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Vienatone LY230

by Xiamen Vienatone Medical Technology Co., Ltd.

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 Number06973967150573 UDI-DI Date28 Apr 2026ListedStatusListed 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  • Withdrawn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
Vienatone
Generic Name
Air-conduction hearing aid, behind-the-ear
Model / Reference
LY230
Primary DI / UDI-DI
06973967150573
FDA Product Code
QUF
GMDN Term
Air-conduction hearing aid, behind-the-ear
Device Class
Class I
Regulation Number
874.3300
GUDID distribution status
In Commercial Distribution
Size
Length — 33.43 Millimeter
Width — 31.94 Millimeter
Height — 25.79 Millimeter

Other devices from Xiamen Vienatone Medical Technology Co., Ltd.

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Properties

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

Other properties (11)

  • 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
  • Manufacturing Date: No