BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    BIOS Diagnostics Clarity Blood Pressure Monitor BD323

    Reg #: 3006537699 · FEI: 3006537699 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    THERMOR LTD.
    Registration Number
    3006537699
    FEI Number
    3006537699
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    16975 Leslie Street
    City
    Newmarket Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K160019

    Owner / Operator

    Firm Name
    Thermor Ltd.
    Operator Number
    10037045
    Address
    16975 Leslie Street
    City
    Newmarket
    State
    Ontario
    Postal Code
    L3Y 9A1
    Country
    CA
    Correspondent
    Iona Wenzel

    US Agent

    Business Name
    Global Test Supply
    Contact Name
    Kelly Medina
    Address
    312 Raleigh St. Unit 9
    City
    Wilmington
    State
    NC
    ZIP
    28412
    Country
    US
    Email
    [email protected]
    Phone
    910 4422164 ext. 5101

    Products

    Device Name Product Code
    System, Measurement, Blood-Pressure, Non-Invasive DXN

    Proprietary Names

    BIOS Diagnostics Clarity Blood Pressure Monitor BD323 BIOS Diagnostics Easy Read Blood Pressure Monitor BD201 BIOS Diagnostics Precision Blood Pressure Monitor BD240 BIOS Diagnostics Insight Blood Pressure Monitor BD252 BIOS Diagnostics Simplicity Blood Pressure Monitor BD313

    Establishment Types

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