BEUDAMED
    FDA Registration Active 🇨🇳 China

    HANGZHOU CLONGENE BIOTECH CO., LTD.

    Reg #: 3009414546 · FEI: 3009414546 · Expires 2026
    View on FDA
    Products
    21
    Proprietary Names
    22
    Establishment Types
    1
    Classifications
    21

    Registration Details

    Registration Name
    HANGZHOU CLONGENE BIOTECH CO., LTD.
    Registration Number
    3009414546
    FEI Number
    3009414546
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No.1 Yichuang Road, Yuhang Sub-district, Yuhang District
    City
    Hangzhou Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K252118

    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, Follicle Stimulating Hormone (Fsh), Over The Counter NGA
    Test, Benzodiazepine, Over The Counter NFV
    Test, Tricyclic Antidepressants, Over The Counter QAW
    Test, Propoxyphene, Over The Counter QBF
    Test, Amphetamine, Over The Counter NFT
    Test, Cocaine And Cocaine Metabolites, Over The Counter NFY
    Test, Methamphetamine, Over The Counter NGG
    Test, Barbiturate, Over The Counter PTH
    Test, Cannabinoid, Over The Counter NFW
    Test, Opiates, Over The Counter NGL
    Test, Methadone, Over The Counter PTG
    Test, Phencyclidine (Pcp), Over The Counter NGM
    Test, Luteinizing Hormone (Lh), Over The Counter NGE
    Thin Layer Chromatography, Methamphetamine DJC
    Enzyme Immunoassay, Cannabinoids LDJ
    Enzyme Immunoassay, Opiates DJG
    Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIO
    Enzyme Immunoassay, Amphetamine DKZ
    Enzyme Immunoassay, Benzodiazepine JXM
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX
    Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus GQG

    Proprietary Names

    CLUNGENE® FSH Menopause Rapid Test Strip CLUNGENE® FSH Menopause Rapid Test Cassette CLUNGENE® FSH Menopause Rapid Test Midstream CLUNGENE Multi-Drug Home Test Easy Cup CLUNGENE Multi-Drug Test Easy Cup CLUNGENE® Multi-Drug Test Cup CLUNGENE® Multi-Drug Test Dip Card Clungene LH Ovulation Rapid Test Midstream Clungene LH Ovulation Rapid Test Strip Clungene LH Ovulation Rapid Test Cassette CLUNGENE Fentanyl Test Cassette CLUNGENE Fentanyl Home Test Cassette CLUNGENE Drug Tests Cup CLUNGENE Drug Tests Dip Card CLUNGENE Drug Tests Cassette CLUNGENE Amphetamine Tests CLUNGENE Oxazepam Tests CLUNGENE Cocaine Tests CLUNGENE HCG Pregnancy Rapid Test Strip CLUNGENE HCG Pregnancy Rapid Test Cassette CLUNGENE HCG Pregnancy Rapid Test Midstream Clungene RSV Antigen Rapid Test

    Establishment Types

    Manufacture Medical Device