OTOS Ortopedska tehnika d.o.o.
HR-MF-000040944 · Croatia · Osijek
OTOS Ortopedska tehnika d.o.o. is registered in the European database on medical devices as a manufacturer, with 137 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 137 |
|---|
Devices declared under this manufacturer
- Ortopedski uložak UNI RELAX br.29
- Ortopedski uložak UNI RELAX, vanserijska veličina
- Ortopedski uložak UNI RELAX sa sup.klinom br.22
- Ortopedski uložak UNI RELAX sa sup.klinom br.32
- Ortopedski uložak UNI RELAX sa sup.klinom br.46
- Ortopedski uložak UNI RELAX, br.37
- Ortopedski uložak UNI RELAX, br.40
- Ortopedski uložak UNI RELAX, br.41
- Ortoza za Hallux valgus, desna, S (br.36-37)
- Ortoza za Hallux valgus, lijeva, XXL (br.44-45)
- Pojas trbušni tekstilni - Otos, vel. 2
- Pojas trbušni tekstilni - Otos, vel. 3 NISKI
Showing 12 of 137 declared devices.
Catalogue references include 5065224, 5065242, 5065245, 8105100, 8105137, 8105140.
European nomenclature codes declared: Y061203, Y060406, V9099, V080399, V0804, Y060312.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 137 |
| Country of registration | Croatia |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 137 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. OTOS Ortopedska tehnika d.o.o. was not found in either the U.S. or the Canadian register.