BEUDAMED
    MDR MDR QMS Supplemented Expired

    HZ 1762136-1

    Manufacturer: Stryker Leibinger GmbH & Co.KG
    Basic UDI-DIs
    0
    Scopes
    20
    Preceding Certs
    1
    Risk Classes
    4
    Characteristics
    1
    Revision
    Rev. 8
    169
    Expired 169 days ago
    Expiry: December 21, 2025

    Basic Information

    Number
    HZ 1762136-1
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    December 23, 2024
    Expiry Date
    December 21, 2025 Expired
    Revision
    Rev. 8
    Manufacturer
    Stryker Leibinger GmbH & Co.KG

    Certificate Lifecycle

    December 23, 2024 December 21, 2025

    Scopes

    20 scopes covering 4 risk classes

    Quality Procedure Scope

    Device Group Class IIa

    P091280 - Osteosynthesis Devices, Devices for Tendons and Ligaments Synthesis - Accessories

    Quality Procedure Scope

    Device Group Class III

    Z120114 - GENERAL AND MULTIDISCIPLINARY SURGERY INSTRUMENTS SURGICAL NAVIGATION INSTRUMENTS

    Quality Procedure Scope

    Device Group Class I Reusable Surgical Instrument

    L010499 - Surgical scissors - others

    Quality Procedure Scope

    Device Group Class I Reusable Surgical Instrument

    L0312 - Trocars (not in category A)

    Quality Procedure Scope

    Device Group Class I Reusable Surgical Instrument

    L031401 - Retractors, general surgery

    Quality Procedure Scope

    Device Group Class I Reusable Surgical Instrument

    L0902 - Elevators, orthopaedic surgery

    Quality Procedure Scope

    Device Group Class I Reusable Surgical Instrument

    L090401 - Osteotomes, orthopaedic surgery

    Quality Procedure Scope

    Device Group Class I Reusable Surgical Instrument

    L090402 - Chisels, orthopaedic surgery

    Quality Procedure Scope

    Device Group Class I Reusable Surgical Instrument

    L090403 - Gouges, orthopaedic surgery

    Quality Procedure Scope

    Device Group Class I Reusable Surgical Instrument

    L090999 - Orthopaedic surgery, cutting instruments - others

    Quality Procedure Scope

    Device Group Class I Reusable Surgical Instrument

    L091001 - Instruments for insertion and extraction of osteosynthesis devices

    Quality Procedure Scope

    Device Group Class I Reusable Surgical Instrument

    L091099 - Osteosynthesis instruments, reusable - others

    Quality Procedure Scope

    Device Group Class I Reusable Surgical Instrument

    L091303 - Foreceps, bone reduction

    Quality Procedure Scope

    Device Group Class I Reusable Surgical Instrument

    L091399 - Foreceps, orthopaedic surgery - others

    Quality Procedure Scope

    Device Group Class III Class I Reusable Surgical Instrument

    Z120114 - Surgery navigation instruments

    Quality Procedure Scope

    Device Group Class IIb

    P900403 - Tissue materials, filler, substitutive and reconstructive Non-biodegradable devices, filler and reconstructive

    Quality Procedure Scope

    Device Group Class IIb

    P091205 - Osteosynthesis devices, devices for tendon and ligament synthesis Bone fixation plates

    Quality Procedure Scope

    Device Group Class IIb

    P091206 - Osteosynthesis devices, devices for tendon and ligament synthesis Bone fixation screws, tendon and ligament synthesis screws

    Quality Procedure Scope

    Device Group Class III

    P900403 - Tissue materials, filler, substitutive and reconstructive Non-biodegradable devices, filler and reconstructive

    Quality Procedure Scope

    Device Group Class IIa

    Z120114 – Surgery Navigation Instruments

    Preceding Certificates

    HZ 1762136-1 Supplemented
    Issued: October 28, 2024 Expires: December 21, 2025

    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.