BEUDAMED
    FDA Registration Active 🇨🇳 China

    Synthgene Home Test HCG Test Cassette

    Reg #: 3016902172 · FEI: 3016902172 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    NANJING SYNTHGENE MEDICAL TECHNOLOGY CO., LTD.
    Registration Number
    3016902172
    FEI Number
    3016902172
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Building B6-2, No. 9, Weidi Road, Xianlin University Town, Xianlin Subdistrict, Qixia District, Nanjing City,
    City
    Nanjing Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K242135

    Owner / Operator

    Firm Name
    Nanjing Synthgene Medical Technology Co., Ltd.
    Operator Number
    10084444
    Address
    Building B6-2, No. 9, Weidi Road, Xianlin University Town, Xianlin Subdistrict, Qixia District, Nanjing City,
    City
    Nanjing
    State
    Jiangsu
    Postal Code
    210000
    Country
    CN
    Correspondent
    ALVIN QIAN

    US Agent

    Business Name
    Areterna LLC
    Contact Name
    Lin Li
    Address
    15810 Gaither Drive, Suite 230, Gaithersburg, MD 20877
    City
    Gaithersburg
    State
    MD
    ZIP
    20877
    Country
    US
    Email
    [email protected]
    Phone
    240 4061859

    Products

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

    Proprietary Names

    Synthgene Home Test HCG Test Cassette Synthgene Home Test HCG Test Midstream Synthgene Home Test HCG Test Strip

    Establishment Types

    Manufacture Medical Device