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Brainomix 360 e-ASPECTS

by Brainomix Limited United Kingdom EUDAMED

Ref e-ASPECTS 14.3

EMDN Z11030592

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++B720EASPECTSCEGK Basic UDI-DIDate29 Sep 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
e-ASPECTS 14.3
Primary DI / UDI-DI
+B720EASPECTS143CE0/
Basic UDI-DI
++B720EASPECTSCEGK
Direct Marketing DI
+B720EASPECTS143CE0/
EMDN Code
Z11030592 Radiology instruments - medical device software
Device Class
Class IIb
Special Device Type
Software
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
GB-MF-000017336
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Brainomix Limited

See all devices from Brainomix Limited →

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED e97e6cc5-a7bb-4535-98c9-ed88ab2a2532 61 fields · synced 22 Oct 2026