Identity
- Trade Name
- U2 Total Knee System EUDAMED
- Device Name
- U2 Total Knee System XPE Tibial Insert, Mobile Bearing, #1, 11mm Thick EUDAMED
- Model / Reference
- 2303-7512 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711605585477 EUDAMED
- Basic UDI-DI
- B-04711605585477 EUDAMED
- EMDN Code
- P090903020201 BICOMPARTMENTAL PRIMARY IMPLANT MOBILE BEARING TIBIAL INSERTS EUDAMED
Classification
- Device Class
- Class III 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 III — 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-04711605585477 | Class III | 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 d8f3e735-e87c-41ce-bd16-4129ed994015 61 fields · synced Jun 9, 2026