Identity
- Trade Name
- Tibial Augment(half block) EUDAMED
- Device Name
- Tibial Augment(half block) EUDAMED
- Model / Reference
- H 15mm EUDAMED7703-4515 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941126919583 EUDAMED
- Basic UDI-DI
- B-06941126919583 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
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-06941126919583 | 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 a6bb7983-9795-41dc-be93-e6967a9e5eaf 61 fields · synced Aug 4, 2026