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AK-ABM Distal Femoral Stem
EUDAMEDClass III (EU MDR)
Ref A2164-1615SModel φ16×155S
Identity
- Trade Name
- AK-ABM Distal Femoral Stem EUDAMED
- Device Name
- AK-ABM Distal Femoral Stem EUDAMED
- Model / Reference
- φ16×155S EUDAMEDA2164-1615S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941126900895 EUDAMED
- Basic UDI-DI
- B-06941126900895 EUDAMED
- EMDN Code
- P090804030202 REVISION UNCEMENTED FEMORAL STEMS, WITH MODULAR NECK 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-ABM Distal Femoral Stem 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-06941126900895 | 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 284502fd-2431-45a8-8fee-777e49c17d17 61 fields · synced Oct 6, 2026