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Thermoplastic Thumb And Wrist Splint-Right-L
EUDAMEDClass I (EU MDR)
Ref ARH34-R-LRG
Identity
- Trade Name
- THERMOPLASTIC THUMB AND WRIST SPLINT-RIGHT-L EUDAMED
- Device Name
- HAND&WRIST EUDAMED
- Model / Reference
- ARH34-R-LRG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08680853104234 EUDAMED
- Basic UDI-DI
- 868085311HND&WRST2T EUDAMED
- Direct Marketing DI
- 08680853104234 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
Thermoplastic Thumb And Wrist Splint-Right-L by Hegeli̇ Ortopedi̇k Ürünler San.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 | 868085311HND&WRST2T | Class I | Active |
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Manufacturer
- Manufacturer
- Hegeli̇ Ortopedi̇k Ürünler San.ltd.şti̇
- EUDAMED SRN
- TR-MF-000030874
Sources (1)
- EUDAMED a491a8b9-ce90-4534-a528-c45ef12b5c75 61 fields · synced Oct 6, 2026