EMDN U10: Obstetrics Devices

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.

• U10Obstetrics Devices
  • U1001Obstetrics Catheters
    • U100101Catheters for Voluntary Termination of Pregnancyterminal
    • U100102Postpartum Intrauterine Cathetersterminal
    • U100199Obstetrical Catheters - Otherterminal
  • U1002Fetal Study Devices
    • U100201Foetal Scalp Electrodesterminal
    • U100299Foetal Study Devices - Otherterminal
  • U1003Puerperium DevicesMDR 96.0% Class I · n=51terminal

    Registered in EUDAMED under MDR with this code: 49 of 51 devices carry Class I on their registration (as of 8 Sep 2026).

    • 49 Class I (96.0%)
    • 2 Class IIa (3.9%)

    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.

  • U1004Manual Obstetrical Extractors, Single-Useterminal
  • U1005Amniotic Membrane Perforatorsterminal
  • U1006Single-Use Rigid Amnioscopesterminal
  • U1007Uterine Cerclage Devicesterminal
  • U1080Obstetrics Devices - Accessoriesterminal
  • U1099Obstetrics Devices - OtherMDR 3 classes · n=60terminal

    Registered in EUDAMED under MDR with this code, the 60 devices are split across classes (as of 8 Sep 2026).

    • 36 Class IIa (60.0%)
    • 23 Class I (38.3%)
    • 1 Class IIb (1.6%)

    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.