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FondCircle FBP-U1

by FondCircle Inc.

FondCircle FBP-U1 is a Class II device made by FondCircle Inc., listed in FDA GUDID since 14 Jan 2025 (UDI-DI 00850070979122), registry data as of 22 Oct 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850070979122 UDI-DI Date14 Jan 2025ListedStatusListed 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  • Withdrawn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-U1
Primary DI / UDI-DI
00850070979122
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

Related devices

Category: Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Similar devices in this category

Other devices filed under Automatic-inflation electronic sphygmomanometer, portable, arm/wrist.

Other devices from FondCircle Inc.

See all devices from FondCircle Inc. →

Properties

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