BEUDAMED
    FDA Registration Active 🇨🇳 China

    CLUNGENE HCG Pregnancy Rapid Test Strip

    Reg #: 3009414546 · FEI: 3009414546 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HANGZHOU CLONGENE BIOTECH CO., LTD.
    Registration Number
    3009414546
    FEI Number
    3009414546
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.1 Yichuang Road, Yuhang Sub-district, Yuhang District
    City
    Hangzhou Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K193132

    Owner / Operator

    Firm Name
    Hangzhou Clongene Biotech Co., Ltd.
    Operator Number
    10051623
    Address
    No.1 Yichuang Road, Yuhang Sub-district, Yuhang District
    City
    Hangzhou
    State
    Zhejiang
    Postal Code
    311121
    Country
    CN
    Correspondent
    Shujian Zheng

    US Agent

    Business Name
    LSI International Inc
    Contact Name
    Joe Xia
    Address
    504 E Diamond Ave Ste I
    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

    CLUNGENE HCG Pregnancy Rapid Test Strip CLUNGENE HCG Pregnancy Rapid Test Cassette CLUNGENE HCG Pregnancy Rapid Test Midstream

    Establishment Types

    Manufacture Medical Device