BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    BACTRACK S80

    Reg #: 3007343307 · FEI: 3007343307 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    DA TECH CO LTD
    Registration Number
    3007343307
    FEI Number
    3007343307
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    13, Seounsandan-ro 4-gil, Gyeyang-gu
    City
    Incheon
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K090067

    Owner / Operator

    Firm Name
    DA TECH CO LTD
    Operator Number
    10027379
    Address
    13, Seounsandan-ro 4-gil, Gyeyang-gu
    City
    Incheon
    State
    KR-28
    Postal Code
    21072
    Country
    KR

    US Agent

    Business Name
    KHN Solutions, LLC
    Contact Name
    Keith Nothacker
    Address
    300 Broadway St., Ste 26
    City
    San Francisco
    State
    CA
    ZIP
    94133
    Country
    US
    Email
    [email protected]
    Phone
    415 6939756

    Products

    Device Name Product Code
    Devices, Breath Trapping, Alcohol DJZ

    Proprietary Names

    BACTRACK S80 BACTRACK Element BACTRACK S75 BACTRACK S82 BACTRACK S78

    Establishment Types

    Manufacture Medical Device