BEUDAMED
    FDA Registration Active 🇨🇳 China

    CLUNGENE Fentanyl Test Cassette

    Reg #: 3009414546 · FEI: 3009414546 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    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
    K242802

    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
    Test, Opiates, Over The Counter NGL

    Proprietary Names

    CLUNGENE Fentanyl Test Cassette CLUNGENE Fentanyl Home Test Cassette

    Establishment Types

    Manufacture Medical Device