BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    TRAUS SIP 10

    Reg #: 3007958831 · FEI: 3007958831 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SAESHIN PRECISION CO., LTD.
    Registration Number
    3007958831
    FEI Number
    3007958831
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun
    City
    Daegu
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K123695

    Owner / Operator

    Firm Name
    Saeshin Precision Co., Ltd.
    Operator Number
    10030579
    Address
    52, Secheon-ro 1-gil, Dasa-eup,, Dalseong-gun
    City
    Daegu
    State
    KR-27
    Postal Code
    42921
    Country
    KR
    Correspondent
    Jung Ho LEE

    US Agent

    Business Name
    Saeshin America, Inc
    Contact Name
    Youngsun Lee
    Address
    32 Mauchly, Unit C
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US
    Email
    [email protected]
    Phone
    949 8256925

    Products

    Device Name Product Code
    Handpiece, Water-Powered EKY

    Proprietary Names

    TRAUS SIP 10 BIODENT SIP10

    Establishment Types

    Manufacture Medical Device