BEUDAMED
    MDR MDR QMS Issued

    HZ 2180931-1

    Manufacturer: Shanghai Kinetic Medical Co., Ltd.
    Basic UDI-DIs
    0
    Scopes
    3
    Preceding Certs
    0
    Risk Classes
    2
    Characteristics
    1
    Revision
    0
    1043
    Valid for 1043 days
    Expiry: April 16, 2029

    Basic Information

    Number
    HZ 2180931-1
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    April 17, 2024
    Expiry Date
    April 16, 2029
    Manufacturer
    Shanghai Kinetic Medical Co., Ltd.

    Certificate Lifecycle

    April 17, 2024 April 16, 2029

    Device Characteristics

    Sterile

    Scopes

    3 scopes covering 2 risk classes

    Quality Procedure Scope

    Device Group Class IIa

    P099002 - ORTHOPAEDIC CEMENTS, FITTING AND APPLICATION DEVICES AND KITS - Balloon Catheters - Puncture Needles - Bone Filler Devices - Cannulas - Dilators - Drills - Guide Wires - Bone Drills - Kyphoplasty Multifunctional Tools - Biopsy Instruments - Curets - Vertebral Osteotomes K030201 - ARTHROSCOPIC CANNULAS, SINGLE-USE - Arthroscopic Cannulas

    Quality Procedure Scope

    Device Group Class I Sterile

    P099002 - ORTHOPAEDIC CEMENTS, FITTING AND APPLICATION DEVICES AND KITS - Medical Balloon Catheter Syringe Pumps - Bone Cement Delivery Systems - Bone Cement Injection Guns

    Quality Procedure Scope

    System Procedure Pack

    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.