BEUDAMED
    IVDR IVDR QMS Supplemented

    HX 1061883-1

    Manufacturer: Microgenics Corporation
    Basic UDI-DIs
    0
    Scopes
    3
    Preceding Certs
    1
    Risk Classes
    2
    Characteristics
    0
    Revision
    Rev. 1
    917
    Valid for 917 days
    Expiry: December 11, 2028

    Basic Information

    Number
    HX 1061883-1
    Type
    IVDR QMS
    Legislation
    IVDR
    Issue Date
    February 8, 2024
    Expiry Date
    December 11, 2028
    Revision
    Rev. 1
    Manufacturer
    Microgenics Corporation

    Certificate Lifecycle

    February 8, 2024 December 11, 2028

    Scopes

    3 scopes covering 2 risk classes

    Quality Procedure Scope

    Device Group Class B

    W01020901 - DRUGS OF ABUSE W01020902 - TOXICOLOGY W01021521 - MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS

    Quality Procedure Scope

    Device Group Class C

    IVR 0605: W01020407 - THYROXINE W01020801 - CARDIOVASCULAR TDM W01020802 - CENTRAL NERVOUS SYSTEMS TDM W01020803 - ANTIBIOTIC TDM / ANTIVIRUS TDM W01020806 - IMMUNOSUPPRESSANT TDM W01020901 - DRUGS OF ABUSE W01020902 - TOXICOLOGY W01021521 - MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY

    Quality Procedure Scope

    Device Group Class C

    IVR 0302: W01060299 - TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

    Preceding Certificates

    HX 1061883-1 Issued
    Issued: December 12, 2023 Expires: December 11, 2028

    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.