BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    NaviAid¿ BGC Disposable

    Reg #: 3005261802 · FEI: 3005261802 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    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
    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

    Proprietary Names

    NaviAid¿ BGC Disposable NaviAid¿ BGC Operation Kit NaviAid¿ ABC Disposable NaviAid¿ ABC Operation Kit NaviAid¿ Single Balloon Air Supply Unit NaviAid¿ SPARK

    Establishment Types

    Manufacture Medical Device