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 |
|---|
Devices declared under this manufacturer
- NIOX
- NIOX PRO
- NIOX VERO
Catalogue references include 12-1020, 12-1630, 12-1650, 20-1000, 20-1020, NIOX Filters.
European nomenclature codes declared: R049001, W0201069085, Z1399, W0201069099, W0201069080.
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 |
Device-level evidence
| Devices with a numeric GTIN | 12 |
|---|---|
| Found in the U.S. device database | 6 |
| Share | 50.0 % |
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: United States only. NIOX AB is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
IX 1379539-1 | issued | 2031-06-11 |
HX 1379539-1 | issued | 2031-06-11 |