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

    PT/INR test strip

    Code: B-06953792720134
    View on EUDAMED
    Devices
    1
    Certificates
    1
    Notified Bodies
    1
    Auth. Representatives
    1

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    Basic Information

    UDI-DI Code
    B-06953792720134
    Issuing Agency
    EUDAMED
    Types
    Kit Self testing Reagent
    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    Expired / Withdrawn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
    PROTHROMBIN TIME RT & POC On the market