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GKS PRIME FLEX: TRIAL POST for CR/PS Inserts - Femur 4-5-6 GREY
EUDAMEDClass IIa (EU MDR)
Ref S54375Ref S54377Ref S54376
Identity
- Trade Name
- GKS PRIME FLEX: TRIAL POST for CR/PS Inserts - Femur 4-5-6 GREY EUDAMEDGKS PRIME FLEX: TRIAL POST for CR/PS Inserts - Femur 11-12-13 BLACK EUDAMEDGKS PRIME FLEX: TRIAL POST for CR/PS Inserts - Femur 7-8-9-10 YELLOW EUDAMED
- Device Name
- Trial component EUDAMED
- Model / Reference
- S54375 EUDAMEDS54377 EUDAMEDS54376 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08050323062171 EUDAMED08050323062195 EUDAMED08050323062188 EUDAMED
- Basic UDI-DI
- B-08050323062171 EUDAMEDB-08050323062195 EUDAMEDB-08050323062188 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 POST for CR/PS Inserts - Femur 4-5-6 GREY 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-08050323062171 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Permedica S.p.A
- EUDAMED SRN
- IT-MF-000008110
Sources (3)
- EUDAMED a05c379c-5808-42bf-addb-1ff887dc0f14 61 fields · synced Oct 5, 2026
- EUDAMED d994ba95-9abc-4ca7-a09d-5d7983c50528 61 fields · synced May 17, 2026
- EUDAMED 2d0e0065-07f4-4529-846e-9a5bd2b562a1 61 fields · synced May 18, 2026