BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    LELTEK Ultrasound Imaging System

    Reg #: 3014555455 · FEI: 3014555455 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Leltek Inc.
    Registration Number
    3014555455
    FEI Number
    3014555455
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6F.-3, No. 293, Sec. 1, Beixin Rd., Xindian Dist.,
    City
    New Taipei City
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K222365

    Owner / Operator

    Firm Name
    LELTEK
    Operator Number
    10074230
    Address
    6F.-3, No. 293, Sec. 1, Beixin Rd., Xindian Dist.,
    City
    New Taipei City
    State
    TW-TPE
    Postal Code
    23147
    Country
    TW
    Correspondent
    Paul Chang

    US Agent

    Business Name
    Qualtech Consulting LLC
    Contact Name
    Chi-Feng Chang
    Address
    532 Arboles Street
    City
    Monterey Park
    State
    CA
    ZIP
    91754
    Country
    US
    Email
    [email protected]
    Phone
    626 3455899

    Products

    Device Name Product Code
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Doppler, Ultrasonic IYN

    Proprietary Names

    LELTEK Ultrasound Imaging System ASUS Ultrasound Imaging System

    Establishment Types

    Manufacture Medical Device