BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    SpiroDef

    Reg #: 3006419626 · FEI: 3006419626 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    GANSHORN MEDIZIN ELECTRONIC GMBH
    Registration Number
    3006419626
    FEI Number
    3006419626
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Industriestr. 6-8
    City
    Niederlauer Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K240706

    Owner / Operator

    Firm Name
    GANSHORN Medizin Electronic GmbH
    Operator Number
    10054030
    Address
    Industriestr. 6-8
    City
    Niederlauer
    State
    Bavaria
    Postal Code
    97618
    Country
    DE
    Correspondent
    Stefan Ponto

    US Agent

    Business Name
    Schiller Americas
    Contact Name
    Ramon Martorell
    Address
    10903 NW 33rd Street
    City
    Doral
    State
    FL
    ZIP
    33172
    Country
    US
    Email
    [email protected]
    Phone
    786 8450620

    Products

    Device Name Product Code
    Spirometer, Diagnostic BZG
    Filter, Bacterial, Breathing-Circuit CAH
    Plethysmograph, Volume JEH

    Proprietary Names

    SpiroDef PowerCube Body+ / Diffusion+ PowerCube Diffusion+ PowerCube Body+ PowerCube+ Series

    Establishment Types

    Manufacture Medical Device