BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    BLUEWIND MEDICAL LTD.

    Reg #: 3012239564 · FEI: 3012239564 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BLUEWIND MEDICAL LTD.
    Registration Number
    3012239564
    FEI Number
    3012239564
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4 Maskit Street, Building C, Eastern Side
    City
    Herzliya Tel Aviv
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K240037

    Owner / Operator

    Firm Name
    BlueWind Medical Ltd.
    Operator Number
    10088572
    Address
    250 E 200 S, Site 1600
    City
    Salt Lake City
    State
    UT
    Postal Code
    84111
    Country
    US
    Correspondent
    Angel Estrada

    US Agent

    Business Name
    BlueWind Medical
    Contact Name
    Angel Estrada
    Address
    250 E 200 S Ste 1600
    City
    Salt Lake City
    State
    UT
    ZIP
    84111
    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 Revi Implant Revi Hub

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility