Identity
- Trade Name
- AK CPII Acetabular Cup EUDAMED
- Device Name
- AK CPII Acetabular Cup EUDAMED
- Model / Reference
- 52/28 EUDAMED2300-1052 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06943735120848 EUDAMED
- Basic UDI-DI
- B-06943735120848 EUDAMED
- EMDN Code
- P090803010202 PRIMARY IMPLANT UNCEMENTED ONE-PIECE POLYETHYLENE ACETABULAR CUPS 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
AK CPII Acetabular Cup 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-06943735120848 | 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 275327ef-c6b1-4f6c-a41e-9fe5aef0e45c 61 fields · synced Aug 2, 2026