal
      Registered in EUDAMED under MDR with this code, the 88 devices are split across classes (as of 8 Sep 2026).
      67 Class IIa (76.1%)
      21 Class I (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.
    - Z12040112Oncology Tissue Interferometersterminal
    - Z12040113Regional Plethysmographsterminal
    - Z12040114Systems for the Study of Autonomic Neuropathiesterminal
    - Z12040115Blood Sugar Monitoring Systems
      - Z1204011501Non Invasive Blood Sugar Monitoring SystemsMDR 95.2% Class IIb · n=127terminal
        Registered in EUDAMED under MDR with this code: 121 of 127 devices carry Class IIb on their registration (as of 8 Sep 2026).
        121 Class IIb (95.2%)
        3 Class I (2.3%)
        3 Class IIa (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.
      - Z1204011502Invasive Blood Sugar Monitoring SystemsMDR 2 classes · n=55terminal
        Registered in EUDAMED under MDR with this code, the 55 devices are split across classes (as of 8 Sep 2026).
        52 Class IIb (94.5%)
        3 Class IIa (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.
      - Z1204011585Invasive Blood Sugar Monitoring Systems, Single–use SensorsMDR 100.0% Class IIb · n=149MDD 2 classes · n=20terminal
        Registered in EUDAMED under MDR with this code: 149 of 149 devices carry Class IIb on their registration (as of 8 Sep 2026).
        149 Class IIb (100.0%)
        Registered in EUDAMED under MDD with this code, the 20 devices are split across classes (as of 8 Sep 2026).
        13 Class IIb (65.0%)
        7 Class IIa (35.0%)
        Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
      - Z1204011599Blood Sugar Monitoring Systems - OtherMDR 3 classes · n=80terminal
        Registered in EUDAMED under MDR with this code, the 80 devices are split across classes (as of 8 Sep 2026).
        54 Class IIb (67.5%)
        21 Class I (26.2%)
        5 Class IIa (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.
    - Z12040116Spectrophotometers for Early Detection of Melanomaterminal
    - Z12040117Metabolic and Physical Activity Holter SystemsMDD 100.0% Class IIa · n=51terminal
      Registered in EUDAMED under MDD with this code: 51 of 51 devices carry Class IIa on their registration (as of 8 Sep 2026).
      51 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - Z12040118Video DermatoscopesMDR 100.0% Class I · n=33terminal
      Registered in EUDAMED under MDR with this code: 33 of 33 devices carry Class I on their registration (as of 8 Sep 2026).
      33 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.
    - Z12040180General Medicine Diagnosis and Monitoring Instruments - Hardware AccessoriesMDR 99.8% Class I · n=3,375terminal
      Registered in EUDAMED under MDR with this code: 3,370 of 3,375 devices carry Class I on their registration (as of 8 Sep 2026).
      3,370 Class I (99.8%)
      4 Class IIa (0.1%)
      1 Class IIb (<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.
    - Z12040182General Medicine Diagnosis and Monitoring Instruments - Software AccessoriesMDR 3 classes · n=75terminal
      Registered in EUDAMED under MDR with this code, the 75 devices are split across classes (as of 8 Sep 2026).
      46 Class IIa (61.3%)
      27 Class I (36.0%)
      2 Class IIb (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.
    - Z12040185General Medicine Diagnosis and Monitoring Instruments - ConsumablesMDR 2 classes · n=39terminal
      Registered in EUDAMED under MDR with this code, the 39 devices are split across classes (as of 8 Sep 2026).
      37 Class I (94.8%)
      2 Class IIa (5.1%)
      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.
    - Z12040192General Medicine Diagnosis and Monitoring Instruments - Medical Device SoftwareMDR 4 classes · n=216MDD 3 classes · n=43terminal
      Registered in EUDAMED under MDR with this code, the 216 devices are split across classes (as of 8 Sep 2026).
      149 Class IIa (68.9%)
      43 Class I (19.9%)
      20 Class IIb (9.2%)
      4 Class III (1.8%)
      Registered in EUDAMED under MDD with this code, the 43 devices are split across classes (as of 8 Sep 2026).
      36 Class I (83.7%)
      5 Class IIa (11.6%)
      2 Class IIb (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.
    - Z12040199General Medicine Diagnosis and Monitoring Instruments - OtherMDR 2 classes · n=194terminal
      Registered in EUDAMED under MDR with this code, the 194 devices are split across classes (as of 8 Sep 2026).
      158 Class I (81.4%)
      36 Class IIa (18.5%)
      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.
  - Z120402General Medicine Therapeutic Treatment Instruments
    - Z12040201Photoepilation EquipmentMDR 2 classes · n=45terminal
      Registered in EUDAMED under MDR with this code, the 45 devices are split across classes (as of 8 Sep 2026).
      41 Class IIa (91.1%)
      4 Class IIb (8.8%)
      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.
    - Z12040202Phototherapy EquipmentMDR 3 classes · n=123MDD 3 classes · n=141terminal
      Registered in EUDAMED under MDR with this code, the 123 devices are split across classes (as of 8 Sep 2026).
      60 Class IIa (48.7%)
      37 Class I (30.0%)
      26 Class IIb (21.1%)
      Registered in EUDAMED under MDD with this code, the 141 devices are split across classes (as of 8 Sep 2026).
      77 Class IIa (54.6%)
      62 Class IIb (43.9%)
      2 Class I (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.
    - Z12040203Dermal Regeneration EquipmentMDR 3 classes · n=93MDD 3 classes · n=29terminal
      Registered in EUDAMED under MDR with this code, the 93 devices are split across classes (as of 8 Sep 2026).
      44 Class IIb (47.3%)
      38 Class I (40.8%)
      11 Class IIa (11.8%)
      Registered in EUDAMED under MDD with this code, the 29 devices are split across classes (as of 8 Sep 2026).
      17 Class IIb (58.6%)
      8 Class IIa (27.5%)
      4 Class III (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.
    - Z12040205Vacuum Medication EquipmentMDR 2 classes · n=21terminal
      Registered in EUDAMED under MDR with this code, the 21 devices are split across classes (as of 8 Sep 2026).
      18 Class I (85.7%)
      3 Class IIb (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.
    - Z12040206Mesotherapy Equipmentterminal
    - Z12040207Ozone Therapy Equipmentterminal
    - Z12040208Body Thermoregulation EquipmentMDR 3 classes · n=221MDD 2 classes · n=59terminal
      Registered in EUDAMED under MDR with this code, the 221 devices are split across classes (as of 8 Sep 2026).
      183 Class I (82.8%)
      31 Class IIb (14.0%)
      7 Class IIa (3.1%)
      Registered in EUDAMED under MDD with this code, the 59 devices are split across classes (as of 8 Sep 2026).
      47 Class IIb (79.6%)
      12 Class IIa (20.3%)
      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.
    - Z12040210Ultrasonic NebulisersMDR 100.0% Class IIa · n=161MDD 100.0% Class IIa · n=33terminal
      Registered in EUDAMED under MDR with this code: 161 of 161 devices carry Class IIa on their registration (as of 8 Sep 2026).
      161 Class IIa (100.0%)
      Registered in EUDAMED under MDD with this code: 33 of 33 devices carry Class IIa on their registration (as of 8 Sep 2026).
      33 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - Z12040211Artificial Pancreasterminal
    - Z12040213Patient Washing Systemsterminal
    - Z12040214Liposuction SystemsMDR 3 classes · n=44terminal
      Registered in EUDAMED under MDR with this code, the 44 devices are split across classes (as of 8 Sep 2026).
      28 Class IIa (63.6%)
      11 Class IIb (25.0%)
      5 Class I (11.3%)
      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.
    - Z12040215Multi-District Oncological Therapy Instruments (Excluding Radiotherapy)
      - Z1204021501Multi-District Oncological Hyperthermia Equipmentterminal
      - Z1204021502Tumor Treating Fields (Ttfields) Equipmentterminal
      - Z1204021580Multi-District Oncological Therapy Instruments (Excluding Radiotherapy) - Hardware AccessoriesMDD 97.0% Class IIb · n=34terminal
        Registered in EUDAMED under MDD with this code: 33 of 34 devices carry Class IIb on their registration (as of 8 Sep 2026).
        33 Class IIb (97.0%)
        1 Class IIa (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.
      - Z1204021582Multi-District Oncological Therapy Instruments (Excluding Radiotherapy) - Software Accessoriesterminal
      - Z1204021585Multi-District Oncological Therapy Instruments (Excluding Radiotherapy) - Consumablesterminal
      - Z1204021592Multi-District Oncological Therapy Instruments (Excluding Radiotherapy) - Medical Device Softwareterminal
      - Z1204021599Multi-District Oncological Therapy Instruments (Excluding Radiotherapy) - Otherterminal
    - Z12040216Portable Microinfusion Instruments
      - Z1204021601Portable Insulin Infusion Instruments
        Z120402160101Portable Insulin MicroinfusorsMDR 100.0% Class IIb · n=24MDD 100.0% Class IIb · n=41terminal
        Registered in EUDAMED under MDR with this code: 24 of 24 devices carry Class IIb on their registration (as of 8 Sep 2026).
        24 Class IIb (100.0%)
        Registered in EUDAMED under MDD with this code: 41 of 41 devices carry Class IIb on their registration (as of 8 Sep 2026).
        41 Class IIb (100.0%)
        Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
        Z120402160102Portable Insulin Microinfusors with Handheld Glucose Meterterminal
        Z120402160103Portable Insulin Microinfusors Connectable to Continuous Glucose Monitoring SystemsMDR 2 classes · n=87terminal
        Registered in EUDAMED under MDR with this code, the 87 devices are split across classes (as of 8 Sep 2026).
        82 Class III (94.2%)
        5 Class IIb (5.7%)
        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.
      - Z1204021602Portable Pain Therapy Instrumentsterminal
      - Z1204021603Portable Dobutamine Infusion Instrumentsterminal
      - Z1204021680Portable Microinfusion Instruments - Hardware Accessoriesterminal
      - Z1204021685Portable Microinfusion Instruments - Consumablesterminal
      - Z1204021699Portable Microinfusion Instruments - Otherterminal
    - Z12040218Endermology TreatmentsMDD 2 classes · n=20terminal
      Registered in EUDAMED under MDD with this code, the 20 devices are split across classes (as of 8 Sep 2026).
      14 Class IIb (70.0%)
      6 Class IIa (30.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - Z12040219Regional Perfusion Unitsterminal
    - Z12040280General Medicine Therapeutic Treatment Instruments - Hardware AccessoriesMDR 3 classes · n=77terminal
      Registered in EUDAMED under MDR with this code, the 77 devices are split across classes (as of 8 Sep 2026).
      68 Class I (88.3%)
      5 Class IIb (6.4%)
      4 Class IIa (5.1%)
      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.
    - Z12040282General Medicine Therapeutic Treatment Instruments - Software AccessoriesMDR 3 classes · n=76terminal
      Registered in EUDAMED under MDR with this code, the 76 devices are split across classes (as of 8 Sep 2026).
      38 Class IIa (50.0%)
      37 Class I (48.6%)
      1 Class IIb (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.
    - Z12040285General Medicine Therapeutic Treatment Instruments - ConsumablesMDR 2 classes · n=86MDD 95.4% Class IIa · n=22terminal
      Registered in EUDAMED under MDR with this code, the 86 devices are split across classes (as of 8 Sep 2026).
      68 Class I (79.0%)
      18 Class IIb (20.9%)
      Registered in EUDAMED under MDD with this code: 21 of 22 devices carry Class IIa on their registration (as of 8 Sep 2026).
      21 Class IIa (95.4%)
      1 Class IIb (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.
    - Z12040292General Medicine Therapeutic Treatment Instruments - Medical Device SoftwareMDR 3 classes · n=334MDD 97.1% Class I · n=35terminal
      Registered in EUDAMED under MDR with this code, the 334 devices are split across classes (as of 8 Sep 2026).
      271 Class IIb (81.1%)
      35 Class IIa (10.4%)
      28 Class I (8.3%)
      Registered in EUDAMED under MDD with this code: 34 of 35 devices carry Class I on their registration (as of 8 Sep 2026).
      34 Class I (97.1%)
      1 Class IIb (2.8%)
      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.
    - Z12040299General Medicine Therapeutic Treatment Instruments - OtherMDR 3 classes · n=71MDD 3 classes · n=32terminal
      Registered in EUDAMED under MDR with this code, the 71 devices are split across classes (as of 8 Sep 2026).
      34 Class I (47.8%)
      31 Class IIa (43.6%)
      6 Class IIb (8.4%)
      Registered in EUDAMED under MDD with this code, the 32 devices are split across classes (as of 8 Sep 2026).
      19 Class IIb (59.3%)
      9 Class IIa (28.1%)
      4 Class I (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.
  - Z120499General Medicine Instruments - OtherMDR 3 classes · n=488terminal
    Registered in EUDAMED under MDR with this code, the 488 devices are split across classes (as of 8 Sep 2026).
    429 Class I (87.9%)
    58 Class IIa (11.8%)
    1 Class IIb (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.
- Z1205Cardiology and Cardiosurgery Instruments
  - Z120501Stress Analysis Instruments
    - Z12050101Stress Analysis SystemsMDR 97.8% Class IIa · n=47MDD 100.0% Class IIa · n=26terminal
      Registered in EUDAMED under MDR with this code: 46 of 47 devices carry Class IIa on their registration (as of 8 Sep 2026).
      46 Class IIa (97.8%)
      1 Class I (2.1%)
      Registered in EUDAMED under MDD with this code: 26 of 26 devices carry Class IIa on their registration (as of 8 Sep 2026).
      26 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - Z12050180Stress Analysis Instruments - Hardware Accessoriesterminal
    - Z12050182Stress Analysis Instruments - Software Accessoriesterminal
    - Z12050185Stress Analysis Instruments - Consumablesterminal
    - Z12050192Stress Analysis Instruments - Medical Device Softwareterminal
  - Z120502Extra-Corporeal Circulation Instruments
    - Z12050201Extra-Corporeal Circulation Systemsterminal
    - Z12050280Extra-Corporeal Circulation Instruments - Hardware AccessoriesMDR 2 classes · n=40terminal
      Registered in EUDAMED under MDR with this code, the 40 devices are split across classes (as of 8 Sep 2026).
      35 Class I (87.5%)
      5 Class IIb (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.
    - Z12050282Extra-Corporeal Circulation Instruments - Software Accessoriesterminal
    - Z12050285Extra-Corporeal Circulation Instruments - Consumablesterminal
    - Z12050292Extra-Corporeal Circulation Instruments - Medical Device Softwareterminal
  - Z120503Electrocardiographs
    - Z12050301General Purpose ElectrocardiographsMDR 2 classes · n=255MDD 100.0% Class IIa · n=125terminal
      Registered in EUDAMED under MDR with this code, the 255 devices are split across classes (as of 8 Sep 2026).
      204 Class IIa (80.0%)
      51 Class I (20.0%)
      Registered in EUDAMED under MDD with this code: 125 of 125 devices carry Class IIa on their registration (as of 8 Sep 2026).
      125 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - Z12050302Advanced Diagnosis ElectrocardiographsMDD 100.0% Class IIa · n=58terminal
      Registered in EUDAMED under MDD with this code: 58 of 58 devices carry Class IIa on their registration (as of 8 Sep 2026).
      58 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - Z12050303Cardiophonesterminal
    - Z12050380Electrocardiographs - Hardware AccessoriesMDR 98.0% Class I · n=1,604terminal
      Registered in EUDAMED under MDR with this code: 1,572 of 1,604 devices carry Class I on their registration (as of 8 Sep 2026).
      1,572 Class I (98.0%)
      32 Class IIa (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.
    - Z12050382Electrocardiographs - Software Accessoriesterminal
    - Z12050385Electrocardiographs - ConsumablesMDR 99.8% Class I · n=902terminal
      Registered in EUDAMED under MDR with this code: 901 of 902 devices carry Class I on their registration (as of 8 Sep 2026).
      901 Class I (99.8%)
      1 Class IIa (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.
    - Z12050392Electrocardiographs - Medical Device SoftwareMDR 3 classes · n=43terminal
      Registered in EUDAMED under MDR with this code, the 43 devices are split across classes (as of 8 Sep 2026).
      22 Class IIa (51.1%)
      20 Class IIb (46.5%)
      1 Class I (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.
  - Z120504Holter System Instruments for Cardiovascular Parameters
    - Z12050401Cardiovascular Holter Analysersterminal
    - Z12050402Multi–parameter Cardiovascular Holter Recorders (ECG, Nipb, Etc.)terminal
    - Z12050403ECG Holter RecordersMDR 2 classes · n=171MDD 100.0% Class IIa · n=83terminal
      Registered in EUDAMED under MDR with this code, the 171 devices are split across classes (as of 8 Sep 2026).
      147 Class IIa (85.9%)
      24 Class I (14.0%)
      Registered in EUDAMED under MDD with this code: 83 of 83 devices carry Class IIa on their registration (as of 8 Sep 2026).
      83 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - Z12050404Blood Pressure Holter Recordersterminal
    - Z12050480Holter System Instruments for Cardiovascular Parameters - Hardware AccessoriesMDR 98.9% Class I · n=97terminal
      Registered in EUDAMED under MDR with this code: 96 of 97 devices carry Class I on their registration (as of 8 Sep 2026).
      96 Class I (98.9%)
      1 Class IIa (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.
    - Z12050482Holter System Instruments for Cardiovascular Parameters - Software Accessoriesterminal
    - Z12050485Holter System Instruments for Cardiovascular Parameters - ConsumablesMDR 100.0% Class I · n=56terminal
      Registered in EUDAMED under MDR with this code: 56 of 56 devices carry Class I on their registration (as of 8 Sep 2026).
      56 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.
    - Z12050492Holter System Instruments for Cardiovascular Parameters - Medical Device Softwareterminal
    - Z12050499Holter System Instruments for Cardiovascular Parameters – Otherterminal
  - Z120505Cardiac Output Measurement Instruments
    - Z12050501Cardiac Output Measurement Metersterminal
    - Z12050580Cardiac Output Measurement Instruments - Hardware AccessoriesMDR 2 classes · n=22terminal
      Registered in EUDAMED under MDR with this code, the 22 devices are split across classes (as of 8 Sep 2026).
      20 Class I (90.9%)
      2 Class IIa (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.
    - Z12050582Cardiac Output Measurement Instruments - Software Accessoriesterminal
    - Z12050585Cardiac Output Measurement Instruments - Consumablesterminal
    - Z12050592Cardiac Output Measurement Instruments - Medical Device Softwareterminal
  - Z120506Non–implantable Cardiac Stimulators
    - Z12050601Transoesophageal Cardiac Stimulatorsterminal
    - Z12050602Invasive Cardiac Stimulatorsterminal
    - Z12050603Transthoracic Cardiac Stimulatorsterminal
    - Z12050680Non-Implantable Cardiac Stimulators - Hardware AccessoriesMDR 100.0% Class I · n=188terminal
      Registered in EUDAMED under MDR with this code: 188 of 188 devices carry Class I on their registration (as of 8 Sep 2026).
      188 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.
    - Z12050682Non-Implantable Cardiac Stimulators - Software Accessoriesterminal
    - Z12050685Non-Implantable Cardiac Stimulators - Consumablesterminal
    - Z12050692Non-Implantable Cardiac Stimulators - Medical Device Softwareterminal
    - Z12050699Non–implantable Cardiac Stimulators – Otherterminal
  - Z120507Cardiography Instruments
    - Z12050701Complete Cardiography SystemsMDR 3 classes · n=60terminal
      Registered in EUDAMED under MDR with this code, the 60 devices are split across classes (as of 8 Sep 2026).
      41 Class I (68.3%)
      16 Class IIb (26.6%)
      3 Class IIa (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.
    - Z12050702Polygraphy Systems for Haemodynamic StudiesMDR 3 classes · n=32terminal
      Registered in EUDAMED under MDR with this code, the 32 devices are split across classes (as of 8 Sep 2026).
      21 Class I (65.6%)
      8 Class IIb (25.0%)
      3 Class IIa (9.3%)
      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.
    - Z12050703Polygraphy Systems for Electrophysiological Studiesterminal
    - Z12050780Cardiography Instruments - Hardware Accessories
      - Z1205078001Cardiac Electrophysiology Stimulatorsterminal
      - Z1205078099Instruments for Cardiological Polygraphy - Hardware Accessories - Otherterminal
    - Z12050782Instruments for Cardiological Polygraphy - Software Accessoriesterminal
    - Z12050785Instruments for Cardiological Polygraphy - ConsumablesMDR 97.6% Class I · n=85terminal
      Registered in EUDAMED under MDR with this code: 83 of 85 devices carry Class I on their registration (as of 8 Sep 2026).
      83 Class I (97.6%)
      2 Class IIa (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.
    - Z12050792Instruments for Cardiological Polygraphy - Medical Device Softwareterminal
  - Z120508Cardiac Telemetry Instruments
    - Z12050801Complete Cardiac Telemetry Systemsterminal
    - Z12050802Electrocardiograph Telemetry System Receiversterminal
    - Z12050803Electrocardiograph Telemetry System Transmittersterminal
    - Z12050804Ergospirometric Telemetry Transmittersterminal
    - Z12050880Cardiac Telemetry Instruments - Hardware Accessoriesterminal
    - Z12050882Cardiac Telemetry Instruments - Software Accessoriesterminal
    - Z12050885Cardiac Telemetry Instruments - Consumablesterminal
    - Z12050892Cardiac Telemetry Instruments - Medical Device Softwareterminal
    - Z12050899Cardiac Telemetry Instruments - Otherterminal
  - Z120590Various Instruments for Cardiology and Cardiac Surgery
    - Z12059001Pacing Sensing Analysersterminal
    - Z12059002Cardiac Mapping EquipmentMDR 3 classes · n=43terminal
      Registered in EUDAMED under MDR with this code, the 43 devices are split across classes (as of 8 Sep 2026).
      31 Class I (72.0%)
      10 Class IIb (23.2%)
      2 Class IIa (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.
    - Z12059003Clot Aspiratorsterminal
    - Z12059004Aortic Pumpsterminal
    - Z12059005Blood Flow Velocimetersterminal
    - Z12059006Fibrillatorsterminal
    - Z12059007Intra-Cardiac Oximetersterminal
    - Z12059008Laser Fluximetry Systemsterminal
    - Z12059009ECG Data Management SystemsMDR 98.2% Class I · n=1,027terminal
      Registered in EUDAMED under MDR with this code: 1,009 of 1,027 devices carry Class I on their registration (as of 8 Sep 2026).
      1,009 Class I (98.2%)
      18 Class IIa (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.
    - Z12059010Sternotomesterminal
    - Z12059011Cardiac Ablation EquipmentMDR 3 classes · n=78terminal
      Registered in EUDAMED under MDR with this code, the 78 devices are split across classes (as of 8 Sep 2026).
      42 Class I (53.8%)
      34 Class IIb (43.5%)
      2 Class IIa (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.
    - Z12059012Phonocardiographsterminal
    - Z12059013Magnetocardiographsterminal
    - Z12059080Various Instruments for Cardiology and Cardiac Surgery - Hardware AccessoriesMDR 3 classes · n=90terminal
      Registered in EUDAMED under MDR with this code, the 90 devices are split across classes (as of 8 Sep 2026).
      83 Class I (92.2%)
      5 Class IIb (5.5%)
      2 Class IIa (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.
    - Z12059082Various Instruments for Cardiology and Cardiac Surgery - Software Accessoriesterminal
    - Z12059085Various Instruments for Cardiology and Cardiac Surgery - Consumablesterminal
    - Z12059092Various Instruments for Cardiology and Cardiac Surgery - Medical Device SoftwareMDR 3 classes · n=87MDD 3 classes · n=26terminal
      Registered in EUDAMED under MDR with this code, the 87 devices are split across classes (as of 8 Sep 2026).
      73 Class IIb (83.9%)
      9 Class IIa (10.3%)
      5 Class I (5.7%)
      Registered in EUDAMED under MDD with this code, the 26 devices are split across classes (as of 8 Sep 2026).
      22 Class IIb (84.6%)
      3 Class I (11.5%)
      1 Class IIa (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.
    - Z12059099Various Instruments for Cardiology and Cardiac Surgery -OtherMDR 4 classes · n=32terminal
      Registered in EUDAMED under MDR with this code, the 32 devices are split across classes (as of 8 Sep 2026).
      11 Class I (34.3%)
      10 Class IIa (31.2%)
      8 Class IIb (25.0%)
      3 Class III (9.3%)
      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.
- Z1206Physiotherapy and Rehabilitation Instruments
  - Z120601Electrotherapy Equipment (Included Tens)MDR 3 classes · n=264MDD 2 classes · n=35terminal
    Registered in EUDAMED under MDR with this code, the 264 devices are split across classes (as of 8 Sep 2026).
    165 Class I (62.5%)
    78 Class IIa (29.5%)
    21 Class IIb (7.9%)
    Registered in EUDAMED under MDD with this code, the 35 devices are split across classes (as of 8 Sep 2026).
    30 Class IIa (85.7%)
    5 Class IIb (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.
  - Z120602Physiotherapy EquipmentMDR 3 classes · n=2,051MDD 3 classes · n=120terminal
    Registered in EUDAMED under MDR with this code, the 2,051 devices are split across classes (as of 8 Sep 2026).
    1,603 Class I (78.1%)
    437 Class IIa (21.3%)
    11 Class IIb (0.5%)
    Registered in EUDAMED under MDD with this code, the 120 devices are split across classes (as of 8 Sep 2026).
    82 Class IIa (68.3%)
    23 Class I (19.1%)
    15 Class IIb (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.
  - Z120603Passive Rehabilitative Gymnastics EquipmentMDR 3 classes · n=510terminal
    Registered in EUDAMED under MDR with this code, the 510 devices are split across classes (as of 8 Sep 2026).
    445 Class I (87.2%)
    63 Class IIa (12.3%)
    2 Class IIb (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.
  - Z120604Iontophoresis EquipmentMDR 2 classes · n=43terminal
    Registered in EUDAMED under MDR with this code, the 43 devices are split across classes (as of 8 Sep 2026).
    32 Class I (74.4%)
    11 Class IIa (25.5%)
    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.
  - Z120605Equipment for Electromyographic Analysisterminal
  - Z120606Magnetotherapy EquipmentMDR 2 classes · n=501MDD 2 classes · n=61terminal
    Registered in EUDAMED under MDR with this code, the 501 devices are split across classes (as of 8 Sep 2026).
    443 Class IIa (88.4%)
    58 Class I (11.5%)
    Registered in EUDAMED under MDD with this code, the 61 devices are split across classes (as of 8 Sep 2026).
    54 Class IIa (88.5%)
    7 Class I (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. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
  - Z120607Pneumatic Compression EquipmentMDR 2 classes · n=715MDD 99.4% Class IIa · n=184terminal
    Registered in EUDAMED under MDR with this code, the 715 devices are split across classes (as of 8 Sep 2026).
    431 Class I (60.2%)
    284 Class IIa (39.7%)
    Registered in EUDAMED under MDD with this code: 183 of 184 devices carry Class IIa on their registration (as of 8 Sep 2026).
    183 Class IIa (99.4%)
    1 Class IIb (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.
  - Z120608Microwave Therapy EquipmentMDR 99.8% Class IIb · n=514MDD 2 classes · n=38terminal
    Registered in EUDAMED under MDR with this code: 513 of 514 devices carry Class IIb on their registration (as of 8 Sep 2026).
    513 Class IIb (99.8%)
    1 Class I (0.1%)
    Registered in EUDAMED under MDD with this code, the 38 devices are split across classes (as of 8 Sep 2026).
    27 Class IIa (71.0%)
    11 Class IIb (28.9%)
    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.
  - Z120609Shortwave Therapy Equipmentterminal
  - Z120610Ultrasound Therapy EquipmentMDR 3 classes · n=56MDD 2 classes · n=42terminal
    Registered in EUDAMED under MDR with this code, the 56 devices are split across classes (as of 8 Sep 2026).
    24 Class I (42.8%)
    23 Class IIb (41.0%)
    9 Class IIa (16.0%)
    Registered in EUDAMED under MDD with this code, the 42 devices are split across classes (as of 8 Sep 2026).
    23 Class IIb (54.7%)
    19 Class IIa (45.2%)
    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.
  - Z120611Vacuum Therapy EquipmentMDR 2 classes · n=78terminal
    Registered in EUDAMED under MDR with this code, the 78 devices are split across classes (as of 8 Sep 2026).
    55 Class I (70.5%)
    23 Class IIa (29.4%)
    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.
  - Z120612Endoral Electric Massage EquipmentMDR 2 classes · n=35terminal
    Registered in EUDAMED under MDR with this code, the 35 devices are split across classes (as of 8 Sep 2026).
    18 Class I (51.4%)
    17 Class IIa (48.5%)
    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.
  - Z120613Rehabilitative Therapy Furnacesterminal
  - Z120614Infrared Ultraviolet Ray LampsMDR 3 classes · n=42MDD 2 classes · n=36terminal
    Registered in EUDAMED under MDR with this code, the 42 devices are split across classes (as of 8 Sep 2026).
    20 Class I (47.6%)
    20 Class IIa (47.6%)
    2 Class IIb (4.7%)
    Registered in EUDAMED under MDD with this code, the 36 devices are split across classes (as of 8 Sep 2026).
    32 Class IIa (88.8%)
    4 Class I (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. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
  - Z120615Therapeutic LasersMDR 3 classes · n=186MDD 2 classes · n=162terminal
    Registered in EUDAMED under MDR with this code, the 186 devices are split across classes (as of 8 Sep 2026).
    111 Class IIb (59.6%)
    46 Class IIa (24.7%)
    29 Class I (15.5%)
    Registered in EUDAMED under MDD with this code, the 162 devices are split across classes (as of 8 Sep 2026).
    140 Class IIb (86.4%)
    22 Class IIa (13.5%)
    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.
  - Z120616Electromechanical Systems for Physical TherapyMDR 2 classes · n=173terminal
    Registered in EUDAMED under MDR with this code, the 173 devices are split across classes (as of 8 Sep 2026).
    95 Class I (54.9%)
    78 Class IIa (45.0%)
    Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
  - Z120617Movement Analysis Integrated Systemsterminal
  - Z120618Hydrogymnastics and Hydrotherapy SystemsMDR 2 classes · n=132MDD 100.0% Class IIa · n=157terminal
    Registered in EUDAMED under MDR with this code, the 132 devices are split across classes (as of 8 Sep 2026).
    77 Class IIa (58.3%)
    55 Class I (41.6%)
    Registered in EUDAMED under MDD with this code: 157 of 157 devices carry Class IIa on their registration (as of 8 Sep 2026).
    157 Class IIa (100.0%)
    Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
  - Z120619Paraffin Therapy SystemsMDR 97.1% Class I · n=35terminal
    Registered in EUDAMED under MDR with this code: 34 of 35 devices carry Class I on their registration (as of 8 Sep 2026).
    34 Class I (97.1%)
    1 Class IIa (2.8%)
    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.
  - Z120620Vertebral Column Electroanalgesic Stimulatorsterminal
  - Z120621Facial StimulatorsMDR 100.0% Class I · n=21terminal
    Registered in EUDAMED under MDR with this code: 21 of 21 devices carry Class I on their registration (as of 8 Sep 2026).
    21 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.
  - Z120622Muscle StimulatorsMDR 2 classes · n=113terminal
    Registered in EUDAMED under MDR with this code, the 113 devices are split across classes (as of 8 Sep 2026).
    106 Class IIa (93.8%)
    7 Class I (6.1%)
    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.
  - Z120623Acupuncture StimulatorsMDR 2 classes · n=32terminal
    Registered in EUDAMED under MDR with this code, the 32 devices are split across classes (as of 8 Sep 2026).
    27 Class I (84.3%)
    5 Class IIa (15.6%)
    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.
  - Z120624Biofeedback Instruments
    - Z12062401Electromyographic Biofeedback SystemsMDR 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.
    - Z12062402Positional Biofeedback Systemsterminal
    - Z12062403Temperature Biofeedback SystemsMDR 100.0% Class I · n=69terminal
      Registered in EUDAMED under MDR with this code: 69 of 69 devices carry Class I on their registration (as of 8 Sep 2026).
      69 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.
    - Z12062404Electrodermal Signal Biofeedback SystemsMDR 100.0% Class IIa · n=33terminal
      Registered in EUDAMED under MDR with this code: 33 of 33 devices carry Class IIa on their registration (as of 8 Sep 2026).
      33 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
    - Z12062480Biofeedback Instruments - Hardware AccessoriesMDR 100.0% Class I · n=38terminal
      Registered in EUDAMED under MDR with this code: 38 of 38 devices carry Class I on their registration (as of 8 Sep 2026).
      38 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.
    - Z12062482Biofeedback Instruments - Software Accessoriesterminal
    - Z12062485Biofeedback Instruments - Consumablesterminal
    - Z12062492Biofeedback Instruments - Medical Device Softwareterminal
    - Z12062499Biofeedback Instruments - OtherMDR 100.0% Class I · n=33terminal
      Registered in EUDAMED under MDR with this code: 33 of 33 devices carry Class I on their registration (as of 8 Sep 2026).
      33 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.
  - Z120625Kinematic Motion Capture Analysis Systems
    - Z12062501Kinematic Goniometric Motion Capture Analysis Systemsterminal
    - Z12062502Kinematic Inertial Motion Capture Analysis Systemsterminal
    - Z12062503Kinematic Optoelectronic Motion Capture Analysis Systems Using Passive Markersterminal
    - Z12062504Kinematic Optoelectronic Motion Capture Analysis Systems Using Active Markersterminal
    - Z12062505Kinematic Ultrasound Motion Capture Analysis Systemsterminal
    - Z12062506Kinematic Electromagnetic Field Motion Capture Analysis Systemsterminal
    - Z12062580Kinematic Motion Capture Analysis Systems - Hardware Accessoriesterminal
    - Z12062582Kinematic Motion Capture Analysis Systems - Software Accessoriesterminal
    - Z12062585Kinematic Motion Capture Analysis Systems - Consumablesterminal
    - Z12062592Kinematic Motion Capture Analysis Systems - Medical Device Softwareterminal
    - Z12062599Kinematic Motion Capture Analysis Systems - OtherMDR 2 classes · n=32MDD 95.0% Class IIa · n=20terminal
      Registered in EUDAMED under MDR with this code, the 32 devices are split across classes (as of 8 Sep 2026).
      29 Class I (90.6%)
      3 Class IIa (9.3%)
      Registered in EUDAMED under MDD with this code: 19 of 20 devices carry Class IIa on their registration (as of 8 Sep 2026).
      19 Class IIa (95.0%)
      1 Class I (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.
  - Z120626Dynamometric Systems for Movement Analysis
    - Z12062601Dynamometric Platformsterminal
    - Z12062602Sensor-Based InsolesMDR 100.0% Class I · n=41terminal
      Registered in EUDAMED under MDR with this code: 41 of 41 devices carry Class I on their registration (as of 8 Sep 2026).
      41 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.
    - Z12062603Sensor-Based PlatformsMDR 100.0% Class I · n=48terminal
      Registered in EUDAMED under MDR with this code: 48 of 48 devices carry Class I on their registration (as of 8 Sep 2026).
      48 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.
    - Z12062680Dynamometric Systems for Movement Analysis - Hardware Accessoriesterminal
    - Z12062682Dynamometric Systems for Movement Analysis - Software Accessoriesterminal
    - Z12062685Dynamometric Systems for Movement Analysis - Consumablesterminal
    - Z12062692Dynamometric Systems for Movement Analysis - Medical Device Softwareterminal
    - Z12062699Dynamometric Systems for Movement Analysis – OtherMDR 2 classes · n=22terminal
      Registered in EUDAMED under MDR with this code, the 22 devices are split across classes (as of 8 Sep 2026).
      15 Class I (68.1%)
      7 Class IIa (31.8%)
      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.
  - Z120627Functional Electrical Stimulation Systems
    - Z12062701Perineal Stimulatorsterminal
    - Z12062702Hoisting and Walking Stimulatorsterminal
    - Z12062703Cycling Stimulatorsterminal
    - Z12062704Prehension Stimulatorsterminal
    - Z12062705Myoelectric Control Stimulatorsterminal
    - Z12062780Functional Electrical Stimulation Systems - Hardware AccessoriesMDR 2 classes · n=57terminal
      Registered in EUDAMED under MDR with this code, the 57 devices are split across classes (as of 8 Sep 2026).
      45 Class IIa (78.9%)
      12 Class I (21.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
    - Z12062782Functional Electrical Stimulation Systems - Software Accessoriesterminal
    - Z12062785Functional Electrical Stimulation Systems - Consumablesterminal
    - Z12062792Functional Electrical Stimulation Systems - Medical Device Softwareterminal
    - Z12062799Functional Electrical Stimulation Systems - OtherMDR 100.0% Class IIa · n=32terminal
      Registered in EUDAMED under MDR with this code: 32 of 32 devices carry Class IIa on their registration (as of 8 Sep 2026).
      32 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
  - Z120628Neuromuscular Stimulation Equipment
    - Z12062801Muscle Reinforcement Stimulators for Innervated MusclesMDR 97.2% Class IIa · n=181MDD 100.0% Class IIa · n=20terminal
      Registered in EUDAMED under MDR with this code: 176 of 181 devices carry Class IIa on their registration (as of 8 Sep 2026).
      176 Class IIa (97.2%)
      4 Class IIb (2.2%)
      1 Class I (0.5%)
      Registered in EUDAMED under MDD with this code: 20 of 20 devices carry Class IIa on their registration (as of 8 Sep 2026).
      20 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - Z12062802Stimulators for Scoliosis Treatmentterminal
    - Z12062880Neuromuscular Stimulation Equipment - Hardware AccessoriesMDR 96.5% Class I · n=29terminal
      Registered in EUDAMED under MDR with this code: 28 of 29 devices carry Class I on their registration (as of 8 Sep 2026).
      28 Class I (96.5%)
      1 Class IIa (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.
    - Z12062882Neuromuscular Stimulation Equipment - Software Accessoriesterminal
    - Z12062885Neuromuscular Stimulation Equipment - ConsumablesMDR 2 classes · n=122terminal
      Registered in EUDAMED under MDR with this code, the 122 devices are split across classes (as of 8 Sep 2026).
      102 Class I (83.6%)
      20 Class IIa (16.3%)
      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.
    - Z12062892Neuromuscular Stimulation Equipment - Medical Device Softwareterminal
    - Z12062899Neuromuscular Stimulation Equipment - OtherMDR 2 classes · n=133MDD 2 classes · n=21terminal
      Registered in EUDAMED under MDR with this code, the 133 devices are split across classes (as of 8 Sep 2026).
      110 Class IIa (82.7%)
      23 Class I (17.2%)
      Registered in EUDAMED under MDD with this code, the 21 devices are split across classes (as of 8 Sep 2026).
      17 Class IIa (80.9%)
      4 Class IIb (19.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
  - Z120690Various Physiotherapy and Rehabilitation Instruments
    - Z12069001Electric Hoists and WalkersMDR 100.0% Class I · n=501terminal
      Registered in EUDAMED under MDR with this code: 501 of 501 devices carry Class I on their registration (as of 8 Sep 2026).
      501 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.
    - Z12069002Assisted Locomotion SystemsMDR 2 classes · n=24terminal
      Registered in EUDAMED under MDR with this code, the 24 devices are split across classes (as of 8 Sep 2026).
      15 Class IIa (62.5%)
      9 Class I (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.
    - Z12069003Cryotherapy Chambersterminal
    - Z12069080Various Physiotherapy and Rehabilitation Instruments - Hardware AccessoriesMDR 2 classes · n=298terminal
      Registered in EUDAMED under MDR with this code, the 298 devices are split across classes (as of 8 Sep 2026).
      278 Class I (93.2%)
      20 Class IIa (6.7%)
      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.
    - Z12069082Various Physiotherapy and Rehabilitation Instruments - Software Accessoriesterminal
    - Z12069085Various Physiotherapy and Rehabilitation Instruments - Specific Materialsterminal
    - Z12069092Various Physiotherapy and Rehabilitation Instruments - Medical Device SoftwareMDR 2 classes · n=141terminal
      Registered in EUDAMED under MDR with this code, the 141 devices are split across classes (as of 8 Sep 2026).
      106 Class I (75.1%)
      35 Class IIa (24.8%)
      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.
    - Z12069099Various Physiotherapy and Rehabilitation Instruments - OtherMDR 95.7% Class I · n=2,807MDD 3 classes · n=47terminal
      Registered in EUDAMED under MDR with this code: 2,689 of 2,807 devices carry Class I on their registration (as of 8 Sep 2026).
      2,689 Class I (95.7%)
      89 Class IIa (3.1%)
      29 Class IIb (1.0%)
      Registered in EUDAMED under MDD with this code, the 47 devices are split across classes (as of 8 Sep 2026).
      24 Class IIa (51.0%)
      22 Class I (46.8%)
      1 Class IIb (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. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
- Z1207Gastroenterological Instruments
  - Z120701Gastroenterological Manometry Equipmentterminal
  - Z120702Gastroesophageal Ph Holter Recordersterminal
  - Z120703Oesophageal Functionality Analysis Equipmentterminal
  - Z120704Gastric Ph MonitorMDR 2 classes · n=39terminal
    Registered in EUDAMED under MDR with this code, the 39 devices are split across classes (as of 8 Sep 2026).
    32 Class IIa (82.0%)
    7 Class I (17.9%)
    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.
  - Z120706Equipment for Radiofrequency Treatment of the Cardiasterminal
  - Z120707Lactose Intolerance Equipmentterminal
  - Z120780Gastroenterology Instruments - Hardware Accessoriesterminal
  - Z120782Gastroenterology Instruments - Software Accessoriesterminal
  - Z120785Gastroenterology Instruments - Consumablesterminal
  - Z120792Gastroenterology Instruments - Medical Device Softwareterminal
  - Z120799Gastroenterology Instruments -Otherterminal
- Z1208Obstetrics and Gynaecology Instruments
  - Z120801Prenatal Diagnostic Instruments
    - Z12080101Foetal MonitorsMDR 3 classes · n=89MDD 2 classes · n=107terminal
      Registered in EUDAMED under MDR with this code, the 89 devices are split across classes (as of 8 Sep 2026).
      56 Class IIb (62.9%)
      20 Class IIa (22.4%)
      13 Class I (14.6%)
      Registered in EUDAMED under MDD with this code, the 107 devices are split across classes (as of 8 Sep 2026).
      98 Class IIa (91.5%)
      9 Class IIb (8.4%)
      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.
    - Z12080102Foetal Ph Monitorsterminal
    - Z12080103Foetal Heartbeat DetectorsMDR 100.0% Class IIa · n=65terminal
      Registered in EUDAMED under MDR with this code: 65 of 65 devices carry Class IIa on their registration (as of 8 Sep 2026).
      65 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
    - Z12080104Cardiotocographic Telemetry Instruments
      - Z1208010401Complete Cardiotocographic Telemetry Systemsterminal
      - Z1208010402Receiving Units for Cardiotocographic Telemetryterminal
      - Z1208010403Transmitting Units for Cardiotocographic Telemetryterminal
      - Z1208010480Cardiotocographic Telemetry Instruments - Hardware Accessoriesterminal
      - Z1208010482Cardiotocographic Telemetry Instruments - Software Accessoriesterminal
      - Z1208010485Cardiotocographic Telemetry Instruments - Consumablesterminal
      - Z1208010492Cardiotocographic Telemetry Instruments - Medical Device Softwareterminal
      - Z1208010499Cardiotocographic Telemetry Instruments - Otherterminal
    - Z12080105Foetal Acoustic Stimulatorsterminal
    - Z12080180Prenatal Diagnostic Instruments - Hardware Accessoriesterminal
    - Z12080182Prenatal Diagnostic Instruments - Software AccessoriesMDR 100.0% Class IIb · n=39terminal
      Registered in EUDAMED under MDR with this code: 39 of 39 devices carry Class IIb on their registration (as of 8 Sep 2026).
      39 Class IIb (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
    - Z12080185Prenatal Diagnostic Instruments - ConsumablesMDR 100.0% Class I · n=30terminal
      Registered in EUDAMED under MDR with this code: 30 of 30 devices carry Class I on their registration (as of 8 Sep 2026).
      30 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.
    - Z12080192Prenatal Diagnostic Instruments - Medical Device Softwareterminal
    - Z12080199Prenatal Diagnostic Instruments - Otherterminal
  - Z120802Gynaecology and Fertility Treatment Instruments
    - Z12080201Endometrial Ablation Equipmentterminal
    - Z12080202Oocyte Aspiration Equipmentterminal
    - Z12080203Hysterosuction Surgical Aspiratorsterminal
    - Z12080204MorcellatorsMDR 2 classes · n=36terminal
      Registered in EUDAMED under MDR with this code, the 36 devices are split across classes (as of 8 Sep 2026).
      32 Class IIa (88.8%)
      4 Class IIb (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.
    - Z12080205Oocyte Laser Drillsterminal
    - Z12080280Gynaecology and Fertility Treatment Instruments - Hardware AccessoriesMDD 2 classes · n=27terminal
      Registered in EUDAMED under MDD with this code, the 27 devices are split across classes (as of 8 Sep 2026).
      18 Class I (66.6%)
      9 Class IIa (33.3%)
      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.
    - Z12080282Gynaecology and Fertility Treatment Instruments - Software Accessoriesterminal
    - Z12080285Gynaecology and Fertility Treatment Instruments - Consumablesterminal
    - Z12080292Gynaecology and Fertility Treatment Instruments - Medical Device Softwareterminal
    - Z12080299Gynaecology and Fertility Treatment Instruments - OtherMDR 3 classes · n=75terminal
      Registered in EUDAMED under MDR with this code, the 75 devices are split across classes (as of 8 Sep 2026).
      59 Class I (78.6%)
      12 Class IIa (16.0%)
      4 Class IIb (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.
  - Z120803Childbirth Support and Maternal Assistance Instruments
    - Z12080301Obstetric Vacuum ExtractorsMDR 2 classes · n=39terminal
      Registered in EUDAMED under MDR with this code, the 39 devices are split across classes (as of 8 Sep 2026).
      25 Class IIa (64.1%)
      14 Class I (35.8%)
      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.
    - Z12080303Breast PumpsMDR 97.4% Class IIa · n=78MDD 100.0% Class IIa · n=35terminal
      Registered in EUDAMED under MDR with this code: 76 of 78 devices carry Class IIa on their registration (as of 8 Sep 2026).
      76 Class IIa (97.4%)
      2 Class I (2.5%)
      Registered in EUDAMED under MDD with this code: 35 of 35 devices carry Class IIa on their registration (as of 8 Sep 2026).
      35 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - Z12080304Ultrasonic Bladder Volume ScannersMDR 100.0% Class IIa · n=24terminal
      Registered in EUDAMED under MDR with this code: 24 of 24 devices carry Class IIa on their registration (as of 8 Sep 2026).
      24 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
    - Z12080305Birthing Bathsterminal
    - Z12080380Various Childbirth Support and Maternal Assistance Instruments - Hardware AccessoriesMDR 100.0% Class I · n=52terminal
      Registered in EUDAMED under MDR with this code: 52 of 52 devices carry Class I on their registration (as of 8 Sep 2026).
      52 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.
    - Z12080382Various Childbirth Support and Maternal Assistance Instruments - Software Accessoriesterminal
    - Z12080385Various Childbirth Support and Maternal Assistance Instruments - Consumablesterminal
    - Z12080392Various Childbirth Support and Maternal Assistance Instruments - Medical Device Softwareterminal
    - Z12080399Various Childbirth Support and Maternal Assistance Instruments - OtherMDR 2 classes · n=186terminal
      Registered in EUDAMED under MDR with this code, the 186 devices are split across classes (as of 8 Sep 2026).
      151 Class IIa (81.1%)
      35 Class I (18.8%)
      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.
  - Z120804Neonatology Instruments
    - Z12080401Paediatric Phototherapy EquipmentMDR 2 classes · n=115MDD 98.6% Class IIa · n=143terminal
      Registered in EUDAMED under MDR with this code, the 115 devices are split across classes (as of 8 Sep 2026).
      107 Class IIa (93.0%)
      8 Class I (6.9%)
      Registered in EUDAMED under MDD with this code: 141 of 143 devices carry Class IIa on their registration (as of 8 Sep 2026).
      141 Class IIa (98.6%)
      2 Class IIb (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.
    - Z12080402Neonatal ScalesMDR 100.0% Class I · n=59terminal
      Registered in EUDAMED under MDR with this code: 59 of 59 devices carry Class I on their registration (as of 8 Sep 2026).
      59 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.
    - Z12080403Neonatal Incubators
      - Z1208040301Fixed Neonatal IncubatorsMDR 96.5% Class IIb · n=58MDD 100.0% Class IIb · n=68terminal
        Registered in EUDAMED under MDR with this code: 56 of 58 devices carry Class IIb on their registration (as of 8 Sep 2026).
        56 Class IIb (96.5%)
        2 Class I (3.4%)
        Registered in EUDAMED under MDD with this code: 68 of 68 devices carry Class IIb on their registration (as of 8 Sep 2026).
        68 Class IIb (100.0%)
        Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
      - Z1208040302Mobile Neonatal IncubatorsMDR 100.0% Class IIb · n=65MDD 100.0% Class IIb · n=65terminal
        Registered in EUDAMED under MDR with this code: 65 of 65 devices carry Class IIb on their registration (as of 8 Sep 2026).
        65 Class IIb (100.0%)
        Registered in EUDAMED under MDD with this code: 65 of 65 devices carry Class IIb on their registration (as of 8 Sep 2026).
        65 Class IIb (100.0%)
        Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
      - Z1208040380Neonatal Incubators - Hardware Accessoriesterminal
      - Z1208040382Neonatal Incubators - Software Accessoriesterminal
      - Z1208040385Neonatal Incubators - Consumablesterminal
      - Z1208040392Neonatal Incubators - Medical Device Softwareterminal
    - Z12080404Paediatric Infrared Lampsterminal
    - Z12080405Neonatal Resuscitation Bedsterminal
    - Z12080406Apnoea Monitorsterminal
    - Z12080407Neonatal Radiant WarmersMDR 3 classes · n=68MDD 2 classes · n=70terminal
      Registered in EUDAMED under MDR with this code, the 68 devices are split across classes (as of 8 Sep 2026).
      61 Class IIb (89.7%)
      5 Class I (7.3%)
      2 Class IIa (2.9%)
      Registered in EUDAMED under MDD with this code, the 70 devices are split across classes (as of 8 Sep 2026).
      65 Class IIb (92.8%)
      5 Class IIa (7.1%)
      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.
    - Z12080408Sweat Test Stimulatorsterminal
    - Z12080409Infrared Cerebral Topographsterminal
