BEUDAMED
    FDA Registration Active 🇨🇳 China

    HCG One Step Pregnancy Test Midstream OTC

    Reg #: 3025349997 · FEI: 3025349997 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    HANGZHOU AICHEK MEDICAL TECHNOLOGY CO., LTD.
    Registration Number
    3025349997
    FEI Number
    3025349997
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3rd Floor, Building 9, Hexiang Technology Center, Xiasha Street, Qiantang District
    City
    Hangzhou Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K233624

    Owner / Operator

    Firm Name
    Hangzhou Aichek Medical Technology Co., Ltd.
    Operator Number
    10086006
    Address
    3rd Floor, Building 9, Hexiang Technology Center, Xiasha Street, Qiantang District
    City
    Hangzhou
    State
    Zhejiang
    Postal Code
    310018
    Country
    CN

    US Agent

    Business Name
    LSI International
    Contact Name
    Joe Shia
    Address
    504E Diamond Ave.
    City
    Gaithersburg
    State
    MD
    ZIP
    20877
    Country
    US
    Email
    [email protected]
    Phone
    240 5057880

    Products

    Device Name Product Code
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX
    Visual, Pregnancy Hcg, Prescription Use JHI

    Proprietary Names

    HCG One Step Pregnancy Test Midstream OTC Vivoo hCG Pregnancy Test HCG One Step Pregnancy Test Strip Rx HCG One Step Pregnancy Test Midstream Rx HCG One Step Pregnancy Test Strip OTC

    Establishment Types

    Manufacture Medical Device