OT Bioelettronica srl
IT-MF-000033348 · Italy · Torino
OT Bioelettronica srl is registered in the European database on medical devices as a manufacturer, with 163 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 163 |
|---|
Most frequent device types declared: ADHESIVE FOAM, Accessories, Adapters, Bruxism Monitor Device, DYNAMOMETERS.
Devices declared under this manufacturer
- Bruxoff+
- DUE+PRO 6
- DUE+PRO 8
- EL10MM1305
- FOA05MM0108
- FOA10MM0116
- GR20MM1604
- GR30MM1305
- HAND
- HD08MM1106
- MUOVISTRAP
- Muovi+Lite
Showing 12 of 163 declared devices.
Catalogue references include OT0153, OT0164, OT0191, OT0253, OT0264, OT0282.
European nomenclature codes declared: Z12100780, N010101, Z12100701, M03030203, Z12100785, Z120605.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 163 |
| Country of registration | Italy |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 163 |
|---|---|
| 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. OT Bioelettronica srl was not found in either the U.S. or the Canadian register.