EMDN U06: Urological Guidewires

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.

• U06Urological Guidewires
  • U0601Urological Guidewires, HydrophilicMDR 99.8% Class IIa · n=790MDD 100.0% Class IIa · n=30terminal

    Registered in EUDAMED under MDR with this code: 789 of 790 devices carry Class IIa on their registration (as of 8 Sep 2026).

    • 789 Class IIa (99.8%)
    • 1 Class I (0.1%)

    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.

  • U0602Urological Guidewires, not HydrophilicMDR 100.0% Class IIa · n=447MDD 100.0% Class IIa · n=143terminal

    Registered in EUDAMED under MDR with this code: 447 of 447 devices carry Class IIa on their registration (as of 8 Sep 2026).

    • 447 Class IIa (100.0%)

    Registered in EUDAMED under MDD with this code: 143 of 143 devices carry Class IIa on their registration (as of 8 Sep 2026).

    • 143 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.

  • U0699Urological Guidewires - OtherMDR 97.9% Class IIa · n=143MDD 2 classes · n=47terminal

    Registered in EUDAMED under MDR with this code: 140 of 143 devices carry Class IIa on their registration (as of 8 Sep 2026).

    • 140 Class IIa (97.9%)
    • 3 Class I (2.0%)

    Registered in EUDAMED under MDD with this code, the 47 devices are split across classes (as of 8 Sep 2026).

    • 41 Class IIa (87.2%)
    • 6 Class I (12.7%)

    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.