BEUDAMED
    FDA Registration Active 🇨🇳 China

    Gemini360RT X/Gamma Ray Integrated Digital Radiotherapy System

    Reg #: 3015620182 · FEI: 3015620182 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    OUR UNITED CORPORATION
    Registration Number
    3015620182
    FEI Number
    3015620182
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    B19 Factory, Xi 'an Geely Supporting Parts Industrial Base, No. 1 Geely Avenue, Jingwei New Town, Xi 'an Economic and Technological Development Zone, Shaanxi Province
    City
    Xi'an Shaanxi
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K210921

    Owner / Operator

    Firm Name
    OUR United Corporation
    Operator Number
    10087551
    Address
    Room 10301, 3rd Floor, Unit 1, Block 28, Shou Chuang International Business Center, NO. 66 Fengcheng 12 Road, Xi'an Economic & Technological Development Zone, 710018, Shaanxi, China.
    City
    Xi'an
    State
    Shaanxi
    Postal Code
    710018
    Country
    CN

    US Agent

    Business Name
    Akesis Inc.
    Contact Name
    Lien Pham
    Address
    5129 Commercial Cir
    City
    Concord
    State
    CA
    ZIP
    94520
    Country
    US
    Email
    [email protected]
    Phone
    925 3498782

    Products

    Device Name Product Code
    System, Radiation Therapy, Radionuclide IWB
    Accelerator, Linear, Medical IYE

    Proprietary Names

    Gemini360RT X/Gamma Ray Integrated Digital Radiotherapy System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)