BEUDAMED
    MDR MDR QMS Issued

    HZ 2047383-1

    Manufacturer: Asahi Kasei Medical Co., Ltd.
    Basic UDI-DIs
    0
    Scopes
    1
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    Rev.3
    370
    Valid for 370 days
    Expiry: June 13, 2027

    Basic Information

    Number
    HZ 2047383-1
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    January 26, 2024
    Expiry Date
    June 13, 2027
    Revision
    Rev.3
    Manufacturer
    Asahi Kasei Medical Co., Ltd.

    Certificate Lifecycle

    January 26, 2024 June 13, 2027

    Device Characteristics

    Sterile

    Scopes

    Quality Procedure Scope

    Device Group Class IIb

    F010601 - HAEMODIALYSIS, HAEMOFILTRATION, HAEMODIAFILTRATION FILTERS DIALYSERS - UFC < 18 ml/h/mmHg F010602 - HAEMODIALYSIS, HAEMOFILTRATION, HAEMODIAFILTRATION FILTERS DIALYSERS - UFC = 18 - 35 ml/h/mmHg F010603 - HAEMODIALYSIS, HAEMOFILTRATION, HAEMODIAFILTRATION FILTERS DIALYSERS - UFC > 35 ml/h/mmHg B030201 - APHERESIS THERAPY DEVICES PLASMAPHERESIS DEVICES AND KITS B030203 – APHERESIS THERAPY DEVICES SINGLE PLASMA COMPONENTS REMOVAL DEVICES AND KITS

    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.