BEUDAMED
    FDA Registration Active 🇨🇳 China

    iRay Imaging Technology (Haining) Limited

    Reg #: 3023546785 · FEI: 3023546785 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    iRay Imaging Technology (Haining) Limited
    Registration Number
    3023546785
    FEI Number
    3023546785
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2nd floor and 3rd Floor, Building B, No. 2, Caohejing RD., Haining, Jiaxing, 314499 Zhejiang P.R. China
    City
    Haining Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K223010

    Owner / Operator

    Firm Name
    iRay Imaging Technology (Haining) Limited
    Operator Number
    10085791
    Address
    No. 2, Caohejing RD., Haining 314499, Jiaxing, Zhejiang, P.R.China
    City
    Haining
    State
    Zhejiang
    Postal Code
    314499
    Country
    CN
    Correspondent
    Junjie Qian

    US Agent

    Business Name
    MID-LINK INTERNATIONAL CO., LTD
    Contact Name
    Marco Mu
    Address
    2219 Rimlang Drive, Suite 301
    City
    Bellingham
    State
    WA
    ZIP
    98226
    Country
    US
    Email
    [email protected]
    Phone
    702 2095185

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ
    Collimator, Manual, Radiographic IZX
    Collimator, Automatic, Radiographic IZW
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    Unit, X-Ray, Extraoral With Timer EHD

    Proprietary Names

    Digital Radiographic Imaging Acquisition Software - DR (RiasDR) CRUX FR10 CRUX PR01 CRUX RF10 Canis014D07 Venu1748V

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device