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Optego 94278

by Optego Vision USA, Inc.

Optego 94278 is a vision testing/training flipper (FDA Class I; FDA product code HPC, Set, Lens, Trial, Ophthalmic) made by Optego Vision USA, Inc., listed in FDA GUDID since 10 Jan 2024 (UDI-DI 00360843008060), 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 Number00360843008060 UDI-DI Date10 Jan 2024ListedStatusListed 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  • Withdrawn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
Optego
Generic name
Vision testing/training flipper
Model / reference
94278
Primary DI / UDI-DI
00360843008060
FDA product code
HPC
GMDN term
Vision testing/training flipper
Device class
Class I
Regulation number
886.1405
GUDID distribution status
In Commercial Distribution

Related devices

Category: Vision testing/training flipper

Similar devices

Other devices filed under FDA product code HPC (Set, Lens, Trial, Ophthalmic).

Other devices from Optego Vision USA, Inc.

See all devices from Optego Vision USA, Inc. →

Properties

  • Premarket exempt
  • Lot / batch number
Other properties (13, all answered No)