BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    GAL-1E Blood Glucose Monitoring System

    Reg #: 9616936 · FEI: 3002671736 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    APEX BIOTECHNOLOGY CORP.
    Registration Number
    9616936
    FEI Number
    3002671736
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    NO. 7, LI-HSIN ROAD V,, HSINCHU SCIENCE PARK
    City
    HSINCHU
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K113547

    Owner / Operator

    Firm Name
    APEX BIOTECHNOLOGY CORP.
    Operator Number
    9034629
    Address
    NO. 7, LI-HSIN ROAD V,, HSINCHU SCIENCE PARK
    City
    HSINCHU
    State
    TW-NOTA
    Postal Code
    30078
    Country
    TW

    US Agent

    Business Name
    ARKRAY Factory USA, Inc.
    Contact Name
    Tom Speikers
    Address
    8260 NW 27th Street, Suite 403
    City
    Miami
    State
    FL
    ZIP
    33122
    Country
    US
    Email
    [email protected]
    Phone
    952 6463168

    Products

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

    Proprietary Names

    GAL-1E Blood Glucose Monitoring System GAL-1E Blood Glucose Test Strips

    Establishment Types

    Manufacture Medical Device