BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    Hayek RTX Respirator

    Reg #: 3008808130 · FEI: 3008808130 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    UNITED HAYEK INDUSTRIES MANUFACTURING LTD
    Registration Number
    3008808130
    FEI Number
    3008808130
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    10 Downage
    City
    London Barnet
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K082657

    Owner / Operator

    Firm Name
    United Hayek Industries Manufacturing Ltd
    Operator Number
    10034905
    Address
    10 Downage
    City
    London
    State
    Barnet
    Postal Code
    NW4 1AA
    Country
    GB
    Correspondent
    Shahar Hayek

    US Agent

    Business Name
    Buffalo Respiratory Therapy, LLC
    Contact Name
    Joe Polito
    Address
    17 Limestone Drive, Suite #3
    City
    Williamsville
    State
    NY
    ZIP
    14221
    Country
    US
    Email
    [email protected]
    Phone
    716 9327581

    Products

    Device Name Product Code
    Ventilator, External Body, Negative Pressure, Adult (Cuirass) BYT

    Proprietary Names

    Hayek RTX Respirator Hayek Oscillator

    Establishment Types

    Manufacture Medical Device