BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Ewoosoft Co., Ltd

    Reg #: 3011189058 · FEI: 3011189058 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    25
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Ewoosoft Co., Ltd
    Registration Number
    3011189058
    FEI Number
    3011189058
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    801-ho, Vatechnetworks Bldg., 13, Samsung 1-ro 2-gil
    City
    Hwaseong-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K230468

    Owner / Operator

    Firm Name
    Ewoosoft Co., Ltd
    Operator Number
    10047111
    Address
    801-ho, Vatechnetworks Bldg., 13, Samsung 1-ro 2-gil
    City
    Hwaseong-si
    State
    Gyeonggi
    Postal Code
    18449
    Country
    KR
    Correspondent
    Hyeonguk Kang

    US Agent

    Business Name
    LK Consulting Group USA, Inc.
    Contact Name
    Priscilla Chung
    Address
    2552 Walnut Ave Ste 230, Tustin CA 92780
    City
    Irvine
    State
    CA
    ZIP
    92612
    Country
    US
    Email
    [email protected]
    Phone
    714 9225276

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ
    Automated Radiological Image Processing Software QIH

    Proprietary Names

    EzDent Web Ez3D-i E3 EzOrtho v1.3 Ez3D Plus EzMobile OrthoVision EzOrtho EZ3D-I EzDent-i; E2; ProraView Clever One EzDent-I/ E2/ Prora View/ Smart M Viewer EzDent-i Prora View E2 Ez3D-i/E3 PRORA VIEW EZDENTI-I ProraView Smart M Viewer Ez3D-i /E3 EzDent-i / E2 / Prora View / Smart M Viewer (v3.5) EzDent-i / E2 / ProraView/ Smart M Viewer ORTHOVISION EzDent-i / E2 / Prora View/ Smart M Viewer

    Establishment Types

    Manufacture Medical Device