← Back to catalogue
GKS PRIME FLEX: Trial Insert TOP AS - Size B-Cx17mm LEFT - GREEN
EUDAMEDClass IIa (EU MDR)
Ref S53618Ref S53617
Identity
- Trade Name
- GKS PRIME FLEX: Trial Insert TOP AS - Size B-Cx17mm LEFT - GREEN EUDAMEDGKS PRIME FLEX: Trial Insert TOP AS - Size B-Cx17mm RIGHT - GREEN EUDAMED
- Device Name
- Trial component EUDAMED
- Model / Reference
- S53618 EUDAMEDS53617 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08050323076994 EUDAMED08050323076987 EUDAMED
- Basic UDI-DI
- B-08050323076994 EUDAMEDB-08050323076987 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 B-Cx17mm LEFT - GREEN 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-08050323076994 | 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 77e8cea8-f38e-447e-97bc-7271a1ba4e91 61 fields · synced Jul 20, 2026
- EUDAMED 6bcf4664-5950-42cb-92c1-f28dbd12e6ce 61 fields · synced May 18, 2026