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Austar Atom X

by Austar Hearing Science & Technology (Xiamen) Co., Ltd men) Co., Ltd.

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06943786079911 UDI-DI Date3 Dec 2025ListedStatusListed 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  • Withdrawn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
Austar
Generic Name
Air-conduction hearing aid, in-the-ear
Model / Reference
ATOM X
Primary DI / UDI-DI
06943786079911
FDA Product Code
QUG
GMDN Term
Air-conduction hearing aid, in-the-ear
Device Class
Class II
Regulation Number
874.3305
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Conditional

Other devices from Austar Hearing Science & Technology (Xiamen) Co., Ltd men) Co., Ltd.

See all devices from Austar Hearing Science & Technology (Xiamen) Co., Ltd men) Co., Ltd. →

Properties

  • Over-the-Counter
  • Premarket Exempt
  • Serial Number
  • Expiration Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Manufacturing Date: No