BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    TULSA-PRO

    Reg #: 3012604011 · FEI: 3012604011 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    PROFOUND MEDICAL INC.
    Registration Number
    3012604011
    FEI Number
    3012604011
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2400 Skymark Avenue, Unit 6
    City
    Mississauga Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K191200

    Owner / Operator

    Firm Name
    Profound Medical Inc.
    Operator Number
    10061262
    Address
    2400 Skymark Avenue, Unit 6
    City
    Mississauga
    State
    Ontario
    Postal Code
    L4W 5K5
    Country
    CA
    Correspondent
    Imen Ferchichi

    Products

    Device Name Product Code
    High Intensity Ultrasound System For Prostate Tissue Ablation PLP

    Proprietary Names

    TULSA-PRO

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198