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Enobio 8

by Neuroelectrics Barcelona, S.L.U. Spain EUDAMED

Ref NE003WF.G.MD:EU / NE003WF.S.MD:EUModel Enobio 8 EMDN Z12100302

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-18436612820207 Basic UDI-DIDate20 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Enobio
Model / Reference
Enobio 8, NE003WF.G.MD:EU / NE003WF.S.MD:EU
Primary DI / UDI-DI
18436612820207
Basic UDI-DI
B-18436612820207
EMDN Code
Z12100302 Electroencephalographs
Device Class
Class IIa
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000033432

Other devices from Neuroelectrics Barcelona, S.L.U.

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Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 860ab769-ea4e-4d02-8097-da918760b390 61 fields · synced 22 Oct 2026