BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    AlcoScan AL6000

    Reg #: 3003383868 · FEI: 3003383868 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    38
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SENTECH KOREA CORP.
    Registration Number
    3003383868
    FEI Number
    3003383868
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    21-6, Jimok-ro 75beon-gil
    City
    PAJU-SI Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K060343

    Owner / Operator

    Firm Name
    Sentech Korea Corp
    Operator Number
    9066277
    Address
    21-6, Jimok-ro, 75beon-gil
    City
    Paju-Si
    State
    Gyeonggi
    Postal Code
    10880
    Country
    KR

    US Agent

    Business Name
    Kamm & Associates
    Contact Name
    Daniel Kamm
    Address
    8870 Ravello Ct
    City
    Naples
    State
    FL
    ZIP
    34114
    Country
    US
    Email
    [email protected]
    Phone
    239 4171727

    Products

    Device Name Product Code
    Devices, Breath Trapping, Alcohol DJZ

    Proprietary Names

    AlcoScan AL6000 AlcoMate Prestige AL8800 TX2600 TX8000NFC TX8800 AL5500 ALC-2 ACE II Basic TX2500 Prime ACE X AL2500 Elite TX6010L ACE III Basic AL7000 AL6000L AL2600 TX2500 ACE Neo TX20 TX7010 TX9010 AL8000NFC AL8000 TX8000 AL9000 ACE Easy AL7010 AL9010 TX9050L AL9000L TX5500 TX9030 ACE Soild ALP-1 AL1100 ALCOSCAN AL1100 ACE Trusty

    Establishment Types

    Manufacture Medical Device