BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    AGNES MEDICAL CO.,LTD

    Reg #: 3010164891 · FEI: 3010164891 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    AGNES MEDICAL CO.,LTD
    Registration Number
    3010164891
    FEI Number
    3010164891
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    #401-402, 24 Dunchon-daero, 388beon-gil,Jungwon-gu,
    City
    Seongnam-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K192728

    Owner / Operator

    Firm Name
    AGNES MEDICAL CO., LTD.
    Operator Number
    10049778
    Address
    5F Coco-Plaza B/D 20,, Seohyeon-Ro 210 beon-gil, Bundang-Gu
    City
    Seongnam
    State
    Gyeonggi
    Postal Code
    13591
    Country
    KR

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Epilator, High Frequency, Needle-Type KCW
    Vibrator, Therapeutic IRO

    Proprietary Names

    AGNES-S AGNES PlazMagik AGNES Ultra AG-CN18G, AG-CN19G, AG-CN20G, AG-CN21G, AG-CN-23G Single Use RF electrode (Needle Type) / GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1A AG-CN-23G AG-CN20G AG-CN19G AG-CN18G AG-CN21G AGNES+

    Establishment Types

    Manufacture Medical Device