BEUDAMED
    FDA Registration Active 🇨🇳 China

    SEJOY BIOMEDICAL CO., LTD.

    Reg #: 3005395953 · FEI: 3005395953 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    SEJOY BIOMEDICAL CO., LTD.
    Registration Number
    3005395953
    FEI Number
    3005395953
    Status
    Active
    Expiry Year
    2026
    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
    Test, Luteinizing Hormone (Lh), Over The Counter NGE
    Test, Follicle Stimulating Hormone (Fsh), Over The Counter NGA
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX
    System, Test, Blood Glucose, Over The Counter NBW
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX

    Proprietary Names

    LH One Step Ovulation Test Midstream,LH One Step Ovulation Test Strip,LH One Step Ovulation Test Cassette Vivoo At-Home Ovulation Test Vivoo At-Home Ovulation & Pregnancy Tests FSH One Step Menopause Test Midstream,FSH One Step Menopause Test Strip,FSH One Step Menopause Cassette Vivoo At-Home Fertility Test Sejoy hCG One Step Pregnancy Test Midstream Sejoy hCG One Step Pregnancy Test Cassette hCG One Step Pregnancy Test Midstream Sejoy hCG One Step Pregnancy Test Strip hCG One Step Pregnancy Test Strip hCG One Step Pregnancy Test Cassette

    Establishment Types

    Manufacture Medical Device