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GKS ONE Evo: TRIAL FEMUR CH - Med. LEFT / Lat. RIGHT - Size 1
EUDAMEDClass IIa (EU MDR)
Ref S59752Ref S59762Ref S59758
Identity
- Trade Name
- GKS ONE Evo: TRIAL FEMUR CH - Med. LEFT / Lat. RIGHT - Size 1 EUDAMEDGKS ONE Evo: TRIAL FEMUR CH - Med. LEFT / Lat. RIGHT - Size 6 EUDAMEDGKS ONE Evo: TRIAL FEMUR CH - Med. LEFT / Lat. RIGHT - Size 4 EUDAMED
- Device Name
- Trial component EUDAMED
- Model / Reference
- S59752 EUDAMEDS59762 EUDAMEDS59758 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08050323080762 EUDAMED08050323080861 EUDAMED08050323080823 EUDAMED
- Basic UDI-DI
- B-08050323080762 EUDAMEDB-08050323080861 EUDAMEDB-08050323080823 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. LEFT / Lat. RIGHT - Size 1 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-08050323080762 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Permedica S.p.A
- EUDAMED SRN
- IT-MF-000008110
Sources (3)
- EUDAMED 9c1e8258-8e50-41f0-b2e0-78991768622a 61 fields · synced Oct 6, 2026
- EUDAMED 20a77e62-7e19-4e33-b273-56ae266a20ff 61 fields · synced May 18, 2026
- EUDAMED c79a36f4-025d-4a74-b9fa-7cdb5817c3e3 61 fields · synced May 19, 2026