EMDN P08: Urogenital 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.

• P08Urogenital Prostheses
  • P0801Urinary Incontinence Prostheses
    • P080102Artificial Urinary Sphinctersterminal
    • P080199Urinary Incontinence Prostheses - OtherMDR 3 classes · n=22terminal

      Registered in EUDAMED under MDR with this code, the 22 devices are split across classes (as of 8 Sep 2026).

      • 14 Class IIb (63.6%)
      • 4 Class I (18.1%)
      • 4 Class III (18.1%)

      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.

  • P0802Male Genital System Prostheses
    • P080201Testicle ProsthesesMDD 100.0% Class IIb · n=34terminal

      Registered in EUDAMED under MDD with this code: 34 of 34 devices carry Class IIb on their registration (as of 8 Sep 2026).

      • 34 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.

    • P080202Penile ProsthesesMDD 100.0% Class IIb · n=33terminal

      Registered in EUDAMED under MDD with this code: 33 of 33 devices carry Class IIb on their registration (as of 8 Sep 2026).

      • 33 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.

    • P080299Male Genital System Prostheses - Otherterminal
  • P0803Urinary Obstruction Prostheses
    • P080301Urethral Prostheses
      • P08030101Trans-Prostatic Urethral Prosthesesterminal
      • P08030102Vas Deferens Prosthesesterminal
      • P08030199Endourethral Prostheses - Otherterminal
    • P080302Ureteral ProsthesesMDD 99.4% Class IIb · n=193terminal

      Registered in EUDAMED under MDD with this code: 192 of 193 devices carry Class IIb on their registration (as of 8 Sep 2026).

      • 192 Class IIb (99.4%)
      • 1 Class III (0.5%)

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

    • P080399Urinary Obstruction Prostheses - Otherterminal
  • P0804Female Genital System Prostheses
    • P080401Fallopian Tube Prosthesesterminal
    • P080499Female Genital System Prostheses - Otherterminal
  • P0805Urinary Tract Implantable Valvesterminal
  • P0880Urogenital Prostheses - Accessoriesterminal
  • P0899Urogenital Prostheses - Otherterminal