BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    Ohmega (G2-x)

    Reg #: 3011790297 · FEI: 3011790297 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    DEMCON PRODUCTION B.V.
    Registration Number
    3011790297
    FEI Number
    3011790297
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Institutenweg 50
    City
    Enschede Overijssel
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K060166

    Owner / Operator

    Firm Name
    Demcon Production B.V.
    Operator Number
    10049517
    Address
    Institutenweg 50
    City
    Enschede
    State
    Overijssel
    Postal Code
    7521 PK
    Country
    NL

    US Agent

    Business Name
    ADINSTRUMENTS, INC.
    Contact Name
    Marissa Theorin
    Address
    4360 Arrowswest Dr
    City
    Colorado Springs
    State
    CO
    ZIP
    80907
    Country
    US
    Email
    [email protected]
    Phone
    719 3060305

    Products

    Device Name Product Code
    System, Gastrointestinal Motility (Electrical) FFX

    Proprietary Names

    Ohmega (G2-x)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)