OTN Innovations B.V.
NL-MF-000023058 · Netherlands · Nijmegen
OTN Innovations B.V. is registered in the European database on medical devices as a manufacturer, with 30 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 30 |
|---|
Devices declared under this manufacturer
- OTNI Luci Female Set
- OTNI Luci Female Set Inverted
- OTNI Luci Grit plate
- OTNI Luci Male Part
- OTNI M14 Abutment Screw
- OTNI Offsetplate 0mm
- OTNI Offsetplate 10mm
- OTNI Offsetplate 20mm
- OTNI Offsetplate 30mm Kink
- OTNI Offsetplate 40mm Kink
- OTNI Offsetplate 50mm
- OTNI Offsetplate 60mm
Showing 12 of 30 declared devices.
Catalogue references include OTNI 1423, OTNI 16, OTNI 1707, OTNI 1709, OTNI 1720, OTNI 1740K.
European nomenclature codes declared: Y062499.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 30 |
| Country of registration | Netherlands |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 30 |
|---|---|
| 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. OTN Innovations B.V. was not found in either the U.S. or the Canadian register.