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Titanium Trabecular Augment(BTS-I)
EUDAMEDClass IIb (EU MDR)
Ref A2505-6201Model 62L
Identity
- Trade Name
- Titanium Trabecular Augment(BTS-I) EUDAMED
- Device Name
- Titanium Trabecular Augment(BTS-I) EUDAMED
- Model / Reference
- 62L EUDAMEDA2505-6201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06943735154249 EUDAMED
- Basic UDI-DI
- B-06943735154249 EUDAMED
- EMDN Code
- P09088003 HIP 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
Titanium Trabecular Augment(BTS-I) 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-06943735154249 | 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 128f2e3d-b58d-49a3-8e55-e0083f8f5c1a 61 fields · synced Sep 17, 2026