BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    Simpleware Product Group, SYNOPSYS NORTHERN EUROPE

    Reg #: 3011676026 · FEI: 3011676026 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Simpleware Product Group, SYNOPSYS NORTHERN EUROPE
    Registration Number
    3011676026
    FEI Number
    3011676026
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Bradninch Hall, Castle Street
    City
    Exeter Devon
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K142779

    Owner / Operator

    Firm Name
    Synopsys Northern Europe
    Operator Number
    10049175
    Address
    Bradninch Hall, Castle Street
    City
    Exeter
    State
    Devon
    Postal Code
    EX4 3PL
    Country
    GB
    Correspondent
    Jessica A James

    US Agent

    Business Name
    Synopsys, Inc.
    Contact Name
    Mike Zilmer
    Address
    675 Almanor Ave
    City
    Sunnyvale
    State
    CA
    ZIP
    94085
    Country
    US
    Email
    [email protected]
    Phone
    918 4094655

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ

    Proprietary Names

    Simpleware ScanIP Medical Simpleware Medical

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device