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GKS ONE Evo: TRIAL FEMUR R3, slotted - Med. LEFT / Lat. RIGHT - Size 4
EUDAMEDClass IIa (EU MDR)
Ref S59718Ref S59712Ref S59716Ref S59722
Identity
- Trade Name
- GKS ONE Evo: TRIAL FEMUR R3, slotted - Med. LEFT / Lat. RIGHT - Size 4 EUDAMEDGKS ONE Evo: TRIAL FEMUR R3, slotted - Med. LEFT / Lat. RIGHT - Size 1 EUDAMEDGKS ONE Evo: TRIAL FEMUR R3, slotted - Med. LEFT / Lat. RIGHT - Size 3 EUDAMEDGKS ONE Evo: TRIAL FEMUR R3, slotted - Med. LEFT / Lat. RIGHT - Size 6 EUDAMED
- Device Name
- Trial component EUDAMED
- Model / Reference
- S59718 EUDAMEDS59712 EUDAMEDS59716 EUDAMEDS59722 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08050323080588 EUDAMED08050323080526 EUDAMED08050323080564 EUDAMED08050323080625 EUDAMED
- Basic UDI-DI
- B-08050323080588 EUDAMEDB-08050323080526 EUDAMEDB-08050323080564 EUDAMEDB-08050323080625 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. LEFT / Lat. RIGHT - Size 4 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-08050323080588 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Permedica S.p.A
- EUDAMED SRN
- IT-MF-000008110
Sources (4)
- EUDAMED c67711d9-a10a-4163-9bc8-ab726010369d 61 fields · synced Oct 6, 2026
- EUDAMED 1642b2e1-cd58-4776-afb9-942105ccf1d8 61 fields · synced May 18, 2026
- EUDAMED 1b63516c-3a4d-42a4-8590-455d24d0dd0a 61 fields · synced May 18, 2026
- EUDAMED fb35b2db-f2fc-413b-8ec0-ef479b16030d 61 fields · synced May 18, 2026