BEUDAMED
    MDR MDR QMS Issued

    HZ 2094002-1

    Manufacturer: Shenzhen Envisen Industry Co., Ltd.
    Basic UDI-DIs
    0
    Scopes
    1
    Preceding Certs
    0
    Risk Classes
    1
    Characteristics
    0
    Revision
    0
    1021
    Valid for 1021 days
    Expiry: March 25, 2029

    Basic Information

    Number
    HZ 2094002-1
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    March 26, 2024
    Expiry Date
    March 25, 2029
    Manufacturer
    Shenzhen Envisen Industry Co., Ltd.

    Certificate Lifecycle

    March 26, 2024 March 25, 2029

    Device Characteristics

    Sterile

    Scopes

    Quality Procedure Scope

    Device Group Class IIb

    U0103 - URETHRAL PROSTATIC AND BLADDER CATHETERS WITH TEMPERATURE SENSORS

    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.