BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    NervAlign Nerve Cuff

    Reg #: 3022317591 · FEI: 3022317591 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    RENERVE LTD
    Registration Number
    3022317591
    FEI Number
    3022317591
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    L 10 99 Queen Street
    City
    Melbourne Victoria
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K202234

    Owner / Operator

    Firm Name
    ReNerve Ltd
    Operator Number
    10084457
    Address
    Level 10, 99 Queen Street
    City
    Melbourne
    State
    Victoria
    Postal Code
    3000
    Country
    AU
    Correspondent
    David Rhodes

    US Agent

    Business Name
    Kuro Medical LLC
    Contact Name
    Matt Kyle
    Address
    7625 Golden Triangle Dr Ste G
    City
    Eden Prairie
    State
    MN
    ZIP
    55344
    Country
    US
    Email
    [email protected]
    Phone
    612 6362035

    Products

    Device Name Product Code
    Cuff, Nerve JXI

    Proprietary Names

    NervAlign Nerve Cuff

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility