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GKS ONE Evo: TRIAL FEMUR CH - Med. RIGHT / Lat. LEFT - Size 5
EUDAMEDClass IIa (EU MDR)
Ref S59759Ref S59751Ref S59761Ref S59757
Identity
- Trade Name
- GKS ONE Evo: TRIAL FEMUR CH - Med. RIGHT / Lat. LEFT - Size 5 EUDAMEDGKS ONE Evo: TRIAL FEMUR CH - Med. RIGHT / Lat. LEFT - Size 1 EUDAMEDGKS ONE Evo: TRIAL FEMUR CH - Med. RIGHT / Lat. LEFT - Size 6 EUDAMEDGKS ONE Evo: TRIAL FEMUR CH - Med. RIGHT / Lat. LEFT - Size 4 EUDAMED
- Device Name
- Trial component EUDAMED
- Model / Reference
- S59759 EUDAMEDS59751 EUDAMEDS59761 EUDAMEDS59757 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08050323080830 EUDAMED08050323080755 EUDAMED08050323080854 EUDAMED08050323080816 EUDAMED
- Basic UDI-DI
- B-08050323080830 EUDAMEDB-08050323080755 EUDAMEDB-08050323080854 EUDAMEDB-08050323080816 EUDAMED
- EMDN Code
- V06010102 KNEE PROSTHESES TESTING DEVICES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
GKS ONE Evo: TRIAL FEMUR CH - Med. RIGHT / Lat. LEFT - Size 5 by Permedica S.p.A — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08050323080830 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Permedica S.p.A
- EUDAMED SRN
- IT-MF-000008110
Sources (4)
- EUDAMED 9e0e8a0d-cb72-405b-ab11-c54c6be3ac88 61 fields · synced Oct 6, 2026
- EUDAMED 426b025b-1387-4b56-98cf-50f1ccad0795 61 fields · synced May 16, 2026
- EUDAMED 80493981-0366-4ab5-909f-156275f6b473 61 fields · synced May 17, 2026
- EUDAMED 27cd55e7-474a-44d2-8f69-9acfc49eae5b 61 fields · synced May 19, 2026