← Back to catalogue
GKS PRIME FLEX: Trial Insert TOP CR/PS - Size XS-A x 10mm - MAGENTA
EUDAMEDClass IIa (EU MDR)
Ref S54552Ref S54557Ref S54553Ref S54555Ref S54558Ref S54559Ref S54554
Identity
- Trade Name
- GKS PRIME FLEX: Trial Insert TOP CR/PS - Size XS-A x 10mm - MAGENTA EUDAMEDGKS PRIME FLEX: Trial Insert TOP CR/PS - Size XS-A x 17mm - MAGENTA EUDAMEDGKS PRIME FLEX: Trial Insert TOP CR/PS - Size XS-A x 11mm - MAGENTA EUDAMEDGKS PRIME FLEX: Trial Insert TOP CR/PS - Size XS-A x 13mm - MAGENTA EUDAMEDGKS PRIME FLEX: Trial Insert TOP CR/PS - Size XS-A x 20mm - MAGENTA EUDAMEDGKS PRIME FLEX: Trial Insert TOP CR/PS - Size XS-A x 15mm - MAGENTA EUDAMEDGKS PRIME FLEX: Trial Insert TOP CR/PS - Size XS-A x 12mm - MAGENTA EUDAMED
- Device Name
- Trial component EUDAMED
- Model / Reference
- S54552 EUDAMEDS54557 EUDAMEDS54553 EUDAMEDS54555 EUDAMEDS54558 EUDAMEDS54559 EUDAMEDS54554 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08050323082247 EUDAMED08050323082278 EUDAMED08050323133406 EUDAMED08050323133413 EUDAMED08050323082285 EUDAMED08050323133420 EUDAMED08050323082254 EUDAMED
- Basic UDI-DI
- B-08050323082247 EUDAMEDB-08050323082278 EUDAMEDB-08050323133406 EUDAMEDB-08050323133413 EUDAMEDB-08050323082285 EUDAMEDB-08050323133420 EUDAMEDB-08050323082254 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 XS-A x 10mm - MAGENTA 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-08050323082247 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Permedica S.p.A
- EUDAMED SRN
- IT-MF-000008110
Sources (7)
- EUDAMED bfbca714-e515-42e3-b3b4-6fc102587a49 61 fields · synced Aug 4, 2026
- EUDAMED 06c8ed85-51bf-48b2-a14c-94a9b522d99b 61 fields · synced May 17, 2026
- EUDAMED b5ab83e3-d04d-4d26-ab7c-e04526ac15b9 61 fields · synced May 17, 2026
- EUDAMED 198bdec3-1eea-4e7f-8763-e3a2fe3d6d9b 61 fields · synced May 17, 2026
- EUDAMED 6f109ef2-e991-4a80-aeb8-04f756e7d964 61 fields · synced May 18, 2026
- EUDAMED e3b6502a-2ac8-4573-825f-a2bd8733f7d4 61 fields · synced May 18, 2026
- EUDAMED f4bc4d39-55a4-4101-8018-84cb67290832 61 fields · synced May 19, 2026