GEMINI SL Total Knee System
by Waldemar Link GmbH & Co. KG Germany EUDAMED
Ref 318-453/05Model Tibial component, cemented, CoCrMo, mobile bearing, monoblock EMDN P090903020101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number4026575-1-KNP-200015-UK | Date25 Jun 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- 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
- Device Name
- GEMINI SL Total Knee System
- Model / Reference
- Tibial component, cemented, CoCrMo, mobile bearing, monoblock, 318-453/05
- Primary DI / UDI-DI
- 04026575419890
- Basic UDI-DI
- 4026575-1-KNP-200015-UK
- EMDN Code
- P090903020101 Bicompartmental primary implant cemented mobile bearing tibial plates
- Device Class
- Class III
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000005215
Other devices from Waldemar Link GmbH & Co. KG
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 04026575419890|4026575-1-KNP-200015-UK