BEUDAMED
    MDR MDR QMS Issued

    HZ 2292034-1

    Manufacturer: OSSTEM IMPLANT Co., Ltd.
    Basic UDI-DIs
    0
    Scopes
    2
    Preceding Certs
    0
    Risk Classes
    2
    Characteristics
    1
    Revision
    Rev.0
    1163
    Valid for 1163 days
    Expiry: August 15, 2029

    Basic Information

    Number
    HZ 2292034-1
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    August 16, 2024
    Expiry Date
    August 15, 2029
    Revision
    Rev.0
    Manufacturer
    OSSTEM IMPLANT Co., Ltd.

    Certificate Lifecycle

    August 16, 2024 August 15, 2029

    Device Characteristics

    Sterile

    Scopes

    2 scopes covering 2 risk classes

    Quality Procedure Scope

    Device Group Class I Reusable Surgical Instrument

    Product of Class I, reusable surgical instruments: L159099 - ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER L159016 - DENTAL SURGERY INSTRUMENT KITS, REUSABLE The scope of certification is limited to the aspects relating to the reuse of the device, in particular cleaning, disinfection, sterilization, maintenance and functional testing and the related instructions for use.

    Quality Procedure Scope

    Device Group Class IIa

    Product of Class IIa: L159099 - ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER Q010599 - DENTAL INSTRUMENTS, SINGLE-USE - OTHER L159016 - DENTAL SURGERY INSTRUMENT KITS, REUSABLE

    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.