BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    BISTOOL INC

    Reg #: 3014664527 · FEI: 3014664527 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

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    Registration Details

    Registration Name
    BISTOOL INC
    Registration Number
    3014664527
    FEI Number
    3014664527
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1, 3, 5 F, Deokseong-bldg., 9, Gwangnaru-ro 6-gil, Seongdong-gu
    City
    Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K171851

    Owner / Operator

    Firm Name
    Bistool Inc
    Operator Number
    10058048
    Address
    1, 3, 5 F, Deokseong-bldg., 9, Gwangnaru-ro 6-gil, Seongdong-gu
    City
    Seoul
    State
    KR-NOTA
    Postal Code
    04796
    Country
    KR
    Correspondent
    Eunhyun Bae

    US Agent

    Business Name
    KTR Americas Inc.
    Contact Name
    chuljoo jeon
    Address
    18000 Studebaker Rd
    City
    Cerritos
    State
    CA
    ZIP
    90703
    Country
    US
    Email
    [email protected]
    Phone
    562 3172865

    Products

    Device Name Product Code
    Elastomer, Silicone Block MIB

    Proprietary Names

    SOFTXiL

    Establishment Types

    Manufacture Medical Device