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GKS PRIME FLEX: Trial Insert TOP CR/PS - Size H-I x 14mm - ORANGE
EUDAMEDClass IIa (EU MDR)
Ref S54596Ref S54599Ref S54597Ref S54591Ref S54598Ref S54593Ref S54595Ref S54594
Identity
- Trade Name
- GKS PRIME FLEX: Trial Insert TOP CR/PS - Size H-I x 14mm - ORANGE EUDAMEDGKS PRIME FLEX: Trial Insert TOP CR/PS - Size H-I x 15mm - ORANGE EUDAMEDGKS PRIME FLEX: Trial Insert TOP CR/PS - Size H-I x 17mm - ORANGE EUDAMEDGKS PRIME FLEX: Trial Insert TOP CR/PS - Size H-I x 09mm - ORANGE EUDAMEDGKS PRIME FLEX: Trial Insert TOP CR/PS - Size H-I x 20mm - ORANGE EUDAMEDGKS PRIME FLEX: Trial Insert TOP CR/PS - Size H-I x 11mm - ORANGE EUDAMEDGKS PRIME FLEX: Trial Insert TOP CR/PS - Size H-I x 13mm - ORANGE EUDAMEDGKS PRIME FLEX: Trial Insert TOP CR/PS - Size H-I x 12mm - ORANGE EUDAMED
- Device Name
- Trial Component EUDAMED
- Model / Reference
- S54596 EUDAMEDS54599 EUDAMEDS54597 EUDAMEDS54591 EUDAMEDS54598 EUDAMEDS54593 EUDAMEDS54595 EUDAMEDS54594 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08050323082469 EUDAMED08050323152445 EUDAMED08050323082476 EUDAMED08050323152438 EUDAMED08050323082483 EUDAMED08050323152421 EUDAMED08050323152476 EUDAMED08050323082452 EUDAMED
- Basic UDI-DI
- B-08050323082469 EUDAMEDB-08050323152445 EUDAMEDB-08050323082476 EUDAMEDB-08050323152438 EUDAMEDB-08050323082483 EUDAMEDB-08050323152421 EUDAMEDB-08050323152476 EUDAMEDB-08050323082452 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 H-I x 14mm - ORANGE 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-08050323082469 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Permedica S.p.A
- EUDAMED SRN
- IT-MF-000008110
Sources (8)
- EUDAMED aea027eb-d0ee-4199-a805-ee4a7c8f84d5 61 fields · synced Oct 6, 2026
- EUDAMED 4dae75ee-31d3-4e9e-ad89-663c2947667d 61 fields · synced May 16, 2026
- EUDAMED 12c016d8-4a25-45a2-8640-aca59451c562 61 fields · synced May 16, 2026
- EUDAMED 1126540b-c398-4232-b773-22c8a5d4e190 61 fields · synced May 17, 2026
- EUDAMED 650ceb4f-e709-46d0-be1e-615a15538054 61 fields · synced May 17, 2026
- EUDAMED 91b78072-95c1-4a3f-914b-5890184ed822 61 fields · synced May 18, 2026
- EUDAMED 659a9733-5aae-4a61-996c-2a6c7b8d8cdf 61 fields · synced May 19, 2026
- EUDAMED c158ad28-9b77-4a3f-afda-6ffb24d72a6c 61 fields · synced May 19, 2026