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GKS PRIME FLEX RK: Trial Tibial Wedge MR / LL - Size D-E x 15mm - RED
EUDAMEDClass IIa (EU MDR)
Ref S47733Ref S47729Ref S47723Ref S47731Ref S47735Ref S47715Ref S47713
Identity
- Trade Name
- GKS PRIME FLEX RK: Trial Tibial Wedge MR / LL - Size D-E x 15mm - RED EUDAMEDGKS PRIME FLEX RK: Trial Tibial Wedge MR/LL - Size XS-A x 15mm - MAGENTA EUDAMEDGKS PRIME FLEX RK: Trial Tibial Wedge MR / LL - Size D-E x 10mm - RED EUDAMEDGKS PRIME FLEX RK: Trial Tibial Wedge MR / LL - Size B-C x 15mm - GREEN EUDAMEDGKS PRIME FLEX RK: Trial Tibial Wedge MR / LL - Size F-G x 15mm - BLUE EUDAMEDGKS PRIME FLEX RK: Trial Tibial Wedge MR / LL - Size F-G x 05mm - BLUE EUDAMEDGKS PRIME FLEX RK: Trial Tibial Wedge MR / LL - Size D-E x 05mm - RED EUDAMED
- Device Name
- Trial Component EUDAMED
- Model / Reference
- S47733 EUDAMEDS47729 EUDAMEDS47723 EUDAMEDS47731 EUDAMEDS47735 EUDAMEDS47715 EUDAMEDS47713 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08050323145539 EUDAMED08050323146635 EUDAMED08050323145478 EUDAMED08050323145515 EUDAMED08050323145553 EUDAMED08050323145430 EUDAMED08050323145416 EUDAMED
- Basic UDI-DI
- B-08050323145539 EUDAMEDB-08050323146635 EUDAMEDB-08050323145478 EUDAMEDB-08050323145515 EUDAMEDB-08050323145553 EUDAMEDB-08050323145430 EUDAMEDB-08050323145416 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: Trial Tibial Wedge MR / LL - Size D-E x 15mm - 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-08050323145539 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Permedica S.p.A
- EUDAMED SRN
- IT-MF-000008110
Sources (7)
- EUDAMED 42552dd6-06de-4fb1-a9e5-28bf7b93858d 61 fields · synced Sep 18, 2026
- EUDAMED 27982666-61bb-41c4-ae03-c33d193b0e25 61 fields · synced May 16, 2026
- EUDAMED 24749747-640c-40b6-8da8-3f8013710fa1 61 fields · synced May 17, 2026
- EUDAMED 713adb20-22ff-4f55-ae29-55b75f2a3105 61 fields · synced May 18, 2026
- EUDAMED 57a43997-990a-4d5f-af10-9f4b5f4b62cd 61 fields · synced May 18, 2026
- EUDAMED accec454-16ed-481f-822f-e4c5e0693570 61 fields · synced May 19, 2026
- EUDAMED 46116efe-3227-4fb6-a89e-846b41b6f31d 61 fields · synced May 19, 2026