BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    Smart One

    Reg #: 9614860 · FEI: 3004612204 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MIR - MEDICAL INTERNATIONAL RESEARCH S.P.A.
    Registration Number
    9614860
    FEI Number
    3004612204
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Viale Luigi Schiavonetti, 270
    City
    ROMA
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K181666

    Owner / Operator

    Firm Name
    MIR MEDICAL INTL. RESEARCH S.P.A.
    Operator Number
    9034107
    Address
    Viale Luigi Schiavonetti 270, --
    City
    ROMA
    State
    Lazio
    Postal Code
    00173
    Country
    IT

    Products

    Device Name Product Code
    Meter, Peak Flow, Spirometry BZH

    Proprietary Names

    Smart One Cohero - cSpirometer

    Establishment Types

    Manufacture Medical Device