EMDN V02: Neonatology and Paediatric 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.

• V02Neonatology and Paediatric Devices
  • V0201Phototherapy MasksMDR 100.0% Class I · n=93terminal

    Registered in EUDAMED under MDR with this code: 93 of 93 devices carry Class I on their registration (as of 8 Sep 2026).

    • 93 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.

  • V0202Umbilical Clamps and Clippers, Single-UseMDR 100.0% Class I · n=63terminal

    Registered in EUDAMED under MDR with this code: 63 of 63 devices carry Class I on their registration (as of 8 Sep 2026).

    • 63 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.

  • V0203Newborn Nutrition Devices
    • V020301Manual Breast Pumpers and KitsMDR 2 classes · n=119MDD 100.0% Class IIa · n=52terminal

      Registered in EUDAMED under MDR with this code, the 119 devices are split across classes (as of 8 Sep 2026).

      • 112 Class I (94.1%)
      • 7 Class IIa (5.8%)

      Registered in EUDAMED under MDD with this code: 52 of 52 devices carry Class IIa on their registration (as of 8 Sep 2026).

      • 52 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.

    • V020302Baby Bottles and Kitterminal
    • V020303TeatsMDD 100.0% Class IIa · n=27terminal

      Registered in EUDAMED under MDD with this code: 27 of 27 devices carry Class IIa on their registration (as of 8 Sep 2026).

      • 27 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.

    • V020380Newborn Nutrition Devices - AccessoriesMDR 97.0% Class I · n=34terminal

      Registered in EUDAMED under MDR with this code: 33 of 34 devices carry Class I on their registration (as of 8 Sep 2026).

      • 33 Class I (97.0%)
      • 1 Class IIa (2.9%)

      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.

    • V020399Newborn Nutrition Devices - OtherMDR 2 classes · n=60terminal

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

      • 52 Class IIa (86.6%)
      • 8 Class I (13.3%)

      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.

  • V0280Neonatology and Pediatrics Devices - Accessories not Included in Other Classes
    • V028002Neonatology Care Kitsterminal
    • V028099Neonatology and Pediatrics Devices - Accessories not Included in Other Classes - OtherMDR 98.6% Class I · n=145MDD 100.0% Class I · n=101terminal

      Registered in EUDAMED under MDR with this code: 143 of 145 devices carry Class I on their registration (as of 8 Sep 2026).

      • 143 Class I (98.6%)
      • 2 Class IIa (1.3%)

      Registered in EUDAMED under MDD with this code: 101 of 101 devices carry Class I on their registration (as of 8 Sep 2026).

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

  • V0299Neonatology and Paediatric Devices - OtherMDR 97.0% Class I · n=476terminal

    Registered in EUDAMED under MDR with this code: 462 of 476 devices carry Class I on their registration (as of 8 Sep 2026).

    • 462 Class I (97.0%)
    • 11 Class IIa (2.3%)
    • 3 Class III (0.6%)

    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.