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GKS PRIME FLEX RK: Distal Femoral Trial Wedge - Size 9-12 x 12mm
EUDAMEDClass IIa (EU MDR)
Ref S47198Ref S47196Ref S47197
Identity
- Trade Name
- GKS PRIME FLEX RK: Distal Femoral Trial Wedge - Size 9-12 x 12mm EUDAMEDGKS PRIME FLEX RK: Distal Femoral Trial Wedge - Size 9-12 x 4mm EUDAMEDGKS PRIME FLEX RK: Distal Femoral Trial Wedge - Size 9-12 x 8mm EUDAMED
- Device Name
- Trial Component EUDAMED
- Model / Reference
- S47198 EUDAMEDS47196 EUDAMEDS47197 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08050323151769 EUDAMED08050323151745 EUDAMED08050323151752 EUDAMED
- Basic UDI-DI
- B-08050323151769 EUDAMEDB-08050323151745 EUDAMEDB-08050323151752 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 RK: Distal Femoral Trial Wedge - Size 9-12 x 12mm 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-08050323151769 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Permedica S.p.A
- EUDAMED SRN
- IT-MF-000008110
Sources (3)
- EUDAMED 540174dc-e52a-4986-abe1-35f50f460f01 61 fields · synced Oct 6, 2026
- EUDAMED 7783c956-b8b7-4881-911b-6f930e096d01 61 fields · synced May 18, 2026
- EUDAMED 84328f08-eadc-4a04-b423-f218bb5b1609 61 fields · synced May 18, 2026