BEUDAMED
    IVDR IVDR QMS Supplemented

    HX 7091841-1

    Manufacturer: Siemens Healthcare Diagnostics Inc.
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    1
    Risk Classes
    2
    Characteristics
    0
    Revision
    Rev.6
    140
    Expires in 140 days
    Expiry: October 26, 2026

    Basic Information

    Number
    HX 7091841-1
    Type
    IVDR QMS
    Legislation
    IVDR
    Issue Date
    October 23, 2024
    Expiry Date
    October 26, 2026
    Revision
    Rev.6
    Manufacturer
    Siemens Healthcare Diagnostics Inc.

    Certificate Lifecycle

    October 23, 2024 October 26, 2026

    Scopes

    2 scopes covering 2 risk classes

    Quality Procedure Scope

    Device Group Class C Class B

    CLINICAL CHEMISTRY

    Quality Procedure Scope

    Device Group Class C Class B

    IMMUNOCHEMISTRY (IMMUNOLOGY)

    Preceding Certificates

    HX 7091841-1 Supplemented
    Issued: January 17, 2024 Expires: October 26, 2026

    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.