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A3 CR Lipped Tibial Insert
EUDAMEDClass III (EU MDR)
Ref A1326-1514Model BC#14mm
Identity
- Trade Name
- A3 CR Lipped Tibial Insert EUDAMED
- Device Name
- A3 CR Lipped Tibial Insert EUDAMED
- Model / Reference
- BC#14mm EUDAMEDA1326-1514 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941126947159 EUDAMED
- Basic UDI-DI
- B-06941126947159 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 CR Lipped 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-06941126947159 | 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 8aaedd14-1459-4322-89fa-fe767284d921 61 fields · synced Sep 30, 2026