BEUDAMED
    FDA Registration Active 🇨🇳 China

    EGENS One Step HCG Urine Pregnancy Test Kit (Strip, Cassette, Midstream)

    Reg #: 3006361161 · FEI: 3006361161 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    NANTONG EGENS BIOTECHNOLOGY CO.,LTD.
    Registration Number
    3006361161
    FEI Number
    3006361161
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Building 15, Building 12 (west), No. 1692 Xinghu Avenue, Nantong Economy & Technology Development Zone
    City
    NANTONG Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K123050

    Owner / Operator

    Firm Name
    NANTONG EGENS BIOTECHNOLOGY CO.,LTD.
    Operator Number
    9103205
    Address
    Building 15, Building 12 (west), No. 1692 Xinghu Avenue, Nantong Economy & Technology Development Zone
    City
    NANTONG
    State
    Jiangsu
    Postal Code
    226010
    Country
    CN
    Correspondent
    LL - Su

    US Agent

    Business Name
    LSI International Inc
    Contact Name
    Joe Xia
    Address
    504E E Diamond Ave Suite I
    City
    Gaithersburg
    State
    MD
    ZIP
    20878
    Country
    US
    Email
    [email protected]
    Phone
    301 2500831

    Products

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

    Proprietary Names

    EGENS One Step HCG Urine Pregnancy Test Kit (Strip, Cassette, Midstream)

    Establishment Types

    Manufacture Medical Device