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GKS PRIME FLEX: Trial Insert TOP CR/PS - Size B-C x 15mm - GREEN
EUDAMEDClass IIa (EU MDR)
Ref S54569Ref S54566Ref S54565Ref S54564Ref S54567Ref S54568
Identity
- Trade Name
- GKS PRIME FLEX: Trial Insert TOP CR/PS - Size B-C x 15mm - GREEN EUDAMEDGKS PRIME FLEX: Trial Insert TOP CR/PS - Size B-C x 14mm - GREEN EUDAMEDGKS PRIME FLEX: Trial Insert TOP CR/PS - Size B-C x 13mm - GREEN EUDAMEDGKS PRIME FLEX: Trial Insert TOP CR/PS - Size B-C x 12mm - GREEN EUDAMEDGKS PRIME FLEX: Trial Insert TOP CR/PS - Size B-C x 17mm - GREEN EUDAMEDGKS PRIME FLEX: Trial Insert TOP CR/PS - Size B-C x 20mm - GREEN EUDAMED
- Device Name
- Trial Component EUDAMED
- Model / Reference
- S54569 EUDAMEDS54566 EUDAMEDS54565 EUDAMEDS54564 EUDAMEDS54567 EUDAMEDS54568 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08050323133468 EUDAMED08050323082315 EUDAMED08050323133451 EUDAMED08050323082308 EUDAMED08050323082322 EUDAMED08050323082339 EUDAMED
- Basic UDI-DI
- B-08050323133468 EUDAMEDB-08050323082315 EUDAMEDB-08050323133451 EUDAMEDB-08050323082308 EUDAMEDB-08050323082322 EUDAMEDB-08050323082339 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 CR/PS - Size B-C x 15mm - 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-08050323133468 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Permedica S.p.A
- EUDAMED SRN
- IT-MF-000008110
Sources (6)
- EUDAMED 12c0db0d-4fff-4167-aa91-2bd05f60537f 61 fields · synced Oct 6, 2026
- EUDAMED f93a9510-eeb4-47b8-9909-f99152a8d77c 61 fields · synced May 16, 2026
- EUDAMED d16f8afc-ef40-4fb4-887f-9771e7671e3f 61 fields · synced May 16, 2026
- EUDAMED 044bb211-28ed-44b3-b791-fef918ea3f58 61 fields · synced May 17, 2026
- EUDAMED 503ecd14-080b-498f-8aae-5e53eefb0dd0 61 fields · synced May 18, 2026
- EUDAMED b411ba6c-64d2-4a29-bbf6-3c39b6084a83 61 fields · synced May 19, 2026