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GKS PRIME FLEX RK: Trial Tibial Wedge ML / LR - Size D-E x 10mm - RED
EUDAMEDClass IIa (EU MDR)
Ref S47724Ref S47730Ref S47726Ref S47736Ref S47716Ref S47722Ref S47712
Identity
- Trade Name
- GKS PRIME FLEX RK: Trial Tibial Wedge ML / LR - Size D-E x 10mm - RED EUDAMEDGKS PRIME FLEX RK: Trial Tibial Wedge ML/LR - Size XS-A x 15mm - MAGENTA EUDAMEDGKS PRIME FLEX RK: Trial Tibial Wedge ML / LR - Size F-G x 10mm - BLUE EUDAMEDGKS PRIME FLEX RK: Trial Tibial Wedge ML / LR - Size F-G x 15mm - BLUE EUDAMEDGKS PRIME FLEX RK: Trial Tibial Wedge ML / LR - Size F-G x 05mm - BLUE EUDAMEDGKS PRIME FLEX RK: Trial Tibial Wedge ML / LR - Size B-C x 10mm - GREEN EUDAMEDGKS PRIME FLEX RK: Trial Tibial Wedge ML / LR - Size B-C x 05mm - GREEN EUDAMED
- Device Name
- Trial Component EUDAMED
- Model / Reference
- S47724 EUDAMEDS47730 EUDAMEDS47726 EUDAMEDS47736 EUDAMEDS47716 EUDAMEDS47722 EUDAMEDS47712 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08050323145485 EUDAMED08050323146642 EUDAMED08050323145508 EUDAMED08050323145560 EUDAMED08050323145447 EUDAMED08050323145461 EUDAMED08050323145409 EUDAMED
- Basic UDI-DI
- B-08050323145485 EUDAMEDB-08050323146642 EUDAMEDB-08050323145508 EUDAMEDB-08050323145560 EUDAMEDB-08050323145447 EUDAMEDB-08050323145461 EUDAMEDB-08050323145409 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 PRIME FLEX RK: Trial Tibial Wedge ML / LR - Size D-E x 10mm - RED 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-08050323145485 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Permedica S.p.A
- EUDAMED SRN
- IT-MF-000008110
Sources (7)
- EUDAMED 1d1bbcd8-73f4-4758-be2a-cc5980436007 61 fields · synced Oct 6, 2026
- EUDAMED 4ecaa6ec-cd8b-4ab3-9926-0215af6833b0 61 fields · synced May 16, 2026
- EUDAMED e9f66a8e-a959-4da8-b27b-67bbaf6a2433 61 fields · synced May 17, 2026
- EUDAMED 5392311b-9301-4fa9-8d2f-e4238fc6aa08 61 fields · synced May 17, 2026
- EUDAMED 36b925c2-043c-4347-90a9-480573ef9ad9 61 fields · synced May 17, 2026
- EUDAMED 6fc912b4-bf18-45f6-b8c8-8b9622bfb31d 61 fields · synced May 17, 2026
- EUDAMED 2ac19355-30b1-42e3-a142-1f9c3c136cd2 61 fields · synced May 19, 2026