BEUDAMED
    IVDR IVDR QMS Issued

    HX 1545122-1

    Manufacturer: QIAGEN Sciences LLC
    Basic UDI-DIs
    0
    Scopes
    1
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    Rev. 0
    1189
    Valid for 1189 days
    Expiry: September 9, 2029

    Basic Information

    Number
    HX 1545122-1
    Type
    IVDR QMS
    Legislation
    IVDR
    Issue Date
    September 10, 2024
    Expiry Date
    September 9, 2029
    Revision
    Rev. 0
    Manufacturer
    QIAGEN Sciences LLC

    Certificate Lifecycle

    September 10, 2024 September 9, 2029

    Scopes

    Quality Procedure Scope

    Device Group Class C

    IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 0608 Devices intended to be used for screening, determination or monitoring of physiological markers W01020190 􀂱 OTHER SPECIFIC PROTEINS

    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.