BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Bluewind Medical, Inc.

    Reg #: 3038988751 · FEI: 3038988751 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

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    Registration Details

    Registration Name
    Bluewind Medical, Inc.
    Registration Number
    3038988751
    FEI Number
    3038988751
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    250 E 200 S Ste 1600
    City
    Salt Lake City
    State
    UT
    ZIP
    84111
    Country
    US

    Regulatory Submissions

    510(k) Number
    K252391

    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

    Products

    Device Name Product Code
    Implanted Tibial Electrical Urinary Continence Device QXM

    Proprietary Names

    Revi System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility