BEUDAMED
    FDA Registration Active 🇨🇳 China

    U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E )

    Reg #: 3011654863 · FEI: 3011654863 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SHENZHEN URION TECHNOLOGY CO., LTD.
    Registration Number
    3011654863
    FEI Number
    3011654863
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Floor 4th-6th of Building D , Jiale Science&Technology Industrial Zone, No.3 , ChuangWei Road ,Heshuikou, Community,MaTian St.,GuangMing New District
    City
    Shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K243115

    Owner / Operator

    Firm Name
    Shenzhen Urion Technology Co., Ltd.
    Operator Number
    10049394
    Address
    Floor 4th-6th of Building D , Jiale Science&Technology Industrial Zone, No.3 , ChuangWei Road ,, Heshuikou Community,MaTian Street,GuangMing New District
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518106
    Country
    CN

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    System, Measurement, Blood-Pressure, Non-Invasive DXN

    Proprietary Names

    U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ) U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z) U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) U81CH Upper Arm Electronic Blood Pressure Monitor U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH)

    Establishment Types

    Manufacture Medical Device