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FondCircle VGS01

by FondCircle Inc.

FondCircle VGS01 is a Class II device made by FondCircle Inc., listed in FDA GUDID since 26 Oct 2026 (UDI-DI 00850070979344), registry data as of 9 Nov 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 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850070979344 UDI-DI Date26 Oct 2026ListedStatusListed 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  • Withdrawn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
FondCircle
Generic name
Glucose monitoring system IVD, home-use
Model / reference
VGS01
Primary DI / UDI-DI
00850070979344
FDA product code
NBW
GMDN term
Glucose monitoring system IVD, home-use
Device class
Class II
Regulation number
862.1345
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code NBW (System, Test, Blood Glucose, Over The Counter).

Other devices from FondCircle Inc.

See all devices from FondCircle Inc. →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)