    - Z12080410Transcutaneous Bilirubinometersterminal
    - Z12080480Neonatology Instruments - Hardware Accessoriesterminal
    - Z12080482Neonatology Instruments - Software Accessoriesterminal
    - Z12080485Neonatology Instruments - ConsumablesMDR 100.0% Class I · n=41terminal
      Registered in EUDAMED under MDR with this code: 41 of 41 devices carry Class I on their registration (as of 8 Sep 2026).
      41 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.
    - Z12080492Neonatology Instruments - Medical Device Softwareterminal
    - Z12080499Neonatology Instruments - OtherMDR 2 classes · n=32terminal
      Registered in EUDAMED under MDR with this code, the 32 devices are split across classes (as of 8 Sep 2026).
      25 Class I (78.1%)
      7 Class IIb (21.8%)
      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.
  - Z120899Gynaecology and Maternal-Infants Instruments - OtherMDR 2 classes · n=23terminal
    Registered in EUDAMED under MDR with this code, the 23 devices are split across classes (as of 8 Sep 2026).
    17 Class I (73.9%)
    6 Class IIa (26.0%)
    Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
- Z1209Nephrology and Haemodialysis Instruments
  - Z120901Peritoneal Dialysis Instruments
    - Z12090101Peritoneal Dialysis Equipmentterminal
    - Z12090180Peritoneal Dialysis Instruments - Hardware Accessoriesterminal
    - Z12090182Peritoneal Dialysis Instruments - Software Accessoriesterminal
    - Z12090185Peritoneal Dialysis Instruments - Consumablesterminal
    - Z12090192Peritoneal Dialysis Instruments - Medical Device Softwareterminal
  - Z120902Haemodialysis Instruments
    - Z12090201Haemodialysis EquipmentMDR 100.0% Class IIb · n=46terminal
      Registered in EUDAMED under MDR with this code: 46 of 46 devices carry Class IIb on their registration (as of 8 Sep 2026).
      46 Class IIb (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
    - Z12090280Haemodialysis Instruments - Hardware Accessoriesterminal
    - Z12090282Haemodialysis Instruments - Software Accessoriesterminal
    - Z12090285Haemodialysis Instruments - Consumablesterminal
    - Z12090292Haemodialysis Instruments - Medical Device Softwareterminal
  - Z120903Haemofiltration Instruments
    - Z12090301Haemofiltration Equipmentterminal
    - Z12090380Haemofiltration Instruments - Hardware Accessoriesterminal
    - Z12090382Haemofiltration Instruments - Software Accessoriesterminal
    - Z12090385Haemofiltration Instruments - Consumablesterminal
    - Z12090392Haemofiltration Instruments - Medical Device Softwareterminal
  - Z120990Various Nephrology and Haemodialysis Instruments
    - Z12099001Body Impedance AnalysersMDR 2 classes · n=52MDD 100.0% Class IIa · n=25terminal
      Registered in EUDAMED under MDR with this code, the 52 devices are split across classes (as of 8 Sep 2026).
      43 Class IIa (82.6%)
      9 Class I (17.3%)
      Registered in EUDAMED under MDD with this code: 25 of 25 devices carry Class IIa on their registration (as of 8 Sep 2026).
      25 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - Z12099002Monitoring Centres for Dialysis Treatmentterminal
    - Z12099003Hospital Beds or Armchair Scales for Dialysisterminal
    - Z12099004Heparin Pumpsterminal
    - Z12099005Blood Pumpsterminal
    - Z12099006Liquid Dialysis PreparationsMDR 100.0% Class IIa · n=234terminal
      Registered in EUDAMED under MDR with this code: 234 of 234 devices carry Class IIa on their registration (as of 8 Sep 2026).
      234 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
    - Z12099007Dialysis Water Treatment SystemsMDR 97.9% Class IIb · n=484MDD 100.0% Class IIb · n=122terminal
      Registered in EUDAMED under MDR with this code: 474 of 484 devices carry Class IIb on their registration (as of 8 Sep 2026).
      474 Class IIb (97.9%)
      10 Class IIa (2.0%)
      Registered in EUDAMED under MDD with this code: 122 of 122 devices carry Class IIb on their registration (as of 8 Sep 2026).
      122 Class IIb (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - Z12099080Various Nephrology and Haemodialysis Instruments - Hardware Accessoriesterminal
    - Z12099082Various Nephrology and Haemodialysis Instruments - Software Accessoriesterminal
    - Z12099085Various Nephrology and Haemodialysis Instruments - Consumablesterminal
    - Z12099092Various Nephrology and Haemodialysis Instruments - Medical Device Softwareterminal
    - Z12099099Various Nephrology and Haemodialysis Instruments - Otherterminal
- Z1210Neurology and Neurosurgery Instruments
  - Z121001Radiofrequency Nervous Tissue Ablation Instrumentsterminal
  - Z121002Nervous System Monitoring SystemsMDR 3 classes · n=318MDD 2 classes · n=308terminal
    Registered in EUDAMED under MDR with this code, the 318 devices are split across classes (as of 8 Sep 2026).
    190 Class IIa (59.7%)
    120 Class I (37.7%)
    8 Class IIb (2.5%)
    Registered in EUDAMED under MDD with this code, the 308 devices are split across classes (as of 8 Sep 2026).
    231 Class IIa (75.0%)
    77 Class I (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.
  - Z121003Electroencephalography Instruments
    - Z12100301EEG Spectral Analysersterminal
    - Z12100302ElectroencephalographsMDR 3 classes · n=152MDD 2 classes · n=27terminal
      Registered in EUDAMED under MDR with this code, the 152 devices are split across classes (as of 8 Sep 2026).
      117 Class IIa (76.9%)
      22 Class I (14.4%)
      13 Class IIb (8.5%)
      Registered in EUDAMED under MDD with this code, the 27 devices are split across classes (as of 8 Sep 2026).
      25 Class IIa (92.5%)
      2 Class IIb (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. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - Z12100303Systems for Analysing and Managing EEG TracesMDD 100.0% Class IIa · n=214terminal
      Registered in EUDAMED under MDD with this code: 214 of 214 devices carry Class IIa on their registration (as of 8 Sep 2026).
      214 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - Z12100380Electroencephalography Instruments - Hardware AccessoriesMDR 96.4% Class I · n=250terminal
      Registered in EUDAMED under MDR with this code: 241 of 250 devices carry Class I on their registration (as of 8 Sep 2026).
      241 Class I (96.4%)
      7 Class IIa (2.8%)
      2 Class IIb (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.
    - Z12100382Electroencephalography Instruments - Software Accessoriesterminal
    - Z12100385Electroencephalography Instruments - ConsumablesMDR 96.0% Class I · n=25terminal
      Registered in EUDAMED under MDR with this code: 24 of 25 devices carry Class I on their registration (as of 8 Sep 2026).
      24 Class I (96.0%)
      1 Class IIa (4.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
    - Z12100392Electroencephalography Instruments - Medical Device Softwareterminal
  - Z121004Electromyography Instruments
    - Z12100401ElectromyographsMDR 3 classes · n=34terminal
      Registered in EUDAMED under MDR with this code, the 34 devices are split across classes (as of 8 Sep 2026).
      15 Class IIb (44.1%)
      10 Class I (29.4%)
      9 Class IIa (26.4%)
      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.
    - Z12100480Electromyography Instruments - Hardware AccessoriesMDR 3 classes · n=160terminal
      Registered in EUDAMED under MDR with this code, the 160 devices are split across classes (as of 8 Sep 2026).
      86 Class I (53.7%)
      38 Class IIa (23.7%)
      36 Class IIb (22.5%)
      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.
    - Z12100482Electromyography Instruments - Software Accessoriesterminal
    - Z12100485Electromyography Instruments - ConsumablesMDR 2 classes · n=48terminal
      Registered in EUDAMED under MDR with this code, the 48 devices are split across classes (as of 8 Sep 2026).
      45 Class IIa (93.7%)
      3 Class I (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.
    - Z12100492Electromyography Instruments -Medical Device Softwareterminal
  - Z121005Polysomnography Instruments
    - Z12100501PolysomnographsMDR 97.7% Class IIa · n=181MDD 100.0% Class IIa · n=55terminal
      Registered in EUDAMED under MDR with this code: 177 of 181 devices carry Class IIa on their registration (as of 8 Sep 2026).
      177 Class IIa (97.7%)
      4 Class I (2.2%)
      Registered in EUDAMED under MDD with this code: 55 of 55 devices carry Class IIa on their registration (as of 8 Sep 2026).
      55 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - Z12100580Polysomnography Instruments - Hardware AccessoriesMDR 2 classes · n=268terminal
      Registered in EUDAMED under MDR with this code, the 268 devices are split across classes (as of 8 Sep 2026).
      230 Class I (85.8%)
      38 Class IIa (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.
    - Z12100582Polysomnography Instruments - Software Accessoriesterminal
    - Z12100585Polysomnography Instruments - ConsumablesMDR 97.2% Class I · n=430terminal
      Registered in EUDAMED under MDR with this code: 418 of 430 devices carry Class I on their registration (as of 8 Sep 2026).
      418 Class I (97.2%)
      12 Class IIa (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.
    - Z12100592Polysomnography Instruments - Medical Device Softwareterminal
  - Z121006Stereotactic Neurosurgery Instruments
    - Z12100601Stereotactic Neurosurgery Systemsterminal
    - Z12100680Stereotactic Neurosurgery Instruments - Hardware AccessoriesMDR 97.5% Class I · n=165terminal
      Registered in EUDAMED under MDR with this code: 161 of 165 devices carry Class I on their registration (as of 8 Sep 2026).
      161 Class I (97.5%)
      4 Class IIa (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.
    - Z12100682Stereotactic Neurosurgery Instruments - Software Accessoriesterminal
    - Z12100685Stereotactic Neurosurgery Instruments - ConsumablesMDR 3 classes · n=22terminal
      Registered in EUDAMED under MDR with this code, the 22 devices are split across classes (as of 8 Sep 2026).
      13 Class I (59.0%)
      6 Class IIa (27.2%)
      3 Class III (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.
    - Z12100692Stereotactic Neurosurgery Instruments - Medical Device Softwareterminal
  - Z121007Electromyographic (EMG) Telemetry Instruments
    - Z12100701EMG Telemetry SystemsMDR 2 classes · n=30terminal
      Registered in EUDAMED under MDR with this code, the 30 devices are split across classes (as of 8 Sep 2026).
      27 Class I (90.0%)
      3 Class IIa (10.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
    - Z12100702EMG Telemetric Transmittersterminal
    - Z12100703EMG Telemetry Receiversterminal
    - Z12100780EMG Telemetry Instruments - Hardware AccessoriesMDR 100.0% Class I · n=63terminal
      Registered in EUDAMED under MDR with this code: 63 of 63 devices carry Class I on their registration (as of 8 Sep 2026).
      63 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.
    - Z12100782EMG Telemetry Instruments - Software Accessoriesterminal
    - Z12100785EMG Telemetry Instruments - Consumablesterminal
    - Z12100792EMG Telemetry Instruments - Medical Device Softwareterminal
  - Z121008Electroencephalographic (EEG) Telemetry Instruments
    - Z12100801EEG Telemetry Systemsterminal
    - Z12100802EEG Telemetry Transmittersterminal
    - Z12100803EEG Telemetry Receiversterminal
    - Z12100880EEG Telemetry Instruments - Hardware Accessoriesterminal
    - Z12100882EEG Telemetry Instruments - Software Accessoriesterminal
    - Z12100885EEG Telemetry Instruments - Consumablesterminal
    - Z12100892EEG Telemetry Instruments - Medical Device Softwareterminal
  - Z121009Instruments for Motorised Neurosurgery Systems
    - Z12100901Motorised Neurosurgery Systemsterminal
    - Z12100902Drills for NeurosurgeryMDD 96.7% Class IIa · n=91terminal
      Registered in EUDAMED under MDD with this code: 88 of 91 devices carry Class IIa on their registration (as of 8 Sep 2026).
      88 Class IIa (96.7%)
      3 Class III (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.
    - Z12100980Instruments for Motorised Neurosurgery Systems - Hardware AccessoriesMDR 99.2% Class IIa · n=987terminal
      Registered in EUDAMED under MDR with this code: 980 of 987 devices carry Class IIa on their registration (as of 8 Sep 2026).
      980 Class IIa (99.2%)
      7 Class I (0.7%)
      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.
    - Z12100982Instruments for Motorised Neurosurgery Systems - Software Accessoriesterminal
    - Z12100985Instruments for Motorised Neurosurgery Systems - ConsumablesMDD 100.0% Class IIa · n=299terminal
      Registered in EUDAMED under MDD with this code: 299 of 299 devices carry Class IIa on their registration (as of 8 Sep 2026).
      299 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - Z12100992Instruments for Motorised Neurosurgery Systems - Medical Device Softwareterminal
  - Z121010Electroencephalographic (EEG) Holter Systems Instruments
    - Z12101001EEG Holter Systemsterminal
    - Z12101002EEG Holter Readersterminal
    - Z12101003EEG Holter Recordersterminal
    - Z12101080EEG Holter Systems Instruments - Hardware Accessoriesterminal
    - Z12101082EEG Holter Systems Instruments - Software Accessoriesterminal
    - Z12101085EEG Holter Systems Instruments - Consumablesterminal
    - Z12101092EEG Holter Systems Instruments - Medical Device Softwareterminal
  - Z121011Peripheral or Central Neuro Stimulation and Assessment Instruments
    - Z12101101Somatosensory Evoked Potential Analysersterminal
    - Z12101102Electrode Positioning Systems for Brain StimulationMDR 2 classes · n=27terminal
      Registered in EUDAMED under MDR with this code, the 27 devices are split across classes (as of 8 Sep 2026).
      24 Class I (88.8%)
      3 Class IIb (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.
    - Z12101103Somatosensory Evoked Potential Integrated Systemsterminal
    - Z12101104Cerebral Mapping Systemsterminal
    - Z12101105Magnetic StimulatorsMDR 2 classes · n=76MDD 96.5% Class IIa · n=29terminal
      Registered in EUDAMED under MDR with this code, the 76 devices are split across classes (as of 8 Sep 2026).
      43 Class IIa (56.5%)
      33 Class IIb (43.4%)
      Registered in EUDAMED under MDD with this code: 28 of 29 devices carry Class IIa on their registration (as of 8 Sep 2026).
      28 Class IIa (96.5%)
      1 Class IIb (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.
    - Z12101106Neurological StimulatorsMDR 2 classes · n=102MDD 96.2% Class IIa · n=53terminal
      Registered in EUDAMED under MDR with this code, the 102 devices are split across classes (as of 8 Sep 2026).
      61 Class I (59.8%)
      41 Class IIa (40.1%)
      Registered in EUDAMED under MDD with this code: 51 of 53 devices carry Class IIa on their registration (as of 8 Sep 2026).
      51 Class IIa (96.2%)
      2 Class IIb (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.
    - Z12101180Peripheral or Central Neuro Stimulation and Assessment Instruments - Hardware AccessoriesMDR 2 classes · n=26terminal
      Registered in EUDAMED under MDR with this code, the 26 devices are split across classes (as of 8 Sep 2026).
      24 Class I (92.3%)
      2 Class IIa (7.6%)
      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.
    - Z12101182Peripheral or Central Neuro Stimulation and Assessment Instruments - Software Accessoriesterminal
    - Z12101185Peripheral or Central Neuro Stimulation and Assessment Instruments - ConsumablesMDR 3 classes · n=50MDD 100.0% Class IIa · n=110terminal
      Registered in EUDAMED under MDR with this code, the 50 devices are split across classes (as of 8 Sep 2026).
      46 Class I (92.0%)
      2 Class IIa (4.0%)
      2 Class IIb (4.0%)
      Registered in EUDAMED under MDD with this code: 110 of 110 devices carry Class IIa on their registration (as of 8 Sep 2026).
      110 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - Z12101192Peripheral or Central Neuro Stimulation and Assessment Instruments - Medical Device Softwareterminal
    - Z12101199Peripheral or Central Neuro Stimulation and Assessment Instruments - Otherterminal
  - Z121012Magnetoencephalography Instruments
    - Z12101201Magnetoencephalography Systemsterminal
    - Z12101280Magnetoencephalography Instruments – Hardware Accessoriesterminal
    - Z12101282Magnetoencephalography Instruments – Software Accessoriesterminal
    - Z12101285Magnetoencephalography Instruments - Consumablesterminal
    - Z12101292Magnetoencephalography Instruments – Medical Device Softwareterminal
  - Z121090Various Neurology and Neurosurgery Instruments
    - Z12109001Detachable Coil Equipment for Brain AneurysmsMDR 98.3% Class III · n=246MDD 99.1% Class III · n=115terminal
      Registered in EUDAMED under MDR with this code: 242 of 246 devices carry Class III on their registration (as of 8 Sep 2026).
      242 Class III (98.3%)
      2 Class I (0.8%)
      1 Class IIa (0.4%)
      1 Class IIb (0.4%)
      Registered in EUDAMED under MDD with this code: 114 of 115 devices carry Class III on their registration (as of 8 Sep 2026).
      114 Class III (99.1%)
