BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    GlucoLeader Blood Glucose Test System

    Reg #: 3003902721 · FEI: 3003902721 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    HMD BIOMEDICAL, INC.
    Registration Number
    3003902721
    FEI Number
    3003902721
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No 181 Minsheng St, Xinpu Township
    City
    Hsinchu County
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K023279

    Owner / Operator

    Firm Name
    GL DIABETES CORPORATION
    Operator Number
    9053177
    Address
    9676 Oviedo St.,
    City
    San Diego
    State
    CA
    Postal Code
    92129
    Country
    US

    US Agent

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

    Products

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

    Proprietary Names

    GlucoLeader Blood Glucose Test System

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device