EMDN P04: Respiratory Prostheses

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.

• P04Respiratory Prostheses
  • P0401Tracheobronchial ProsthesesMDR 100.0% Class IIb · n=693MDD 100.0% Class IIb · n=116terminal

    Registered in EUDAMED under MDR with this code: 693 of 693 devices carry Class IIb on their registration (as of 8 Sep 2026).

    • 693 Class IIb (100.0%)

    Registered in EUDAMED under MDD with this code: 116 of 116 devices carry Class IIb on their registration (as of 8 Sep 2026).

    • 116 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.

  • P0480Respiratory Prostheses - AccessoriesMDR 100.0% Class I · n=24terminal

    Registered in EUDAMED under MDR 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.

  • P0499Respiratory Prostheses - Otherterminal