BEUDAMED
    FDA Registration Active 🇨🇳 China

    iHealth Acacia Blood Glucose Monitoring System (model:AG-607)

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

    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
    K153561

    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, Test, Blood Glucose, Over The Counter NBW
    Glucose Dehydrogenase, Glucose LFR

    Proprietary Names

    iHealth Acacia Blood Glucose Monitoring System (model:AG-607) AG-607 Multi Blood Glucose Monitoring System

    Establishment Types

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