BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    EDGECARE INC.

    Reg #: 3031569584 · FEI: 3031569584 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    EDGECARE INC.
    Registration Number
    3031569584
    FEI Number
    3031569584
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    12F, 8 Yangpyeong-ro 25-gil
    City
    Yeongdeungpo-gu Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K252237

    Owner / Operator

    Firm Name
    Edgecare Inc.
    Operator Number
    10090903
    Address
    12F, 8 Yangpyeong-ro 25-gil
    City
    Yeongdeungpo-gu
    State
    Seoul
    Postal Code
    07207
    Country
    KR
    Correspondent
    Yangmo Yoo

    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
    Automated Radiological Image Processing Software QIH
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Media, Coupling, Ultrasound MUI

    Proprietary Names

    EdgeFlow UW20 EdgeFlow Gel Pad EdgeFlow UH10L EdgeFlow UH10 EdgeFlow UH10S

    Establishment Types

    Manufacture Medical Device