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FondCircle FBP-A3XL

by FondCircle Inc.

FondCircle FBP-A3XL is a Class II device made by FondCircle Inc., listed in FDA GUDID since 21 Oct 2026 (UDI-DI 00850070979412), registry data as of 2 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 2 Nov 2026.

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850070979412 UDI-DI Date21 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  • Withdrawn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
Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Model / reference
FBP-A3XL
Primary DI / UDI-DI
00850070979412
FDA product code
DXN
GMDN term
Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Device class
Class II
Regulation number
870.1130
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code DXN (System, Measurement, Blood-Pressure, Non-Invasive).

Other devices from FondCircle Inc.

See all devices from FondCircle Inc. →

Properties

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