Skip to content

Scio

by Mandelay Magyarország Kft Hungary EUDAMED

Ref SXModel SCIO

EMDN Z12062404

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-05999861425013 Basic UDI-DIDate27 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
SCIO, SX
Primary DI / UDI-DI
05999861425013
Basic UDI-DI
B-05999861425013
EMDN Code
Z12062404 Electrodermal signal biofeedback systems
Device Class
Class IIa
Market of Registration
Hungary

Manufacturer details

EUDAMED SRN
HU-MF-000011146

Other devices from Mandelay Magyarország Kft

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (10)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 6658329a-5ce4-44aa-ab58-e0e3383cabed 61 fields · synced 22 Oct 2026