BEUDAMED
    IVDR IVDR QMS Issued

    HX 1804149-1

    Manufacturer: Immucor GTI Diagnostics, Inc
    Basic UDI-DIs
    0
    Scopes
    1
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    Rev. 0
    1050
    Valid for 1050 days
    Expiry: April 23, 2029

    Basic Information

    Number
    HX 1804149-1
    Type
    IVDR QMS
    Legislation
    IVDR
    Issue Date
    April 24, 2024
    Expiry Date
    April 23, 2029
    Revision
    Rev. 0
    Manufacturer
    Immucor GTI Diagnostics, Inc

    Certificate Lifecycle

    April 24, 2024 April 23, 2029

    Scopes

    Quality Procedure Scope

    Device Group Class C

    HAEMATOLOGY / HAEMOSTASIS / IMMUNOHAEMATOLOGY / HISTOLOGY / CYTOLOGY W01030402 - HLA Antibody Screening

    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.