EMDN U99: Devices for Urogenital System - Other

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.

• U99Devices for Urogenital System - OtherMDR 3 classes · n=196MDD 3 classes · n=72terminal

  Registered in EUDAMED under MDR with this code, the 196 devices are split across classes (as of 8 Sep 2026).

  • 102 Class I (52.0%)
  • 65 Class IIa (33.1%)
  • 29 Class IIb (14.7%)

  Registered in EUDAMED under MDD with this code, the 72 devices are split across classes (as of 8 Sep 2026).

  • 59 Class IIa (81.9%)
  • 9 Class I (12.5%)
  • 4 Class IIb (5.5%)

  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.