BEUDAMED
    FDA Registration Active 🇨🇳 China

    EverestView 4343X X-ray Flat Panel Detector

    Reg #: 3011158427 · FEI: 3011158427 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    CARERAY DIGITAL MEDICAL TECHNOLOGY CO., LTD.
    Registration Number
    3011158427
    FEI Number
    3011158427
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    A2-201/B3-501, Biobay, 218 Xinghu Street, Suzhou Industrial Park
    City
    SuZhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K223687

    Owner / Operator

    Firm Name
    CareRay Digital Medical Technology Co., Ltd.
    Operator Number
    10050244
    Address
    A2-201/B3-501, Biobay, 218 Xinghu Street, Suzhou Industrial Park
    City
    SuZhou
    State
    Jiangsu
    Postal Code
    215123
    Country
    CN
    Correspondent
    Jianqiang Liu

    US Agent

    Business Name
    Compass InnovationsInc.
    Contact Name
    Mei Shen
    Address
    2352 Walsh Ave., SantaClara
    City
    Santa Clara
    State
    CA
    ZIP
    95051
    Country
    US
    Email
    [email protected]
    Phone
    408 4183985

    Products

    Device Name Product Code
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB

    Proprietary Names

    EverestView 4343X X-ray Flat Panel Detector

    Establishment Types

    Manufacture Medical Device