BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FONDCIRCLE INC.

    Reg #: 3034603279 · FEI: 3034603279 · Expires 2026
    View on FDA
    Products
    11
    Proprietary Names
    26
    Establishment Types
    1
    Classifications
    11

    Registration Details

    Registration Name
    FONDCIRCLE INC.
    Registration Number
    3034603279
    FEI Number
    3034603279
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    4695 MacArthur Court 11th Floor
    City
    Newport Beach
    State
    CA
    ZIP
    92660
    Country
    US

    Regulatory Submissions

    510(k) Number
    K243306

    Owner / Operator

    Firm Name
    FondCircle Inc.
    Operator Number
    10092209
    Address
    4695 MacArthur Court 11th Floor
    City
    Newport Beach
    State
    CA
    Postal Code
    92660
    Country
    US

    Products

    Device Name Product Code
    Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature QRK
    Multiple Use Blood Lancet For Single Patient Use Only QRL
    Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature FMK
    Otoscope ERA
    Oximeter DQA
    Analyzer, Body Composition, Exempt PUH
    System, Test, Blood Glucose, Over The Counter NBW
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Continuous Measurement Thermometer FLL
    Meter, Peak Flow, Spirometry BZH
    Electrocardiograph DPS

    Proprietary Names

    FondCircle Twist Lancet IK FondCircle Multi-Function Smart Otoscope and Oral Camera FMC-N1 FondCircle Ear, Nose & Throat Smart Otoscope-FMC-S1 FondCircle Pulse Oximeter FPO-F1 FondCircle Weight Scale FBF-W1 FondCircle Body Fat Scale FBF-F3 FondCircle Body Fat Scale FBF-F2 FondCircle Body Fat Scale FBF-F4 FondCircle Blood Glucose Test Strips- VGS01 FondCircle Control Solution- VGC01 FondCircle Blood Glucose Monitoring System FBG-M2 FondCircle Blood Glucose Monitoring System Kit FBG-M1 FondCircle Blood Glucose Meter M1 FondCircle Blood Glucose Test Strips M1-S50 FondCircle Blood Pressure Monitor FBP-A2 FondCircle Arm Blood Pressure Monitor FBP-U1 FondCircle Blood Pressure Monitor FBP-A3XL FondCircle Blood Pressure Monitor FBP-A3 FondCircle Digital Thermometer FTM-B1 FondCircle Wrist Blood Pressure Monitor FBP-W1 FondCircle Infrared Thermometer FTM-D1 FondCircle Electronic Peak Flow Meter FPF-S1 FondCircle Portable ECG Monitor-FHR-P1 FondCircle Blood Pressure Monitor FBP-A1 FondCircle Lancing Device HH-XIII-T FondCircle Single Use Lancets 30G-I

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility