← Back to catalogue
GKS PRIME FLEX: TRIAL FEMUR, Flat Inner, Titanium - Size 11 RIGHT
EUDAMEDClass IIa (EU MDR)
Ref S54485Ref S54486
Identity
- Trade Name
- GKS PRIME FLEX: TRIAL FEMUR, Flat Inner, Titanium - Size 11 RIGHT EUDAMEDGKS PRIME FLEX: TRIAL FEMUR, Flat Inner, Titanium - Size 11 LEFT EUDAMED
- Device Name
- Trial component EUDAMED
- Model / Reference
- S54485 EUDAMEDS54486 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08050323151165 EUDAMED08050323151172 EUDAMED
- Basic UDI-DI
- B-08050323151165 EUDAMEDB-08050323151172 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 FEMUR, Flat Inner, Titanium - Size 11 RIGHT 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-08050323151165 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Permedica S.p.A
- EUDAMED SRN
- IT-MF-000008110
Sources (2)
- EUDAMED 0436c484-bc9e-4b35-9466-892e7a417cb7 61 fields · synced Oct 6, 2026
- EUDAMED fc85aca2-c568-4032-8924-3a4958095be5 61 fields · synced May 16, 2026