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

    CERA-CHEK™ Hb Plus Hemoglobin Test Strip

    Code: B-08800065140022
    View on EUDAMED
    Devices
    1
    Certificates
    1
    Notified Bodies
    1
    Auth. Representatives
    1

    Basic Information

    UDI-DI Code
    B-08800065140022
    Issuing Agency
    EUDAMED
    Device Model
    H 400
    Types
    Professional testing Near patient testing Self testing Reagent
    Regulation
    Eu Ivdd Legacy
    Classification
    Eu Ivd Self Testing
    Manufacturer
    GC MEDIS Corp.
    Last Updated
    June 11, 2024

    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    Expired / Withdrawn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™ Hb Plus Hemoglobin Test Strip On the market