BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    SIGNIFIER MEDICAL TECHNOLOGIES LIMITED

    Reg #: 3018192374 · FEI: 3018192374 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SIGNIFIER MEDICAL TECHNOLOGIES LIMITED
    Registration Number
    3018192374
    FEI Number
    3018192374
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    107 Leadenhall Street, 7th Floor
    City
    London London, City of
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K240328

    Owner / Operator

    Firm Name
    Signifier Medical Technologies LLC
    Operator Number
    10080665
    Address
    907 Gateway Commons Cir, Suite 888
    City
    Wake Forest
    State
    NC
    Postal Code
    27587
    Country
    US
    Correspondent
    Mariam Ismail

    Products

    Device Name Product Code
    Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea QNO

    Proprietary Names

    eXciteOSA remote control only (14001) eXciteOSA starter kit - without remote control (13010) eXciteOSA control unit only pack (warranty replacement) (17000) eXciteOSA starter kit - with remote control (18010) eXciteOSA mouthpiece replacement (16000) eXciteOSA remote control only (warranty replacement) (14000) eXciteOSA

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device