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BRAINOMIX LIMITED

United Kingdom (ex Northern Ireland)·GB-MF-000017336

Last updated September 17, 2026

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.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: United Kingdom (ex Northern Ireland)
Address: First Floor Seacourt Tower,, Oxford, United Kingdom (ex Northern Ireland)
Website: www.brainomix.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +44 (0) 1865 582730
PRRC Contact: Timothy Bubb
EUDAMED SRN: GB-MF-000017336
FDA FEI Number: 3017210169
DUNS Number: 216967482

Catalogue (34)

Device	Model / Reference	Registries	Class	Status
Brainomix 360 e-CTA	e-CTA 12.1	EUDAMED	Class IIb	Active
Brainomix 360 e-CTP/e-MRI	e-CTP/e-MRI 14.3	EUDAMED	Class IIb	Active
e-CTA	14.0	FDA UDI	Class II	Active
e-CTA	11.1	FDA UDI	Class II	Active
Triage ICH	11.1	FDA UDI	Class II	Active
Brainomix 360 e-CTA	11.3	FDA UDI	Class II	Active
e-ASPECTS	11.3	FDA UDI	Class II	Active
Triage Stroke	14.0	FDA UDI	Class II	Active
e-CTP	11.1	FDA UDI	Class II	Active
e-ASPECTS	11.1	FDA UDI	Class II	Active
Triage Stroke	11.2	FDA UDI	Class II	Active
e-CTP	14.0	FDA UDI	Class II	Active
e-MRI	11.1	FDA UDI	Class II	Active
Triage LVO	14.0	FDA UDI	Class II	Active
Triage ICH	14.0	FDA UDI	Class II	Active
e-Lung	2.2	FDA UDI	Class II	Active
e-Lung	1.0	FDA UDI	Class II	Active
e-Lung	2.1	FDA UDI	Class II	Active
Triage LVO	11.1	FDA UDI	Class II	Active
e-ASPECTS	14.0	FDA UDI	Class II	Active
Brainomix 360 Triage LVO	K231837	FDA 510(k)	Class II	Active
Brainomix 360 Triage Stroke	K232496	FDA 510(k)	Class II	Active
Brainomix 360 Triage Stroke	K251983	FDA 510(k)	Class II	Active
Brainomix 360 Triage ICH	K231195	FDA 510(k)	Class II	Active
Brainomix 360 e-ASPECTS	e-ASPECTS 14.2	EUDAMED	Class IIb	Active
Brainomix 360 e-CTA	e-CTA 12.1	EUDAMED	Class IIb	Active
e-ASPECTS	e-ASPECTS v11	EUDAMED	Class IIa	Active
Brainomix 360 e-Lung	Brainomix 360 e-Lung v2.3	EUDAMED	Class IIb	Active
e-ASPECTS	e-ASPECTS v11.3	EUDAMED	Class IIa	Active
Brainomix 360 e-CTP/e-MRI	e-CTP/e-MRI 12.1	EUDAMED	Class IIb	Active
e-CTP	e-CTP v11.2	EUDAMED	Class IIa	Active
Brainomix 360 e-CTP/e-MRI	e-CTP/e-MRI 14.2	EUDAMED	Class IIb	Active
Brainomix 360 e-ASPECTS	e-ASPECTS 14.1	EUDAMED	Class IIb	Active
Brainomix 360 e-CTA	e-CTA 14.2	EUDAMED	Class IIb	Active

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