BEUDAMED
    MDR MDR QMS Issued

    HZ 2138909-1

    Manufacturer: Ningbo HicRen Biotechnology Co., Ltd.
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    0
    Risk Classes
    2
    Characteristics
    1
    Revision
    0
    1287
    Valid for 1287 days
    Expiry: December 17, 2029

    Basic Information

    Number
    HZ 2138909-1
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    December 18, 2024
    Expiry Date
    December 17, 2029
    Manufacturer
    Ningbo HicRen Biotechnology Co., Ltd.

    Certificate Lifecycle

    December 18, 2024 December 17, 2029

    Device Characteristics

    Sterile

    Scopes

    2 scopes covering 2 risk classes

    Quality Procedure Scope

    Device Group Class I Sterile

    P099002 - ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS - Location Plates - Inflation Devices - Bone Cement Mixing Sets

    Quality Procedure Scope

    Device Group Class IIa

    P099002 - ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS - Percutaneous Access Needles - Guide Wires - Dilators - Bone Drills - Balloon Catheters - Bone Cement Delivery Cannulas

    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.