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Fysh F-3642 INDIGO CHAMPGNE

by WestGroupe Optical 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00676190398816 UDI-DI Date8 Jul 2020ListedStatusListed 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  • Withdrawn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
Fysh
Generic Name
Spectacle frame
Model / Reference
F-3642 INDIGO CHAMPGNE
Primary DI / UDI-DI
00676190398816
FDA Product Code
HQZ
GMDN Term
Spectacle frame
Device Class
Class I
Regulation Number
886.5842
GUDID distribution status
In Commercial Distribution

Related devices

Category: Spectacle frame

Other devices from WestGroupe Optical Inc

See all devices from WestGroupe Optical Inc →

Properties

  • Premarket Exempt

Other properties (13)

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