BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    COMMWELL RESEARCH AND DEVELOPMENT LTD

    Reg #: 3008881835 · FEI: 3008881835 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    COMMWELL RESEARCH AND DEVELOPMENT LTD
    Registration Number
    3008881835
    FEI Number
    3008881835
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    yad haruzim 4
    City
    kfar saba Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K133703

    Owner / Operator

    Firm Name
    Commwell Research and Development Ltd
    Operator Number
    10035078
    Address
    yad haruzim 4
    City
    kfar saba
    State
    IL-NOTA
    Postal Code
    4464102
    Country
    IL
    Correspondent
    Doron David

    US Agent

    Business Name
    Advanced Data Systems Corporation
    Contact Name
    DAVID BARZILAI
    Address
    15 Prospect St
    City
    Paramus
    State
    NJ
    ZIP
    07652
    Country
    US
    Email
    [email protected]
    Phone
    201 2891449 ext. 0

    Products

    Device Name Product Code
    Medical Device Data System OUG
    Electrocardiograph DPS
    Transmitters And Receivers, Electrocardiograph, Telephone DXH
    Electrode, Electrocardiograph DRX

    Proprietary Names

    Health e-Care PHYSIOGLOVE ET SYSTEM PHYSIOGLOVE ES WITH ECG ANALYSIS PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1 PHYSIOGLOVE ES REMOTE PRESENCE AND CARE SYSTEM (RPCS 5000) ECG SETINEL System

    Establishment Types

    Manufacture Medical Device