Identity
- Trade Name
- AHK Tibial Insert EUDAMED
- Device Name
- AHK Tibial Insert EUDAMED
- Model / Reference
- 3#22mm EUDAMED8108-3222 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06943735173813 EUDAMED
- Basic UDI-DI
- B-06943735173813 EUDAMED
- EMDN Code
- P090905020202 REVISION KNEE PROSTHESES FIXED BEARING TIBIAL INSERTS 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
AHK Tibial Insert 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-06943735173813 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
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 339db5aa-8d7c-4c24-bda4-245414d307f8 61 fields · synced Aug 4, 2026