BEUDAMED
    IVDR IVDR QMS Issued

    HX 1804155-1

    Manufacturer: Dominion Biologicals Limited
    Basic UDI-DIs
    0
    Scopes
    1
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    Rev. 0
    1142
    Valid for 1142 days
    Expiry: July 24, 2029

    Basic Information

    Number
    HX 1804155-1
    Type
    IVDR QMS
    Legislation
    IVDR
    Issue Date
    July 25, 2024
    Expiry Date
    July 24, 2029
    Revision
    Rev. 0
    Manufacturer
    Dominion Biologicals Limited

    Certificate Lifecycle

    July 25, 2024 July 24, 2029

    Scopes

    Quality Procedure Scope

    Device Group Class C

    HAEMATOLOGY / HAEMOSTASIS / IMMUNOHAEMATOLOGY / HISTOLOGY / CYTOLOGY IVR 0106 Other devices intended to be used for blood grouping W01030303 - ANTIBODY DETECTION (IMMUNOHAEMATOLOGY)

    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.