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FondCircle FBG-M2

by FondCircle Inc. 2 variants

FondCircle FBG-M2 is a Class II device made by FondCircle Inc., listed in FDA GUDID since 27 Oct 2026 (UDI-DI 00850070979375), 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 Number00850070979375 UDI-DI Date27 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  • Withdrawn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
Manual blood lancing device, single-use
Model / reference
FBG-M2
Primary DI / UDI-DI
00850070979375
FDA product code
QRL, NBW
GMDN term
Manual blood lancing device, single-use
Device class
Class II
Regulation number
878.4850, 862.1345
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code QRL (Multiple Use Blood Lancet For Single Patient Use Only).

Other devices from FondCircle Inc.

See all devices from FondCircle Inc. →

Properties

  • Lot / batch number
  • Manufacturing date
Other properties (13, all answered No)