BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    WellAir Pro XL

    Reg #: 3010238358 · FEI: 3010238358 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Novaerus Ltd
    Registration Number
    3010238358
    FEI Number
    3010238358
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Oyster Point, Temple Road
    City
    Blackrock Dublin
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K200321

    Owner / Operator

    Firm Name
    Novaerus US Inc.
    Operator Number
    10082124
    Address
    3540 Toringdon Way, Suite 200
    City
    Charlotte
    State
    NC
    Postal Code
    28277
    Country
    US
    Correspondent
    Lisa Lawlor

    US Agent

    Business Name
    Novaerus US Inc
    Contact Name
    Lisa Lawlor
    Address
    3540 Toringdon Way, suite 200
    City
    Charlotte
    State
    NC
    ZIP
    28277
    Country
    US
    Email
    [email protected]
    Phone
    866 5081118

    Products

    Device Name Product Code
    Cleaner, Air, Medical Recirculating FRF

    Proprietary Names

    WellAir Pro XL WellAir Defend 1050 Novaerus Defend 1050 Novaerus Pro XL WellAir NV400 Novaerus NV400 WellAir NV1050 Novaerus Defend 400 Novaerus NV1050 WellAir Defend 400

    Establishment Types

    Manufacture Medical Device