BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Focal One

    Reg #: 1287394 · FEI: 1287394 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Edap Technomed Inc.
    Registration Number
    1287394
    FEI Number
    1287394
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    5321 Industrial Oaks Blvd, Suite 110
    City
    Austin
    State
    TX
    ZIP
    78735
    Country
    US

    Regulatory Submissions

    510(k) Number
    K172721

    Owner / Operator

    Firm Name
    EDAP Technomed Inc.
    Operator Number
    10040253
    Address
    5321 Industrial Oaks Blvd., Suite 110
    City
    Austin
    State
    TX
    Postal Code
    78735
    Country
    US
    Correspondent
    Hugo Embert

    Products

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

    Proprietary Names

    Focal One

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198