BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    EasyMate

    Reg #: 3005706626 · FEI: 3005706626 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Bioptik Technology, Inc.
    Registration Number
    3005706626
    FEI Number
    3005706626
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.188, Jhonghua South Road, Gongguan Village
    City
    Jhunan Township Miaoli
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K053312

    Owner / Operator

    Firm Name
    Bioptik Technology, Inc.
    Operator Number
    10023609
    Address
    No. 188, Jhonghua South road,, Gongguan Village,
    City
    Jhunan Township
    State
    Miaoli
    Postal Code
    35057
    Country
    TW
    Correspondent
    Chin-Chang Yang

    US Agent

    Business Name
    HARVEST & VICTORY CONSULTING CORP. (USA)
    Contact Name
    JENNIFER REICH
    Address
    2904 N Boldt Dr
    City
    Flagstaff
    State
    AZ
    ZIP
    86001
    Country
    US
    Email
    [email protected]
    Phone
    928 8638140

    Products

    Device Name Product Code
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    System, Test, Blood Glucose, Over The Counter NBW

    Proprietary Names

    EasyMate

    Establishment Types

    Manufacture Medical Device