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GKS ONE Evo: TRIAL FEMUR R3, slotted - Med. RIGHT / Lat. LEFT - Size 1
EUDAMEDClass IIa (EU MDR)
Ref S59711Ref S59719Ref S59721Ref S59717
Identity
- Trade Name
- GKS ONE Evo: TRIAL FEMUR R3, slotted - Med. RIGHT / Lat. LEFT - Size 1 EUDAMEDGKS ONE Evo: TRIAL FEMUR R3, slotted - Med. RIGHT / Lat. LEFT - Size 5 EUDAMEDGKS ONE Evo: TRIAL FEMUR R3, slotted - Med. RIGHT / Lat. LEFT - Size 6 EUDAMEDGKS ONE Evo: TRIAL FEMUR R3, slotted - Med. RIGHT / Lat. LEFT - Size 4 EUDAMED
- Device Name
- Trial component EUDAMED
- Model / Reference
- S59711 EUDAMEDS59719 EUDAMEDS59721 EUDAMEDS59717 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08050323080519 EUDAMED08050323080595 EUDAMED08050323080618 EUDAMED08050323080571 EUDAMED
- Basic UDI-DI
- B-08050323080519 EUDAMEDB-08050323080595 EUDAMEDB-08050323080618 EUDAMEDB-08050323080571 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 R3, slotted - Med. RIGHT / Lat. LEFT - 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-08050323080519 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Permedica S.p.A
- EUDAMED SRN
- IT-MF-000008110
Sources (4)
- EUDAMED edd6c826-25fc-46f6-a5e7-55989d7c214b 61 fields · synced Oct 6, 2026
- EUDAMED ad3abd89-8bdd-403d-a620-66bf1192ade4 61 fields · synced May 18, 2026
- EUDAMED 693afebb-61e5-4504-ac2e-c23555d5063b 61 fields · synced May 18, 2026
- EUDAMED 42f7036e-0a05-46ee-ac6e-3158eaa95bd3 61 fields · synced May 18, 2026