BEUDAMED
    FDA Registration Active 🇺🇸 United States

    uSmart 3200T Plus

    Reg #: 3002315840 · FEI: 3002315840 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    TERATECH CORP.
    Registration Number
    3002315840
    FEI Number
    3002315840
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    77-79 Terrace Hall Ave
    City
    BURLINGTON
    State
    MA
    ZIP
    01803
    Country
    US

    Regulatory Submissions

    510(k) Number
    K201633

    Owner / Operator

    Firm Name
    TERATECH CORP.
    Operator Number
    9038586
    Address
    77-79 TERRACE HALL AVE., --
    City
    Burlington
    State
    MA
    Postal Code
    01803
    Country
    US
    Correspondent
    Nick Collins

    Products

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

    Proprietary Names

    uSmart 3200T Plus

    Establishment Types

    Manufacture Medical Device