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GKS PRIME FLEX: Trial Insert TOP CR/PS - Size D-E x 11mm - RED
EUDAMEDClass IIa (EU MDR)
Ref S54573Ref S54572Ref S54577Ref S54575Ref S54578
Identity
- Trade Name
- GKS PRIME FLEX: Trial Insert TOP CR/PS - Size D-E x 11mm - RED EUDAMEDGKS PRIME FLEX: Trial Insert TOP CR/PS - Size D-E x 10mm - RED EUDAMEDGKS PRIME FLEX: Trial Insert TOP CR/PS - Size D-E x 17mm - RED EUDAMEDGKS PRIME FLEX: Trial Insert TOP CR/PS - Size D-E x 13mm - RED EUDAMEDGKS PRIME FLEX: Trial Insert TOP CR/PS - Size D-E x 20mm - RED EUDAMED
- Device Name
- Trial Component EUDAMED
- Model / Reference
- S54573 EUDAMEDS54572 EUDAMEDS54577 EUDAMEDS54575 EUDAMEDS54578 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08050323133482 EUDAMED08050323082346 EUDAMED08050323082377 EUDAMED08050323133499 EUDAMED08050323082384 EUDAMED
- Basic UDI-DI
- B-08050323133482 EUDAMEDB-08050323082346 EUDAMEDB-08050323082377 EUDAMEDB-08050323133499 EUDAMEDB-08050323082384 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 D-E x 11mm - 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-08050323133482 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Permedica S.p.A
- EUDAMED SRN
- IT-MF-000008110
Sources (5)
- EUDAMED 93c8cf69-537c-487d-b688-1052f11334b1 61 fields · synced Jul 30, 2026
- EUDAMED 667a5f24-ac5d-4a78-864b-d127bfa7e141 61 fields · synced May 17, 2026
- EUDAMED 3c96223d-5291-49ca-af7e-759bcbcae706 61 fields · synced May 17, 2026
- EUDAMED dd6d86c1-da80-4c45-a557-f211d95f77c7 61 fields · synced May 18, 2026
- EUDAMED 92613693-2922-47b0-a39e-a86a1970341f 61 fields · synced May 18, 2026