BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    SHL TeleMedicine International

    Reg #: 3003647588 · FEI: 3003647588 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    3

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    Registration Details

    Registration Name
    SHL TeleMedicine International
    Registration Number
    3003647588
    FEI Number
    3003647588
    Status
    Active
    Expiry Year
    2026
    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

    Products

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

    Proprietary Names

    Smartheart Pro Smartheart MODEL S-CV7-00 CARDIO MONITOR CENTER VISION Cardio'R CardioSenC MODEL S-CV5-96 CARDIOVISION SOFTWARE, CCM and Receiving Software

    Establishment Types

    Manufacture Medical Device