FOCAL ONE - ARCSA Registration 9bb416702c12a8abd81f9400eb7ba11e
Access comprehensive regulatory information for FOCAL ONE in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 9bb416702c12a8abd81f9400eb7ba11e and manufactured by EDAP TMS FRANCE. The device was registered on May 22, 2020.
This page provides complete registration details including product type (Active), manufacturer information, authorized representative details, and regulatory compliance data from the official Ecuador ARCSA medical device database. Pure Global AI offers free access to Ecuador's complete medical device registry.
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ARCSA Official Data
III
9bb416702c12a8abd81f9400eb7ba11e
FOCAL ONE
ARCSA ID: 9bb416702c12a8abd81f9400eb7ba11e
Device Classification
Risk Class
III
Product Type
Active
Brand Name
EDAP TMS
Commercial Name
Ultrasonic Therapy Systems
Registration Information
Analysis ID
9bb416702c12a8abd81f9400eb7ba11e
Registration Date
May 22, 2020
Expiration Date
May 22, 2025
Product Use
IT IS A COMPUTER-CONTROLLED MEDICAL DEVICE FOR THE TREATMENT OF PROSTATE CANCER WITH HIGH-INTENSITY FOCUSED ULTRASOUND OR HIFU.
Manufacturer
Name
EDAP TMS FRANCECountry
FRENCH
Address
PARC D ACTIVITES LA POUDRETTE LAMARTINE - 4 RUE DUDAUPHINE- 69120 VAULX EN VELIN
Product Owner
Name
EDAP TMS FRANCE
Country
FRENCH
Authorized Representative
Address
PICHINCHA / QUITO / IÑAQUITO / AV. DIEGO DE ALMAGRO N31-36 AND ALPALLANA / NORTH TOWER / GALICIA BUILDING
Phone
22556496