BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    TYSON BIORESEARCH, INC.

    Reg #: 3003132490 · FEI: 3003132490 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    17
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    TYSON BIORESEARCH, INC.
    Registration Number
    3003132490
    FEI Number
    3003132490
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5F., No. 16, 18, 20, 22, Kedong 3rd Rd.
    City
    Zhunan Township Miaoli
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K101543

    Owner / Operator

    Firm Name
    TYSON BIORESEARCH, INC.
    Operator Number
    9047348
    Address
    5F., No. 16, 18, 20, 22, Kedong 3rd Rd.,
    City
    Zhunan Township, Miaoli County
    State
    TW-NOTA
    Postal Code
    35053
    Country
    TW

    US Agent

    Business Name
    Dynamic Biotech, Inc.
    Contact Name
    David Lee
    Address
    29122 Rancho Viejo Rd Ste 212
    City
    San Juan Capistrano
    State
    CA
    ZIP
    92675
    Country
    US
    Email
    [email protected]
    Phone
    949 2180929

    Products

    Device Name Product Code
    System, Test, Blood Glucose, Over The Counter NBW
    Glucose Oxidase, Glucose CGA
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX

    Proprietary Names

    TysonBio AC200 Blood Glucose Monitoring System Tyson Bio HT100-B Blood Glucose Monitoring System Tyson Bio HT100 Blood Glucose Monitoring System Glucomate HT100 Blood Glucose Monitoring System TysonBio AC500 Blood Glucose Monitoring System ONE-CARE PRO (Model AC500 PRO) Blood Glucose Monitoring System ONE-CARE (Model AC500) Blood Glucose Monitoring System TysonBio AC500 PRO Blood Glucose Monitoring System TysonBio Evolve Blood Glucose Monitoring System Easy Touch Blood Glucose Monitoring System Easy Touch Tyson Bio HS100 Blood Glucose Monitoring System Tyson Bio HS100-B Blood Glucose Monitoring System Tyson Bio HS200-B Blood Glucose Monitoring System Tyson Bio HS200 Blood Glucose Monitoring System GLUCO-CARE HS100 Blood Glucose Monitoring System Genteel HS100 Blood Glucose Monitoring System

    Establishment Types

    Manufacture Medical Device