Identity
- Trade Name
- U2 Total Knee System EUDAMED
- Device Name
- U2 Total Knee System Femoral Augment, PS, Posterior / Distal, #5, Left EUDAMED
- Model / Reference
- 2603-5305 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04712771480269 EUDAMED
- Basic UDI-DI
- B-04712771480269 EUDAMED
- EMDN Code
- P09098001 KNEE PROSTHESES AUGMENTS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
U2 Total Knee System by United Orthopedic Corporation — Class IIb — 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-04712771480269 | Class IIb | Active |
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Manufacturer
- Manufacturer
- United Orthopedic Corporation
- EUDAMED SRN
- TW-MF-000009523
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED 4d356a23-b690-47b5-b870-d6f6227f21b6 61 fields · synced Oct 6, 2026