BEUDAMED
    FDA Registration Active 🇫🇷 France

    Focal One

    Reg #: 9612448 · FEI: 3002806876 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    EDAP TMS France SA
    Registration Number
    9612448
    FEI Number
    3002806876
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4 rue du Dauphine
    City
    Vaulx en Velin Rhone
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K172721

    Owner / Operator

    Firm Name
    EDAP TMS, France SA
    Operator Number
    8023014
    Address
    4-6 RUE DU DAUPHINE, PARC D'ACTIVITE LA POUDRETTE LAMARTINE
    City
    VAULX-EN-VELIN
    State
    FR-NOTA
    Postal Code
    69120
    Country
    FR

    US Agent

    Business Name
    EDAP Technomed Inc
    Contact Name
    Hugo Embert
    Address
    5321 Industrial Oaks Blvd, Suite 110
    City
    Austin
    State
    TX
    ZIP
    78735
    Country
    US
    Email
    [email protected]
    Phone
    512 8327956 ext. 103

    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