BEUDAMED
    FDA Registration Active 🇭🇺 Hungary

    Spirosonic

    Reg #: 3011382174 · FEI: 3011382174 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Uscom Kft
    Registration Number
    3011382174
    FEI Number
    3011382174
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Boglarka street 17
    City
    Budapest
    Country
    HU

    Regulatory Submissions

    510(k) Number
    K150137

    Owner / Operator

    Firm Name
    Uscom Kft
    Operator Number
    10051262
    Address
    Boglarka street 17
    City
    Budapest
    State
    HU-BU
    Postal Code
    1119
    Country
    HU

    US Agent

    Business Name
    Primority Ltd dba Global Import Agent
    Contact Name
    James Flynn
    Address
    9160 Forum Corporate Parkway, Suite 350
    City
    Fort Myers
    State
    FL
    ZIP
    33905
    Country
    US
    Email
    [email protected]
    Phone
    415 8710682

    Products

    Device Name Product Code
    Spirometer, Diagnostic BZG

    Proprietary Names

    Spirosonic SpiroSonic AIR mSpiro mSpirometer SpiroSonic

    Establishment Types

    Manufacture Medical Device