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Mintal Tracker

by Hiclub, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 21 Oct 2026. What this means

Regulatory status

as of registry sync 21 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04595318292019 UDI-DI Date21 Apr 2023ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Sleep disorder interpretive software, patient-use
Model / Reference
/
Primary DI / UDI-DI
04595318292019
FDA Product Code
IKK
GMDN Term
Sleep disorder interpretive software, patient-use
Device Class
Class II
Regulation Number
890.1925
GUDID distribution status
In Commercial Distribution

Related devices

Category: Sleep disorder interpretive software, patient-use

Similar devices

Also classified as Sleep disorder interpretive software, patient-use.

Properties

  • Premarket Exempt

Other properties (13)

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