BEUDAMED
    FDA Registration Active 🇨🇳 China

    Sejoy hCG One Step Pregnancy Test Strip

    Reg #: 3005395953 · FEI: 3005395953 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SEJOY BIOMEDICAL CO., LTD.
    Registration Number
    3005395953
    FEI Number
    3005395953
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Area C, Building 2, No.365, Wuzhou Road, Yuhang Economic Development Zone
    City
    Hangzhou City Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K212447

    Owner / Operator

    Firm Name
    SEJOY BIOMEDICAL CO., LTD.
    Operator Number
    9078355
    Address
    Area C,Building 2,No.365, Wuzhou Road,, Yuhang Economic Development Zone,
    City
    HANGZHOU
    State
    Zhejiang
    Postal Code
    311100
    Country
    CN
    Correspondent
    YUNHUA - REN

    Products

    Device Name Product Code
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX

    Proprietary Names

    Sejoy hCG One Step Pregnancy Test Strip Sejoy hCG One Step Pregnancy Test Cassette hCG One Step Pregnancy Test Strip Sejoy hCG One Step Pregnancy Test Midstream hCG One Step Pregnancy Test Midstream hCG One Step Pregnancy Test Cassette

    Establishment Types

    Manufacture Medical Device