BEUDAMED
    FDA Registration Active 🇫🇮 Finland

    Elekta Neuromag®

    Reg #: 9680891 · FEI: 3006563303 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    MEGIN OY
    Registration Number
    9680891
    FEI Number
    3006563303
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Keilasatama 5
    City
    Espoo Uusimaa
    Country
    FI

    Regulatory Submissions

    510(k) Number
    K050035

    Owner / Operator

    Firm Name
    Megin Oy
    Operator Number
    10058907
    Address
    Keilasatama 5
    City
    Espoo
    State
    Uusimaa
    Postal Code
    02150
    Country
    FI

    US Agent

    Business Name
    MEGIN US, LLC
    Contact Name
    Rick Goepfert
    Address
    11772 West Sample Road
    City
    Coral Springs
    State
    FL
    ZIP
    33065
    Country
    US
    Email
    [email protected]
    Phone
    703 3624920

    Products

    Device Name Product Code
    Magnetoencephalograph OLY
    Source Localization Software For Electroencephalograph Or Magnetoencephalograph OLX
    Full-Montage Standard Electroencephalograph GWQ

    Proprietary Names

    Elekta Neuromag®

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198