BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Contour Next EZ Blood Glucose Meter

    Reg #: 1810909 · FEI: 1810909 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    Ascensia Diabetes Care US Inc.
    Registration Number
    1810909
    FEI Number
    1810909
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    100 Summit Lake Drive
    City
    Valhalla
    State
    NY
    ZIP
    10595
    Country
    US

    Regulatory Submissions

    510(k) Number
    K111268

    Owner / Operator

    Firm Name
    Ascensia Diabetes Care Holdings AG
    Operator Number
    10050965
    Address
    5 WOOD HOLLOW RD
    City
    Parsippany
    State
    NJ
    Postal Code
    07054
    Country
    US

    Products

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

    Proprietary Names

    Contour Next EZ Blood Glucose Meter Contour Next Control Solution Contour Next Blood Glucose Test Strips

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198