BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    ONERA B.V.

    Reg #: 3026753386 · FEI: 3026753386 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    3

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    Registration Details

    Registration Name
    ONERA B.V.
    Registration Number
    3026753386
    FEI Number
    3026753386
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Torenallee 42-54
    City
    Eindhoven Noord-Brabant
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K243220

    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
    Automatic Event Detection Software For Polysomnograph With Electroencephalograph OLZ

    Proprietary Names

    Onera Sleep Test System 2 Onera STS 2 Onera SleepMap Onera STS

    Establishment Types

    Manufacture Medical Device