Skip to content

ENT Pocket Light PL3 Black

by C F M Technologies Inc

ENT Pocket Light PL3 Black (PL3-BK) is an otoscope (FDA Class I) made by C F M Technologies Inc, listed in FDA GUDID since 3 Jan 2020 (UDI-DI 00850013958023), 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 Number00850013958023 UDI-DI Date3 Jan 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  • Withdrawn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
ENT Pocket Light
Generic name
Otoscope, direct
Model / Ref / Catalog
PL3 BLACK, PL3-BK
Primary DI / UDI-DI
00850013958023
FDA product code
JYG, ERA
GMDN term
Otoscope, direct
Device class
Class I
Regulation number
874.4420, 874.4770
GUDID distribution status
In Commercial Distribution

Related devices

Category: Ear speculum, reusableEndaural surgical curette, reusableOtoscope, directENT diagnostic set

Similar devices

Other devices filed under FDA product code JYG (Curette, Ear).

Other devices from C F M Technologies Inc

See all devices from C F M Technologies Inc →

Properties

  • Over-the-counter
  • Convenience kit
  • Premarket exempt
Other properties (12, all answered No)