BEUDAMED
    FDA Registration Active 🇨🇳 China

    CARERAY DIGITAL MEDICAL TECHNOLOGY CO., LTD.

    Reg #: 3011158427 · FEI: 3011158427 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    16
    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
    2026
    Initial Importer
    No
    Address
    A2-201/B3-501, Biobay, 218 Xinghu Street,No. 15, Songbei Road, Suzhou Industrial Park
    City
    SuZhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K153492

    Owner / Operator

    Firm Name
    CareRay Digital Medical Technology Co., Ltd.
    Operator Number
    10050244
    Address
    No. 15, Songbei Road, Suzhou Industrial Park
    City
    SuZhou
    State
    Jiangsu
    Postal Code
    215024
    Country
    CN
    Correspondent
    Jianqiang Liu

    US Agent

    Business Name
    Compass InnovationsInc.
    Contact Name
    Mei Shen
    Address
    990 Richard Ave Ste 110
    City
    Santa Clara
    State
    CA
    ZIP
    95050
    Country
    US
    Email
    [email protected]
    Phone
    408 4183985

    Products

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

    Proprietary Names

    CareView 1800L X-ray Flat Panel Detectors CareView 1500P X-ray Flat Panel Detectors CareView 1500L X-ray Flat Panel Detectors CareView 1500C X-ray Flat Panel Detectors CareView 1800Le X-Ray Flat Panel Detectors CareView 1800R X-ray Flat Panel Detectors CareView 1800RF X-ray Flat Panel Detector EverestView 4343X X-ray Flat Panel Detector CareView 1800Cwe X-ray Flat Panel Detectors CareView 1500Cwe X-ray Flat Panel Detectors CareView 1800Cw X-ray Flat Panel Detectors YosemiteView 4343W/ YosemiteView 3643W X-ray Flat Panel Detector CareView 3600RF X-ray Flat Panel Detectors CareView 750C X-ray Flat Panel Detectors CareView 750Cw X-ray Flat Panel Detectors CareView 1500Cw X-ray Flat Panel Detectors

    Establishment Types

    Manufacture Medical Device