Identity
- Trade Name
- Pojas trbušni tekstilni - Otos, vel. 1 EUDAMED
- Device Name
- Elastični trbušni pojas EUDAMED
- Model / Reference
- 5065223 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03858893980001 EUDAMED
- Basic UDI-DI
- 38588939850652235K EUDAMED
- Direct Marketing DI
- 03858893980001 EUDAMED
- EMDN Code
- Y060406 ABDOMINAL HERNIA SUPPORTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Croatia 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
Pojas trbušni tekstilni - Otos, vel. 1 by OTOS Ortopedska tehnika d.o.o. — 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 | 38588939850652235K | Class I | Active |
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Manufacturer
- Manufacturer
- OTOS Ortopedska tehnika d.o.o.
- EUDAMED SRN
- HR-MF-000040944
Sources (1)
- EUDAMED 31c67b37-03c2-411b-b47e-dbf206c70383 61 fields · synced Oct 6, 2026