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Neuronaute® Touchproof Adapter

by Bioserenity Medical Devices Group EUDAMEDGUDID

Active European Union

Ref 1001-15024-UN

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number03615220003846 UDI-DIDate17 Apr 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number361522WEMUelectrodsFY Basic UDI-DIDate22 Jan 2025RegisteredStatusActive

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  • Withdrawn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 25 Oct 2026.

Specification

EUDAMED · GUDID

Generic Name
Electroencephalographic electrode cap, single-use
Device Name
IceCap 2
Model / Ref / Catalog
1001-15024-UN, 1001-15024-US
Primary DI / UDI-DI
03615220003846
Basic UDI-DI
361522WEMUelectrodsFY
Direct Marketing DI
03615220003846
FDA Product Code
GXY
EMDN Code
N01010299 EEG electrodes - other
GMDN Term
Electroencephalographic electrode cap, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
882.1320
Market of Registration
France
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
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
  • Manufacturing Date

Other properties (21)

  • 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
  • Serial Number: No
  • Expiration Date: No