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Eyekinetix

by Konan Medical USA, Inc.

Eyekinetix is a Class I device made by Konan Medical USA, Inc., listed in FDA GUDID since 9 Sep 2019 (UDI-DI 04582275270051), 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 Number04582275270051 UDI-DI Date9 Sep 2019ListedStatusListed 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  • Withdrawn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

Generic name
Pupillograph
Model / reference
Eyekinetix
Primary DI / UDI-DI
04582275270051
FDA product code
HRI
GMDN term
Pupillograph
Device class
Class I
Regulation number
886.1690
GUDID distribution status
In Commercial Distribution

Other devices from Konan Medical USA, Inc.

See all devices from Konan Medical USA, Inc. →

Properties

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