← Back to catalogue
OTOS Elastični trbušni pojas za stomu vel. 4
EUDAMEDClass I (EU MDR)
Ref 6910336
Identity
- Trade Name
- OTOS Elastični trbušni pojas za stomu vel. 4 EUDAMED
- Device Name
- Elastični trbušni pojas EUDAMED
- Model / Reference
- 6910336 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03858893980247 EUDAMED
- Basic UDI-DI
- 38588939850652235K EUDAMED
- Direct Marketing DI
- 03858893980247 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
OTOS Elastični trbušni pojas za stomu vel. 4 by OTOS Ortopedska tehnika d.o.o. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Abdominal hernia truss, reusable.
- Ζώνη Ομφαλοκήλης XXLarge — ADCO ORTHOPAEDICS LTD · Class I
- Tynor — Tynor Orthotics Pvt Ltd · Class I
- CINTO ERNIARIO MONOLATERALE — SAFTE S.r.l. · Class I
- Cinto erniario doppio — G.L.O. SRL · Class I
- Bederní pás - kýlní LU002UM, vel. XXL — Josef Nehonský · Class I
- HPH Corp. — INDACO SRL · Class I
- SLIP PER ERNIA (DONNA) — SAFTE S.r.l. · Class I
- CINTO OMBELICALE — SAFTE S.r.l. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- OTOS Ortopedska tehnika d.o.o.
- EUDAMED SRN
- HR-MF-000040944
Sources (1)
- EUDAMED 9a42f4a1-1e5e-43c6-8435-be9e4ce1b9cf 61 fields · synced Oct 6, 2026