BEUDAMED
    FDA Registration Active 🇫🇷 France

    ONIRIS Pro

    Reg #: 3013548547 · FEI: 3013548547 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ONIRIS
    Registration Number
    3013548547
    FEI Number
    3013548547
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    147 avenue Paul Doumer
    City
    RUEIL MALMAISON Hauts-de-Seine
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K150566

    Owner / Operator

    Firm Name
    ONIRIS
    Operator Number
    10054416
    Address
    147 avenue Paul Doumer
    City
    RUEIL MALMAISON
    State
    FR-NOTA
    Postal Code
    92500
    Country
    FR

    US Agent

    Business Name
    Regulatory Insight, Inc.
    Contact Name
    Kevin Walls
    Address
    33 Golden Eagle Lane
    City
    Littleton
    State
    CO
    ZIP
    80127
    Country
    US
    Email
    [email protected]
    Phone
    720 9625412

    Products

    Device Name Product Code
    Device, Anti-Snoring LRK

    Proprietary Names

    ONIRIS Pro

    Establishment Types

    Manufacture Medical Device