BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    SENTECH KOREA CORP.

    Reg #: 3003383868 · FEI: 3003383868 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    100
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SENTECH KOREA CORP.
    Registration Number
    3003383868
    FEI Number
    3003383868
    Status
    Active
    Expiry Year
    2026
    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
    847 3741727

    Products

    Device Name Product Code
    Devices, Breath Trapping, Alcohol DJZ
    Mouthpiece, Breathing BYP

    Proprietary Names

    AlcoMate Prestige AlcoScan AL6000 TX8800 ACE X ACE Easy AL7010 TX2500 Prime AL7000 TX8000 ALC-2 TX9010 AL8000 AL2500 Elite TX6010L TX9050L AL9000L AL6000L AL5500 AL8000NFC TX5500 TX9030 AL9010 ACE III Basic AL8800 TX7010 ACE II Basic AL2600 TX2600 TX8000NFC AL9000 TX20 ACE Neo ACE Soild TX2500 ALP-1 ALCOSCAN AL1100 AL1100 ACE Trusty AlcoMate SafeGuard AlcoScan AL2500 iSOBER10 iSOBER70 iSOBER30 ALCOSCAN AL7000 iSOBER400 iSOBER 10 iSOBER200 iSOBER70Pro iSOBER 90 iSOBER nano iSOBER90 ALCOSCAN AL9000 ALCOSCAN AL2500 ALCOSCAN AL8800BT iblow 10 ALCOSCAN AL8000 ALCOSCAN ALC-1 iblow 20 iSOBER50 iSOBER 70 ALCOSCAN ADBs ALCOSCAN ALC-2 iSOBER S ALCOSCAN AL9010 ALCOSCAN AL6000 iSOBER 200 ALCOSCAN AL7010 ALCOSCAN ALP-1 Lite ALCOSCAN AL3100 ALCOSCAN AL8800 ALCOSCAN AL5500 ALCOSCAN AL6000Lite iSOBER 400 ALCOSCAN ALP-1 ALCOSCAN AL3200 ALCOSCAN AL1100F ALCOSCAN AL4000 ALCOSCAN AL9000Lite iSOBER 50 iSOBER 30 ALCOSCAN EBS ALCOSCAN AL2500Elite ALCOSCAN EBS-010 iblow 10C iSOBER 5 AL8000Plus ALCOSCAN iSOBER S Pro Alcoscan AL8500 ACE XS ALX3000 iBLOW100 ALCOSCAN Ki Lite ALCOSCAN Ki ACE XS Lite iBLOW10 Pro AlcoMate Premium MP1000 MP6000 MP-1

    Establishment Types

    Manufacture Medical Device