BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    EdgeFlow UH10

    Reg #: 3031569584 · FEI: 3031569584 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    EDGECARE INC.
    Registration Number
    3031569584
    FEI Number
    3031569584
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    403, Teilhard Hall, 35, Baekbeom-ro
    City
    Mapo-gu Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K231677

    Owner / Operator

    Firm Name
    Edgecare Inc.
    Operator Number
    10090903
    Address
    403, Teilhard Hall, 35, Baekbeom-ro
    City
    Mapo-gu
    State
    Seoul
    Postal Code
    04107
    Country
    KR
    Correspondent
    Yangmo Yoo

    US Agent

    Business Name
    KMC USA, Inc
    Contact Name
    SEOK WOO KIM
    Address
    5450 ASTOR LANE #203
    City
    Rolling Mdws
    State
    IL
    ZIP
    60008
    Country
    US
    Email
    [email protected]
    Phone
    847 9241545

    Products

    Device Name Product Code
    Automated Radiological Image Processing Software QIH
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Echo, Ultrasonic IYO

    Proprietary Names

    EdgeFlow UH10

    Establishment Types

    Manufacture Medical Device