BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    SG LANSET I, SG LANCETS, SOFT LANCETS, Sure Comfort Lancet

    Reg #: 3015980633 · FEI: 3015980633 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SEWON MEDICAL CO.
    Registration Number
    3015980633
    FEI Number
    3015980633
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Na-104, 5, Garak-daero 373beonga-gil
    City
    Gangseo-gu Busan
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K230712

    Owner / Operator

    Firm Name
    SEWON MEDICAL CO.
    Operator Number
    10061481
    Address
    Na-104, 5, Garak-daero 373beonga-gil
    City
    Gangseo-gu
    State
    Busan
    Postal Code
    46750
    Country
    KR
    Correspondent
    Jong-ok Kim

    US Agent

    Business Name
    SMB USA LLC.
    Contact Name
    HUICHAO LEE
    Address
    44855 Lafayette Dr.
    City
    Novi
    State
    MI
    ZIP
    48377
    Country
    US
    Email
    [email protected]
    Phone
    734 6297552

    Products

    Device Name Product Code
    Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature QRK

    Proprietary Names

    SG LANSET I, SG LANCETS, SOFT LANCETS, Sure Comfort Lancet

    Establishment Types

    Manufacture Medical Device