Nox Medical
IS-MF-000000950 · Iceland · Reykjavik
Nox Medical is registered in the European database on medical devices as a manufacturer, with 50 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 50 |
|---|
Most frequent device types declared: APSG1SEU, ASDB1SEU, ESNAP10SASLM, NOX-C1KIT1, NOX-MDR_CANAF40.
Among these devices, 10 are declared active.
Devices declared under this manufacturer
- A1s Recorder
- Nox Filter Tube Connector
- Nox Nasal Pressure Cannula with Filter
- Nox RIP Belts Disposable - Medium - 20 sets
- Nox RIP Belts Disposable - Small
- Nox SAS Body Cable – Right
- Nox Snap-on Double Lead, 148/150 cm
- Nox Snap-on Double Lead, 98/100 cm
- Nox Snap-on Lead, 150 cm
- Nox Snap-on Lead, 50 cm
- Noxturnal Language Pack CD
- Noxturnal Web
Showing 12 of 50 declared devices.
Catalogue references include 539011, 551030, 552010, 552011, 552110, 554023.
European nomenclature codes declared: Z12100580, Z12100585, Z12100582, Z12100501.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | NOX MEDICAL (IS) · FDA 3007389703 |
| Devices in EUDAMED | 50 |
| Country of registration | Iceland |
Device-level evidence
| Devices with a numeric GTIN | 50 |
|---|---|
| Found in the U.S. device database | 40 |
| Share | 80.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | NOX MEDICAL |
What it holds in Canada
| Licences on record | 8 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 8 |
| First licensed | 2015-07-07 |
Licence types: Single Device (4), System (3), Device Group Family (1).
Licensed under: NOX SLEEP ASSESSMENT SYSTEMS, NOX ELECTRODE CABLES AND LEADS, NOX RIP BELTS AND CABLES, NOX NASAL PRESSURE CANNULA WITH FILTER, NOX C1 KIT, NOX FILTER TUBE CONNECTORS.
North American profile: Both markets. Nox Medical is registered in both the United States and Canada.