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GKS PRIME FLEX: CR Trial Insert - Size Bx10mm
EUDAMEDClass IIa (EU MDR)
Ref S54054
Identity
- Trade Name
- GKS PRIME FLEX: CR Trial Insert - Size Bx10mm EUDAMED
- Device Name
- Trial component EUDAMED
- Model / Reference
- S54054 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08050323058259 EUDAMED
- Basic UDI-DI
- B-08050323058259 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: CR Trial Insert - Size Bx10mm 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-08050323058259 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Permedica S.p.A
- EUDAMED SRN
- IT-MF-000008110
Sources (1)
- EUDAMED e3eadafe-bbb8-4452-b6e1-df80490381f4 61 fields · synced Jun 20, 2026