BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    G-EYE System

    Reg #: 3005261802 · FEI: 3005261802 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SMART MEDICAL SYSTEMS LTD.
    Registration Number
    3005261802
    FEI Number
    3005261802
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5 Hanofar Str.
    City
    Raanana Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K220158

    Owner / Operator

    Firm Name
    Smart Medical Systems Ltd.
    Operator Number
    10025066
    Address
    5 Hanofar Street
    City
    Raanana
    State
    Central
    Postal Code
    4366404
    Country
    IL
    Correspondent
    Ahava Stein

    Products

    Device Name Product Code
    Colonoscope And Accessories, Flexible/Rigid FDF

    Proprietary Names

    G-EYE System

    Establishment Types

    Manufacture Medical Device