NOxBOX Limited
GB-MF-000009734 · United Kingdom · Sittingbourne
NOxBOX Limited is registered in the European database on medical devices as a manufacturer, with 16 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 2 |
|---|---|
| Class IIa | 14 |
Most frequent device types declared: NOXFLOW-2, NOXKIT-1-10, NOXKIT-2-12, NOXKIT-2-15, NOXKIT-EMER.
Among these devices, 2 are declared active, 2 with a measuring function.
Authorised representative in the Union: Emergo Europe B.V..
Devices declared under this manufacturer
- Emergency Backup Kit for the NOxBOXi system
- NOxBOXi
- NOxFLOW sensor for use with NOxBOXi system
- Single-use 10mm delivery and sampling kit
- Single-use 15mm delivery and sampling kit
- Single-use 22mm delivery and sampling kit
- Single-use delivery and sampling kit for Bunnell Life Pulse
- Single-use kit for adapting 10 mm kit to 12 mm circuits
Showing 12 of 16 declared devices.
Catalogue references include NOXBOX-I, NOXDC-I, NOXFLOW-2, NOXKIT-1-10, NOXKIT-2-12, NOXKIT-2-15, NOXKIT-2-22.
European nomenclature codes declared: Z1203019002,Z1203019085, Z1203019002.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | NOXBOX LIMITED (GB) · FDA 3012796317 |
| Devices in EUDAMED | 16 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 16 |
|---|---|
| Found in the U.S. device database | 14 |
| Share | 87.5 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | NOXBOX LIMITED |
North American profile: Both markets. NOxBOX Limited is registered in both the United States and Canada.