BEUDAMED
    MDR MDR QMS Issued

    HZ 1518511-1

    Manufacturer: Bain Medical Equipment(Guangzhou)Co.,Ltd.
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    0
    Risk Classes
    2
    Characteristics
    0
    Revision
    0

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    1230
    Valid for 1230 days
    Expiry: December 8, 2029

    Basic Information

    Number
    HZ 1518511-1
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    December 9, 2024
    Expiry Date
    December 8, 2029
    Manufacturer
    Bain Medical Equipment(Guangzhou)Co.,Ltd.

    Certificate Lifecycle

    December 9, 2024 December 8, 2029

    Device Characteristics

    Sterile

    Scopes

    2 scopes covering 2 risk classes

    Quality Procedure Scope

    Device Group Class IIa

    F020102 - ARTERIOVENOUS DIALYSIS LINES, TWO NEEDLES - Tubing Sets for Hemodialysis

    Quality Procedure Scope

    Device Group Class IIb

    F01060203- HAEMODIALYSIS, HAEMOFILTRATION, HAEMODIAFILTRATION FILTERS DIALYSERS - UFC = 18 - 35 ml/h/mmHg, SYNTHETIC MEMBRANES - Hollow Fiber Dialyzer F01060303- HAEMODIALYSIS, HAEMOFILTRATION, HAEMODIAFILTRATION FILTERS DIALYSERS - UFC > 35 ml/h/mmHg, SYNTHETIC MEMBRANES - Hollow Fiber Dialyzer

    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.