BEUDAMED
    FDA Registration Active 🇵🇱 Poland

    Ascensia Contour Blood Glucose Meter, Model 7151;

    Reg #: 3008606429 · FEI: 3008606429 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    RR Donnelley GTS Poland Sp. z o.o.
    Registration Number
    3008606429
    FEI Number
    3008606429
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Zakladowa 90/92
    City
    Lodz Lodzkie
    Country
    PL

    Regulatory Submissions

    510(k) Number
    K062058

    Owner / Operator

    Firm Name
    RR Donnelley GTS Poland Sp. z o.o.
    Operator Number
    10033813
    Address
    Zakladowa 90/92
    City
    Lodz
    State
    PL-NOTA
    Postal Code
    92-402
    Country
    PL
    Correspondent
    Anna Srogosz

    US Agent

    Business Name
    RR Donnelley
    Contact Name
    Lee Rush
    Address
    6315 West by Northwest Blvd , Houston
    City
    Houston
    State
    TX
    ZIP
    77040
    Country
    US
    Email
    [email protected]
    Phone
    979 4841734 ext. 0

    Products

    Device Name Product Code
    System, Test, Blood Glucose, Over The Counter NBW
    Glucose Dehydrogenase, Glucose LFR

    Proprietary Names

    Ascensia Contour Blood Glucose Meter, Model 7151; Reagent Strip;

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device for Another Party (Contract Manufacturer)