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Ba 454
EUDAMEDClass I (EU MDR)
Ref BA 454Model SPLINTS
by Bi̇oakti̇f Tibbi̇ Ürünler Ve Tekni̇k Teksti̇l San. Ti̇c. Ltd. Şti̇.
Identity
- Trade Name
- BA 454 EUDAMED
- Device Name
- SPLINTS EUDAMED
- Model / Reference
- SPLINTS EUDAMEDBA 454 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08682495019242 EUDAMED
- Basic UDI-DI
- 86824950ATELXT EUDAMED
- Direct Marketing DI
- 08682495019242 EUDAMED
- EMDN Code
- Y060613 WRIST-HAND-FINGERS ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Ba 454 by Bi̇oakti̇f Tibbi̇ Ürünler Ve Tekni̇k Teksti̇l San. Ti̇c. Ltd. Şti̇. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 86824950ATELXT | Class I | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000045383
Sources (1)
- EUDAMED 7e7ad209-d5a1-45db-b4a2-0409e3c39188 61 fields · synced Oct 6, 2026