BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    Onera STS

    Reg #: 3026753386 · FEI: 3026753386 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ONERA B.V.
    Registration Number
    3026753386
    FEI Number
    3026753386
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Torenallee 42-54
    City
    Eindhoven Noord-Brabant
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K210593

    Owner / Operator

    Firm Name
    Onera B.V.
    Operator Number
    10087157
    Address
    Torenallee 42-54
    City
    Eindhoven
    State
    Noord-Brabant
    Postal Code
    5617BD
    Country
    NL
    Correspondent
    Mindy McCann

    US Agent

    Business Name
    Qserve Group US Inc.
    Contact Name
    Mindy McCann
    Address
    350 S Main Street, Suite 309
    City
    Doylestown
    State
    PA
    ZIP
    18901
    Country
    US
    Email
    [email protected]
    Phone
    424 2718169

    Products

    Device Name Product Code
    Standard Polysomnograph With Electroencephalograph OLV
    Ventilatory Effort Recorder MNR

    Proprietary Names

    Onera STS

    Establishment Types

    Manufacture Medical Device