BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    Elekta Synergy, Elekta Infinity, Versa HD, Elekta Harmony/Harmony Pro

    Reg #: 9617016 · FEI: 3002806900 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ELEKTA LIMITED
    Registration Number
    9617016
    FEI Number
    3002806900
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Cornerstone, London Road
    City
    CRAWLEY West Sussex
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K210500

    Owner / Operator

    Firm Name
    ELEKTA AB
    Operator Number
    8030893
    Address
    Hagaplan 4
    City
    Stockholm
    State
    SE-AB
    Postal Code
    SE11368
    Country
    SE

    US Agent

    Business Name
    Elekta
    Contact Name
    Thomas Valentine
    Address
    400 Perimeter Center Terrace, Suite 50
    City
    ATL
    State
    GA
    ZIP
    30346
    Country
    US
    Email
    [email protected]
    Phone
    404 7972537

    Products

    Device Name Product Code
    Accelerator, Linear, Medical IYE

    Proprietary Names

    Elekta Synergy, Elekta Infinity, Versa HD, Elekta Harmony/Harmony Pro

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)