BEUDAMED
    FDA Registration Active 🇨🇳 China

    Equate Covid-19 Test Kit Single

    Reg #: 3008573045 · FEI: 3008573045 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Andon Medical co., LTD
    Registration Number
    3008573045
    FEI Number
    3008573045
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    NO.26 HANGYU ROAD, TIANJIN AIRPORT ECONOMIC AREA, TIANJIN , TIANJIN , 300381 , CHINA
    City
    Tianjin
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K233842

    Owner / Operator

    Firm Name
    ANDON MEDICAL CO.,LTD
    Operator Number
    10033742
    Address
    No.26 Hangyu Road,, Tianjin Airport Economic Area
    City
    TIANJIN
    State
    CN-TJ
    Postal Code
    300381
    Country
    CN
    Correspondent
    Guijun Ren

    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
    Over-The-Counter Covid-19 Antigen Test QYT

    Proprietary Names

    Equate Covid-19 Test Kit Single iHealth COVID-19 Antigen Rapid Test

    Establishment Types

    Manufacture Medical Device