← Back to catalogue
Thermoplastic Kleinert Atelle-Left-Size 1
EUDAMEDClass I (EU MDR)
Ref ARH35-L-S/M/L
Identity
- Trade Name
- THERMOPLASTIC KLEINERT ATELLE-LEFT-SIZE 1 EUDAMED
- Device Name
- HAND&WRIST EUDAMED
- Model / Reference
- ARH35-L-S/M/L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08680853112062 EUDAMED
- Basic UDI-DI
- 868085311HND&WRST2T EUDAMED
- Direct Marketing DI
- 08680853112062 EUDAMED
- EMDN Code
- Y0503 HANDS AND FINGERS RE-EDUCATION DEVICES 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 Kleinert Atelle-Left-Size 1 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 |
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 (1)
- EUDAMED c506b0c5-619c-40d5-9002-e97fd93d8a17 61 fields · synced Jun 18, 2026