BEUDAMED
    IVDR IVDR QMS Issued

    HX 1038121-1

    Manufacturer: MACHEREY-NAGEL GmbH & Co. KG
    Basic UDI-DIs
    0
    Scopes
    4
    Preceding Certs
    0
    Risk Classes
    2
    Characteristics
    0
    Revision
    Rev. 0

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    659
    Valid for 659 days
    Expiry: May 15, 2028

    Basic Information

    Number
    HX 1038121-1
    Type
    IVDR QMS
    Legislation
    IVDR
    Issue Date
    May 16, 2023
    Expiry Date
    May 15, 2028
    Revision
    Rev. 0
    Manufacturer
    MACHEREY-NAGEL GmbH & Co. KG

    Certificate Lifecycle

    May 16, 2023 May 15, 2028

    Scopes

    4 scopes covering 2 risk classes

    Quality Procedure Scope

    Device Group Class B

    IVR 608: W01010602 URINE TESTING (CC) - RT & POC

    Quality Procedure Scope

    Device Group Class B

    Products of class B, for near-patient testing: IVR 608: W01010602 URINE TESTING (CC) - RT & POC W01010699 CLIN. CHEM. RT & POC - OTHER

    Quality Procedure Scope

    Device Group Class B

    Products of class B, for self-testing: IVR 608: W01010602 URINE TESTING (CC) - RT & POC

    Quality Procedure Scope

    Device Group Class C

    Products of class C, for self-testing: IVR 608: W01010602 URINE TESTING (CC) - RT & 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.