BEUDAMED
    IVDR IVDR QMS Issued

    HX 1936892-1

    Manufacturer: Tosoh Europe N.V.
    Basic UDI-DIs
    0
    Scopes
    10
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    Rev. 0
    1238
    Valid for 1238 days
    Expiry: October 29, 2029

    Basic Information

    Number
    HX 1936892-1
    Type
    IVDR QMS
    Legislation
    IVDR
    Issue Date
    October 30, 2024
    Expiry Date
    October 29, 2029
    Revision
    Rev. 0
    Manufacturer
    Tosoh Europe N.V.

    Certificate Lifecycle

    October 30, 2024 October 29, 2029

    Scopes

    10 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Group Class C

    IVR 0301: Devices intended to be used in screening, diagnosis, staging or monitoring of cancer

    Quality Procedure Scope

    Device Group Class C

    IVR 0608: Devices intended to be used for screening, determination or monitoring of physiological markers

    Quality Procedure Scope

    Device Group Class C

    IVR 0606: Devices intended to be used for non-infectious disease staging

    Quality Procedure Scope

    Device Group Class C

    W01021521 - MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS

    Quality Procedure Scope

    Device Group Class C

    IVR 0602: Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease

    Quality Procedure Scope

    Device Group Class C

    IVR 0603: Devices intended to be used for screening, confirmation / determination, or monitoring of allergies and intolerances

    Quality Procedure Scope

    Device Group Class C

    IVR 0604: Other devices intended to be used for a specific disease

    Quality Procedure Scope

    Device Group Class C

    IVR 0609: Other devices intended to be used to define or monitor physiological status and therapeutic measures

    Quality Procedure Scope

    Device Group Class C

    IVR 0302: Other devices intended to be used for markers of cancer and non-malignant tumours

    Quality Procedure Scope

    Device Group Class C

    IVR 0607: Devices intended to be used for detection of pregnancy or fertility testing

    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.