BEUDAMED
    MDR MDR QMS Issued

    HZ 2020208-1

    Manufacturer: META BIOMED CO., LTD.
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    0
    Risk Classes
    2
    Characteristics
    1
    Revision
    1
    441
    Valid for 441 days
    Expiry: August 23, 2027

    Basic Information

    Number
    HZ 2020208-1
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    June 3, 2024
    Expiry Date
    August 23, 2027
    Revision
    1
    Manufacturer
    META BIOMED CO., LTD.

    Certificate Lifecycle

    June 3, 2024 August 23, 2027

    Scopes

    2 scopes covering 2 risk classes

    Quality Procedure Scope

    Device Group Class I Reusable Surgical Instrument

    Product of Class I, reusable surgical instruments: H030101 - MULTIPLE CLIP APPLIERS FOR OPEN SURGERY H030201 - MULTIPLE CLIP APPLIERS FOR VIDEOSURGERY The scope of certification is limited to the aspects relating to the reuse of the device, in particular cleaning, disinfection, sterilization, maintenance and functional testing and the related instructions for use.

    Quality Procedure Scope

    Device Group Class IIb

    Product of Class IIb: H030102 - HAEMOSTASIS CLIPS FOR OPEN SURGERY SINGULAR CLIPS FOR OPEN SURGERY NON-ABSORBABLE SINGULAR CLIPS FOR OPEN SURGERY H030299 - HAEMOSTASIS CLIPS FOR VIDEOSURGERY HAEMOSTASIS CLIPS FOR VIDEOSURGERY – OTHER

    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.