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GKS PRIME FLEX: Trial Tibial Insert - Size F-G x 10mm - BLUE
EUDAMEDClass IIa (EU MDR)
Ref S54365Ref S54368Ref S54366Ref S54367
Identity
- Trade Name
- GKS PRIME FLEX: Trial Tibial Insert - Size F-G x 10mm - BLUE EUDAMEDGKS PRIME FLEX: Trial Tibial Insert - Size F-G x 17mm - BLUE EUDAMEDGKS PRIME FLEX: Trial Tibial Insert - Size F-G x 12mm - BLUE EUDAMEDGKS PRIME FLEX: Trial Tibial Insert - Size F-G x 14mm - BLUE EUDAMED
- Device Name
- Trial component EUDAMED
- Model / Reference
- S54365 EUDAMEDS54368 EUDAMEDS54366 EUDAMEDS54367 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08050323062126 EUDAMED08050323062157 EUDAMED08050323062133 EUDAMED08050323062140 EUDAMED
- Basic UDI-DI
- B-08050323062126 EUDAMEDB-08050323062157 EUDAMEDB-08050323062133 EUDAMEDB-08050323062140 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: Trial Tibial Insert - Size F-G x 10mm - BLUE 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-08050323062126 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Permedica S.p.A
- EUDAMED SRN
- IT-MF-000008110
Sources (4)
- EUDAMED 21e79b4d-1f8f-4c0a-b937-8491f0bf838e 61 fields · synced Jul 30, 2026
- EUDAMED 6bfd6476-f85a-4b0f-af41-662633980186 61 fields · synced May 16, 2026
- EUDAMED 5f22d88f-bd6b-45fb-85c4-7c54bd413c01 61 fields · synced May 16, 2026
- EUDAMED f1f71a54-5f21-4508-93b6-6f11ad305a5d 61 fields · synced May 18, 2026