BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    MEDISOFT S.A.

    Reg #: 3003630525 · FEI: 3003630525 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    MEDISOFT S.A.
    Registration Number
    3003630525
    FEI Number
    3003630525
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Rue du Clairon 5
    City
    DINANT Namur
    Country
    BE

    Regulatory Submissions

    510(k) Number
    K213611

    Owner / Operator

    Firm Name
    MEDISOFT S.A.
    Operator Number
    9049133
    Address
    Rue du Clairon 5
    City
    Sorinnes
    State
    Namur
    Postal Code
    5503
    Country
    BE
    Correspondent
    Eric Dion

    US Agent

    Business Name
    MGC Diagnostic
    Contact Name
    James M. McGurran
    Address
    350 Oak Grove Parkway
    City
    Saint Paul
    State
    MN
    ZIP
    55127
    Country
    US
    Email
    [email protected]
    Phone
    651 7663495

    Products

    Device Name Product Code
    System, Test, Breath Nitric Oxide MXA
    Calculator, Pulmonary Function Data BZC
    Plethysmograph, Volume JEH
    Spirometer, Diagnostic BZG

    Proprietary Names

    Fenom Pro TransAir2 Body Box SpiroAir

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device