BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    MEDIFIELD MEDICAL CO., LTD.

    Reg #: 3033519208 · FEI: 3033519208 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    26
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    MEDIFIELD MEDICAL CO., LTD.
    Registration Number
    3033519208
    FEI Number
    3033519208
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    94-40, Yongjeonggyeongje-ro 1-gil, Gunnae-myeon, Pocheon-si, Gyeonggi-do, 1st floor, Gadong
    City
    Pocheon Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K243368

    Owner / Operator

    Firm Name
    MEDIFIELD MEDICAL CO., LTD.
    Operator Number
    10091668
    Address
    94-40, Yongjeonggyeongje-ro 1-gil, Gunnae-myeon, Pocheon-si, Gyeonggi-do, 1st floor, Gadong
    City
    Pocheon
    State
    Gyeonggi
    Postal Code
    11154
    Country
    KR
    Correspondent
    yourim Park

    US Agent

    Business Name
    KMC USA, Inc
    Contact Name
    Jung Ryun Ahn
    Address
    115 East 34th street, 13J
    City
    New York
    State
    NY
    ZIP
    10016
    Country
    US
    Email
    [email protected]
    Phone
    646 3576058

    Products

    Device Name Product Code
    Tray, Surgical, Instrument FSM
    Plate, Fixation, Bone HRS
    Screw, Fixation, Bone HWC
    Orthopedic Manual Surgical Instrument LXH

    Proprietary Names

    Tray; The Montblanc Radius Plate System Tray; The Montblanc Ankle Plate System Montblanc Plate System Depth Gauge; Green Drill Bit; 2mm Screw Holder; 3.6mm Cortical Drill Guide; Radius Drill Bit; 2.7mm Screw Holder; 3mm Guide Block – Standard(Left) Guide Block – Wide(Left) Depth Gauge; Blue Locking Drill Guide; Radius Guide Block – Narrow(Left) Guide Block – Narrow(Right) AO Type Handle Driver Shaft; 3mm Lag Drill Bit; 3.6mm Guide Block – Standard(Right) Lag Drill Guide; Ankle Plate Track; 1.3mm Locking Drill Guide; Ankle Cortical Drill Guide; Ankle Guide Block – Wide(Right) Guide Block Drill Guide; Radius Driver Shaft; 3.5mm

    Establishment Types

    Manufacture Medical Device