BEUDAMED
    FDA Registration Active 🇨🇳 China

    uDR 380i Pro

    Reg #: 3011015597 · FEI: 3011015597 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SHANGHAI UNITED IMAGING HEALTHCARE CO.,LTD.
    Registration Number
    3011015597
    FEI Number
    3011015597
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.2258 Chengbei Rd. Jiading District
    City
    Shanghai
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K222339

    Owner / Operator

    Firm Name
    Shanghai United Imaging Healthcare Co.,Ltd.
    Operator Number
    10057992
    Address
    No.2258 Chengbei Rd. Jiading District
    City
    Shanghai
    State
    CN-SH
    Postal Code
    201807
    Country
    CN
    Correspondent
    Shumei WANG

    Products

    Device Name Product Code
    System, X-Ray, Mobile IZL

    Proprietary Names

    uDR 380i Pro

    Establishment Types

    Manufacture Medical Device