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GEMINI SL Total Knee System

by Waldemar Link GmbH & Co. KG EUDAMED

Active European Union

Ref 318-212/25Model Femoral component, TiCaP coating, uncemented, CoCrMo, fixed bearing PS

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4026575-1-KNP-200007-UL Basic UDI-DIDate25 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 13803GB450251029 Supplemented

    Technical documentation EU MDR

    Notified body
    Notified body 0482
    Issued
    29 Oct 2025
    Expires
    17 Jan 2029
    Reason
    Add device or group

Specification

EUDAMED

Device Name
GEMINI SL Total Knee System
Model / Reference
Femoral component, TiCaP coating, uncemented, CoCrMo, fixed bearing PS, 318-212/25
Primary DI / UDI-DI
04026575394555
Basic UDI-DI
4026575-1-KNP-200007-UL
EMDN Code
P0909030102 Bicompartmental primary implant uncemented femoral components
Device Class
Class III
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000005215

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Properties

Show properties
  • Sterile
  • Implantable
  • CMR Substance
Other properties (10)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No