BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    JPI Healthcare Co., Ltd

    Reg #: 3006115340 · FEI: 3006115340 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    11
    Establishment Types
    3
    Classifications
    4

    Registration Details

    Registration Name
    JPI Healthcare Co., Ltd
    Registration Number
    3006115340
    FEI Number
    3006115340
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    28, Digital-ro 33-gil, Woolim e-Biz Center #608
    City
    Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K213057

    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
    Grid, Radiographic IXJ
    System, Image Processing, Radiological LLZ
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB

    Proprietary Names

    ExamVue Duo Single Layered 2D Grid Grid-1000 Grid-2100 ExamVue PACS ExamVue DR XVue DRE Duo EVA 17W EVA 14W EVA 10W

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device