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Earscan 3 ES3

by Micro Audiometrics Corp.

Earscan 3 ES3 (05.001) is a Class II device made by Micro Audiometrics Corp., listed in FDA GUDID since 8 Sep 2016 (UDI-DI 00862185000325), 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 Number00862185000325 UDI-DI Date8 Sep 2016ListedStatusListed 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  • Withdrawn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
Earscan 3
Generic name
Tone audiometer
Model / Ref / Catalog
ES3, 05.001
Primary DI / UDI-DI
00862185000325
FDA product code
EWO
GMDN term
Tone audiometer
Device class
Class II
Regulation number
874.1050
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Related devices

Category: Tone audiometer, automated

Other devices from Micro Audiometrics Corp.

See all devices from Micro Audiometrics Corp. →

Properties

  • Premarket exempt
  • Serial number
Other properties (13, all answered No)