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Ba 589 Uni
EUDAMEDClass I (EU MDR)
Ref BA 589 UNIModel FOOT HEALTH SUPPORT
by Bi̇oakti̇f Tibbi̇ Ürünler Ve Tekni̇k Teksti̇l San. Ti̇c. Ltd. Şti̇.
Identity
- Trade Name
- BA 589 UNI EUDAMED
- Device Name
- FOOT HEALTH SUPPORT PRODUCTS EUDAMED
- Model / Reference
- FOOT HEALTH SUPPORT EUDAMEDBA 589 UNI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08682495008239 EUDAMED
- Basic UDI-DI
- 86824950AYAKURUNLERISE EUDAMED
- Direct Marketing DI
- 08682495008239 EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT 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
Category: Ankle/foot orthosis
Ba 589 Uni by Bi̇oakti̇f Tibbi̇ Ürünler Ve Tekni̇k Teksti̇l San. Ti̇c. Ltd. Şti̇. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ankle/foot orthosis.
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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 | 86824950AYAKURUNLERISE | Class I | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000045383
Sources (1)
- EUDAMED de194008-0337-458e-b1af-21d10f7ef163 61 fields · synced Oct 7, 2026