BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    PROFOUND MEDICAL INC.

    Reg #: 3012604011 · FEI: 3012604011 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    4
    Classifications
    1

    Registration Details

    Registration Name
    PROFOUND MEDICAL INC.
    Registration Number
    3012604011
    FEI Number
    3012604011
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2400 Skymark Avenue, Unit 6
    City
    Mississauga Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K211858
    PMA Number
    H190003

    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
    QND

    Proprietary Names

    TULSA-PRO Sonalleve MR-HIFU

    Establishment Types

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