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NearBright 16238

by Reichert Inc.

NearBright 16238 is a Class I device made by Reichert Inc., listed in FDA GUDID since 12 Aug 2025 (UDI-DI 00812559012003), 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 Number00812559012003 UDI-DI Date12 Aug 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  • Withdrawn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
NearBright
Generic name
Vision testing/training chart
Model / reference
16238
Primary DI / UDI-DI
00812559012003
FDA product code
HOX
GMDN term
Vision testing/training chart
Device class
Class I
Regulation number
886.1150
GUDID distribution status
In Commercial Distribution

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Properties

  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)