BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System

    Reg #: 3011121740 · FEI: 3010700165 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Ascensia Diabetes Care US Inc.
    Registration Number
    3011121740
    FEI Number
    3010700165
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5 Wood Hollow Road
    City
    Parsippany
    State
    NJ
    ZIP
    07054
    Country
    US

    Regulatory Submissions

    510(k) Number
    K241787

    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
    System, Test, Blood Glucose, Over The Counter NBW

    Proprietary Names

    CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility