BEUDAMED
    Basic UDI-DI Eu Ivdd Eu Ivd Annex 2 List B 🇰🇷 South Korea

    Hemoglobin Control Solution

    Code: B-08800065170203
    View on EUDAMED
    Devices
    1
    Certificates
    1
    Notified Bodies
    1
    Auth. Representatives
    1

    Basic Information

    UDI-DI Code
    B-08800065170203
    Issuing Agency
    EUDAMED
    Device Model
    M 400
    Types
    Near patient testing Self testing
    Regulation
    Eu Ivdd Legacy
    Classification
    Eu Ivd Annex 2 List B
    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    Expired / Withdrawn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) V1 091763 0015 May 26, 2024

    Associated Devices

    This Basic UDI-DI is associated with 1 device.

    Name Status
    CERA-CHEK™ 3 in 1 GHL Hemoglobin Control Solution On the market