BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    Leltek Inc.

    Reg #: 3014555455 · FEI: 3014555455 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    0
    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
    K243226

    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 Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Echo, Ultrasonic IYO

    Establishment Types

    Manufacture Medical Device