BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SONEX HEALTH, Inc

    Reg #: 3013479847 · FEI: 3013479847 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    SONEX HEALTH, Inc
    Registration Number
    3013479847
    FEI Number
    3013479847
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    950 Blue Gentian Road, Suite 200
    City
    Eagan
    State
    MN
    ZIP
    55121
    Country
    US

    Regulatory Submissions

    510(k) Number
    K252594

    Owner / Operator

    Firm Name
    Sonex Health, Inc
    Operator Number
    10053414
    Address
    950 Blue Gentian Road, Suite 200
    City
    Eagan
    State
    MN
    Postal Code
    55121
    Country
    US
    Correspondent
    Sara Petrie

    Products

    Device Name Product Code
    Orthopedic Manual Surgical Instrument LXH
    Arthroscope HRX

    Proprietary Names

    UltraGuideTFR™ UltraGuideCTR™

    Establishment Types

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