Identity
- Trade Name
- AK-L-II-Liner UHMWPE EUDAMED
- Device Name
- AK-L-II-Liner UHMWPE EUDAMED
- Model / Reference
- 48/32 EUDAMED1310-2448 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06943735113000 EUDAMED
- Basic UDI-DI
- B-06943735113000 EUDAMED
- EMDN Code
- P090803040101 STANDARD POLYETHYLENE HIP PROSTHESES 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
Category: Non-constrained polyethylene acetabular liner
AK-L-II-Liner UHMWPE by Beijing AK Medical Co., Ltd. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Non-constrained polyethylene acetabular liner.
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- PINNACLE — DEPUY ORTHOPAEDICS, INC. · Class II
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-06943735113000 | 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 62d3a618-2154-4f15-8dcb-6aa4b2d33894 61 fields · synced Aug 2, 2026