Identity
- Trade Name
- ACCK Femoral Condylar EUDAMED
- Device Name
- ACCK Femoral Condylar EUDAMED
- Model / Reference
- R3 EUDAMED6915-1330 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06943735160714 EUDAMED
- Basic UDI-DI
- B-06943735160714 EUDAMED
- EMDN Code
- P09090501 REVISION KNEE PROSTHESES FEMORAL COMPONENTS 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 Femoral Condylar 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-06943735160714 | 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 fad636a0-7089-41b6-a12e-7221c1b9ecb1 61 fields · synced Oct 6, 2026