BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Accu-Chek Guide Link FC US MG/DL

    Reg #: 3011393376 · FEI: 3011393376 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ROCHE DIABETES CARE, INC.
    Registration Number
    3011393376
    FEI Number
    3011393376
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    9115 Hague Road
    City
    Indianapolis
    State
    IN
    ZIP
    46250
    Country
    US

    Regulatory Submissions

    PMA Number
    P160017

    Owner / Operator

    Firm Name
    Roche Diagnostics Operations Inc.
    Operator Number
    9039767
    Address
    9115 Hague Road
    City
    Indianapolis
    State
    IN
    Postal Code
    46250
    Country
    US
    Correspondent
    Brian Frazier

    Products

    Device Name Product Code
    Automated Insulin Dosing Device System, Single Hormonal Control OZP

    Proprietary Names

    Accu-Chek Guide Link FC US MG/DL Accu-Chek Guide Link Blood Glucose Monitoring System Accu-Chek Guide Link Replacement Kit US

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device