      1 Class IIb (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.
    - Z12109002Electroconvulsive Therapy (Ect) EquipmentMDR 100.0% Class I · n=67terminal
      Registered in EUDAMED under MDR with this code: 67 of 67 devices carry Class I on their registration (as of 8 Sep 2026).
      67 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.
    - Z12109003Cerebrospinal Fluid Pressure Monitoring Systemsterminal
    - Z12109004Vibration Threshold Meters (Vibrometer)terminal
    - Z12109005Reaction Time/Reflex Metersterminal
    - Z12109006Brain Tissue Monitoring SystemsMDR 3 classes · n=20terminal
      Registered in EUDAMED under MDR with this code, the 20 devices are split across classes (as of 8 Sep 2026).
      14 Class I (70.0%)
      5 Class IIa (25.0%)
      1 Class III (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.
    - Z12109007Psychometric Testing Systemsterminal
    - Z12109080Various Neurology and Neurosurgery Instruments - Hardware AccessoriesMDR 3 classes · n=221terminal
      Registered in EUDAMED under MDR with this code, the 221 devices are split across classes (as of 8 Sep 2026).
      204 Class I (92.3%)
      13 Class IIa (5.8%)
      4 Class IIb (1.8%)
      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.
    - Z12109082Various Neurology and Neurosurgery Instruments - Software Accessoriesterminal
    - Z12109085Various Neurology and Neurosurgery Instruments - Specific Materialsterminal
    - Z12109092Various Neurology and Neurosurgery Instruments - Medical Device Softwareterminal
    - Z12109099Various Neurology and Neurosurgery Instruments - OtherMDR 3 classes · n=42MDD 98.4% Class III · n=130terminal
      Registered in EUDAMED under MDR with this code, the 42 devices are split across classes (as of 8 Sep 2026).
      19 Class IIa (45.2%)
      14 Class III (33.3%)
      9 Class IIb (21.4%)
      Registered in EUDAMED under MDD with this code: 128 of 130 devices carry Class III on their registration (as of 8 Sep 2026).
      128 Class III (98.4%)
      2 Class IIa (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.
- Z1211Dental Stomatology Instruments
  - Z121101Instruments for Dental Treatment Units
    - Z12110101Dental Treatment UnitsMDR 2 classes · n=1,030MDD 96.3% Class IIa · n=136terminal
      Registered in EUDAMED under MDR with this code, the 1,030 devices are split across classes (as of 8 Sep 2026).
      743 Class IIa (72.1%)
      287 Class I (27.8%)
      Registered in EUDAMED under MDD with this code: 131 of 136 devices carry Class IIa on their registration (as of 8 Sep 2026).
      131 Class IIa (96.3%)
      3 Class I (2.2%)
      1 Class IIb (0.7%)
      1 Class III (0.7%)
      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.
    - Z12110102Dental DrillsMDR 99.9% Class IIa · n=58,712MDD 97.9% Class IIa · n=3,777terminal
      Registered in EUDAMED under MDR with this code: 58,703 of 58,712 devices carry Class IIa on their registration (as of 8 Sep 2026).
      58,703 Class IIa (99.9%)
      9 Class I (<0.1%)
      Registered in EUDAMED under MDD with this code: 3,701 of 3,777 devices carry Class IIa on their registration (as of 8 Sep 2026).
      3,701 Class IIa (97.9%)
      74 Class I (1.9%)
      2 Class III (<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.
    - Z12110180Instruments for Dental Treatment Units - Hardware AccessoriesMDR 2 classes · n=871MDD 95.0% Class IIa · n=100terminal
      Registered in EUDAMED under MDR with this code, the 871 devices are split across classes (as of 8 Sep 2026).
      533 Class I (61.1%)
      338 Class IIa (38.8%)
      Registered in EUDAMED under MDD with this code: 95 of 100 devices carry Class IIa on their registration (as of 8 Sep 2026).
      95 Class IIa (95.0%)
      5 Class I (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.
    - Z12110182Instruments for Dental Treatment Units - Software Accessoriesterminal
    - Z12110185Instruments for Dental Treatment Units - Consumablesterminal
    - Z12110192Instruments for Dental Treatment Units - Medical Device Softwareterminal
    - Z12110199Instruments for Dental Treatment Units - OtherMDR 2 classes · n=709MDD 2 classes · n=25terminal
      Registered in EUDAMED under MDR with this code, the 709 devices are split across classes (as of 8 Sep 2026).
      361 Class IIa (50.9%)
      348 Class I (49.0%)
      Registered in EUDAMED under MDD with this code, the 25 devices are split across classes (as of 8 Sep 2026).
      20 Class IIa (80.0%)
      5 Class I (20.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
  - Z121190Various Dental Stomatology Instruments
    - Z12119001Tartar AblatorsMDR 95.2% Class IIa · n=125MDD 100.0% Class IIa · n=108terminal
      Registered in EUDAMED under MDR with this code: 119 of 125 devices carry Class IIa on their registration (as of 8 Sep 2026).
      119 Class IIa (95.2%)
      6 Class I (4.8%)
      Registered in EUDAMED under MDD with this code: 108 of 108 devices carry Class IIa on their registration (as of 8 Sep 2026).
      108 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - Z12119002AmalgamatorsMDR 100.0% Class I · n=27terminal
      Registered in EUDAMED under MDR with this code: 27 of 27 devices carry Class I on their registration (as of 8 Sep 2026).
      27 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.
    - Z12119003Cold Light Dental EquipmentMDR 100.0% Class I · n=111terminal
      Registered in EUDAMED under MDR with this code: 111 of 111 devices carry Class I on their registration (as of 8 Sep 2026).
      111 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.
    - Z12119004Equipment for Diagnosis of Periodontal Diseasesterminal
    - Z12119005Pulp Vitality Analysersterminal
    - Z12119006Dental Cleaning/Washing Handpiece EquipmentsMDR 2 classes · n=182terminal
      Registered in EUDAMED under MDR with this code, the 182 devices are split across classes (as of 8 Sep 2026).
      127 Class IIa (69.7%)
      55 Class I (30.2%)
      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.
    - Z12119007Dental Prophylaxis EquipmentMDR 2 classes · n=30terminal
      Registered in EUDAMED under MDR with this code, the 30 devices are split across classes (as of 8 Sep 2026).
      27 Class IIa (90.0%)
      3 Class I (10.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
    - Z12119008Endodontic Compactorsterminal
    - Z12119009Apex Locatorsterminal
    - Z12119080Various Dental Stomatology Instruments - Hardware AccessoriesMDR 2 classes · n=84terminal
      Registered in EUDAMED under MDR with this code, the 84 devices are split across classes (as of 8 Sep 2026).
      55 Class I (65.4%)
      29 Class IIa (34.5%)
      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.
    - Z12119082Various Dental Stomatology Instruments - Software Accessoriesterminal
    - Z12119085Various Dental Stomatology Instruments - ConsumablesMDR 96.8% Class I · n=64terminal
      Registered in EUDAMED under MDR with this code: 62 of 64 devices carry Class I on their registration (as of 8 Sep 2026).
      62 Class I (96.8%)
      2 Class IIa (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.
    - Z12119092Various Dental Stomatology Instruments - Medical Device Softwareterminal
    - Z12119099Various Dental Stomatology Instruments - OtherMDR 2 classes · n=915MDD 100.0% Class IIa · n=27terminal
      Registered in EUDAMED under MDR with this code, the 915 devices are split across classes (as of 8 Sep 2026).
      620 Class I (67.7%)
      295 Class IIa (32.2%)
      Registered in EUDAMED under MDD with this code: 27 of 27 devices carry Class IIa on their registration (as of 8 Sep 2026).
      27 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
- Z1212Ophthalmology Instruments
  - Z121201Ophtalmology Assessments and Diagnosis Instruments
    - Z12120101Laser Polarimetry Equipmentterminal
    - Z12120102Computerised Optical BiometersMDR 2 classes · n=25terminal
      Registered in EUDAMED under MDR with this code, the 25 devices are split across classes (as of 8 Sep 2026).
      23 Class IIa (92.0%)
      2 Class IIb (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.
    - Z12120103Electroretinographsterminal
    - Z12120104Exophthalmometersterminal
    - Z12120105Fluoroangiographsterminal
    - Z12120106Fluorophotometersterminal
    - Z12120107Photocheratoscopesterminal
    - Z12120108Slit LampsMDR 99.0% Class I · n=415terminal
      Registered in EUDAMED under MDR with this code: 411 of 415 devices carry Class I on their registration (as of 8 Sep 2026).
      411 Class I (99.0%)
      4 Class IIa (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.
    - Z12120109Retinoscopy Lampsterminal
    - Z12120110Corneal Confocal Microscopesterminal
    - Z12120111Eye Movement Monitorsterminal
    - Z12120112Glasses for Nystagmusterminal
    - Z12120113OphthalmometersMDR 2 classes · n=20terminal
      Registered in EUDAMED under MDR with this code, the 20 devices are split across classes (as of 8 Sep 2026).
      14 Class I (70.0%)
      6 Class IIa (30.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
    - Z12120114OphthalmoscopesMDR 99.3% Class I · n=495terminal
      Registered in EUDAMED under MDR with this code: 492 of 495 devices carry Class I on their registration (as of 8 Sep 2026).
      492 Class I (99.3%)
      3 Class IIa (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.
    - Z12120115OptometersMDR 2 classes · n=59terminal
      Registered in EUDAMED under MDR with this code, the 59 devices are split across classes (as of 8 Sep 2026).
      43 Class I (72.8%)
      16 Class IIa (27.1%)
      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.
    - Z12120116Pachymetersterminal
    - Z12120117Intra-Ocular Pressure Regulatorsterminal
    - Z12120118RetinoscopesMDR 100.0% Class I · n=47terminal
      Registered in EUDAMED under MDR with this code: 47 of 47 devices carry Class I on their registration (as of 8 Sep 2026).
      47 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.
    - Z12120119Ophthalmological Treatment UnitsMDR 99.3% Class I · n=158terminal
      Registered in EUDAMED under MDR with this code: 157 of 158 devices carry Class I on their registration (as of 8 Sep 2026).
      157 Class I (99.3%)
      1 Class IIa (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.
    - Z12120120Instruments for the Assessment of Visual Functionality
      - Z1212012001Visual Functional Assessment EquipmentMDR 2 classes · n=172terminal
        Registered in EUDAMED under MDR with this code, the 172 devices are split across classes (as of 8 Sep 2026).
        148 Class I (86.0%)
        24 Class IIa (13.9%)
        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.
      - Z1212012002Adaptometersterminal
      - Z1212012003Peripheral Vision AnalysersMDR 2 classes · n=28terminal
        Registered in EUDAMED under MDR with this code, the 28 devices are split across classes (as of 8 Sep 2026).
        19 Class I (67.8%)
        9 Class IIa (32.1%)
        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.
      - Z1212012004Hess Screensterminal
      - Z1212012005Anomaloscopesterminal
      - Z1212012080Instruments for the Assessment of Visual Functionality - Hardware AccessoriesMDR 99.2% Class I · n=141terminal
        Registered in EUDAMED under MDR with this code: 140 of 141 devices carry Class I on their registration (as of 8 Sep 2026).
        140 Class I (99.2%)
        1 Class IIa (0.7%)
        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.
      - Z1212012082Instruments for the Assessment of Visual Functionality - Software Accessoriesterminal
      - Z1212012085Instruments for the Assessment of Visual Functionality - Consumablesterminal
      - Z1212012092Instruments for the Assessment of Visual Functionality - Medical Device Softwareterminal
      - Z1212012099Instruments for the Assessment of Visual Functionality - OtherMDR 100.0% Class I · n=830terminal
        Registered in EUDAMED under MDR with this code: 830 of 830 devices carry Class I on their registration (as of 8 Sep 2026).
        830 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.
    - Z12120121Optical Consistency TomographsMDR 2 classes · n=64terminal
      Registered in EUDAMED under MDR with this code, the 64 devices are split across classes (as of 8 Sep 2026).
      60 Class IIa (93.7%)
      4 Class I (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.
    - Z12120122TonometersMDR 2 classes · n=70MDD 2 classes · n=59terminal
      Registered in EUDAMED under MDR with this code, the 70 devices are split across classes (as of 8 Sep 2026).
      50 Class IIa (71.4%)
      20 Class I (28.5%)
      Registered in EUDAMED under MDD with this code, the 59 devices are split across classes (as of 8 Sep 2026).
      37 Class IIa (62.7%)
      22 Class I (37.2%)
      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.
    - Z12120123Computerised Corneal TopographsMDR 2 classes · n=28terminal
      Registered in EUDAMED under MDR with this code, the 28 devices are split across classes (as of 8 Sep 2026).
      25 Class IIa (89.2%)
      3 Class I (10.7%)
      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.
    - Z12120124Video/ElectronystagmographsMDR 2 classes · n=39terminal
      Registered in EUDAMED under MDR with this code, the 39 devices are split across classes (as of 8 Sep 2026).
      23 Class IIa (58.9%)
      16 Class I (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.
    - Z12120125Pupillometersterminal
    - Z12120180Ophtalmology Assessments and Diagnosis Instruments - Hardware AccessoriesMDR 99.5% Class I · n=234MDD 100.0% Class I · n=44terminal
      Registered in EUDAMED under MDR with this code: 233 of 234 devices carry Class I on their registration (as of 8 Sep 2026).
      233 Class I (99.5%)
      1 Class IIa (0.4%)
      Registered in EUDAMED under MDD with this code: 44 of 44 devices carry Class I on their registration (as of 8 Sep 2026).
      44 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.
    - Z12120182Ophtalmology Assessments and Diagnosis Instruments - Software Accessoriesterminal
    - Z12120185Ophtalmology Assessments and Diagnosis Instruments - Consumablesterminal
    - Z12120192Ophtalmology Assessments and Diagnosis Instruments - Medical Device SoftwareMDR 3 classes · n=31terminal
      Registered in EUDAMED under MDR with this code, the 31 devices are split across classes (as of 8 Sep 2026).
      22 Class IIa (70.9%)
      5 Class IIb (16.1%)
      4 Class I (12.9%)
      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.
    - Z12120199Ophtalmology Assessments and Diagnosis Instruments – OtherMDR 2 classes · n=432MDD 3 classes · n=27terminal
      Registered in EUDAMED under MDR with this code, the 432 devices are split across classes (as of 8 Sep 2026).
      359 Class I (83.1%)
      73 Class IIa (16.8%)
      Registered in EUDAMED under MDD with this code, the 27 devices are split across classes (as of 8 Sep 2026).
      15 Class IIa (55.5%)
      7 Class IIb (25.9%)
      5 Class I (18.5%)
      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.
  - Z121202Therapeutic and Surgical Ophtholmological Treatments Instruments
    - Z12120201Cross–eye Convergence Trainersterminal
    - Z12120202Laser Photocoagulatorsterminal
    - Z12120203Corneal Millerterminal
    - Z12120204Synoptiscopesterminal
    - Z12120205Instruments for Microkeratome Surgery
      - Z1212020501Microkeratome Lasersterminal
      - Z1212020502Microblade Microkeratomesterminal
      - Z1212020580Microkeratomy Instruments - Hardware Accessoriesterminal
      - Z1212020582Microkeratomy Instruments - Software Accessoriesterminal
      - Z1212020585Microkeratomy Instruments - ConsumablesMDD 98.1% Class IIa · n=107terminal
        Registered in EUDAMED under MDD with this code: 105 of 107 devices carry Class IIa on their registration (as of 8 Sep 2026).
        105 Class IIa (98.1%)
        2 Class I (1.8%)
        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.
      - Z1212020592Microkeratomy Instruments - Medical Device Softwareterminal
      - Z1212020599Microkeratomy Instruments - OtherMDD 100.0% Class IIa · n=42terminal
        Registered in EUDAMED under MDD with this code: 42 of 42 devices carry Class IIa on their registration (as of 8 Sep 2026).
        42 Class IIa (100.0%)
        Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - Z12120206Ophthalmic Electrosurgery Instruments
      - Z1212020601Ophthalmic Electrosurgery Equipmentterminal
      - Z1212020602Ophthalmic Microdiathermy Coagulatorsterminal
      - Z1212020680Ophthalmic Electrosurgery Instruments - Hardware Accessoriesterminal
      - Z1212020682Ophthalmic Electrosurgery Instruments - Software Accessoriesterminal
      - Z1212020685Ophthalmic Electrosurgery Instruments - Consumablesterminal
      - Z1212020692Ophthalmic Electrosurgery Instruments - Medical Device Softwareterminal
      - Z1212020699Ophthalmic Electrosurgery Instruments – Otherterminal
    - Z12120207Phaco-Vitrectomy Instruments
      - Z1212020701Phaco-Emulsifiersterminal
      - Z1212020702Phaco-Vitrectomy SystemsMDD 100.0% Class IIb · n=22terminal
