BEUDAMED
    FDA Registration Active 🇨🇳 China

    Gochek2 Blood Glucose Monitoring System; Gochek2 Connect Blood Glucose Monitoring System; Pancares App

    Reg #: 3014302067 · FEI: 3014302067 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    MICROTECH MEDICAL (HANGZHOU) CO., LTD.
    Registration Number
    3014302067
    FEI Number
    3014302067
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.108 Liuze St., Yuhang District
    City
    Hangzhou Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K193340

    Owner / Operator

    Firm Name
    MicroTech Medical (Hangzhou) Co., Ltd.
    Operator Number
    10074553
    Address
    No.108 Liuze St., Cangqian, Yuhang District
    City
    Hangzhou
    State
    Zhejiang
    Postal Code
    311121
    Country
    CN
    Correspondent
    Dore Mark

    US Agent

    Business Name
    Microtech Medical, inc.
    Contact Name
    Dore Mark
    Address
    1999 S. Bascom Ave, Suite 700
    City
    Campbell
    State
    CA
    ZIP
    95008
    Country
    US
    Email
    [email protected]
    Phone
    408 5440744

    Products

    Device Name Product Code
    System, Test, Blood Glucose, Over The Counter NBW

    Proprietary Names

    Gochek2 Blood Glucose Monitoring System; Gochek2 Connect Blood Glucose Monitoring System; Pancares App

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198