BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    Smartheart Pro

    Reg #: 3003647588 · FEI: 3003647588 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SHL TeleMedicine International
    Registration Number
    3003647588
    FEI Number
    3003647588
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    90 Igal Alon Street
    City
    Tel-Aviv Tel Aviv
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K113514

    Owner / Operator

    Firm Name
    SHL TeleMedicine International Ltd
    Operator Number
    10023481
    Address
    90 Yigal Alon street
    City
    Tel Aviv
    State
    IL-NOTA
    Postal Code
    6789132
    Country
    IL
    Correspondent
    Yoram Levy

    US Agent

    Business Name
    Qsite
    Contact Name
    Tova Rivnay
    Address
    77 Dorcar Rd
    City
    Newton
    State
    MA
    ZIP
    02459
    Country
    US
    Email
    [email protected]
    Phone
    512 5354930

    Products

    Device Name Product Code
    Transmitters And Receivers, Electrocardiograph, Telephone DXH

    Proprietary Names

    Smartheart Pro Smartheart

    Establishment Types

    Manufacture Medical Device