BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    One Step

    Reg #: 3006798115 · FEI: 3006798115 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Home Health (UK) Ltd.
    Registration Number
    3006798115
    FEI Number
    3006798115
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Unit A, Greatham Road Industrial Estate,, Greatham Road
    City
    Bushey Hertfordshire
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K053033

    Owner / Operator

    Firm Name
    Home Health (UK) Ltd.
    Operator Number
    10023140
    Address
    Unit A, Greatham Road Industrial Estate, Greatham Road,
    City
    Bushey
    State
    Hertfordshire
    Postal Code
    WD23 2NZ
    Country
    GB
    Correspondent
    Mark R Hanson

    US Agent

    Business Name
    Home Health (US)
    Contact Name
    Mark Hanson
    Address
    4414 Useppa Drive
    City
    Bradenton
    State
    FL
    ZIP
    34203
    Country
    US
    Email
    [email protected]
    Phone
    941 2422952

    Products

    Device Name Product Code
    Thin Layer Chromatography, Methamphetamine DJC

    Proprietary Names

    One Step

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device