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AHK Tibial Augment(half block)
EUDAMEDClass IIb (EU MDR)
Ref 8400-5110Model 5#10mm
Identity
- Trade Name
- AHK Tibial Augment(half block) EUDAMED
- Device Name
- AHK Tibial Augment(half block) EUDAMED
- Model / Reference
- 5#10mm EUDAMED8400-5110 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06943735175138 EUDAMED
- Basic UDI-DI
- B-06943735175138 EUDAMED
- EMDN Code
- P09098001 KNEE PROSTHESES AUGMENTS EUDAMED
Classification
- Device Class
- Class IIb 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 Augment(half block) by Beijing AK Medical Co., Ltd. — Class IIb — 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-06943735175138 | Class IIb | 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 e2f246a0-a617-4b63-a84f-8c4cb7187af6 61 fields · synced Oct 7, 2026