Identity
- Trade Name
- LACE-UP WRIST SPLINT EUDAMED
- Device Name
- ARMO JEANS EUDAMED
- Model / Reference
- ARH19FB EUDAMEDARMOJEANS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08680853162081 EUDAMED08680853162074 EUDAMED
- Basic UDI-DI
- 0868085ARMOJEANSND EUDAMED08680ARMOJEANN5 EUDAMED
- Direct Marketing DI
- 08680853162081 EUDAMED08680853162074 EUDAMED
- EMDN Code
- Y060613 WRIST-HAND-FINGERS ORTHOSES EUDAMEDY060612 WRIST-HAND 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
Lace-Up Wrist Splint 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 | 0868085ARMOJEANSND | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hegeli̇ Ortopedi̇k Ürünler San.ltd.şti̇
- EUDAMED SRN
- TR-MF-000030874
Sources (2)
- EUDAMED 0fcfddc1-c54c-44aa-85ab-e9c2cbfee906 61 fields · synced Jul 9, 2026
- EUDAMED 09f69304-bca4-4166-8cee-8cd71a9f061b 61 fields · synced May 19, 2026