BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    ELFO AG

    Reg #: 1000154583 · FEI: 1000154583 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ELFO AG
    Registration Number
    1000154583
    FEI Number
    1000154583
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Edisriederstrasse 106
    City
    Sachseln Obwalden
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K161534

    Owner / Operator

    Firm Name
    elfo ag
    Operator Number
    10058377
    Address
    Edisriederstrasse 106
    City
    Sachseln
    State
    Obwalden
    Postal Code
    6072
    Country
    CH
    Correspondent
    Dominic Zajonc

    US Agent

    Business Name
    ndd Medical Technologies
    Contact Name
    Joy Tobin
    Address
    300 Brickstone Sq Ste 604
    City
    Andover
    State
    MA
    ZIP
    01810
    Country
    US
    Email
    [email protected]
    Phone
    978 4700923 ext. 124

    Products

    Device Name Product Code
    Calculator, Predicted Values, Pulmonary Function BTY
    Mouthpiece, Breathing BYP

    Establishment Types

    Manufacture Medical Device