BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    NIOX

    Reg #: 3008662397 · FEI: 3008662397 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    NIOX AB
    Registration Number
    3008662397
    FEI Number
    3008662397
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Hansellisgatan 13
    City
    Uppsala
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K101034

    Owner / Operator

    Firm Name
    Circassia Inc
    Operator Number
    9057041
    Address
    1100 Perimeter Park Dr., STE 114
    City
    Morrisville
    State
    NC
    Postal Code
    27560
    Country
    US
    Correspondent
    Tom Scaccia

    US Agent

    Business Name
    NIOX Inc
    Contact Name
    Tom Scaccia
    Address
    1100 PERIMETER PARK DR., STE 114 MORRISVILLE
    City
    Morrisville
    State
    NC
    ZIP
    27560
    Country
    US
    Email
    [email protected]
    Phone
    918 8174494

    Products

    Device Name Product Code
    System, Test, Breath Nitric Oxide MXA

    Proprietary Names

    NIOX

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility