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GKS PRIME FLEX: Trial Insert MOBILE UC/PS - Size 10x12mm
EUDAMEDClass IIa (EU MDR)
Ref S52773Ref S52750Ref S52711Ref S52715Ref S52740Ref S52760Ref S52780Ref S52717Ref S52716Ref S52776
Identity
- Trade Name
- GKS PRIME FLEX: Trial Insert MOBILE UC/PS - Size 10x12mm EUDAMEDGKS PRIME FLEX: Trial Insert MOBILE UC/PS Size 8x9mm EUDAMEDGKS PRIME FLEX: Trial Insert MOBILE UC/PS Size 4x10mm EUDAMEDGKS PRIME FLEX: Trial Insert MOBILE UC/PS Size 4x14mm EUDAMEDGKS PRIME FLEX: Trial Insert MOBILE UC/PS Size 7x9mm EUDAMEDGKS PRIME FLEX: Trial Insert MOBILE UC/PS Size 9x9mm EUDAMEDGKS PRIME FLEX: Trial Insert MOBILE UC/PS Size 11x9mm EUDAMEDGKS PRIME FLEX: Trial Insert MOBILE UC/PS Size 4x17mm EUDAMEDGKS PRIME FLEX: Trial Insert MOBILE UC/PS Size 4x15mm EUDAMEDGKS PRIME FLEX: Trial Insert MOBILE UC/PS Size 10x15mm EUDAMED
- Device Name
- Trial Component EUDAMED
- Model / Reference
- S52773 EUDAMEDS52750 EUDAMEDS52711 EUDAMEDS52715 EUDAMEDS52740 EUDAMEDS52760 EUDAMEDS52780 EUDAMEDS52717 EUDAMEDS52716 EUDAMEDS52776 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08050323130979 EUDAMED08050323130740 EUDAMED08050323130351 EUDAMED08050323130399 EUDAMED08050323130641 EUDAMED08050323130849 EUDAMED08050323131044 EUDAMED08050323130412 EUDAMED08050323130405 EUDAMED08050323131006 EUDAMED
- Basic UDI-DI
- B-08050323130979 EUDAMEDB-08050323130740 EUDAMEDB-08050323130351 EUDAMEDB-08050323130399 EUDAMEDB-08050323130641 EUDAMEDB-08050323130849 EUDAMEDB-08050323131044 EUDAMEDB-08050323130412 EUDAMEDB-08050323130405 EUDAMEDB-08050323131006 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 MOBILE UC/PS - Size 10x12mm 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-08050323130979 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Permedica S.p.A
- EUDAMED SRN
- IT-MF-000008110
Sources (10)
- EUDAMED 85a22ed0-2bcf-47ca-ba48-a0619f3505a9 61 fields · synced Sep 18, 2026
- EUDAMED ed698c1a-d3c3-49bc-bc56-74ec43a6555a 61 fields · synced Jun 18, 2026
- EUDAMED 5ce30add-7b4a-4db6-a5b6-5d5414447995 61 fields · synced Jun 20, 2026
- EUDAMED 4b77884a-d43c-46bc-b55e-78739e267e81 61 fields · synced Jul 9, 2026
- EUDAMED 3c5f2335-f0d0-4e74-b9d9-b51c07344438 61 fields · synced Jul 9, 2026
- EUDAMED 1c313fa4-92e4-40ff-a06f-9a282f610094 61 fields · synced Jul 12, 2026
- EUDAMED 46be198f-2c1f-4016-85d1-5a8d91556383 61 fields · synced Jul 13, 2026
- EUDAMED e095e8df-0f7a-4b60-a7bd-318895c9874e 61 fields · synced Jul 17, 2026
- EUDAMED 66399f72-b44b-4168-8018-743c44635eb2 61 fields · synced Jul 20, 2026
- EUDAMED e9c412dd-c575-483f-b4f1-76886d8128e5 61 fields · synced Sep 18, 2026