BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    NUVOAIR AB

    Reg #: 3013744763 · FEI: 3013744763 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    NUVOAIR AB
    Registration Number
    3013744763
    FEI Number
    3013744763
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Riddargatan 17D, 3 tr
    City
    Stockholm
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K183089

    Owner / Operator

    Firm Name
    NuvoAir AB
    Operator Number
    10063987
    Address
    Riddargatan 17D, 3 tr
    City
    Stockholm
    State
    SE-AB
    Postal Code
    11457
    Country
    SE
    Correspondent
    Mircea Campian

    US Agent

    Business Name
    QA/RA CONSULTING GROUP, INC.
    Contact Name
    Scott Bednar
    Address
    3335 Tuscarawas Rd
    City
    Beaver
    State
    PA
    ZIP
    15009
    Country
    US
    Email
    [email protected]
    Phone
    412 4188066

    Products

    Device Name Product Code
    Spirometer, Diagnostic BZG

    Proprietary Names

    Air Next

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device