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GKS PRIME FLEX PS: Trial Module for Femur Size 11-12 RIGHT
EUDAMEDClass IIa (EU MDR)
Ref S47191Ref S54418Ref S47192
Identity
- Trade Name
- GKS PRIME FLEX PS: Trial Module for Femur Size 11-12 RIGHT EUDAMEDGKS PRIME FLEX: PS Trial FEMUR - Size 12 LEFT EUDAMEDGKS PRIME FLEX PS: Trial Module for Femur Size 11-12 LEFT EUDAMED
- Device Name
- Trial Component EUDAMED
- Model / Reference
- S47191 EUDAMEDS54418 EUDAMEDS47192 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08050323150083 EUDAMED08050323070732 EUDAMED08050323150090 EUDAMED
- Basic UDI-DI
- B-08050323150083 EUDAMEDB-08050323070732 EUDAMEDB-08050323150090 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 PS: Trial Module for Femur Size 11-12 RIGHT 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-08050323150083 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Permedica S.p.A
- EUDAMED SRN
- IT-MF-000008110
Sources (3)
- EUDAMED c4a45be7-286e-4242-9d96-fa7b1e5b5716 61 fields · synced Jul 20, 2026
- EUDAMED 72c3ca10-24da-477c-bb69-11f85b513f0c 61 fields · synced May 16, 2026
- EUDAMED 3e2c6a3c-48b3-47cd-8e7d-21af52c83c6b 61 fields · synced May 18, 2026