BEUDAMED
    MDR MDR QMS Supplemented

    HZ 2183950-1

    Manufacturer: Guangdong Optomedic Technologies, Inc.
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    1
    Risk Classes
    2
    Characteristics
    0
    Revision
    1
    850
    Valid for 850 days
    Expiry: October 6, 2028

    Basic Information

    Number
    HZ 2183950-1
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    September 20, 2024
    Expiry Date
    October 6, 2028
    Revision
    1
    Manufacturer
    Guangdong Optomedic Technologies, Inc.

    Certificate Lifecycle

    September 20, 2024 October 6, 2028

    Scopes

    2 scopes covering 2 risk classes

    Quality Procedure Scope

    Device Group Class IIa

    Z120190 - VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY Z120204 - INSTRUMENTS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES Z120290 - VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI-INVASIVE SURGERY

    Quality Procedure Scope

    Device Group Class IIb

    Z12029008 - ENDOSCOPIC AND MINMALLY INVASIVE SURGERY INSTRUMENTS VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI- INVASIVE SURGERY GAS INFLATORS

    Preceding Certificates

    HZ 2183950-1 Issued
    Issued: October 7, 2023 Expires: October 6, 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.