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Oroi Neuro Experience

by Oroi Wellbeing S.L Spain EUDAMED

Ref v1.0.0Model MDSW

EMDN Z12040292

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8437030589NEUROBF Basic UDI-DIDate25 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Oroi Neuro Experience
Model / Reference
MDSW, v1.0.0
Primary DI / UDI-DI
08437030589113
Basic UDI-DI
8437030589NEUROBF
Direct Marketing DI
08437030589113
EMDN Code
Z12040292 General medicine therapeutic treatment instruments - medical device software
Device Class
Class I
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000053024

Other devices from Oroi Wellbeing S.L

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 c82c3c96-acc9-47f8-b329-3ffd3d06f508 61 fields · synced 24 Oct 2026