BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Autokeeper®

    Reg #: 3003589279 · FEI: 3003589279 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MEDEXEL CO., LTD.
    Registration Number
    3003589279
    FEI Number
    3003589279
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    252, GeumgwangOsan-Ro, Geumgwang-myeon
    City
    Anseong-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K172095

    Owner / Operator

    Firm Name
    MEDEXEL CO., LTD.
    Operator Number
    9047850
    Address
    252, GeumgwangOsan-Ro, Geumgwang-myeon
    City
    Anseong-si
    State
    Gyeonggi
    Postal Code
    17535
    Country
    KR
    Correspondent
    Hee Nam KIM

    Products

    Device Name Product Code
    Needle, Hypodermic, Single Lumen FMI

    Proprietary Names

    Autokeeper® Ulticare® SureComfort Autokeeper® Safety Pen Needle

    Establishment Types

    Manufacture Medical Device