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GKS PRIME FLEX: Trial Tibial Insert - Size XS-A x 14mm - MAGENTA
EUDAMEDClass IIa (EU MDR)
Ref S54352Ref S54354Ref S54351Ref S54353Ref S54350
Identity
- Trade Name
- GKS PRIME FLEX: Trial Tibial Insert - Size XS-A x 14mm - MAGENTA EUDAMEDGKS PRIME FLEX: Trial Tibial Insert - Size XS-A x 20mm - MAGENTA EUDAMEDGKS PRIME FLEX: Trial Tibial Insert - Size XS-A x 12mm - MAGENTA EUDAMEDGKS PRIME FLEX: Trial Tibial Insert - Size XS-A x 17mm - MAGENTA EUDAMEDGKS PRIME FLEX: Trial Tibial Insert - Size XS-A x 10mm - MAGENTA EUDAMED
- Device Name
- Trial component EUDAMED
- Model / Reference
- S54352 EUDAMEDS54354 EUDAMEDS54351 EUDAMEDS54353 EUDAMEDS54350 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08050323061990 EUDAMED08050323062010 EUDAMED08050323061983 EUDAMED08050323062003 EUDAMED08050323061976 EUDAMED
- Basic UDI-DI
- B-08050323061990 EUDAMEDB-08050323062010 EUDAMEDB-08050323061983 EUDAMEDB-08050323062003 EUDAMEDB-08050323061976 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 XS-A x 14mm - MAGENTA 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-08050323061990 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Permedica S.p.A
- EUDAMED SRN
- IT-MF-000008110
Sources (5)
- EUDAMED 73ad923a-fa80-4ac7-980c-98d130109ff1 61 fields · synced Sep 17, 2026
- EUDAMED 3744a4de-21d9-4eb0-832b-cbfd8d7c538b 61 fields · synced May 17, 2026
- EUDAMED e942f9b4-482f-4a69-a510-e51db4bd1b05 61 fields · synced May 17, 2026
- EUDAMED 959bf594-85ef-464b-9ae8-abbefbadb15e 61 fields · synced May 18, 2026
- EUDAMED 78ac1999-af2d-4d2a-bee3-5e064f6e5d5b 61 fields · synced May 18, 2026