BEUDAMED
    FDA Registration Active 🇵🇱 Poland

    RR Donnelley GTS Poland Sp. z o.o.

    Reg #: 3008606429 · FEI: 3008606429 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    10
    Establishment Types
    3
    Classifications
    5

    Registration Details

    Registration Name
    RR Donnelley GTS Poland Sp. z o.o.
    Registration Number
    3008606429
    FEI Number
    3008606429
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Zakladowa 90/92
    City
    Lodz Lodzkie
    Country
    PL

    Regulatory Submissions

    510(k) Number
    K062058
    PMA Number
    P160030

    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
    Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems QLG
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated PZE

    Proprietary Names

    Reagent Strip; Ascensia Contour Blood Glucose Meter, Model 7151; FreeStyle Libre 2 Flash Glucose Monitoring System Next EZ LFR - Glucose dehydrogenase, glucose NBW - System, test, blood glucose, over the counter Xceed Flash 3 Freestyle InsuLinx Contour Next USB Freestyle Libre Flash Glucose Monitoring System

    Establishment Types

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