EMDN U03: Devices for Urethral, Ureteral and Nephrostomic Dilation

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.

• U03Devices for Urethral, Ureteral and Nephrostomic Dilation
  • U0301Devices for Rigid Dilation of the Urinary Tract
    • U030101Sequential Dilators for Percutaneous Nephrostomy
      • U03010101Amplatz Cannulas for Urinary DilationMDR 100.0% Class IIa · n=181terminal

        Registered in EUDAMED under MDR with this code: 181 of 181 devices carry Class IIa on their registration (as of 8 Sep 2026).

        • 181 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.

      • U03010199Percutaneous Nephrostomy, Sequential Dilators - OtherMDR 100.0% Class IIa · n=247MDD 100.0% Class IIa · n=29terminal

        Registered in EUDAMED under MDR with this code: 247 of 247 devices carry Class IIa on their registration (as of 8 Sep 2026).

        • 247 Class IIa (100.0%)

        Registered in EUDAMED under MDD with this code: 29 of 29 devices carry Class IIa on their registration (as of 8 Sep 2026).

        • 29 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.

    • U030102Urethral and Ureteral Dilators
      • U03010201Urethral DilatorsMDR 3 classes · n=351MDD 100.0% Class I · n=35terminal

        Registered in EUDAMED under MDR with this code, the 351 devices are split across classes (as of 8 Sep 2026).

        • 223 Class I (63.5%)
        • 122 Class IIa (34.7%)
        • 6 Class IIb (1.7%)

        Registered in EUDAMED under MDD with this code: 35 of 35 devices carry Class I on their registration (as of 8 Sep 2026).

        • 35 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.

      • U03010202Ureteral DilatorsMDR 2 classes · n=626terminal

        Registered in EUDAMED under MDR with this code, the 626 devices are split across classes (as of 8 Sep 2026).

        • 586 Class IIa (93.6%)
        • 40 Class I (6.3%)

        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.

  • U0302Devices for Pneumatic Dilation of the Urinary Tract
    • U030201Urethral Dilators, with BalloonMDR 100.0% Class IIa · n=107terminal

      Registered in EUDAMED under MDR with this code: 107 of 107 devices carry Class IIa on their registration (as of 8 Sep 2026).

      • 107 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.

    • U030202Ureteral Dilators, with BalloonMDR 2 classes · n=151terminal

      Registered in EUDAMED under MDR with this code, the 151 devices are split across classes (as of 8 Sep 2026).

      • 81 Class IIa (53.6%)
      • 70 Class I (46.3%)

      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.

  • U0380Devices for Urinary Tract Dilation - Accessoriesterminal
  • U0399Devices for Urinary Tract Dilation - OtherMDR 96.9% Class IIa · n=233terminal

    Registered in EUDAMED under MDR with this code: 226 of 233 devices carry Class IIa on their registration (as of 8 Sep 2026).

    • 226 Class IIa (96.9%)
    • 7 Class I (3.0%)

    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.