BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    CER-S Continuous ECG Recording - Suite

    Reg #: 3017840980 · FEI: 3017840980 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    CARDIOCALM SRL
    Registration Number
    3017840980
    FEI Number
    3017840980
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Via Martiri della Liberta 40
    City
    Montichiari Brescia
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K193177

    Owner / Operator

    Firm Name
    CardioCalm Srl
    Operator Number
    10078909
    Address
    Via Martiri della Liberta 40
    City
    Montichiari
    State
    Brescia
    Postal Code
    25018
    Country
    IT
    Correspondent
    Fabio Badilini

    US Agent

    Business Name
    Dawa Medical LLC
    Contact Name
    Stephan Toupin
    Address
    7320 Nw 12th St Ste 103
    City
    Miami
    State
    FL
    ZIP
    33126
    Country
    US
    Email
    [email protected]
    Phone
    305 5999373

    Products

    Device Name Product Code
    Computer, Diagnostic, Programmable DQK
    Electrocardiograph, Ambulatory, With Analysis Algorithm MLO

    Proprietary Names

    CER-S Continuous ECG Recording - Suite

    Establishment Types

    Manufacture Medical Device