BEUDAMED
    FDA Registration Active 🇨🇳 China

    VIVACHEK BIOTECH (HANGZHOU) CO., LTD

    Reg #: 3013223546 · FEI: 3013223546 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    2

    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
    K240124

    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
    Fluorometer, For Clinical Use KHO
    Enzyme Immunoassay, Opiates DJG

    Establishment Types

    Manufacture Medical Device