BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    Pure-Vu EVS System

    Reg #: 3011816755 · FEI: 3011816755 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    MOTUS GI Medical Technologies Ltd.
    Registration Number
    3011816755
    FEI Number
    3011816755
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    22 Keren Ha'yesod st.
    City
    Tirat Carmel Haifa
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K220007

    Owner / Operator

    Firm Name
    MOTUS GI Medical Technologies Ltd
    Operator Number
    10053317
    Address
    1301 E. Broward Blvd., Suite 310
    City
    Fort Lauderdale
    State
    FL
    Postal Code
    33301
    Country
    US
    Correspondent
    Mark Pomeranz

    US Agent

    Business Name
    Motus GI
    Contact Name
    Mark Pomeranz
    Address
    1301 E. Broward Blvd. Suite 310
    City
    Fort Lauderdale
    State
    FL
    ZIP
    33301
    Country
    US
    Email
    [email protected]
    Phone
    941 5418000

    Products

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

    Proprietary Names

    Pure-Vu EVS System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility