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SHOEBOX Audiometry SHOEBOXAUDIOMETER

by SHOEBOX Ltd 2 variants

SHOEBOX Audiometry SHOEBOXAUDIOMETER is a Class II device made by SHOEBOX Ltd, listed in FDA GUDID since 28 May 2020 (UDI-DI B835SHOEBOXAUDIOMETER0), registry data as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB835SHOEBOXAUDIOMETER0 UDI-DI Date28 May 2020ListedStatusListed 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  • Withdrawn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
SHOEBOX Audiometry
Generic name
Tone audiometer
Model / reference
SHOEBOXAUDIOMETER
Primary DI / UDI-DI
B835SHOEBOXAUDIOMETER0
FDA product code
EWO
GMDN term
Tone audiometer
Device class
Class II
Regulation number
874.1050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Tone audiometer

Similar devices in this category

Other devices filed under Tone audiometer.

Other devices from SHOEBOX Ltd

Properties

  • Premarket exempt
  • Manufacturing date
Other properties (13, all answered No)