Brainomix Limited
Active in EUDAMEDUnited Kingdomfrom SRN EUDAMED FDA SRN GB-MF-000017336 FEI 3017210169
Brainomix Limited is a medical device manufacturer based in the United Kingdom, with 80 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II; EU Class IIb and IIa) as of 13 Nov 2026.
- Devices
- 80
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 53
- EUDAMED 22
- FDA 510(k) 5
- Device classes
- FDA Class II 58
- EU Class IIb 17
- EU Class IIa 5
- Top EMDN categories
- Sites and related companies
- Emergo Europe B.V. authorised representative
- Identifiers
- EUDAMED SRN GB-MF-000017336
- FDA FEI 3017210169
- DUNS 216967482
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI
- Authorised rep.
- Emergo Europe B.V.NL
What Brainomix Limited makes
Brainomix Limited develops software tools for interpreting X-ray imaging, including automated analysis for stroke and intracranial hemorrhage detection. Their products focus on e-CTA (electronic computed tomography angiography), e-CTP (electronic computed tomography perfusion), and e-MRI (electronic magnetic resonance imaging) solutions, as well as scoring systems like e-ASPECTS and Triage Stroke for rapid clinical assessment.
The company’s portfolio includes devices classified as Class II, Class IIa, and Class IIb under EU and FDA regulations. Their products are registered in the EU’s eudamed database, the FDA’s 510(k) clearance system, and the FDA’s Unique Device Identifier (UDI) registry. Brainomix Limited is based in the United Kingdom.
Catalogue
Search and filter all 80 devicesShowing 1-50 of 80
Company details
- EUDAMED SRN
- GB-MF-000017336
- FDA FEI number
- 3017210169
- DUNS number
- 216967482
- EU VAT number
- GB139561493
- EUDAMED status
- Active
- EUDAMED registered name
- Brainomix Limited
- Registered address
- First Floor Seacourt Tower,, OX2 0JJ, Oxford, United Kingdom (ex Northern Ireland)
- Website
- www.brainomix.com
- Phone
- +44 (0) 1865 582730
- PRRC contact
- Timothy Bubb
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 17 Jul 2030
TÜV Rheinland LGA Products GmbH 0197 1 certificate
- HZ 1976751-1 Active
Quality management system EU MDR
- Issued
- 18 Jul 2025
- Expires
- 17 Jul 2030
Frequently asked questions
How many devices does BRAINOMIX LIMITED have in the registry?
The registry currently lists 80 devices for BRAINOMIX LIMITED. Devices recorded under merged duplicate company entries are counted once.
Which registries list BRAINOMIX LIMITED's devices?
Among its 50 most recently registered devices, BRAINOMIX LIMITED has devices listed in EUDAMED (6 devices), FDA 510(k) (1 device) and FDA GUDID (43 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do BRAINOMIX LIMITED's devices fall under?
Among its 50 most recently registered devices, the classes recorded for BRAINOMIX LIMITED's devices are Class IIb and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for BRAINOMIX LIMITED?
EUDAMED lists 1 certificate for BRAINOMIX LIMITED (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 18 Jul 2025.
What are the newest devices from BRAINOMIX LIMITED in the registry?
The most recently registered devices listed for BRAINOMIX LIMITED include Brainomix 360 e-CTA, Brainomix 360 e-CTP/e-MRI, e-ASPECTS 12.0 and Brainomix e-ASPECTS 12.1.