Brainomix Limited
GB-MF-000017336 · United Kingdom · Oxford
Brainomix Limited is registered in the European database on medical devices as a manufacturer, with 24 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 16 |
|---|---|
| Class IIa | 8 |
Most frequent device types declared: 11.2, v11.1, v11.2, v11.3.
Among these devices, 24 are declared active.
Authorised representative in the Union: Emergo Europe B.V..
Devices declared under this manufacturer
- Brainomix 360 e-ASPECTS
- Brainomix 360 e-CTA
- Brainomix 360 e-CTP/e-MRI
- Brainomix 360 e-Lung
- e-ASPECTS
- e-CTA
- e-CTP
Showing 12 of 24 declared devices.
Catalogue references include e-ASPECTS 12.1, e-ASPECTS 14.1, e-ASPECTS 14.2, e-ASPECTS v11, e-CTA 12.1, e-CTA 14.1.
European nomenclature codes declared: Z11030592.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | BRAINOMIX LIMITED (GB) · FDA 3017210169 |
| Devices in EUDAMED | 24 |
| Country of registration | United Kingdom |
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. Brainomix Limited is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1976751-1 | issued | 2030-07-17 |