BEUDAMED
    MDR MDR QMS Issued

    HZ 2021396-1

    Manufacturer: Jiangxi Sanxin Medtec Co., Ltd.
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    0
    Risk Classes
    2
    Characteristics
    0
    Revision
    0
    1283
    Valid for 1283 days
    Expiry: December 12, 2029

    Basic Information

    Number
    HZ 2021396-1
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    December 13, 2024
    Expiry Date
    December 12, 2029
    Manufacturer
    Jiangxi Sanxin Medtec Co., Ltd.

    Certificate Lifecycle

    December 13, 2024 December 12, 2029

    Device Characteristics

    Sterile

    Scopes

    2 scopes covering 2 risk classes

    Quality Procedure Scope

    Device Group Class IIb

    F010601 - HAEMODIALYSIS, HAEMOFILTRATION, HAEMODIAFILTRATION FILTERS DIALYSERS - UFC < 18 ml/h/mmHg - Hollow Fiber Dialyzers F010603 - HAEMODIALYSIS, HAEMOFILTRATION, HAEMODIAFILTRATION FILTERS DIALYSERS - UFC > 35 ml/h/mmHg - Hollow Fiber Hemodialysis Dialyzers

    Quality Procedure Scope

    Device Group Class IIa

    A020104 - SYRINGES FOR INJECTORS, SINGLE-USE - Auto-Disable Syringes - Auto-Disable Syringes for Fixed Dose Immunization - Disposable Syringes F020102 - ARTERIOVENOUS DIALYSIS LINES, TWO NEEDLES - Hemodialysis Blood Tubing Sets A010401 - ARTERIOVENOUS FISTULA NEEDLES - A.V. Fistula Needle Sets

    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.