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Angle Adjustable Knee Contracture Orthosis - Extendible-Universal
EUDAMEDClass I (EU MDR)
Ref ARK1011Y-STD
Identity
- Trade Name
- ANGLE ADJUSTABLE KNEE CONTRACTURE ORTHOSIS - EXTENDIBLE-UNIVERSAL EUDAMED
- Device Name
- KNEE AND HIP BRACES EUDAMED
- Model / Reference
- ARK1011Y-STD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08680853112482 EUDAMED
- Basic UDI-DI
- 86808531052LEG75 EUDAMED
- Direct Marketing DI
- 08680853112482 EUDAMED
- EMDN Code
- Y061209 KNEE 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
Angle Adjustable Knee Contracture Orthosis - Extendible-Universal by Hegeli̇ Ortopedi̇k Ürünler San.ltd.şti̇ — Class I — MDR — listed in EUDAMED
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 | 86808531052LEG75 | Class I | Active |
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Manufacturer
- Manufacturer
- Hegeli̇ Ortopedi̇k Ürünler San.ltd.şti̇
- EUDAMED SRN
- TR-MF-000030874
Sources (1)
- EUDAMED 51ecde78-b093-4a69-822f-98c7b45c7539 61 fields · synced Oct 6, 2026