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Neuronaute® Mobile App Android

by Bioserenity Medical Devices Group FDA registration: France EUDAMED

Ref 5100-00024 EMDN Z12101082

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number361522WEMUrecordsV0H7 Basic UDI-DIDate25 Nov 2024RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Neuronaute
Model / Reference
5100-00024
Primary DI / UDI-DI
03615220004195, 03615220004386
Basic UDI-DI
361522WEMUrecordsV0H7
Direct Marketing DI
03615220004195
03615220004386
EMDN Code
Z12101082 EEG holter systems instruments - software accessories
Device Class
Class IIa
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000039391

Other devices from Bioserenity Medical Devices Group

See all devices from Bioserenity Medical Devices Group →

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 (2)

  • EUDAMED 4508c9ef-6740-46f1-af62-5dd628070655 61 fields · synced 25 Oct 2026
  • EUDAMED 03615220004386|361522WEMURECORDSV0H7 61 fields · synced 6 Oct 2026