Identity
- Trade Name
- A3 Fixed Tibial Tray EUDAMED
- Device Name
- A3 Fixed Tibial Tray EUDAMED
- Model / Reference
- L EUDAMED7107-0010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06943735160394 EUDAMED
- Basic UDI-DI
- B-06943735160394 EUDAMED
- EMDN Code
- P090903020106 BICOMPARTMENTAL PRIMARY IMPLANT CEMENTABLE FIXED BEARING TIBIAL PLATES EUDAMED
Classification
- Device Class
- Class III 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
A3 Fixed Tibial Tray by Beijing AK Medical Co., Ltd. — 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-06943735160394 | Class III | Active |
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Manufacturer
- Manufacturer
- Beijing AK Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000018814
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED a6d45082-ce91-4c3e-ac8e-18e90eb2b3cb 61 fields · synced Oct 6, 2026