BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Aerogen® Solo Nebulizer System

    Reg #: 3003399703 · FEI: 3003399703 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    AEROGEN LTD
    Registration Number
    3003399703
    FEI Number
    3003399703
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    GALWAY BUSINESS PARK
    City
    DANGAN Galway
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K070642

    Owner / Operator

    Firm Name
    Aerogen Ltd.
    Operator Number
    10024694
    Address
    Galway Business Park, Dangan
    City
    Galway
    State
    IE-G
    Postal Code
    H91 HE94
    Country
    IE
    Correspondent
    Thelma Marley

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Nebulizer (Direct Patient Interface) CAF

    Proprietary Names

    Aerogen® Solo Nebulizer System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility