← Back to catalogue
GKS PRIME FLEX: Trial Insert TOP AS - Size D-Ex20mm LEFT - RED
EUDAMEDClass IIa (EU MDR)
Ref S53630Ref S53629
Identity
- Trade Name
- GKS PRIME FLEX: Trial Insert TOP AS - Size D-Ex20mm LEFT - RED EUDAMEDGKS PRIME FLEX: Trial Insert TOP AS - Size D-Ex20mm RIGHT - RED EUDAMED
- Device Name
- Trial component EUDAMED
- Model / Reference
- S53630 EUDAMEDS53629 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08050323078035 EUDAMED08050323078028 EUDAMED
- Basic UDI-DI
- B-08050323078035 EUDAMEDB-08050323078028 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-Ex20mm LEFT - 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-08050323078035 | 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 99c68b59-1a90-4bfe-a5ae-a021090f02e6 61 fields · synced Jul 21, 2026
- EUDAMED 8054f899-f801-4025-9ef5-6891582003ba 61 fields · synced May 18, 2026