BEUDAMED
    IVDR IVDR QMS Issued

    HX 2048822-1

    Manufacturer: Tosoh Corporation
    Basic UDI-DIs
    0
    Scopes
    1
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    Rev.0
    1192
    Valid for 1192 days
    Expiry: September 12, 2029

    Basic Information

    Number
    HX 2048822-1
    Type
    IVDR QMS
    Legislation
    IVDR
    Issue Date
    September 13, 2024
    Expiry Date
    September 12, 2029
    Revision
    Rev.0
    Manufacturer
    Tosoh Corporation

    Certificate Lifecycle

    September 13, 2024 September 12, 2029

    Scopes

    Quality Procedure Scope

    Device Group Class C

    CLINICAL CHEMISTRY IVR 602: Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease W01010214 GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC) W01010502 SPECIFIC CONTROLS (CLINICAL CHEMISTRY) W01010503 CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY)

    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.