BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    QT Medical, INC. Taiwan Branch

    Reg #: 3014982325 · FEI: 3014982325 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    32
    Establishment Types
    4
    Classifications
    4

    Registration Details

    Registration Name
    QT Medical, INC. Taiwan Branch
    Registration Number
    3014982325
    FEI Number
    3014982325
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    14F.-8, No. 2, Jian 8th Rd., Zhonghe Dist.
    City
    New Taipei City
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K220795

    Owner / Operator

    Firm Name
    QT MEDICAL, INC
    Operator Number
    10058094
    Address
    1370 Valley Vista Drive, Suite 266
    City
    Diamond Bar
    State
    CA
    Postal Code
    91765
    Country
    US
    Correspondent
    Yu-Ting Chen

    US Agent

    Business Name
    QT MEDICAL, INC
    Contact Name
    Ying-lung Cheng
    Address
    1370 Valley Vista Drive, Suite 266
    City
    Diamond Bar
    State
    CA
    ZIP
    91765
    Country
    US
    Email
    [email protected]
    Phone
    424 5583500

    Products

    Device Name Product Code
    Transmitters And Receivers, Electrocardiograph, Telephone DXH
    Cable, Electrode IKD
    Electrode, Electrocardiograph DRX
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA

    Proprietary Names

    PCA 500 QT ECG 12-Lead Electrocardiograph ECG Recorder (PCA 300) PCA-A110 QHeart Cable Z PCA-A210 QHeart Cable Z PCA-A200 Electrode Cable PCA-A400 Extension Cable PCA-A120 S QHeart Cable GS PCA-A300 ECG Cable Converter PCA-A130 QHeart Cable P PCA-A120 L QHeart Cable GL PCA-A100 QHeart Cable L QT ECG Disposable Electrode Strip (QHeart Sensor) Size XL QT ECG Disposable Electrode Strip (QHeart Sensor) Size S QT ECG Disposable Electrode Strip (QHeart Sensor) Size L QT ECG Disposable Electrode Strip (QHeart Sensor) Size M QT ECG EM Electrode Strip Size S QT ECG Disposable Electrode Strip (QHeart Sensor) Size 3 QT ECG Disposable Electrode Strip (QHeart Sensor) Size 2 QT ECG Disposable Electrode Strip (QHeart Sensor) Size 1 QT ECG EM Electrode Strip Size XL QT ECG EM Electrode Strip Size M QT ECG EM Electrode Strip Size L QT ECG (QHeart SENSOR) Size 0 QT ECG Disposable Electrode Strip (QHeart Sensor) Size F PCA-C100BS AHA Patient Cable PCA-C100 AHA Patient Cable PCA-C100BL AHA Patient Cable PCA-C101BS IEC Patient Cable PCA-C101BL IEC Patient Cable PCA-C101 IEC Patient Cable PCA 500+

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device