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GKS PRIME FLEX: Trial Tibial Insert - Size D-E x 10mm - RED
EUDAMEDClass IIa (EU MDR)
Ref S54360Ref S54363Ref S54364Ref S54362Ref S54361
Identity
- Trade Name
- GKS PRIME FLEX: Trial Tibial Insert - Size D-E x 10mm - RED EUDAMEDGKS PRIME FLEX: Trial Tibial Insert - Size D-E x 17mm - RED EUDAMEDGKS PRIME FLEX: Trial Tibial Insert - Size D-E x 20mm - RED EUDAMEDGKS PRIME FLEX: Trial Tibial Insert - Size D-E x 14mm - RED EUDAMEDGKS PRIME FLEX: Trial Tibial Insert - Size D-E x 12mm - RED EUDAMED
- Device Name
- Trial component EUDAMED
- Model / Reference
- S54360 EUDAMEDS54363 EUDAMEDS54364 EUDAMEDS54362 EUDAMEDS54361 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08050323062072 EUDAMED08050323062102 EUDAMED08050323062119 EUDAMED08050323062096 EUDAMED08050323062089 EUDAMED
- Basic UDI-DI
- B-08050323062072 EUDAMEDB-08050323062102 EUDAMEDB-08050323062119 EUDAMEDB-08050323062096 EUDAMEDB-08050323062089 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 D-E x 10mm - RED 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-08050323062072 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Permedica S.p.A
- EUDAMED SRN
- IT-MF-000008110
Sources (5)
- EUDAMED 6bfcca2e-8282-430f-a699-7518194f3594 61 fields · synced Jul 27, 2026
- EUDAMED 4be1127e-6203-4c6a-976a-8f0d75c2868e 61 fields · synced May 17, 2026
- EUDAMED 6b92c74d-ebab-4aa3-9c28-5164b913e15d 61 fields · synced May 17, 2026
- EUDAMED d55e8ac8-2d9a-40a1-bf05-a259ddfe8a7a 61 fields · synced May 18, 2026
- EUDAMED ced0e69f-2433-454c-93f5-be91402091b5 61 fields · synced May 18, 2026