BEUDAMED
    FDA Registration Active 🇨🇳 China

    Accu-Chek Guide Me Blood Glucose Monitoring System

    Reg #: 3022346573 · FEI: 3022346573 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Altek Medical (kunshan) limited
    Registration Number
    3022346573
    FEI Number
    3022346573
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2F, Building No.1, No. 77, 3rd Main Street
    City
    Kunshan Free Trade Zone Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K181131

    Owner / Operator

    Firm Name
    Altek Biotechnology Corporation
    Operator Number
    10029462
    Address
    4F, No. 12, Li-Hsin Road,, Science-Based Industrial Park
    City
    Hsinchu
    State
    Hsinchu (City)
    Postal Code
    300
    Country
    TW

    Products

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

    Proprietary Names

    Accu-Chek Guide Me Blood Glucose Monitoring System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)