EMDN Y05: Abilities Learning and Training 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.

• Y05Abilities Learning and Training Devices
  • Y0501Continence Training Devices (Including Incontinence Alarm Systems)terminal
  • Y0502Gait Trainers
    • Y050201Standing Support Gait TrainersMDR 100.0% Class I · n=242terminal

      Registered in EUDAMED under MDR with this code: 242 of 242 devices carry Class I on their registration (as of 8 Sep 2026).

      • 242 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.

    • Y050202Standing FramesMDR 100.0% Class I · n=279terminal

      Registered in EUDAMED under MDR with this code: 279 of 279 devices carry Class I on their registration (as of 8 Sep 2026).

      • 279 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.

  • Y0503Hands and Fingers Re-Education DevicesMDR 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.

  • Y0504Arms, Torso and Legs Re-Education DevicesMDR 99.5% Class I · n=1,082MDD 97.1% Class I · n=35terminal

    Registered in EUDAMED under MDR with this code: 1,077 of 1,082 devices carry Class I on their registration (as of 8 Sep 2026).

    • 1,077 Class I (99.5%)
    • 5 Class IIa (0.4%)

    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 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. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

  • Y0580Learning and Training Devices - AccessoriesMDR 100.0% Class I · n=66terminal

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

    • 66 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.

  • Y0599Learning and Training Devices - OtherMDR 98.4% Class I · n=792terminal

    Registered in EUDAMED under MDR with this code: 780 of 792 devices carry Class I on their registration (as of 8 Sep 2026).

    • 780 Class I (98.4%)
    • 12 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.