BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Bonastent

    Reg #: 3009906660 · FEI: 3009906660 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    STANDARD SCI-TECH INC.
    Registration Number
    3009906660
    FEI Number
    3009906660
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1F Sewoon Medical Bldg., 46 Wangsan-Ro, Dongdaemun-Gu
    City
    Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K092144

    Owner / Operator

    Firm Name
    STANDARD SCI-TECH INC.
    Operator Number
    10054336
    Address
    1F Sewoon Medical Bldg., 46 Wangsan-Ro, Dongdaemun-Gu
    City
    Seoul
    State
    KR-NOTA
    Postal Code
    02583
    Country
    KR
    Correspondent
    DaeHyun Shin

    US Agent

    Business Name
    ProMedoss, Inc.
    Contact Name
    Bosmat Friedman
    Address
    3521 Hatwynn Road
    City
    Charlotte
    State
    NC
    ZIP
    28269
    Country
    US
    Email
    [email protected]
    Phone
    980 3081636

    Products

    Device Name Product Code
    Prosthesis, Esophageal ESW

    Proprietary Names

    Bonastent

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device