EMDN U13: Solutions and Kits for Bladder Washing and Instillation

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.

• U13Solutions and Kits for Bladder Washing and Instillation
  • U1301Solutions for Bladder Washing and InstillationMDD 100.0% Class IIa · n=32terminal

    Registered in EUDAMED under MDD with this code: 32 of 32 devices carry Class IIa on their registration (as of 8 Sep 2026).

    • 32 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.

  • U1302Kits for Bladder Washing and Instillationterminal