BEUDAMED
    FDA Registration Active 🇨🇳 China

    Focus HD 35 Detector

    Reg #: 3014544225 · FEI: 3014544225 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    iRay Imaging Technology Taicang Limited
    Registration Number
    3014544225
    FEI Number
    3014544225
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.33 Xinggang Road, Taicang Port Economic and Technological Development Zone
    City
    Taicang Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K213646

    Owner / Operator

    Firm Name
    iRay Imaging Technology Taicang Limited
    Operator Number
    10058988
    Address
    No. 33, Xinggang Road, Taicang Port Economic and Technological Development Zone
    City
    Taicang
    State
    Jiangsu
    Postal Code
    215434
    Country
    CN
    Correspondent
    Wei Pan

    US Agent

    Business Name
    MID-LINK INTERNATIONAL CO., Ltd.
    Contact Name
    Marco Mu
    Address
    2219 Rimlang Drive, Suite 301, Bellingham-Barkley Villiage, WA, 98226
    City
    Bakerview
    State
    WA
    ZIP
    98226
    Country
    US
    Email
    [email protected]
    Phone
    360 3257028

    Products

    Device Name Product Code
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB

    Proprietary Names

    Focus HD 35 Detector

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)