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Firefly ES103

by Firefly Global

Firefly ES103 is a Class I device made by Firefly Global, listed in FDA GUDID since 13 Feb 2020 (UDI-DI 00851289007132), 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 Number00851289007132 UDI-DI Date13 Feb 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  • Withdrawn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
Firefly
Generic name
Otoscope, direct
Model / reference
ES103
Primary DI / UDI-DI
00851289007132
FDA product code
ERA
GMDN term
Otoscope, direct
Device class
Class I
Regulation number
874.4770
GUDID distribution status
In Commercial Distribution

Related devices

Category: Otoscope, direct

Similar devices in this category

Other devices filed under Otoscope, direct.

Other devices from Firefly Global

See all devices from Firefly Global →

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
Other properties (12, all answered No)