BEUDAMED
    MDR MDR QMS Issued

    HZ 2368594-1

    Manufacturer: Jiangsu Kaishou Medical Apparatus Co.,Ltd
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    0
    Risk Classes
    2
    Characteristics
    1
    Revision
    0
    898
    Valid for 898 days
    Expiry: November 22, 2028

    Basic Information

    Number
    HZ 2368594-1
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    November 23, 2023
    Expiry Date
    November 22, 2028
    Manufacturer
    Jiangsu Kaishou Medical Apparatus Co.,Ltd

    Certificate Lifecycle

    November 23, 2023 November 22, 2028

    Device Characteristics

    Sterile

    Scopes

    2 scopes covering 2 risk classes

    Quality Procedure Scope

    Device Group Class I Sterile

    A060301 - COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE

    Quality Procedure Scope

    Device Group Class IIb

    U010201 - URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - URETHRAL PROSTATIC AND BLADDER CATHETERS, NELATON, WITH BALLOON

    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.