BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Accu-chek Guide Me

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

    510(k) Number
    K181131

    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
    System, Test, Blood Glucose, Over The Counter NBW

    Proprietary Names

    Accu-chek Guide Me

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device