BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Livongo

    Reg #: 3017026121 · FEI: 3017026121 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    KAIFA TECHNOLOGY MALAYSIA SDN. BHD.
    Registration Number
    3017026121
    FEI Number
    3017026121
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Lot 35008 Jalan Persiaran Sinergi Utama, Senai, Johor, 81400 Malaysia
    City
    Senai Johor
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K133584

    Owner / Operator

    Firm Name
    Kaifa Technology Malaysia SDN. BHD.
    Operator Number
    10066879
    Address
    Lot 35008 Jalan Persiaran Sinergi Utama, Senai, Johor, 81400 Malaysia
    City
    Senai
    State
    Johor
    Postal Code
    81400
    Country
    MY

    US Agent

    Business Name
    Kaifa Technology USA Inc
    Contact Name
    Kwan Hwa Gan
    Address
    227 Devcon Drive ,San Jose, CA 95112 , United States San Jose, California, 95112, UNITED STATES
    City
    San Jose
    State
    CA
    ZIP
    95112
    Country
    US
    Email
    [email protected]
    Phone
    408 4765311

    Products

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

    Proprietary Names

    Livongo

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)