BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    NEONAVIA AB

    Reg #: 3042940295 · FEI: 3042940295 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

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    Registration Details

    Registration Name
    NEONAVIA AB
    Registration Number
    3042940295
    FEI Number
    3042940295
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Stolp-Ekeby 11
    City
    Vallentuna Stockholm
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K220595

    Owner / Operator

    Firm Name
    NeoNavia Ab
    Operator Number
    10094565
    Address
    Stolp-Ekeby 11
    City
    Vallentuna
    State
    Stockholm
    Postal Code
    18695
    Country
    SE
    Correspondent
    Magnus Olsen

    US Agent

    Business Name
    Pro Pharma Group
    Contact Name
    Cherita James
    Address
    1129 20th St Nw Ste 600
    City
    Washington
    State
    DC
    ZIP
    20036
    Country
    US
    Email
    [email protected]
    Phone
    347 9540624

    Products

    Device Name Product Code
    Instrument, Biopsy KNW
    Biopsy Needle FCG

    Proprietary Names

    FlexiPulse, VacuPulse NeoNavia Biopsy System

    Establishment Types

    Manufacture Medical Device