BEUDAMED
    FDA Registration Active 🇨🇳 China

    Amazewell™ Pregnancy Rapid Test Strip

    Reg #: 3017904598 · FEI: 3017904598 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    18
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    Guangzhou Decheng Biotechnology Co., Ltd.
    Registration Number
    3017904598
    FEI Number
    3017904598
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Floor 3/4/5/7, Building A1, No.12, Nanyun 1st Road, Science City, Huangpu District
    City
    Guangzhou Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K230038

    Owner / Operator

    Firm Name
    Guangzhou Decheng biotechnology co., Ltd.
    Operator Number
    10079520
    Address
    Floor 3/4/5/7, Building A1, No.12, Nanyun 1st Road, Science City, Huangpu District
    City
    Guangzhou
    State
    Guangdong
    Postal Code
    510663
    Country
    CN
    Correspondent
    haisheng Hu

    US Agent

    Business Name
    LSI International Inc
    Contact Name
    Joe Xia
    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

    Proprietary Names

    Amazewell™ Pregnancy Rapid Test Strip Amazewell™ Pregnancy Rapid Test Midstream MissLan® Pregnancy Rapid Test (Midstream) Walgreens Pregnancy Test Strips MGC HEALTH™ ANALOG PREGNANCY RAPID TEST Wondfo Pregnancy Test easy@Home® PREGNANCY TEST MissLan® Pregnancy Rapid Test Midstream pregmate Pregnancy Midstream Test SURESIGN™ Pregnancy Rapid Test PREGMATE® PREGNANCY TEST STRIP Pregnancy Rapid Test Midstream MissLan® Pregnancy Rapid Test (Strip) exchange select™ Analog Pregnancy Rapid Test MissLan® Pregnancy Rapid Test Strip Pregnancy Test Strip kozekoze Pregnancy Test Pregnancy Rapid Test (Strip)

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198