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e-ASPECTS

by Brainomix Limited 2 variants

Ref e-ASPECTS v11Model v11.1, 11.2

e-ASPECTS (e-ASPECTS v11) is a Class IIa device made by Brainomix Limited, registered in EUDAMED on 15 Feb 2023 (Basic UDI-DI B-+B720EASPECTS111CE0), active as of 23 Oct 2026.

Active European Union

CE MDD

Valid until

No date given

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

Source EUDAMED, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-+B720EASPECTS111CE0 Basic UDI-DI Date15 Feb 2023RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Model / reference
v11.1, e-ASPECTS v11, 11.2
Primary DI / UDI-DI
+B720EASPECTS111CE0, +B720EASPECTS112CE0
Basic UDI-DI
B-+B720EASPECTS111CE0, B-+B720EASPECTS112CE0
EMDN code
Z11030592 Radiology instruments - medical device software
Device class
Class IIa
EU registration type
Legacy device (under a directive)
EU market of registration
Finland

Manufacturer details

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

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Properties

Other properties (12, all answered No)