Identity
- Trade Name
- PEDIATRIC UMBILICAL TRUSS-UNIVERSAL EUDAMED
- Device Name
- PEDIATRIC EUDAMED
- Model / Reference
- ARC1422-STD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08680853109901 EUDAMED
- Basic UDI-DI
- 868085310KIDSL4 EUDAMED
- Direct Marketing DI
- 08680853109901 EUDAMED
- EMDN Code
- Y060406 ABDOMINAL HERNIA SUPPORTS 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: Abdominal hernia truss, reusable
Pediatric Umbilical Truss-Universal by Hegeli̇ Ortopedi̇k Ürünler San.ltd.şti̇ — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 868085310KIDSL4 | Class I | Active |
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Manufacturer
- Manufacturer
- Hegeli̇ Ortopedi̇k Ürünler San.ltd.şti̇
- EUDAMED SRN
- TR-MF-000030874
Sources (1)
- EUDAMED f4046366-f8dc-4749-a3e6-25d02def7fd2 61 fields · synced Jul 16, 2026