        Registered in EUDAMED under MDD with this code: 22 of 22 devices carry Class IIb on their registration (as of 8 Sep 2026).
        22 Class IIb (100.0%)
        Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
      - Z1212020703Vitrectomesterminal
      - Z1212020780Phaco-Vitrectomy Instruments - Hardware AccessoriesMDR 3 classes · n=21terminal
        Registered in EUDAMED under MDR with this code, the 21 devices are split across classes (as of 8 Sep 2026).
        18 Class IIb (85.7%)
        2 Class I (9.5%)
        1 Class IIa (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.
      - Z1212020782Phaco-Vitrectomy Instruments - Software Accessoriesterminal
      - Z1212020785Phaco-Vitrectomy Instruments - ConsumablesMDR 3 classes · n=248MDD 96.0% Class IIa · n=410terminal
        Registered in EUDAMED under MDR with this code, the 248 devices are split across classes (as of 8 Sep 2026).
        140 Class IIa (56.4%)
        102 Class IIb (41.1%)
        6 Class I (2.4%)
        Registered in EUDAMED under MDD with this code: 394 of 410 devices carry Class IIa on their registration (as of 8 Sep 2026).
        394 Class IIa (96.0%)
        11 Class I (2.6%)
        5 Class IIb (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.
      - Z1212020792Phaco-Vitrectomy Instruments - Medical Device Softwareterminal
      - Z1212020799Phaco-Vitrectomy Instruments - Otherterminal
    - Z12120208Corneal DrillsMDR 100.0% Class I · n=42terminal
      Registered in EUDAMED under MDR with this code: 42 of 42 devices carry Class I on their registration (as of 8 Sep 2026).
      42 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.
    - Z12120280Therapeutic and Surgical Ophtholmological Treatments Instruments - Hardware AccessoriesMDR 2 classes · n=26terminal
      Registered in EUDAMED under MDR with this code, the 26 devices are split across classes (as of 8 Sep 2026).
      24 Class I (92.3%)
      2 Class IIb (7.6%)
      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.
    - Z12120282Therapeutic and Surgical Ophtholmological Treatments Instruments - Software Accessoriesterminal
    - Z12120285Therapeutic and Surgical Ophtholmological Treatments Instruments - ConsumablesMDR 2 classes · n=55terminal
      Registered in EUDAMED under MDR with this code, the 55 devices are split across classes (as of 8 Sep 2026).
      38 Class IIa (69.0%)
      17 Class IIb (30.9%)
      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.
    - Z12120292Therapeutic and Surgical Ophtholmological Treatments Instruments - Medical Device Softwareterminal
    - Z12120299Therapeutic and Surgical Ophtholmological Treatments Instruments - OtherMDR 3 classes · n=149MDD 3 classes · n=23terminal
      Registered in EUDAMED under MDR with this code, the 149 devices are split across classes (as of 8 Sep 2026).
      120 Class I (80.5%)
      23 Class IIa (15.4%)
      6 Class IIb (4.0%)
      Registered in EUDAMED under MDD with this code, the 23 devices are split across classes (as of 8 Sep 2026).
      15 Class IIa (65.2%)
      4 Class I (17.3%)
      4 Class IIb (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.
  - Z121290Various Ophtalmology Instruments
    - Z12129001Ophthalmological Instrument StandsMDR 100.0% Class I · n=212terminal
      Registered in EUDAMED under MDR with this code: 212 of 212 devices carry Class I on their registration (as of 8 Sep 2026).
      212 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.
    - Z12129080Various Ophtalmology Instruments - Hardware Accessoriesterminal
    - Z12129082Various Ophtalmology Instruments - Software Accessoriesterminal
    - Z12129085Various Ophtalmology Instruments - ConsumablesMDD 100.0% Class IIa · n=33terminal
      Registered in EUDAMED under MDD with this code: 33 of 33 devices carry Class IIa on their registration (as of 8 Sep 2026).
      33 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - Z12129092Various Ophtalmology Instruments - Medical Device Softwareterminal
    - Z12129099Various Ophtalmology Instruments - OtherMDR 2 classes · n=51terminal
      Registered in EUDAMED under MDR with this code, the 51 devices are split across classes (as of 8 Sep 2026).
      43 Class I (84.3%)
      8 Class IIa (15.6%)
      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.
- Z1213Orthopaedic Instruments
  - Z121301Percutaneous Discectomy EquipmentMDD 96.5% Class IIa · n=58terminal
    Registered in EUDAMED under MDD with this code: 56 of 58 devices carry Class IIa on their registration (as of 8 Sep 2026).
    56 Class IIa (96.5%)
    2 Class IIb (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.
  - Z121302Orthopaedic Traction Instruments
    - Z12130201Traction Bedsterminal
    - Z12130202Traction SystemsMDR 96.7% Class I · n=92terminal
      Registered in EUDAMED under MDR with this code: 89 of 92 devices carry Class I on their registration (as of 8 Sep 2026).
      89 Class I (96.7%)
      3 Class IIa (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.
    - Z12130280Orthopaedic Traction Instruments – Hardware AccessoriesMDR 100.0% Class I · n=73terminal
      Registered in EUDAMED under MDR with this code: 73 of 73 devices carry Class I on their registration (as of 8 Sep 2026).
      73 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.
    - Z12130282Orthopaedic Traction Instruments – Software Accessoriesterminal
    - Z12130285Orthopaedic Traction Instruments - ConsumablesMDR 100.0% Class I · n=45terminal
      Registered in EUDAMED under MDR with this code: 45 of 45 devices carry Class I on their registration (as of 8 Sep 2026).
      45 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.
    - Z12130292Orthopaedic Traction Instruments - Medical Device Softwareterminal
  - Z121303Bone Growth Stimulation Instruments
    - Z12130301Bone Growth Stimulatorsterminal
    - Z12130380Bone Growth Stimulation Instruments - Hardware Accessoriesterminal
    - Z12130382Bone Growth Stimulation Instruments - Software Accessoriesterminal
    - Z12130385Bone Growth Stimulation Instruments - Consumablesterminal
    - Z12130392Bone Growth Stimulation Instruments - Medical Device Softwareterminal
  - Z121304Stereotactic Orthopaedic Surgery Instruments
    - Z12130401Stereotactic Orthopaedic Surgery SystemsMDR 3 classes · n=69terminal
      Registered in EUDAMED under MDR with this code, the 69 devices are split across classes (as of 8 Sep 2026).
      55 Class IIb (79.7%)
      12 Class I (17.3%)
      2 Class IIa (2.8%)
      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.
    - Z12130480Stereotactic Orthopaedic Surgery Instruments - Hardware AccessoriesMDR 3 classes · n=375terminal
      Registered in EUDAMED under MDR with this code, the 375 devices are split across classes (as of 8 Sep 2026).
      241 Class IIa (64.2%)
      92 Class I (24.5%)
      42 Class IIb (11.2%)
      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.
    - Z12130482Stereotactic Orthopaedic Surgery Instruments - Software AccessoriesMDR 100.0% Class IIa · n=21terminal
      Registered in EUDAMED under MDR with this code: 21 of 21 devices carry Class IIa on their registration (as of 8 Sep 2026).
      21 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
    - Z12130485Stereotactic Orthopaedic Surgery Instruments - ConsumablesMDR 2 classes · n=26terminal
      Registered in EUDAMED under MDR with this code, the 26 devices are split across classes (as of 8 Sep 2026).
      22 Class IIa (84.6%)
      4 Class IIb (15.3%)
      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.
    - Z12130492Stereotactic Orthopaedic Surgery Instruments - Medical Device Softwareterminal
  - Z121305Motorised Orthopaedic Surgery System Instruments
    - Z12130501Motorised Orthopaedic Surgery SystemsMDR 100.0% Class IIa · n=22MDD 100.0% Class IIa · n=68terminal
      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 MDD with this code: 68 of 68 devices carry Class IIa on their registration (as of 8 Sep 2026).
      68 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - Z12130502Orthopaedic Surgical SawsMDR 2 classes · n=176MDD 99.6% Class IIa · n=601terminal
      Registered in EUDAMED under MDR with this code, the 176 devices are split across classes (as of 8 Sep 2026).
      145 Class IIa (82.3%)
      31 Class I (17.6%)
      Registered in EUDAMED under MDD with this code: 599 of 601 devices carry Class IIa on their registration (as of 8 Sep 2026).
      599 Class IIa (99.6%)
      2 Class I (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.
    - Z12130503Orthopaedic Surgical DrillsMDR 2 classes · n=2,338MDD 2 classes · n=470terminal
      Registered in EUDAMED under MDR with this code, the 2,338 devices are split across classes (as of 8 Sep 2026).
      1,746 Class IIa (74.6%)
      592 Class I (25.3%)
      Registered in EUDAMED under MDD with this code, the 470 devices are split across classes (as of 8 Sep 2026).
      356 Class IIa (75.7%)
      114 Class I (24.2%)
      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.
    - Z12130580Motorised Orthopaedic Surgery System Instruments - Hardware AccessoriesMDR 3 classes · n=1,352MDD 98.1% Class IIa · n=110terminal
      Registered in EUDAMED under MDR with this code, the 1,352 devices are split across classes (as of 8 Sep 2026).
      1,178 Class IIa (87.1%)
      168 Class I (12.4%)
      6 Class III (0.4%)
      Registered in EUDAMED under MDD with this code: 108 of 110 devices carry Class IIa on their registration (as of 8 Sep 2026).
      108 Class IIa (98.1%)
      1 Class I (0.9%)
      1 Class III (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.
    - Z12130582Motorised Orthopaedic Surgery System Instruments - Software Accessoriesterminal
    - Z12130585Motorised Orthopaedic Surgery System Instruments - ConsumablesMDR 98.5% Class IIa · n=346MDD 100.0% Class IIa · n=600terminal
      Registered in EUDAMED under MDR with this code: 341 of 346 devices carry Class IIa on their registration (as of 8 Sep 2026).
      341 Class IIa (98.5%)
      5 Class I (1.4%)
      Registered in EUDAMED under MDD with this code: 600 of 600 devices carry Class IIa on their registration (as of 8 Sep 2026).
      600 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - Z12130592Motorised Orthopaedic Surgery System Instruments - Medical Device Softwareterminal
    - Z12130599Motorised Orthopaedic Surgery System Instruments - OtherMDR 2 classes · n=474MDD 100.0% Class IIa · n=43terminal
      Registered in EUDAMED under MDR with this code, the 474 devices are split across classes (as of 8 Sep 2026).
      443 Class IIa (93.4%)
      31 Class I (6.5%)
      Registered in EUDAMED under MDD with this code: 43 of 43 devices carry Class IIa on their registration (as of 8 Sep 2026).
      43 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
  - Z121390Various Orthopaedic and Traumatology Instruments
    - Z12139001Shock Wave Therapy EquipmentMDR 3 classes · n=67terminal
      Registered in EUDAMED under MDR with this code, the 67 devices are split across classes (as of 8 Sep 2026).
      28 Class I (41.7%)
      21 Class IIb (31.3%)
      18 Class IIa (26.8%)
      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.
    - Z12139002Prosthetic Cement Removal EquipmentMDR 2 classes · n=37terminal
      Registered in EUDAMED under MDR with this code, the 37 devices are split across classes (as of 8 Sep 2026).
      31 Class IIa (83.7%)
      6 Class IIb (16.2%)
      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.
    - Z12139003Podoscope Systemsterminal
    - Z12139004Podological Treatment UnitsMDR 2 classes · n=49terminal
      Registered in EUDAMED under MDR with this code, the 49 devices are split across classes (as of 8 Sep 2026).
      45 Class I (91.8%)
      4 Class IIa (8.1%)
      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.
    - Z12139005Plaster Cast SawsMDR 100.0% Class I · n=161terminal
      Registered in EUDAMED under MDR with this code: 161 of 161 devices carry Class I on their registration (as of 8 Sep 2026).
      161 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.
    - Z12139006Pneumatic TourniquetsMDR 98.9% Class I · n=392terminal
      Registered in EUDAMED under MDR with this code: 388 of 392 devices carry Class I on their registration (as of 8 Sep 2026).
      388 Class I (98.9%)
      2 Class IIa (0.5%)
      2 Class IIb (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.
    - Z12139080Various Orthopaedic and Traumatology Instruments - Hardware AccessoriesMDR 2 classes · n=77terminal
      Registered in EUDAMED under MDR with this code, the 77 devices are split across classes (as of 8 Sep 2026).
      65 Class I (84.4%)
      12 Class IIa (15.5%)
      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.
    - Z12139082Various Orthopaedic and Traumatology Instruments - Software Accessoriesterminal
    - Z12139085Various Orthopaedic and Traumatology Instruments - ConsumablesMDR 98.5% Class IIa · n=67terminal
      Registered in EUDAMED under MDR with this code: 66 of 67 devices carry Class IIa on their registration (as of 8 Sep 2026).
      66 Class IIa (98.5%)
      1 Class I (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.
    - Z12139092Various Orthopaedic and Traumatology Instruments - Medical Device Softwareterminal
    - Z12139099Various Orthopaedic and Traumatology Instruments - OtherMDR 3 classes · n=1,957terminal
      Registered in EUDAMED under MDR with this code, the 1,957 devices are split across classes (as of 8 Sep 2026).
      1,538 Class IIa (78.5%)
      418 Class I (21.3%)
      1 Class IIb (<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.
- Z1214ENT Instruments
  - Z121401AudiometersMDR 2 classes · n=211terminal
    Registered in EUDAMED under MDR with this code, the 211 devices are split across classes (as of 8 Sep 2026).
    191 Class IIa (90.5%)
    20 Class I (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.
  - Z121402ENT Treatment UnitsMDR 2 classes · n=31MDD 100.0% Class IIa · n=28terminal
    Registered in EUDAMED under MDR with this code, the 31 devices are split across classes (as of 8 Sep 2026).
    24 Class I (77.4%)
    7 Class IIa (22.5%)
    Registered in EUDAMED under MDD with this code: 28 of 28 devices carry Class IIa on their registration (as of 8 Sep 2026).
    28 Class IIa (100.0%)
    Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
  - Z121403Evoked Potential Audiometry Instruments
    - Z12140301Evoked Potential Audiometry Integrated Systemsterminal
    - Z12140302Evoked Potential Audiometry Equipmentsterminal
    - Z12140380Evoked Potential Audiometry Instruments - Hardware AccessoriesMDR 100.0% Class I · n=29terminal
      Registered in EUDAMED under MDR with this code: 29 of 29 devices carry Class I on their registration (as of 8 Sep 2026).
      29 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.
    - Z12140382Evoked Potential Audiometry Instruments - Software Accessoriesterminal
    - Z12140385Evoked Potential Audiometry Instruments - Consumablesterminal
    - Z12140392Evoked Potential Audiometry Instruments - Medical Device Softwareterminal
  - Z121404Vestibular System Analysis Instruments
    - Z12140401Vestibular Assessment SystemsMDR 2 classes · n=34terminal
      Registered in EUDAMED under MDR with this code, the 34 devices are split across classes (as of 8 Sep 2026).
      20 Class I (58.8%)
      14 Class IIa (41.1%)
      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.
    - Z12140402Vestibular Assessment Stabilometric Platformsterminal
    - Z12140403Rotating Pendular Chairsterminal
    - Z12140404Posturography Systemsterminal
    - Z12140480Vestibular System Analysis Instruments - Hardware Accessoriesterminal
    - Z12140482Vestibular System Analysis Instruments - Software Accessoriesterminal
    - Z12140485Vestibular System Analysis Instruments - Consumablesterminal
    - Z12140492Vestibular System Analysis Instruments - Medical Device Softwareterminal
  - Z121405Stereotactic ENT Surgery Instruments
    - Z12140501Stereotactic ENT Surgery Systemsterminal
    - Z12140580Stereotactic ENT Surgery Instruments - Hardware Accessoriesterminal
    - Z12140582Stereotactic ENT Surgery Instruments - Software Accessoriesterminal
    - Z12140585Stereotactic ENT Surgery Instruments - Consumablesterminal
    - Z12140592Stereotactic ENT Surgery Instruments - Medical Device Softwareterminal
  - Z121490Various ENT Instruments
    - Z12149001Otoacoustic Emissions Equipmentterminal
    - Z12149002Audiometric ChambersMDR 100.0% Class I · n=189terminal
      Registered in EUDAMED under MDR with this code: 189 of 189 devices carry Class I on their registration (as of 8 Sep 2026).
      189 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.
    - Z12149003Olfactometersterminal
    - Z12149004Oto-Caloric Stimulatorsterminal
    - Z12149005Impedance Meters for the Auditory SystemMDR 2 classes · n=102terminal
      Registered in EUDAMED under MDR with this code, the 102 devices are split across classes (as of 8 Sep 2026).
      84 Class IIa (82.3%)
      18 Class I (17.6%)
      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.
    - Z12149006Direct Outpatient OtoscopesMDR 100.0% Class I · n=262terminal
