BEUDAMED
    FDA Registration Active 🇨🇳 China

    CLUNGENE Oxazepam Tests

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

    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
    K161251

    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
    Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIO
    Enzyme Immunoassay, Amphetamine DKZ
    Enzyme Immunoassay, Benzodiazepine JXM

    Proprietary Names

    CLUNGENE Oxazepam Tests CLUNGENE Amphetamine Tests CLUNGENE Cocaine Tests

    Establishment Types

    Manufacture Medical Device