BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    COSMED S.R.L.

    Reg #: 8021084 · FEI: 2995 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    18
    Establishment Types
    3
    Classifications
    7

    Registration Details

    Registration Name
    COSMED S.R.L.
    Registration Number
    8021084
    FEI Number
    2995
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    VIA DEI PIANI DI MONTE, SAVELLO 37
    City
    ALBANO LAZIALE, ROMA
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K190800

    Owner / Operator

    Firm Name
    COSMED S.R.L.
    Operator Number
    8021084
    Address
    VIA DEI PIANI DI MONTE SAVELLO 37
    City
    ALBANO LAZIALE
    State
    Roma
    Postal Code
    00041
    Country
    IT
    Correspondent
    Andrea - Duca

    US Agent

    Business Name
    COSMED USA Inc
    Contact Name
    Sheemah Kazi
    Address
    1850 Bates Ave
    City
    Concord
    State
    CA
    ZIP
    94520
    Country
    US
    Email
    [email protected]
    Phone
    925 6763724

    Products

    Device Name Product Code
    Calculator, Predicted Values, Pulmonary Function BTY
    Ventilator, Continuous, Facility Use CBK
    Spirometer, Diagnostic BZG
    Oximeter DQA
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Calculator, Pulmonary Function Data BZC
    Computer, Oxygen-Uptake BZL

    Proprietary Names

    Q-NRG Q-NRG+ Quark PFT Quark Series Quark CPET Quark RMR Quark PFT Body Q-Box Quark SPIRO Spiropalm Series COSMED PONY FX Quark T12x COSMED MicroQuark Quark C12x K4 Portable Metabolic Measurement COSMED SRL COSMED FITMATE K5 - Wearable Metabolic Technology K5

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Export Device to the United States But Perform No Other Operation on Device