      Registered in EUDAMED under MDR with this code: 262 of 262 devices carry Class I on their registration (as of 8 Sep 2026).
      262 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.
    - Z12149007Otological Drillsterminal
    - Z12149008Rhinoanemometersterminal
    - Z12149009Rhinometersterminal
    - Z12149010Voice Displaysterminal
    - Z12149011Electric Pharyngeal Stimulatorsterminal
    - Z12149080Various ENT Instruments - Hardware AccessoriesMDR 2 classes · n=99terminal
      Registered in EUDAMED under MDR with this code, the 99 devices are split across classes (as of 8 Sep 2026).
      87 Class I (87.8%)
      12 Class IIa (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.
    - Z12149082Various ENT Instruments - Software Accessoriesterminal
    - Z12149085Various ENT Instruments - ConsumablesMDR 100.0% Class I · n=301terminal
      Registered in EUDAMED under MDR with this code: 301 of 301 devices carry Class I on their registration (as of 8 Sep 2026).
      301 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.
    - Z12149092Various ENT Instruments - Medical Device Softwareterminal
    - Z12149099Various ENT Instruments - OtherMDR 2 classes · n=49terminal
      Registered in EUDAMED under MDR with this code, the 49 devices are split across classes (as of 8 Sep 2026).
      41 Class I (83.6%)
      8 Class IIa (16.3%)
      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.
- Z1215Pneumonology and Respiratory Physiopathology Instruments
  - Z121501Spirometry Instruments
    - Z12150101Clinical/Diagnostic SpirometersMDR 100.0% Class IIa · n=85MDD 96.5% Class IIa · n=29terminal
      Registered in EUDAMED under MDR with this code: 85 of 85 devices carry Class IIa on their registration (as of 8 Sep 2026).
      85 Class IIa (100.0%)
      Registered in EUDAMED under MDD with this code: 28 of 29 devices carry Class IIa on their registration (as of 8 Sep 2026).
      28 Class IIa (96.5%)
      1 Class I (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.
    - Z12150102Peak Flow SpirometersMDR 2 classes · n=82terminal
      Registered in EUDAMED under MDR with this code, the 82 devices are split across classes (as of 8 Sep 2026).
      51 Class IIa (62.1%)
      31 Class I (37.8%)
      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.
    - Z12150180Spirometry Instruments - Hardware AccessoriesMDR 2 classes · n=40terminal
      Registered in EUDAMED under MDR with this code, the 40 devices are split across classes (as of 8 Sep 2026).
      21 Class I (52.5%)
      19 Class IIa (47.5%)
      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.
    - Z12150182Spirometry Instruments - Software Accessoriesterminal
    - Z12150185Spirometry Instruments - ConsumablesMDR 3 classes · n=178MDD 100.0% Class IIa · n=36terminal
      Registered in EUDAMED under MDR with this code, the 178 devices are split across classes (as of 8 Sep 2026).
      72 Class IIb (40.4%)
      61 Class I (34.2%)
      45 Class IIa (25.2%)
      Registered in EUDAMED under MDD with this code: 36 of 36 devices carry Class IIa on their registration (as of 8 Sep 2026).
      36 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
    - Z12150192Spirometry Instruments - Medical Device Softwareterminal
    - Z12150199Spirometry Instruments - OtherMDR 100.0% Class I · n=44terminal
      Registered in EUDAMED under MDR with this code: 44 of 44 devices carry Class I on their registration (as of 8 Sep 2026).
      44 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.
  - Z121502Spirometric Telemetry Instruments
    - Z12150201Complete Spirometric Telemetry Systemsterminal
    - Z12150202Spirometric Telemetry Receiversterminal
    - Z12150203Spirometric Telemetry Transmittersterminal
    - Z12150280Spirometric Telemetry Instruments - Hardware Accessoriesterminal
    - Z12150282Spirometric Telemetry Instruments - Software Accessoriesterminal
    - Z12150285Spirometric Telemetry Instruments - Consumablesterminal
    - Z12150292Spirometric Telemetry Instruments - Medical Device Softwareterminal
  - Z121590Various Pneumology and Respiratory Physiopathology Instruments
    - Z12159001Nitrogen Analysersterminal
    - Z12159002Aerosol EquipmentMDR 2 classes · n=237MDD 97.2% Class IIa · n=36terminal
      Registered in EUDAMED under MDR with this code, the 237 devices are split across classes (as of 8 Sep 2026).
      218 Class IIa (91.9%)
      19 Class I (8.0%)
      Registered in EUDAMED under MDD with this code: 35 of 36 devices carry Class IIa on their registration (as of 8 Sep 2026).
      35 Class IIa (97.2%)
      1 Class IIb (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.
    - Z12159003Diffusion Analysis Equipmentterminal
    - Z12159004Oxygen ConcentratorsMDR 3 classes · n=229MDD 3 classes · n=159terminal
      Registered in EUDAMED under MDR with this code, the 229 devices are split across classes (as of 8 Sep 2026).
      182 Class IIb (79.4%)
      32 Class IIa (13.9%)
      15 Class I (6.5%)
      Registered in EUDAMED under MDD with this code, the 159 devices are split across classes (as of 8 Sep 2026).
      91 Class IIb (57.2%)
      67 Class IIa (42.1%)
      1 Class I (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.
    - Z12159005Bronchostimulation Dosimetersterminal
    - Z12159006Expirated Gas Analysersterminal
    - Z12159007Body PlethysmographsMDR 2 classes · n=51terminal
      Registered in EUDAMED under MDR with this code, the 51 devices are split across classes (as of 8 Sep 2026).
      46 Class IIa (90.1%)
      5 Class I (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.
    - Z12159008Pneumotachographsterminal
    - Z12159009Equipment for Removal of SecretionsMDR 3 classes · n=133terminal
      Registered in EUDAMED under MDR with this code, the 133 devices are split across classes (as of 8 Sep 2026).
      110 Class IIa (82.7%)
      18 Class I (13.5%)
      5 Class IIb (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.
    - Z12159010Rhinomanometersterminal
    - Z12159011Pneumological Navigation Systemterminal
    - Z12159080Various Pneumology and Respiratory Physiopathology Instruments - Hardware AccessoriesMDR 2 classes · n=51terminal
      Registered in EUDAMED under MDR with this code, the 51 devices are split across classes (as of 8 Sep 2026).
      42 Class I (82.3%)
      9 Class IIa (17.6%)
      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.
    - Z12159082Various Pneumology and Respiratory Physiopathology Instruments - Software Accessoriesterminal
    - Z12159085Various Pneumology and Respiratory Physiopathology Instruments - ConsumablesMDR 96.6% Class I · n=120terminal
      Registered in EUDAMED under MDR with this code: 116 of 120 devices carry Class I on their registration (as of 8 Sep 2026).
      116 Class I (96.6%)
      4 Class IIa (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.
    - Z12159092Various Pneumology and Respiratory Physiopathology Instruments - Medical Device Softwareterminal
    - Z12159099Various Pneumology and Respiratory Physiopathology Instruments - OtherMDR 99.1% Class IIa · n=1,062MDD 3 classes · n=128terminal
      Registered in EUDAMED under MDR with this code: 1,053 of 1,062 devices carry Class IIa on their registration (as of 8 Sep 2026).
      1,053 Class IIa (99.1%)
      6 Class I (0.5%)
      3 Class IIb (0.2%)
      Registered in EUDAMED under MDD with this code, the 128 devices are split across classes (as of 8 Sep 2026).
      109 Class IIb (85.1%)
      18 Class IIa (14.0%)
      1 Class I (0.7%)
      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.
- Z1216Urology Instruments
  - Z121601Extracorporeal Lithotripsy Instruments
    - Z12160101Extracorporeal LithotriptersMDR 3 classes · n=24terminal
      Registered in EUDAMED under MDR with this code, the 24 devices are split across classes (as of 8 Sep 2026).
      22 Class IIb (91.6%)
      1 Class I (4.1%)
      1 Class IIa (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.
    - Z12160180Extracorporeal Lithotripsy Instruments - Hardware Accessoriesterminal
    - Z12160182Extracorporeal Lithotripsy Instruments - Software Accessoriesterminal
    - Z12160185Extracorporeal Lithotripsy Instruments - Consumablesterminal
    - Z12160192Extracorporeal Lithotripsy Instruments - Medical Device Softwareterminal
  - Z121602Holter System Instruments for Urodynamic Parameters
    - Z12160201Urodynamic Holter Analysersterminal
    - Z12160202Urodynamic Holter Recordersterminal
    - Z12160280Holter System Instruments for Urodynamic Parameters - Hardware Accessoriesterminal
    - Z12160282Holter System Instruments for Urodynamic Parameters - Software Accessoriesterminal
    - Z12160285Holter System Instruments for Urodynamic Parameters - Consumablesterminal
    - Z12160292Holter System Instruments for Urodynamic Parameters - Medical Device Softwareterminal
  - Z121603Prostate Thermotherapy Instruments
    - Z12160301Equipment for Microwave Prostate Thermotherapyterminal
    - Z12160302Equipment for Liquid Prostate Thermotherapyterminal
    - Z12160303Equipment for Ultrasonic Oncology Therapyterminal
    - Z12160380Prostate Thermotherapy Instruments - Hardware Accessoriesterminal
    - Z12160382Prostate Thermotherapy Instruments - Software Accessoriesterminal
    - Z12160385Prostate Thermotherapy Instruments - Consumablesterminal
    - Z12160392Prostate Thermotherapy Instruments - Medical Device Softwareterminal
    - Z12160399Prostate Thermotherapy Instruments - Otherterminal
  - Z121604Urodynamics Instruments
    - Z12160401Urodynamics Systemsterminal
    - Z12160480Urodynamics Instruments - Hardware Accessoriesterminal
    - Z12160482Urodynamics Instruments - Software Accessoriesterminal
    - Z12160485Urodynamics Instruments - ConsumablesMDR 100.0% Class IIa · n=52terminal
      Registered in EUDAMED under MDR with this code: 52 of 52 devices carry Class IIa on their registration (as of 8 Sep 2026).
      52 Class IIa (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
    - Z12160492Urodynamics Instruments - Medical Device Softwareterminal
  - Z121605UroflowmetersMDR 2 classes · n=25terminal
    Registered in EUDAMED under MDR with this code, the 25 devices are split across classes (as of 8 Sep 2026).
    17 Class IIa (68.0%)
    8 Class I (32.0%)
    Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
  - Z121690Various Instruments for Urology
    - Z12169001Penile Tumescence Measuring Equipmentterminal
    - Z12169002Urological Stimulatorsterminal
    - Z12169003Ejaculation Stimulatorsterminal
    - Z12169004Erectile Dysfunction Stimulatorsterminal
    - Z12169080Various Instruments for Urology - Hardware Accessoriesterminal
    - Z12169082Various Instruments for Urology - Software Accessoriesterminal
    - Z12169085Various Instruments for Urology - Consumablesterminal
    - Z12169092Various Instruments for Urology - Medical Device Softwareterminal
    - Z12169099Various Instruments for Urology - Otherterminal
- Z1217Blood Transfusion Instruments
  - Z121701Blood Banks RefrigeratorsMDR 2 classes · n=103MDD 95.6% Class IIa · n=23terminal
    Registered in EUDAMED under MDR with this code, the 103 devices are split across classes (as of 8 Sep 2026).
    97 Class IIa (94.1%)
    6 Class I (5.8%)
    Registered in EUDAMED under MDD with this code: 22 of 23 devices carry Class IIa on their registration (as of 8 Sep 2026).
    22 Class IIa (95.6%)
    1 Class I (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.
  - Z121702Blood and Blood Components FreezersMDR 100.0% Class IIa · n=223MDD 98.3% Class IIa · n=59terminal
    Registered in EUDAMED under MDR with this code: 223 of 223 devices carry Class IIa on their registration (as of 8 Sep 2026).
    223 Class IIa (100.0%)
    Registered in EUDAMED under MDD with this code: 58 of 59 devices carry Class IIa on their registration (as of 8 Sep 2026).
    58 Class IIa (98.3%)
    1 Class III (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.
  - Z121703Blood and Blood Components Thawersterminal
  - Z121704Apheresis Equipment
    - Z12170401Blood Donation Apheresis Equipmentterminal
    - Z12170402Therapeutic Apheresis EquipmentMDR 100.0% Class IIb · n=38terminal
      Registered in EUDAMED under MDR with this code: 38 of 38 devices carry Class IIb on their registration (as of 8 Sep 2026).
      38 Class IIb (100.0%)
      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
  - Z121780Blood Transfusion Instruments - Hardware Accessoriesterminal
  - Z121799Blood Transfusion Instruments - OtherMDR 3 classes · n=68terminal
    Registered in EUDAMED under MDR with this code, the 68 devices are split across classes (as of 8 Sep 2026).
    36 Class I (52.9%)
    26 Class IIa (38.2%)
    6 Class IIb (8.8%)
    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.
- Z1290Various Instruments for Functional Exploration and Therapeutic Interventions
  - Z129003Cycles for Physiotherapy and/or Diagnostic UsesMDR 2 classes · n=38terminal
    Registered in EUDAMED under MDR with this code, the 38 devices are split across classes (as of 8 Sep 2026).
    25 Class I (65.7%)
    13 Class IIa (34.2%)
    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.
  - Z129004Light SourcesMDR 99.9% Class I · n=1,198terminal
    Registered in EUDAMED under MDR with this code: 1,197 of 1,198 devices carry Class I on their registration (as of 8 Sep 2026).
    1,197 Class I (99.9%)
    1 Class IIa (<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.
  - Z129005Generic Photostimulatorsterminal
  - Z129006Treadmills for Physiotherapy and/or Diagnostic UsesMDR 3 classes · n=425MDD 100.0% Class IIb · n=72terminal
    Registered in EUDAMED under MDR with this code, the 425 devices are split across classes (as of 8 Sep 2026).
    340 Class IIa (80.0%)
    77 Class I (18.1%)
    8 Class IIb (1.8%)
    Registered in EUDAMED under MDD with this code: 72 of 72 devices carry Class IIb on their registration (as of 8 Sep 2026).
    72 Class IIb (100.0%)
    Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
  - Z129007Hanging Units for the Operating Room and Intensive CareMDR 3 classes · n=222terminal
    Registered in EUDAMED under MDR with this code, the 222 devices are split across classes (as of 8 Sep 2026).
    94 Class I (42.3%)
    92 Class IIb (41.4%)
    36 Class IIa (16.2%)
    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.
  - Z129009Equipment for Analysing Potentialterminal
  - Z129010Multi-Disciplinary Holter Systemsterminal
  - Z129011Multi-Disciplinary Telemetry Systemsterminal
  - Z129012Multi-Functional Polygraphic SystemsMDR 2 classes · n=37terminal
    Registered in EUDAMED under MDR with this code, the 37 devices are split across classes (as of 8 Sep 2026).
    26 Class IIa (70.2%)
    11 Class I (29.7%)
    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.
  - Z129013General Auditory and/or Visual StimulatorsMDR 2 classes · n=172terminal
    Registered in EUDAMED under MDR with this code, the 172 devices are split across classes (as of 8 Sep 2026).
    97 Class I (56.3%)
    75 Class IIa (43.6%)
    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.
  - Z129017Bed Head UnitsMDR 3 classes · n=333terminal
    Registered in EUDAMED under MDR with this code, the 333 devices are split across classes (as of 8 Sep 2026).
    250 Class IIb (75.0%)
    50 Class I (15.0%)
    33 Class IIa (9.9%)
    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.
  - Z129080Various Instruments for Functional Exploration and Therapeutic Interventions - Hardware AccessoriesMDR 95.7% Class I · n=95terminal
    Registered in EUDAMED under MDR with this code: 91 of 95 devices carry Class I on their registration (as of 8 Sep 2026).
    91 Class I (95.7%)
    4 Class IIa (4.2%)
    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.
  - Z129082Various Instruments for Functional Exploration and Therapeutic Interventions - Software AccessoriesMDR 3 classes · n=21terminal
    Registered in EUDAMED under MDR with this code, the 21 devices are split across classes (as of 8 Sep 2026).
    12 Class I (57.1%)
    6 Class IIa (28.5%)
    3 Class IIb (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.
  - Z129085Various Instruments for Functional Exploration and Therapeutic Interventions - Specific Materialsterminal
  - Z129092Various Instruments for Functional Exploration and Therapeutic Interventions - Medical Device SoftwareMDR 3 classes · n=63MDD 2 classes · n=24terminal
    Registered in EUDAMED under MDR with this code, the 63 devices are split across classes (as of 8 Sep 2026).
    46 Class IIa (73.0%)
    13 Class I (20.6%)
    4 Class IIb (6.3%)
    Registered in EUDAMED under MDD with this code, the 24 devices are split across classes (as of 8 Sep 2026).
    13 Class IIa (54.1%)
    11 Class I (45.8%)
    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.
  - Z129099Various Instruments for Functional Exploration and Therapeutic Interventions - OtherMDR 4 classes · n=889terminal
    Registered in EUDAMED under MDR with this code, the 889 devices are split across classes (as of 8 Sep 2026).
    707 Class IIa (79.5%)
    179 Class I (20.1%)
    2 Class IIb (0.2%)
    1 Class III (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.

