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    FDA Registration Active 🇸🇪 Sweden

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    Reg #: 3013744763 · FEI: 3013744763 · Expires 2025
    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
    2025
    Initial Importer
    No
    Address
    Riddargatan 17D, 3 tr
    City
    Stockholm
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K231416

    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
    Furat Shawki

    US Agent

    Business Name
    QA/RA Consulting Group, Inc.
    Contact Name
    Scott Bednar
    Address
    3335 Tuscarawas Road
    City
    Beaver
    State
    PA
    ZIP
    15009
    Country
    US
    Email
    [email protected]
    Phone
    412 4188066

    Products

    Device Name Product Code
    Spirometer, Diagnostic BZG

    Proprietary Names

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    Establishment Types

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