EMDN V04: Clinical Use Containers (Non-IVD)

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.

• V04Clinical Use Containers (Non-IVD)
  • V0401Clinical Use BottlesMDR 2 classes · n=21terminal

    Registered in EUDAMED under MDR with this code, the 21 devices are split across classes (as of 8 Sep 2026).

    • 19 Class I (90.4%)
    • 2 Class IIa (9.5%)

    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.

  • V0402Clinical Use Trays and BowlsMDR 99.9% Class I · n=7,818MDD 97.4% Class I · n=116terminal

    Registered in EUDAMED under MDR with this code: 7,817 of 7,818 devices carry Class I on their registration (as of 8 Sep 2026).

    • 7,817 Class I (99.9%)
    • 1 Class IIa (<0.1%)

    Registered in EUDAMED under MDD with this code: 113 of 116 devices carry Class I on their registration (as of 8 Sep 2026).

    • 113 Class I (97.4%)
    • 3 Class IIa (2.5%)

    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.

  • V0480Clinical Use Containers (Non-IVD) - AccessoriesMDR 100.0% Class I · n=564terminal

    Registered in EUDAMED under MDR with this code: 564 of 564 devices carry Class I on their registration (as of 8 Sep 2026).

    • 564 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.

  • V0499Clinical Use Containers (Non-IVD) - OtherMDR 95.8% Class I · n=2,551MDD 2 classes · n=64terminal

    Registered in EUDAMED under MDR with this code: 2,445 of 2,551 devices carry Class I on their registration (as of 8 Sep 2026).

    • 2,445 Class I (95.8%)
    • 106 Class IIa (4.1%)

    Registered in EUDAMED under MDD with this code, the 64 devices are split across classes (as of 8 Sep 2026).

    • 32 Class I (50.0%)
    • 32 Class IIa (50.0%)

    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.