BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Hyper-Box System

    Reg #: 3006538358 · FEI: 3006538358 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    AOTI LTD.
    Registration Number
    3006538358
    FEI Number
    3006538358
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Unit 20 Glenrock Business Park, Ballybane
    City
    GALWAY
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K080966

    Owner / Operator

    Firm Name
    AOTI LTD.
    Operator Number
    9099459
    Address
    Unit 20 Glenrock Business Park, Ballybane
    City
    Galway
    State
    IE-G
    Postal Code
    H91 N23C
    Country
    IE

    US Agent

    Business Name
    AOTI
    Contact Name
    MIKE GRIFFITHS
    Address
    3512 Seagate Way Ste 100
    City
    Oceanside
    State
    CA
    ZIP
    92056
    Country
    US
    Email
    [email protected]
    Phone
    760 6721920

    Products

    Device Name Product Code
    Chamber, Oxygen, Topical, Extremity KPJ

    Proprietary Names

    Hyper-Box System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device