BEUDAMED
    FDA Registration Active 🇨🇳 China

    VIVACHEK BIOTECH (HANGZHOU) CO., LTD

    Reg #: 3013223546 · FEI: 3013223546 · Expires 2025
    View on FDA
    Products
    11
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    11

    Registration Details

    Registration Name
    VIVACHEK BIOTECH (HANGZHOU) CO., LTD
    Registration Number
    3013223546
    FEI Number
    3013223546
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.17 Wuzhou Road, Donghu Street, Linping District, Hangzhou, 311100, Building 2 and Building 3, No.17 Jianxing Road, Taozhu Street, Zhuji, 311800
    City
    Hangzhou, Zhuji Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K233062

    Owner / Operator

    Firm Name
    VivaChek Biotech (Hangzhou) Co., Ltd
    Operator Number
    10055002
    Address
    No.17 Wuzhou Road, Donghu Street, Linping District,
    City
    Hangzhou
    State
    Zhejiang
    Postal Code
    311100
    Country
    CN
    Correspondent
    Frank Shui

    Products

    Device Name Product Code
    Test, Tricyclic Antidepressants, Over The Counter QAW
    Test, Methadone, Over The Counter PTG
    Test, Opiates, Over The Counter NGL
    Test, Methamphetamine, Over The Counter NGG
    Test, Amphetamine, Over The Counter NFT
    Enzyme Immunoassay, Phencyclidine LCM
    Test, Barbiturate, Over The Counter PTH
    Test, Cocaine And Cocaine Metabolites, Over The Counter NFY
    Test, Benzodiazepine, Over The Counter NFV
    Test, Propoxyphene, Over The Counter QBF
    Test, Cannabinoid, Over The Counter NFW

    Establishment Types

    Manufacture Medical Device