BEUDAMED
    MDR MDR QMS Issued

    HZ 2182311-1

    Manufacturer: Beijing LepuImage Technology Co., Ltd.
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    0
    Risk Classes
    2
    Characteristics
    1
    Revision
    0
    1203
    Valid for 1203 days
    Expiry: September 22, 2029

    Basic Information

    Number
    HZ 2182311-1
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    September 23, 2024
    Expiry Date
    September 22, 2029
    Manufacturer
    Beijing LepuImage Technology Co., Ltd.

    Certificate Lifecycle

    September 23, 2024 September 22, 2029

    Device Characteristics

    Sterile

    Scopes

    2 scopes covering 2 risk classes

    Quality Procedure Scope

    Device Group Class IIa

    Z110401 - ULTRASOUND SCANNERS Z110402 - ULTRASOUND PROBES Z120205 - UPPER GASTROINTESTINAL TRACT ENDOSCOPY INSTRUMENTS

    Quality Procedure Scope

    Device Group Class I Sterile

    Z120290 - VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI INVASIVE SURGERY

    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.