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GoCheck MultiScreener i15 Pro

by Gobiquity, Inc.

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB43071000030 UDI-DI Date19 Nov 2025ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
GoCheck MultiScreener
Generic Name
External ocular measurement camera
Model / Reference
i15 Pro
Primary DI / UDI-DI
B43071000030
FDA Product Code
HKO, MMF, HOX, EWO
GMDN Term
External ocular measurement camera
Device Class
Class I
Regulation Number
886.1760, 886.1120, 886.1150, 874.1050
GUDID distribution status
In Commercial Distribution

Other devices from Gobiquity, Inc.

Properties

  • Prescription Use
  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No