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Neuronaute®Plus- IceCap extender

by Bioserenity Medical Devices Group EUDAMEDGUDID

Active European Union

Ref 1001-15022-UN

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number361522WEMUrecordsV0H7 Basic UDI-DIDate25 Nov 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number03615220003662 UDI-DIDate20 Feb 2024ListedStatusListed GUDID: not in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Generic Name
Electroencephalographic ambulatory recorder
Device Name
Neuronaute
Model / Reference
1001-15022-UN
Primary DI / UDI-DI
03615220003662
Basic UDI-DI
361522WEMUrecordsV0H7
Direct Marketing DI
03615220003662
510(k) Number
FDA Product Code
GWQ
EMDN Code
Z12101080 EEG holter systems instruments - hardware accessories
GMDN Term
Electroencephalographic ambulatory recorder
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
882.1400
Market of Registration
France
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
FR-MF-000039391

Other devices from Bioserenity Medical Devices Group

See all devices from Bioserenity Medical Devices Group →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No