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HDx Cognition Assessment Platform 1.0.0

by Head Diagnostics Limited

Listed FDA GUDID listing, not in commercial distribution

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05391546790001 UDI-DI Date15 Sep 2026ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
HDx Cognition Assessment Platform
Generic Name
Cognitive assessment software
Model / Ref / Catalog
1.0.0, HDC0000001
Primary DI / UDI-DI
05391546790001
FDA Product Code
PTY
GMDN Term
Cognitive assessment software
Device Class
Class II
Regulation Number
882.1470
GUDID distribution status
Not in Commercial Distribution

Other devices from Head Diagnostics Limited

Properties

  • Prescription Use
  • Premarket Exempt
  • Serial Number

Other properties (11)

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