BEUDAMED
    IVDR IVDR QMS Issued

    HX 2028254-1

    Manufacturer: DFI Co.,Ltd.
    Basic UDI-DIs
    0
    Scopes
    1
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    Rev.0
    752
    Valid for 752 days
    Expiry: June 29, 2028

    Basic Information

    Number
    HX 2028254-1
    Type
    IVDR QMS
    Legislation
    IVDR
    Issue Date
    June 30, 2023
    Expiry Date
    June 29, 2028
    Revision
    Rev.0
    Manufacturer
    DFI Co.,Ltd.

    Certificate Lifecycle

    June 30, 2023 June 29, 2028

    Scopes

    Quality Procedure Scope

    Device Group Class B

    IVR 0608 Devices intended to be used for screening, determination or monitoring of physiological markers W01010999 - MULTIPLE PARAMETERS URINE TESTING - OTHER

    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.