BEUDAMED
    IVDR IVDR QMS Supplemented

    HX 1192275-1

    Manufacturer: DiaSys Diagnostic Systems GmbH
    Basic UDI-DIs
    0
    Scopes
    3
    Preceding Certs
    1
    Risk Classes
    2
    Characteristics
    0
    Revision
    Rev. 2
    1149
    Valid for 1149 days
    Expiry: August 1, 2029

    Basic Information

    Number
    HX 1192275-1
    Type
    IVDR QMS
    Legislation
    IVDR
    Issue Date
    December 16, 2024
    Expiry Date
    August 1, 2029
    Revision
    Rev. 2
    Manufacturer
    DiaSys Diagnostic Systems GmbH

    Certificate Lifecycle

    December 16, 2024 August 1, 2029

    Scopes

    3 scopes covering 2 risk classes

    Quality Procedure Scope

    Device Group Class B

    CLINICAL CHEMISTRY IVR 0602: Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease W01021110 RHEUMATOID FACTORS W01021522 STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY

    Quality Procedure Scope

    Device Group Class C

    CLINICAL CHEMISTRY IVR 0608: Devices intended to be used for screening, determination or monitoring of physiological markers W01010107 - AMYLASE - TOTAL W01010113 - CREATINE KINASE - TOTAL W01010123 - LIPASE W01010203 - BILIRUBIN W01010501 - MULTICOMPONENT CONTROLS (CLINICAL CHEMISTRY) W01010503 - CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY)

    Quality Procedure Scope

    Device Group Class C

    CLINICAL CHEMISTRY IVR 0602: Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease W01010114 - CREATINE KINASE - MB ACTIVITY (CC) W01010503 - CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY)

    Preceding Certificates

    HX 1192275-1 Supplemented
    Issued: August 16, 2024 Expires: August 1, 2029

    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.