BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CareSens N POP Blood Glucose Monitoring System

    Reg #: 3008780388 · FEI: 3008780388 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    I-SENS USA, INC.
    Registration Number
    3008780388
    FEI Number
    3008780388
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3545 Lomita Blvd., Unit D
    City
    Torrance
    State
    CA
    ZIP
    90505
    Country
    US

    Regulatory Submissions

    510(k) Number
    K120351

    Owner / Operator

    Firm Name
    i-SENS USA, Inc.
    Operator Number
    10034826
    Address
    3545 Lomita Blvd., Unit D
    City
    Torrance
    State
    CA
    Postal Code
    90505
    Country
    US
    Correspondent
    Jeonghan Ha

    Products

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

    Proprietary Names

    CareSens N POP Blood Glucose Monitoring System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198