BEUDAMED
    Basic UDI-DI Eu Ivdd Eu Ivd Self Testing 🇨🇳 China

    HemoPOC Coagulometer

    Code: B-06953792720141
    View on EUDAMED
    Devices
    1
    Certificates
    1
    Notified Bodies
    1
    Auth. Representatives
    1

    Basic Information

    UDI-DI Code
    B-06953792720141
    Issuing Agency
    EUDAMED
    Device Model
    HGINR-1
    Types
    Instrument Self testing
    Regulation
    Eu Ivdd Legacy
    Classification
    Eu Ivd Self Testing
    Manufacturer
    Helixgen (GUANGZHOU) Co., Ltd.
    Last Updated
    March 27, 2025

    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    Expired / Withdrawn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 105461 0002 May 26, 2025

    Associated Devices

    This Basic UDI-DI is associated with 1 device.

    Name Status
    RAPID TEST HEMOSTASIS INSTRUMENTS On the market