BEUDAMED
    IVDR IVDR QMS Issued

    HX 1743284-1

    Manufacturer: Sysmex Partec GmbH
    Basic UDI-DIs
    0
    Scopes
    1
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    Rev.0
    770
    Valid for 770 days
    Expiry: July 18, 2028

    Basic Information

    Number
    HX 1743284-1
    Type
    IVDR QMS
    Legislation
    IVDR
    Issue Date
    July 19, 2023
    Expiry Date
    July 18, 2028
    Revision
    Rev.0
    Manufacturer
    Sysmex Partec GmbH

    Certificate Lifecycle

    July 19, 2023 July 18, 2028

    Scopes

    Quality Procedure Scope

    Device Group Class C

    HAEMATOLOGY / HAEMOSTASIS / IMMUNOHAEMATOLOGY / HISTOLOGY / CYTOLOGY IVR 506: Other devices intended to be used to determine markers of infections/immune status W01030801 - MONOCLONAL ANTIBODIES FOR CELL SURFACE ANTIGENS

    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.