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Audibel Via 2400 Ite R

by Starkey Laboratories Inc.

Audibel Via 2400 Ite R (63225-ABL) is a Class II device made by Starkey Laboratories Inc., listed in FDA GUDID since 11 Mar 2020 (UDI-DI 00842318180445), 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 Number00842318180445 UDI-DI Date11 Mar 2020ListedStatusListed 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  • Withdrawn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
Air-conduction hearing aid, in-the-ear
Model / Ref / Catalog
AUDIBEL VIA 2400 ITE R, 63225-ABL
Primary DI / UDI-DI
00842318180445
FDA product code
KLW, OSM
GMDN term
Air-conduction hearing aid, in-the-ear
Device class
Class II
Regulation number
874.3400, 874.3305
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Similar devices

Other devices filed under FDA product code KLW (Masker, tinnitus).

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)