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Brainomix 360 e-ASPECTS

by Brainomix Limited 6 variants

Ref e-ASPECTS 12.0

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++B720EASPECTSCEGK Basic UDI-DI *+B720EASPECTS120CE0UDI-DIDate29 Sep 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
e-ASPECTS 12.0
Primary DI / UDI-DI
*+B720EASPECTS120CE0
Basic UDI-DI
++B720EASPECTSCEGK
Direct Marketing DI
*+B720EASPECTS120CE0/$$716819/16D202508217*
EMDN Code
Z11030592 Radiology instruments - medical device software
Device Class
Class IIb
Special Device Type
Software
EU 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

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