BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    CHALLENGE-EVER / HL-2060, HL2060A

    Reg #: 3005082946 · FEI: 3005082946 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HALLIM POINT IMPLANT CO., LTD
    Registration Number
    3005082946
    FEI Number
    3005082946
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    12, Mayu-ro, 92beon-gil
    City
    SIHEUNG-SI Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K102223

    Owner / Operator

    Firm Name
    Hallim Point Implant Co., Ltd.
    Operator Number
    9071780
    Address
    12, Mayu-ro, 92beon-gil,, --
    City
    SIHEUNG-SI
    State
    Gyeonggi
    Postal Code
    429-854
    Country
    KR

    US Agent

    Business Name
    Mtech Group LLC
    Contact Name
    Dave Kim
    Address
    7505 Fannin St. Suite 610
    City
    Houston
    State
    TX
    ZIP
    77054
    Country
    US
    Email
    [email protected]
    Phone
    713 4672607

    Products

    Device Name Product Code
    Unit, Operative Dental EIA

    Proprietary Names

    CHALLENGE-EVER / HL-2060, HL2060A

    Establishment Types

    Manufacture Medical Device