← Back to catalogue
GKS PRIME FLEX: Trial Insert TOP AS - Size D-Ex14mm RIGHT - RED
EUDAMEDClass IIa (EU MDR)
Ref S53625Ref S53626
Identity
- Trade Name
- GKS PRIME FLEX: Trial Insert TOP AS - Size D-Ex14mm RIGHT - RED EUDAMEDGKS PRIME FLEX: Trial Insert TOP AS - Size D-Ex14mm LEFT - RED EUDAMED
- Device Name
- Trial component EUDAMED
- Model / Reference
- S53625 EUDAMEDS53626 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08050323077045 EUDAMED08050323077052 EUDAMED
- Basic UDI-DI
- B-08050323077045 EUDAMEDB-08050323077052 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 TOP AS - Size D-Ex14mm RIGHT - 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-08050323077045 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Permedica S.p.A
- EUDAMED SRN
- IT-MF-000008110
Sources (2)
- EUDAMED 8df75391-a0da-4467-ab3d-199e9b5a7cec 61 fields · synced Jul 22, 2026
- EUDAMED 830f5807-0165-4471-a2c2-fe5ec6cc73b2 61 fields · synced May 19, 2026