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A3 Deep Dish Tibial Insert
EUDAMEDClass III (EU MDR)
Ref A1327-1510Model BC#10mm
Identity
- Trade Name
- A3 Deep Dish Tibial Insert EUDAMED
- Device Name
- A3 Deep Dish Tibial Insert EUDAMED
- Model / Reference
- BC#10mm EUDAMEDA1327-1510 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06943735143816 EUDAMED
- Basic UDI-DI
- B-06943735143816 EUDAMED
- EMDN Code
- P090903020202 BICOMPARTMENTAL PRIMARY IMPLANT FIXED BEARING TIBIAL 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
A3 Deep Dish Tibial Insert 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-06943735143816 | 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 d13aafe6-cf08-4733-b5d8-ad9d3cd31f2d 61 fields · synced Sep 17, 2026