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GKS PRIME FLEX: MOBILE Trial Tibial Baseplate v.2 - Size I
EUDAMEDClass IIa (EU MDR)
Ref S53118Ref S53116Ref S53113Ref S53110Ref S53112Ref S53114Ref S53117
Identity
- Trade Name
- GKS PRIME FLEX: MOBILE Trial Tibial Baseplate v.2 - Size I EUDAMEDGKS PRIME FLEX: MOBILE Trial Tibial Baseplate v.2 - Size G EUDAMEDGKS PRIME FLEX: MOBILE Trial Tibial Baseplate v.2 - Size D EUDAMEDGKS PRIME FLEX: MOBILE Trial Tibial Baseplate v.2 - Size A EUDAMEDGKS PRIME FLEX: MOBILE Trial Tibial Baseplate v.2 - Size C EUDAMEDGKS PRIME FLEX: MOBILE Trial Tibial Baseplate v.2 - Size E EUDAMEDGKS PRIME FLEX: MOBILE Trial Tibial Baseplate v.2 - Size H EUDAMED
- Device Name
- Trial Component EUDAMED
- Model / Reference
- S53118 EUDAMEDS53116 EUDAMEDS53113 EUDAMEDS53110 EUDAMEDS53112 EUDAMEDS53114 EUDAMEDS53117 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08050323068098 EUDAMED08050323068074 EUDAMED08050323068043 EUDAMED08050323068012 EUDAMED08050323068036 EUDAMED08050323068050 EUDAMED08050323068081 EUDAMED
- Basic UDI-DI
- B-08050323068098 EUDAMEDB-08050323068074 EUDAMEDB-08050323068043 EUDAMEDB-08050323068012 EUDAMEDB-08050323068036 EUDAMEDB-08050323068050 EUDAMEDB-08050323068081 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: MOBILE Trial Tibial Baseplate v.2 - Size I 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-08050323068098 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Permedica S.p.A
- EUDAMED SRN
- IT-MF-000008110
Sources (7)
- EUDAMED 30f6de39-ed5b-48e3-95e1-ea70d64d9a08 61 fields · synced Aug 4, 2026
- EUDAMED 9411ed66-8a69-48ac-b08e-dedc6cf319c8 61 fields · synced May 17, 2026
- EUDAMED f66dfeca-03ad-40bc-9c15-23cf7aefab2b 61 fields · synced May 17, 2026
- EUDAMED 71ecfda9-5573-4ab9-a249-cc25a300931b 61 fields · synced May 17, 2026
- EUDAMED 72aff2a2-839c-42a7-8ff4-77e8e26132c0 61 fields · synced May 18, 2026
- EUDAMED 8ee208e2-b30e-43c4-976d-8a4424d8ccb5 61 fields · synced May 18, 2026
- EUDAMED c2e1af35-0473-4beb-993c-3a8d0b42e8ef 61 fields · synced May 19, 2026