BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    N1

    Reg #: 3014980469 · FEI: 3014980469 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    OSSTEM IMPLANT CO., LTD.
    Registration Number
    3014980469
    FEI Number
    3014980469
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2 Floor, B-dong, 51, Mayu-ro 238beon-gil
    City
    Siheung-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K232012

    Owner / Operator

    Firm Name
    Osstem Implant Co., Ltd.
    Operator Number
    10058973
    Address
    2 Floor, B-dong, 51, Mayu-ro 238beon-gil
    City
    Siheung-si
    State
    Gyeonggi
    Postal Code
    15079
    Country
    KR
    Correspondent
    Hae Sung Kim

    US Agent

    Business Name
    HIOSSEN, Inc.
    Contact Name
    Mateusz Leszczak
    Address
    85 Ben Fairless Drive
    City
    Fairless Hills
    State
    PA
    ZIP
    19030
    Country
    US
    Email
    [email protected]
    Phone
    201 2660657

    Products

    Device Name Product Code
    Unit, X-Ray, Extraoral With Timer EHD

    Proprietary Names

    N1

    Establishment Types

    Manufacture Medical Device