BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Trex HD (monitoring)

    Reg #: 3007611554 · FEI: 3007611554 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    CREATION TECHNOLOGIES LTD
    Registration Number
    3007611554
    FEI Number
    3007611554
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6820 Creditview Road
    City
    Mississauga Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K162595

    Owner / Operator

    Firm Name
    Creation Technologies LTD
    Operator Number
    10043958
    Address
    110 Clegg Road
    City
    Markham
    State
    Ontario
    Postal Code
    L6G 1E1
    Country
    CA

    Products

    Device Name Product Code
    Full-Montage Standard Electroencephalograph GWQ
    Standard Polysomnograph With Electroencephalograph OLV

    Proprietary Names

    Trex HD (monitoring)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)