Identity
- Trade Name
- ACCK Tibial Tray EUDAMED
- Device Name
- ACCK Tibial Tray EUDAMED
- Model / Reference
- F EUDAMED7106-0007 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06943735162770 EUDAMED
- Basic UDI-DI
- B-06943735162770 EUDAMED
- EMDN Code
- P090905020102 REVISION KNEE PROSTHESES 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
ACCK 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-06943735162770 | 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 7a422b23-a79e-45dc-9af3-5cbf803f9d7c 61 fields · synced Oct 6, 2026