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Neuronaute® Plus - Core Module

by Bioserenity Medical Devices Group United States EUDAMED

Ref 1001-10006-EU EMDN Z12101003

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number361522WEMUrecordsV0H7 Basic UDI-DIDate25 Nov 2024RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Neuronaute
Model / Reference
1001-10006-EU
Primary DI / UDI-DI
03615220003648
Basic UDI-DI
361522WEMUrecordsV0H7
EMDN Code
Z12101003 EEG holter recorders
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 (1)

  • EUDAMED bb8bb860-0d12-420f-9d9e-bb3d166beca0 61 fields · synced 25 Oct 2026