← Back to catalogue
GKS PRIME FLEX: Trial Insert TOP CR/PS - Size F-G x 09mm - BLUE
EUDAMEDClass IIa (EU MDR)
Ref S54581Ref S54589Ref S54583Ref S54586Ref S54582Ref S54587Ref S54585
Identity
- Trade Name
- GKS PRIME FLEX: Trial Insert TOP CR/PS - Size F-G x 09mm - BLUE EUDAMEDGKS PRIME FLEX: Trial Insert TOP CR/PS - Size F-G x 15mm - BLUE EUDAMEDGKS PRIME FLEX: Trial Insert TOP CR/PS - Size F-G x 11mm - BLUE EUDAMEDGKS PRIME FLEX: Trial Insert TOP CR/PS - Size F-G x 14mm - BLUE EUDAMEDGKS PRIME FLEX: Trial Insert TOP CR/PS - Size F-G x 10mm - BLUE EUDAMEDGKS PRIME FLEX: Trial Insert TOP CR/PS - Size F-G x 17mm - BLUE EUDAMEDGKS PRIME FLEX: Trial Insert TOP CR/PS - Size F-G x 13mm - BLUE EUDAMED
- Device Name
- Trial Component EUDAMED
- Model / Reference
- S54581 EUDAMEDS54589 EUDAMEDS54583 EUDAMEDS54586 EUDAMEDS54582 EUDAMEDS54587 EUDAMEDS54585 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08050323133512 EUDAMED08050323152469 EUDAMED08050323133529 EUDAMED08050323082414 EUDAMED08050323082391 EUDAMED08050323082421 EUDAMED08050323133536 EUDAMED
- Basic UDI-DI
- B-08050323133512 EUDAMEDB-08050323152469 EUDAMEDB-08050323133529 EUDAMEDB-08050323082414 EUDAMEDB-08050323082391 EUDAMEDB-08050323082421 EUDAMEDB-08050323133536 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 Insert TOP CR/PS - Size F-G x 09mm - 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-08050323133512 | 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 (7)
- EUDAMED 0db952b0-ce7b-48e0-86b2-25bc1f574265 61 fields · synced Oct 6, 2026
- EUDAMED 48150317-c308-46c4-a7ca-fb4c37cce6ad 61 fields · synced May 16, 2026
- EUDAMED 527f5e2c-ff58-4f73-a19c-c0293f177f69 61 fields · synced May 17, 2026
- EUDAMED 2d880896-8987-458a-aebb-f5103ddcc391 61 fields · synced May 18, 2026
- EUDAMED 1a616a2b-b14e-49f4-b4c5-4de4a251e70c 61 fields · synced May 18, 2026
- EUDAMED ffe78335-5417-42bc-a854-8bfb5248356e 61 fields · synced May 18, 2026
- EUDAMED 6795c21d-15b7-4d83-8349-18125303f269 61 fields · synced May 19, 2026