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GKS PRIME FLEX: Trial Tibial Insert - Size B-C x 10mm - GREEN
EUDAMEDClass IIa (EU MDR)
Ref S54355Ref S54358Ref S54357Ref S54359
Identity
- Trade Name
- GKS PRIME FLEX: Trial Tibial Insert - Size B-C x 10mm - GREEN EUDAMEDGKS PRIME FLEX: Trial Tibial Insert - Size B-C x 17mm - GREEN EUDAMEDGKS PRIME FLEX: Trial Tibial Insert - Size B-C x 14mm - GREEN EUDAMEDGKS PRIME FLEX: Trial Tibial Insert - Size B-C x 20mm - GREEN EUDAMED
- Device Name
- Trial component EUDAMED
- Model / Reference
- S54355 EUDAMEDS54358 EUDAMEDS54357 EUDAMEDS54359 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08050323062027 EUDAMED08050323062058 EUDAMED08050323062041 EUDAMED08050323062065 EUDAMED
- Basic UDI-DI
- B-08050323062027 EUDAMEDB-08050323062058 EUDAMEDB-08050323062041 EUDAMEDB-08050323062065 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 B-C x 10mm - GREEN 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-08050323062027 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Permedica S.p.A
- EUDAMED SRN
- IT-MF-000008110
Sources (4)
- EUDAMED 25080166-e321-4030-9ea3-88abb1f7d6bf 61 fields · synced Aug 5, 2026
- EUDAMED dc8fedc8-7e3f-480d-9555-3c4cf8307e8c 61 fields · synced May 17, 2026
- EUDAMED f9f5ba07-bb2e-4885-8b0b-77b97abd799b 61 fields · synced May 18, 2026
- EUDAMED 495af83b-3ce6-40fa-86a1-de1ce91a7bcc 61 fields · synced May 19, 2026