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Firefly ES201M

by Firefly Global

Firefly ES201M is a Class II device made by Firefly Global, listed in FDA GUDID since 18 Jul 2025 (UDI-DI 00851289007354), 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 Number00851289007354 UDI-DI Date18 Jul 2025ListedStatusListed 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  • Withdrawn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
Endoscopic light source unit, battery-powered
Model / reference
ES201M
Primary DI / UDI-DI
00851289007354
FDA product code
NTN
GMDN term
Endoscopic light source unit, battery-powered
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution

Related devices

Category: Endoscopic light source unit, battery-powered

Other devices from Firefly Global

See all devices from Firefly Global →

Properties

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