BEUDAMED
    MDR MDR QMS Issued

    HZ 2082323-1

    Manufacturer: Fengh Medical Co., Ltd.
    Basic UDI-DIs
    0
    Scopes
    4
    Preceding Certs
    0
    Risk Classes
    3
    Characteristics
    2
    Revision
    2
    635
    Valid for 635 days
    Expiry: March 5, 2028

    Basic Information

    Number
    HZ 2082323-1
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    February 5, 2024
    Expiry Date
    March 5, 2028
    Revision
    2
    Manufacturer
    Fengh Medical Co., Ltd.

    Certificate Lifecycle

    February 5, 2024 March 5, 2028

    Device Characteristics

    Sterile

    Scopes

    4 scopes covering 3 risk classes

    Quality Procedure Scope

    Device Group Class IIa

    H020301 - LINEAR STAPLERS FOR VIDEOSURGERY - Disposable Endoscopic Linear Cutter Staplers K010101 - TROCAR, SINGLE-USE - Disposable Endoscopic Trocars - Disposable Endoscopic Trocar Sleeves K010201 - MINIMALLY INVASIVE SURGERY SURGICAL INSTRUMENTS, SINGLE-USE - Disposable Endoscopic Specimen Retrieval Bags H020301 - LINEAR STAPLERS FOR VIDEOSURGERY H020201 - LINEAR STAPLERS, OPEN SURGERY - Disposable Powered Articulating Endoscopic Linear Cutter Staplers

    Quality Procedure Scope

    Device Group Class I Sterile

    H020301 - LINEAR STAPLERS FOR VIDEOSURGERY - Battery Packs for Disposable Powered Articulating Endoscopic Linear Cutter Staplers

    Quality Procedure Scope

    Device Group Class I Reusable Surgical Instrument

    L070801 - VASCULAR SURGERY FORCEPS, REUSABLE - Reusable Clip Appliers - Reusable Clip Removers

    Quality Procedure Scope

    Device Group Class IIb

    H020301 - STAPLERS FOR VIDEOSURGERY LINEAR STAPLERS FOR VIDEOSURGERY - Disposable Endoscopic Linear Cutter Reload

    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.