BEUDAMED
    FDA Registration Active 🇨🇳 China

    U-Well

    Reg #: 3014611142 · FEI: 3014611142 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    TIANJIN UWELL MEDICAL DEVICE MANUFACTURING CO LTD
    Registration Number
    3014611142
    FEI Number
    3014611142
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    A02, Plant B, No. 278, Hangkong Road,, Tianjin Free Trade Zone(Air Port Industrial Park),
    City
    Tianjin
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K162648

    Owner / Operator

    Firm Name
    Tianjin UWell Medical Device Manufacturing Co.,Ltd
    Operator Number
    10057781
    Address
    A02, Plant B, No. 278, Hangkong Road,, Tianjin Free Trade Zone(Air Port Industrial Park),
    City
    Tianjin
    State
    CN-TJ
    Postal Code
    300308
    Country
    CN
    Correspondent
    Ningning Wang

    US Agent

    Business Name
    CARELIFE USA INC
    Contact Name
    Qian Li
    Address
    1120 Alpha Dr.
    City
    Alpharetta
    State
    GA
    ZIP
    30004
    Country
    US
    Email
    [email protected]
    Phone
    404 6612228

    Products

    Device Name Product Code
    Pneumoperitoneum Needle FHO
    Insufflator, Laparoscopic HIF

    Proprietary Names

    U-Well

    Establishment Types

    Manufacture Medical Device