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GKS PRIME FLEX: Trial Insert MOBILE UC/PS - Size 10x17mm
EUDAMEDClass IIa (EU MDR)
Ref S52777Ref S52797
Identity
- Trade Name
- GKS PRIME FLEX: Trial Insert MOBILE UC/PS - Size 10x17mm EUDAMEDGKS PRIME FLEX: Trial Insert MOBILE UC/PS - Size 12x17mm EUDAMED
- Device Name
- Trial Component EUDAMED
- Model / Reference
- S52777 EUDAMEDS52797 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08050323131013 EUDAMED08050323131211 EUDAMED
- Basic UDI-DI
- B-08050323131013 EUDAMEDB-08050323131211 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 MOBILE UC/PS - Size 10x17mm 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-08050323131013 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Permedica S.p.A
- EUDAMED SRN
- IT-MF-000008110
Sources (2)
- EUDAMED 94abe884-f839-4bd7-a0da-8549e011df95 61 fields · synced Jul 24, 2026
- EUDAMED 3e27c981-e3b2-4086-9d3e-384c1e2ce07c 61 fields · synced Jul 14, 2026