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450a M
EUDAMEDClass I (EU MDR)
Ref 450A MModel ORTHOPEDIC ANKLE BRACES
by Aurafi̇x Health Products Diş Ti̇caret Ve Sanayi̇ Anoni̇m Şi̇rketi̇
Identity
- Trade Name
- 450A M EUDAMED
- Model / Reference
- ORTHOPEDIC ANKLE BRACES EUDAMED450A M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08680395423787 EUDAMED
- Basic UDI-DI
- 86803954ORT08XB EUDAMED
- Direct Marketing DI
- 08680395423787 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
450a M by Aurafi̇x Health Products Diş Ti̇caret Ve Sanayi̇ Anoni̇m Şi̇rketi̇ — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 86803954ORT08XB | Class I | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000046503
Sources (1)
- EUDAMED a9fb977c-add5-41d4-885d-ab4912b8d4d6 61 fields · synced Jul 14, 2026