BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    Fusion Titan Dilation Balloon

    Reg #: 3030446844 · FEI: 3030446844 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PLATINUM FOCUS GROUP LTD.
    Registration Number
    3030446844
    FEI Number
    3030446844
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Unit 5, 1000 North Circular Road
    City
    London London, City of
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K172057

    Owner / Operator

    Firm Name
    Platinum Focus Group Ltd.
    Operator Number
    10089900
    Address
    Unit 5, 1000 North Circular Road
    City
    London
    State
    London, City of
    Postal Code
    NW2 7JP
    Country
    GB

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Stents, Drains And Dilators For The Biliary Ducts FGE

    Proprietary Names

    Fusion Titan Dilation Balloon

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)