BEUDAMED
    MDR MDR QMS Issued

    HZ 2108739-1

    Manufacturer: Innovex Medical Co., Ltd.
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    0
    Risk Classes
    2
    Characteristics
    1
    Revision
    1
    836
    Valid for 836 days
    Expiry: September 21, 2028

    Basic Information

    Number
    HZ 2108739-1
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    May 7, 2024
    Expiry Date
    September 21, 2028
    Revision
    1
    Manufacturer
    Innovex Medical Co., Ltd.

    Certificate Lifecycle

    May 7, 2024 September 21, 2028

    Device Characteristics

    Sterile

    Scopes

    2 scopes covering 2 risk classes

    Quality Procedure Scope

    Device Group Class IIa

    U020199-URETERAL CATHETERS WITHOUT BALLOON – OTHER - Ureteral Access Sheaths U030202-URETERAL DILATORS, WITH BALLOON - Ureteral Dilation Balloon Catheters U0601-UROLOGICAL GUIDEWIRES, HYDROPHILIC - Urological Guidewires U0602-UROLOGICAL GUIDEWIRES, NOT HYDROPHILIC - Urological Guidewires U090101-URINARY STONE RETRIEVAL BASKETS - Urological Stone Extraction Baskets U020302-DOUBLE LOOP URETERAL STENTS - Ureteral Stents R010499- ENDOBRONCHIAL TUBES - OTHER - Endobronchial Blocker Catheters

    Quality Procedure Scope

    Device Group Class I Sterile

    A0699-DRAINAGE AND FLUID COLLECTION DEVICES - OTHER - Urological Sampler Sets

    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.