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ICU Eyewear 10120004X

by Zoom Eyeworks Dba ICU Eyewear, Inc.

ICU Eyewear 10120004X is a Class I device made by Zoom Eyeworks Dba ICU Eyewear, Inc., listed in FDA GUDID since 23 Nov 2022 (UDI-DI 00078041225775), 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 Number00078041225775 UDI-DI Date23 Nov 2022ListedStatusListed 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  • Withdrawn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
ICU Eyewear
Generic name
Magnifying spectacles
Model / reference
10120004X
Primary DI / UDI-DI
00078041225775
FDA product code
HOI
GMDN term
Magnifying spectacles
Device class
Class I
Regulation number
886.5840
GUDID distribution status
In Commercial Distribution

Related devices

Category: Magnifying spectacles

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Properties

  • Over-the-counter
  • Premarket exempt
Other properties (13, all answered No)