BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Alere G1 Blood Glucose Monitoring System

    Reg #: 3007363438 · FEI: 3005664575 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    All Medicus Co., Ltd.
    Registration Number
    3007363438
    FEI Number
    3005664575
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.7102-7107,7402,7403,7406, 140, Beolmal-ro, Dongan-gu
    City
    Anyang-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K083628

    Owner / Operator

    Firm Name
    All Medicus Co., Ltd
    Operator Number
    10027562
    Address
    #7609, 140, Beolmal-ro, Dongan-gu
    City
    Anyang
    State
    Gyeonggi
    Postal Code
    14057
    Country
    KR
    Correspondent
    Hong Joo Park

    US Agent

    Business Name
    LK Consulting Group USA, Inc.
    Contact Name
    Priscilla Chung
    Address
    18881 Von Karman Ave STE 160
    City
    Irvine
    State
    CA
    ZIP
    92612
    Country
    US
    Email
    [email protected]
    Phone
    714 2025789

    Products

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

    Proprietary Names

    Alere G1 Blood Glucose Monitoring System VICTORY Blood Glucose Monitoring System GLUCODR AUTO SYSTEM Embrace Pro Blood Glucose Monitoring System VICTORY

    Establishment Types

    Manufacture Medical Device