EMDN G04: Orally Administered Gastrointestinal 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.

• G04Orally Administered Gastrointestinal Devices
  • G0401Orally Administered Devices for the Therapy of Gastro-Intestinal DisordersMDR 3 classes · n=454MDD 4 classes · n=801terminal

    Registered in EUDAMED under MDR with this code, the 454 devices are split across classes (as of 8 Sep 2026).

    • 347 Class III (76.4%)
    • 106 Class IIb (23.3%)
    • 1 Class I (0.2%)

    Registered in EUDAMED under MDD with this code, the 801 devices are split across classes (as of 8 Sep 2026).

    • 687 Class IIa (85.7%)
    • 102 Class IIb (12.7%)
    • 11 Class III (1.3%)
    • 1 Class I (0.1%)

    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.

  • G0402Orally Administered Devices for Appetite Control and Reduction of Intestinal AbsorptionMDR 99.5% Class IIb · n=936MDD 2 classes · n=82terminal

    Registered in EUDAMED under MDR with this code: 932 of 936 devices carry Class IIb on their registration (as of 8 Sep 2026).

    • 932 Class IIb (99.5%)
    • 4 Class III (0.4%)

    Registered in EUDAMED under MDD with this code, the 82 devices are split across classes (as of 8 Sep 2026).

    • 75 Class IIa (91.4%)
    • 7 Class IIb (8.5%)

    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.

  • G0499Orally Administered Gastrointestinal Devices - OtherMDR 4 classes · n=46MDD 98.7% Class IIa · n=82terminal

    Registered in EUDAMED under MDR with this code, the 46 devices are split across classes (as of 8 Sep 2026).

    • 41 Class IIa (89.1%)
    • 2 Class I (4.3%)
    • 2 Class III (4.3%)
    • 1 Class IIb (2.1%)

    Registered in EUDAMED under MDD with this code: 81 of 82 devices carry Class IIa on their registration (as of 8 Sep 2026).

    • 81 Class IIa (98.7%)
    • 1 Class III (1.2%)

    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.