BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    FACEHEART CORP.

    Reg #: 3028169073 · FEI: 3028169073 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

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    Registration Details

    Registration Name
    FACEHEART CORP.
    Registration Number
    3028169073
    FEI Number
    3028169073
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Rm.1003, 10F., Jan Qi Biomedical Engineering Building, No.75,, Bo'ai St., East Dist.,
    City
    Taiwan Hsinchu (City)
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K243966

    Owner / Operator

    Firm Name
    FaceHeart Corporation
    Operator Number
    10088632
    Address
    Rm.1003, 10F., Jan Qi Biomedical Engineering Building, No.75,, Bo'ai St., East Dist.,
    City
    Hsinchu City
    State
    Hsinchu (City)
    Postal Code
    300
    Country
    TW
    Correspondent
    Meng Liang Chung

    US Agent

    Business Name
    President
    Contact Name
    Jerry Chang
    Address
    1101 Carla Drive,, San Jose, CA 95120, (650) 996-3693
    City
    San Jose
    State
    CA
    ZIP
    95120
    Country
    US
    Email
    [email protected]
    Phone
    650 9963693

    Products

    Device Name Product Code
    Monitor, Breathing Frequency BZQ
    Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate QME

    Proprietary Names

    Software, non contact, optical camera-based measurement of respiratory rate Software, non contact, optical camera-based measurement of pulse rate

    Establishment Types

    Manufacture Medical Device