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Audien FAIP916-Dw

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 Number06943786094839 UDI-DI Date20 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  • Withdrawn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
Audien
Generic Name
Air-conduction hearing aid, behind-the-ear
Model / Reference
FAIP916-DW
Primary DI / UDI-DI
06943786094839
FDA Product Code
QUG
GMDN Term
Air-conduction hearing aid, behind-the-ear
Device Class
Class II
Regulation Number
874.3305
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Conditional

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Properties

  • Over-the-Counter
  • Premarket Exempt
  • Serial Number
  • Manufacturing 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
  • Expiration Date: No