BEUDAMED
    IVDR IVDR QMS Issued

    HX 1624072-1

    Manufacturer: Seramun Diagnostica GmbH
    Basic UDI-DIs
    0
    Scopes
    1
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    Rev. 0
    1217
    Valid for 1217 days
    Expiry: October 8, 2029

    Basic Information

    Number
    HX 1624072-1
    Type
    IVDR QMS
    Legislation
    IVDR
    Issue Date
    October 9, 2024
    Expiry Date
    October 8, 2029
    Revision
    Rev. 0
    Manufacturer
    Seramun Diagnostica GmbH

    Certificate Lifecycle

    October 9, 2024 October 8, 2029

    Scopes

    Quality Procedure Scope

    Device Group Class B

    INFECTIOUS DISEASES IVR 0503: Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents W01050104 - HELICOBACTER PYLORI

    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.