Identity
- Trade Name
- Utega obostrana na gumu EUDAMEDUtega obostrana na gumu, vanserijska veličina EUDAMED
- Device Name
- Utega za ingvinalnu kilu EUDAMED
- Model / Reference
- 5069292 EUDAMED5069001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03858893981152 EUDAMED03858893981350 EUDAMED
- Basic UDI-DI
- 38588939850692906W EUDAMED
- Direct Marketing DI
- 03858893981152 EUDAMED03858893981350 EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER 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: Device sterilization/disinfection container, reusable
Utega obostrana na gumu by OTOS Ortopedska tehnika d.o.o. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Device sterilization/disinfection container, reusable.
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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 | 38588939850692906W | Class I | Active |
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Manufacturer
- Manufacturer
- OTOS Ortopedska tehnika d.o.o.
- EUDAMED SRN
- HR-MF-000040944
Sources (2)
- EUDAMED 9326e6aa-5135-4e19-a112-4b39c55a4f36 61 fields · synced Oct 6, 2026
- EUDAMED 04095b0f-5aa2-4dca-a7f1-2474ed8f11a6 61 fields · synced May 18, 2026