BEUDAMED
    MDR MDR QMS Issued

    HZ 2067890-1

    Manufacturer: Hangzhou Mindray Medical Technology Co., Ltd.
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    0
    Risk Classes
    2
    Characteristics
    0
    Revision
    0
    1010
    Valid for 1010 days
    Expiry: March 14, 2029

    Basic Information

    Number
    HZ 2067890-1
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    March 15, 2024
    Expiry Date
    March 14, 2029
    Manufacturer
    Hangzhou Mindray Medical Technology Co., Ltd.

    Certificate Lifecycle

    March 15, 2024 March 14, 2029

    Device Characteristics

    Sterile

    Scopes

    2 scopes covering 2 risk classes

    Quality Procedure Scope

    Device Group Class IIa

    K010101 - TROCAR, SINGLE-USE K010201 - MINIMALLY INVASIVE SURGERY SURGICAL INSTRUMENTS, SINGLE-USE K0104 - VERESS NEEDLES L031202 - ABDOMINAL TROCAR, REUSABLE L030101 - SUCTION AND IRRIGATION SURGICAL CANNULAS AND HANDPIECES, REUSABLE H020303 - CLIP APPLIERS L0205 - NEEDLE HOLDERS, REUSABLE L1206 - LAPAROSCOPIC AND THORACOSCOPIC SURGERY SPREADERS AND RETRACTORS, REUSABLE L059099 - OBSTETRICS AND GYNECOLOGY INSTRUMENTS, REUSABLE - OTHER L1299 - LAPAROSCOPIC AND THORACOSCOPIC INSTRUMENTS, REUSABLE - OTHER L0207 - KNOT PUSHERS, REUSABLE L1204 - LAPAROSCOPIC AND THORACOSCOPIC SURGERY FORCEPS REUSABLE

    Quality Procedure Scope

    Device Group Class IIb

    K020101 - MONO- AND BIPOLAR DEVICES, SINGLE-USE MONO- AND BIPOLAR SURGICAL INSTRUMENTS, SINGLE-USE

    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.