BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    MEDEXEL CO., LTD.

    Reg #: 3003589279 · FEI: 3003589279 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    12
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    MEDEXEL CO., LTD.
    Registration Number
    3003589279
    FEI Number
    3003589279
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    252, GeumgwangOsan-Ro, Geumgwang-myeon
    City
    Anseong-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K063348

    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
    Syringe, Piston FMF
    Needle, Hypodermic, Single Lumen FMI

    Proprietary Names

    SureComfort Insulin Syringe Top Fine Insulin Syringe Autokeeper® Ulticare® SureComfort Autokeeper® Safety Pen Needle GOOD NEIGHBOR PHARMACY Health Mart. PHARMACY Ulticare™ Disposable Pen Needles Simpli Top Fine® UltiCare® Sure Comfort

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)