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Neuronaute 1.2 - Battery charger 1001-15017-US

by Bioserenity Medical Devices Group

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03615220001798 UDI-DI Date12 Jan 2023ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Neuronaute 1.2 - Battery charger
Generic Name
Electroencephalographic monitoring system
Model / Reference
1001-15017-US
Primary DI / UDI-DI
03615220001798
510(k) Number
FDA Product Code
GWQ
GMDN Term
Electroencephalographic monitoring system
Device Class
Class II
Regulation Number
882.1400
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Unsafe

Properties

  • Prescription Use

Other properties (13)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No