BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    SMART MEDICAL SYSTEMS LTD.

    Reg #: 3005261802 · FEI: 3005261802 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SMART MEDICAL SYSTEMS LTD.
    Registration Number
    3005261802
    FEI Number
    3005261802
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5 Hanofar Str.
    City
    Raanana Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K111760

    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
    Endoscope Channel Accessory ODC
    Colonoscope And Accessories, Flexible/Rigid FDF

    Proprietary Names

    NaviAid¿ SPARK NaviAid¿ ABC Operation Kit NaviAid¿ BGC Disposable NaviAid¿ ABC Disposable NaviAid¿ Single Balloon Air Supply Unit NaviAid¿ BGC Operation Kit NAVIAID ICVI-F,S,B,R DEVICE G-EYE SYSTEM G-EYE Systems G-EYE System

    Establishment Types

    Manufacture Medical Device