BEUDAMED
    IVDR IVDR QMS Issued

    HX 2055510-1

    Manufacturer: WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
    Basic UDI-DIs
    0
    Scopes
    1
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    0
    1017
    Valid for 1017 days
    Expiry: March 21, 2029

    Basic Information

    Number
    HX 2055510-1
    Type
    IVDR QMS
    Legislation
    IVDR
    Issue Date
    March 22, 2024
    Expiry Date
    March 21, 2029
    Manufacturer
    WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.

    Certificate Lifecycle

    March 22, 2024 March 21, 2029

    Scopes

    Quality Procedure Scope

    Device Group Class C

    CLINICAL CHMIESTRY IVR 0608: Devices intended to be used for screening, determination or monitoring of physiological markers W01010606 - ELECTRODES OR CASSETTES FOR BLOOD GAS ANALYSIS INCL. ELECTROLYTES / METABOLITES - POC

    Basic UDI-DIs

    This Certificate doesn't seem to be associated with any Basic UDI-DIs. If you think that sounds weird, so do we. But that's what the EUDAMED data seems to state.