BEUDAMED
    IVDR IVDR QMS Issued

    HX 1060415-1

    Manufacturer: Fujirebio Diagnostics AB
    Basic UDI-DIs
    0
    Scopes
    1
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    Rev.1
    948
    Valid for 948 days
    Expiry: January 11, 2029

    Basic Information

    Number
    HX 1060415-1
    Type
    IVDR QMS
    Legislation
    IVDR
    Issue Date
    January 12, 2024
    Expiry Date
    January 11, 2029
    Revision
    Rev.1
    Manufacturer
    Fujirebio Diagnostics AB

    Certificate Lifecycle

    January 12, 2024 January 11, 2029

    Scopes

    Quality Procedure Scope

    Device Group Class C

    IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 0301: Devices intended to be used in screening, diagnosis, staging or monitoring of cancer W01020301 - CANCER ANTIGENS

    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.