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Audibel Invisibel Syn Iq 1200 Wrls Iic

by Starkey Laboratories Inc.

Audibel Invisibel Syn Iq 1200 Wrls Iic (VN3I) is a Class II device made by Starkey Laboratories Inc., listed in FDA GUDID since 23 Mar 2018 (UDI-DI 00842318130303), registry data as of 22 Oct 2026.

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00842318130303 UDI-DI Date23 Mar 2018ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Audibel
Generic name
Tinnitus masking application software
Model / Ref / Catalog
INVISIBEL SYN IQ 1200 WRLS IIC, VN3I
Primary DI / UDI-DI
00842318130303
FDA product code
KLW, OSM
GMDN term
Tinnitus masking application software
Device class
Class II
Regulation number
874.3400, 874.3305
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Other devices from Starkey Laboratories Inc.

See all devices from Starkey Laboratories Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)