How Z12 is structured

994

terminal codes, selectable in a device record

129

branch headings, not selectable

818

name a specific device type

18%

fallback entries: Other and Accessories

The Instruments for Functional Explorations and Therapeutic Interventions branch runs 5 levels deep. 129 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 994 codes marked terminal.

75 terminal codes are “- Other” entries and 101 are “- Accessories” entries, 18% 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 Z1202 (Endoscopic and Minimally Invasive Surgery Instruments), holding 155 of the 994 terminal codes.

Frequently asked questions

Which Z12 codes can be used in a EUDAMED device record?: 994 of the 1,123 codes listed under Z12 (Instruments for Functional Explorations and Therapeutic Interventions) are terminal and can be selected. The other 129 are branch headings that cannot.
How deep is the Z12 hierarchy?: The Z12 branch runs 5 levels below the group code. Its largest sub-branch is Z1202 (Endoscopic and Minimally Invasive Surgery Instruments), which holds 155 of the 994 terminal codes.
How many Z12 codes are catch-all entries?: 75 terminal codes under Z12 are "- Other" entries and 101 are "- Accessories" entries, 18% of the branch. The remaining 818 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 Z

Z11Bioimaging and Radiotherapy Instruments Z13Non-Specific Consumables for Diagnostic Instruments

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.