EMDN J03: Auditory Active-Implantable Devices

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.

• J03Auditory Active-Implantable Devices
  • J0301Cochlear Implantsterminal
  • J0302Middle Ear Implantsterminal
  • J0303Auditory Brainstem Implantsterminal
  • J0304Bone Conduction Implantsterminal
  • J0380Auditory Active-Implantable Devices - AccessoriesMDR 95.9% Class III · n=99terminal

    Registered in EUDAMED under MDR with this code: 95 of 99 devices carry Class III on their registration (as of 8 Sep 2026).

    • 95 Class III (95.9%)
    • 4 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.

  • J0399Auditory Active-Implantable Devices - Otherterminal