BEUDAMED
    FDA Registration Active 🇨🇳 China

    iHealth Track Blood Pressure Monitor

    Reg #: 3003741676 · FEI: 3003741676 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ANDON HEALTH CO., LTD
    Registration Number
    3003741676
    FEI Number
    3003741676
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 3 Jin Ping Street,Ya An Road,, NANKAI DISTRICT
    City
    TIANJIN
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K160014

    Owner / Operator

    Firm Name
    ANDON HEALTH CO.,LTD
    Operator Number
    9055208
    Address
    No. 3 Jin Ping Street,Ya An Road,, NANKAI DISTRICT
    City
    TIANJIN
    State
    CN-NOTA
    Postal Code
    300190
    Country
    CN
    Correspondent
    YI - LIU

    US Agent

    Business Name
    IHEALTH LABS, INC
    Contact Name
    Yange Wang
    Address
    880 W MAUDE AVE,SUNNYVALE , CALIFORNIA , 94085 , UNITED STATES
    City
    Sunnyvale
    State
    CA
    ZIP
    94085
    Country
    US
    Email
    [email protected]
    Phone
    408 6638349

    Products

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

    Proprietary Names

    iHealth Track Blood Pressure Monitor

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device