BEUDAMED
    FDA Registration Active 🇸🇬 Singapore

    Freestyle Tracker

    Reg #: 3006534878 · FEI: 3006534878 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    18
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    RR DONNELLEY-GLOBAL TURNKEY SOLUTIONS
    Registration Number
    3006534878
    FEI Number
    3006534878
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    30 Toh Guan Road # 05-01
    City
    SINGAPORE South East
    Country
    SG

    Regulatory Submissions

    510(k) Number
    K033845

    Owner / Operator

    Firm Name
    RR Donnelley - Global Turnkey Solutions
    Operator Number
    9100064
    Address
    30 Toh Guan Road #05-01
    City
    Singapore
    State
    SG-NOTA
    Postal Code
    608840
    Country
    SG
    Correspondent
    Kelvin Wong

    US Agent

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

    Products

    Device Name Product Code
    Dinitrophenyl Hydrazone Measurement (Colorimetric), Hydroxybutyric Dehydroge JKF
    System, Test, Blood Glucose, Over The Counter NBW
    Glucose Dehydrogenase, Glucose LFR

    Proprietary Names

    Freestyle Tracker Freestyle Connect Freestyle 600 Precision Xtra Freestyle Lite BGM Freestyle Lite Relion Ultima Precision Precision Optimum FS insulinx AScencia Relion Freestyle Libre 2 Freestyle Lite BG Freestyle Precision Pro Freestyle Lite Blood Glucose Freestyle Libre Freestyle BGMS

    Establishment Types

    Repack or Relabel Medical Device