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R.o.m. Walker - Angle Adjustable Ankle Contraction Orthosis-M
EUDAMEDClass I (EU MDR)
Ref ARA2215-MDM
Identity
- Trade Name
- R.O.M. WALKER - ANGLE ADJUSTABLE ANKLE CONTRACTION ORTHOSIS-M EUDAMED
- Device Name
- ANKLE BRACES EUDAMED
- Model / Reference
- ARA2215-MDM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08680853105590 EUDAMED
- Basic UDI-DI
- 868085310ANKLEH7 EUDAMED
- Direct Marketing DI
- 08680853105590 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
R.o.m. Walker - Angle Adjustable Ankle Contraction Orthosis-M by Hegeli̇ Ortopedi̇k Ürünler San.ltd.şti̇ — Class I — MDR — listed in EUDAMED
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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 | 868085310ANKLEH7 | Class I | Active |
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Manufacturer
- Manufacturer
- Hegeli̇ Ortopedi̇k Ürünler San.ltd.şti̇
- EUDAMED SRN
- TR-MF-000030874
Sources (1)
- EUDAMED 467ece6c-cbd6-4e0b-95a2-9702ca2be22b 61 fields · synced Jun 18, 2026