BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    Revi System

    Reg #: 3012239564 · FEI: 3012239564 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BLUEWIND MEDICAL LTD.
    Registration Number
    3012239564
    FEI Number
    3012239564
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6 Maskit Street
    City
    Herzliya Tel Aviv
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K240037

    Owner / Operator

    Firm Name
    BlueWind Medical Ltd.
    Operator Number
    10088572
    Address
    6 Maskit Street
    City
    Herzliya
    State
    Tel Aviv
    Postal Code
    4614002
    Country
    IL

    US Agent

    Business Name
    MedTech Review, LLC
    Contact Name
    John Beasley
    Address
    257 Garnet Garden St
    City
    Henderson
    State
    NV
    ZIP
    89015
    Country
    US
    Email
    [email protected]
    Phone
    702 7236889

    Products

    Device Name Product Code
    Implanted Tibial Electrical Urinary Continence Device QXM

    Proprietary Names

    Revi System Revi Clinician Program Revi Wearable

    Establishment Types

    Manufacture Medical Device