BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    Helena Laboratories UK Ltd

    Reg #: 3009736003 · FEI: 3009736003 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Helena Laboratories UK Ltd
    Registration Number
    3009736003
    FEI Number
    3009736003
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Queensway South, Team Valley Trading Estate
    City
    Gateshead Newcastle upon Tyne
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K111369

    Owner / Operator

    Firm Name
    Helena Biosciences Europe
    Operator Number
    10041365
    Address
    Queensway South, Team Valley Trading Estate
    City
    Gateshead
    State
    GB-GAT
    Postal Code
    NE11 0SD
    Country
    GB
    Correspondent
    Ben J Johnson

    US Agent

    Business Name
    Director of Regulatory Affairs
    Contact Name
    Rachel Easley
    Address
    1530 Lindbergh Drive, Beaumont
    City
    Beaumont
    State
    TX
    ZIP
    77707
    Country
    US
    Email
    [email protected]
    Phone
    409 8423714 ext. 1275

    Products

    Device Name Product Code
    Immunoelectrophoretic, Immunoglobulins, (G, A, M) CFF
    Electrophoretic, Protein Fractionation CEF

    Proprietary Names

    V8 Immunodisplacement Kit V8 UltraCE Electrophoresis Instrument V8 Nexus Electrophoresis Instrument

    Establishment Types

    Manufacture Medical Device