BEUDAMED
    MDR MDR QMS Supplemented

    HZ 2069530-1

    Manufacturer: Jiangsu Ate Medical Technology Co., Ltd.
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    1
    Risk Classes
    2
    Characteristics
    1
    Revision
    1
    813
    Valid for 813 days
    Expiry: August 29, 2028

    Basic Information

    Number
    HZ 2069530-1
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    October 7, 2024
    Expiry Date
    August 29, 2028
    Revision
    1
    Manufacturer
    Jiangsu Ate Medical Technology Co., Ltd.

    Certificate Lifecycle

    October 7, 2024 August 29, 2028

    Device Characteristics

    Sterile

    Scopes

    2 scopes covering 2 risk classes

    Quality Procedure Scope

    Device Group Class IIa

    G030201 - DIGESTIVE ENDOSCOPY, NEEDLES - Disposable Injection Needles G030801 - GASTROINTESTINAL ENDOSCOPY, FORCEPS, SINGLE-USE - Disposable Grasping Forceps - Disposable Biopsy Forceps K010201 - MINIMALLY INVASIVE SURGERY SURGICAL INSTRUMENTS, SINGLE-USE - Disposable Spray Pipes G030301 - POLYPECTOMY SNARES - Disposable Cold Snares

    Quality Procedure Scope

    Device Group Class I Sterile

    G030803 - GASTROINTESTINAL ENDOSCOPY AND ECHOENDOSCOPY, BRUSHES R070203 - BRONCOPULMONARY ENDOSCOPY BRUSHES, SINGLE-USE - Disposable Cytology Brushes R070203 - BRONCOPULMONARY ENDOSCOPY BRUSHES, SINGLE-USE - Disposable Cytology Brushes

    Preceding Certificates

    HZ 2069530-1 Issued
    Issued: August 30, 2023 Expires: August 29, 2028

    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.