NIOX AB
SE-MF-000010044 · Sweden · Uppsala
NIOX AB is registered in the European database on medical devices as a manufacturer, with 12 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 6 |
|---|---|
| other | 6 |
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | NIOX AB (SE) · FDA 3008662397 |
| Devices in EUDAMED | 12 |
| Country of registration | Sweden |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
IX 1379539-1 | issued | 2031-06-11 |
HX 1379539-1 | issued | 2031-06-11 |