BEUDAMED
    MDR MDR QMS Supplemented

    HZ 1809678-1

    Manufacturer: Medartis AG
    Basic UDI-DIs
    0
    Scopes
    3
    Preceding Certs
    1
    Risk Classes
    3
    Characteristics
    1
    Revision
    Rev. 2
    204
    Valid for 204 days
    Expiry: December 29, 2026

    Basic Information

    Number
    HZ 1809678-1
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    November 4, 2024
    Expiry Date
    December 29, 2026
    Revision
    Rev. 2
    Manufacturer
    Medartis AG

    Certificate Lifecycle

    November 4, 2024 December 29, 2026

    Scopes

    3 scopes covering 3 risk classes

    Quality Procedure Scope

    Device Group Class I Reusable Surgical Instrument

    L091099 - Osteosynthesis Instruments, reusable - other L9099 - Surgical Instruments, reusable - other

    Quality Procedure Scope

    Device Group Class IIa

    L091001 - Instruments for Insertion and Extraction of Materials for Osteosynthesis, reusable Q010403 - Orthodontic Brackets and Buttons V9012 - Non-Specialist Surgical Instruments and Kits, single-use Z121305 - Motorised Orthopaedic Surgery System Instruments Z121390 - Various Orthopaedic and Traumatology Instruments

    Quality Procedure Scope

    Device Group Class IIb

    Osteosynthesis Devices, Devices for Tendon and and Ligament Synthesis P091201 - Osteosynthesis Staples and Anchors P091205 - Bone Fixation Plates P091206 - Bone Fixation Screws, Tendon and Ligament Synthesis Screws Software, CMX Portal V92 - Not Otherwise Classified Devices – Others

    Preceding Certificates

    HZ 1809678-1 Issued
    Issued: June 28, 2023 Expires: December 29, 2026

    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.