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Superflex Collection SF-638 DEMI AMBER BLK

by WestGroupe Optical Inc 2 variants

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 Number00676190695571 UDI-DI Date7 Aug 2023ListedStatusListed 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  • Withdrawn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
Superflex Collection
Generic Name
Spectacle frame
Model / Ref / Catalog
SF-638 DEMI AMBER BLK, SF638S3126118C
Primary DI / UDI-DI
00676190695571
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