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Titanium Trabecular Augment(BTS)
EUDAMEDClass IIb (EU MDR)
Ref A2500-6201Model 62L
Identity
- Trade Name
- Titanium Trabecular Augment(BTS) EUDAMED
- Device Name
- Titanium Trabecular Augment(BTS) EUDAMED
- Model / Reference
- 62L EUDAMEDA2500-6201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06943735182129 EUDAMED
- Basic UDI-DI
- B-06943735182129 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) 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-06943735182129 | 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 732a5eb2-19b4-456a-8d1c-eeee2c880128 61 fields · synced Oct 6, 2026