BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    XVue

    Reg #: 3006115340 · FEI: 3006115340 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    JPI Healthcare Co., Ltd
    Registration Number
    3006115340
    FEI Number
    3006115340
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    28, Digital-ro 33-gil, Woolim e-Biz Center #608
    City
    Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K142930

    Owner / Operator

    Firm Name
    JPI Healthcare Co., Ltd
    Operator Number
    10023091
    Address
    608ho, 28, Digital-ro 33gil
    City
    GURO-GU
    State
    Seoul
    Postal Code
    08377
    Country
    KR
    Correspondent
    Yeongmyeong Kim

    US Agent

    Business Name
    JPI Healthcare Solutions, Inc.
    Contact Name
    Abe Elgohary
    Address
    3555 Veterans Memorial Hwy, Unit D
    City
    Ronkonkoma
    State
    NY
    ZIP
    11779
    Country
    US
    Email
    [email protected]
    Phone
    516 5131330

    Products

    Device Name Product Code
    System, X-Ray, Stationary KPR

    Proprietary Names

    XVue ExamVue DR

    Establishment Types

    Manufacture Medical Device