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Ceretone Essential

by Audicon Corporation 2 variants

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850065321288 UDI-DI Date4 Jun 2025ListedStatusListed GUDID: 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  • Withdrawn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
Ceretone
Generic name
Air-conduction hearing aid, in-the-ear
Model / Ref / Catalog
Essential, CE-A39HT(Skin)
Primary DI / UDI-DI
00850065321288
FDA product code
QUF
GMDN term
Air-conduction hearing aid, in-the-ear
Device class
Class I
Regulation number
874.3300
GUDID distribution status
In Commercial Distribution

Related devices

Category: Air-conduction hearing aid, in-the-ear

Other devices from Audicon Corporation

See all devices from Audicon Corporation →

Properties

  • Over-the-counter
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Manufacturing date

Other properties (10)

  • Supplied sterile: No
  • Sterilise before use: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Prescription use: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Expiration date: No