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Medial Rotation Knee
EUDAMEDClass III (EU MDR)
Ref 156-714Model Medial Rotation Knee
Identity
- Trade Name
- Medial Rotation Knee EUDAMED
- Device Name
- Medial Rotation Knee All Poly Tibia EUDAMED
- Model / Reference
- Medial Rotation Knee EUDAMED156-714 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055455504134 EUDAMED
- Basic UDI-DI
- B-05055455504134 EUDAMED
- EMDN Code
- P090903020301 BICOMPARTMENTAL PRIMARY IMPLANT TIBIAL COMPONENTS, MONOBLOCK MADE OF POLYETHYLENE EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
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
Medial Rotation Knee by MatOrtho Limited — 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-05055455504134 | Class III | Active |
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Manufacturer
- Manufacturer
- MatOrtho Limited
- EUDAMED SRN
- GB-MF-000007614
- Authorised Representative
- MatOrtho Ireland Limited IE-AR-000006856
Sources (1)
- EUDAMED a722e0a4-ebdd-4d19-b9f4-3875e496ca71 61 fields · synced Jun 20, 2026