BEUDAMED
    Basic UDI-DI Eu Ivdd Eu Ivd General 🇰🇷 South Korea

    HbA1c Control Solution

    Code: B-08800065168002
    View on EUDAMED
    Devices
    1
    Certificates
    1
    Notified Bodies
    1
    Auth. Representatives
    1

    Basic Information

    UDI-DI Code
    B-08800065168002
    Issuing Agency
    EUDAMED
    Device Model
    MH 200
    Types
    Professional testing Near patient testing
    Regulation
    Eu Ivdd Legacy
    Classification
    Eu Ivd General
    Manufacturer
    GC MEDIS Corp.
    Last Updated
    November 10, 2022

    Certificate Health

    Total
    1
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    1
    Type Number Expiry Date Status
    IVDD Annex IV (excluding sections 4, 6) Q5 091763 0014 Oct 13, 2025

    Associated Devices

    This Basic UDI-DI is associated with 1 device.

    Name Status
    LabonaCheck™ A1c Control Solution On the market