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ABLATHERM INTEGRATED IMAGING (EDP 900800) - ARCSA Registration 58cf85d0c4f6c00cf3f8aef97b33c9a4

Access comprehensive regulatory information for ABLATHERM INTEGRATED IMAGING (EDP 900800) in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 58cf85d0c4f6c00cf3f8aef97b33c9a4 and manufactured by EDAP TMS FRANCE. The device was registered on December 10, 2018.

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
58cf85d0c4f6c00cf3f8aef97b33c9a4
ABLATHERM INTEGRATED IMAGING (EDP 900800)
ARCSA ID: 58cf85d0c4f6c00cf3f8aef97b33c9a4
Local name: ABLATHERM IMAGERIE INTEGREE (EDP 900800)
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Device Classification
Risk Class
III
Product Type
Active
Brand Name
EDAP TMS
Commercial Name
Ultrasonic Therapy Systems
Registration Information
Analysis ID
58cf85d0c4f6c00cf3f8aef97b33c9a4
Registration Date
December 10, 2018
Expiration Date
December 10, 2023
Creation Date
January 19, 2022
Product Use

THE ABLATHERM IS A COMPUTER-CONTROLLED MEDICAL DEVICE DESIGNED TO PROVIDE HIGH-INTENSITY FOCUSED ULTRASOUND (HIFU) TREATMENT FOR LOCALIZED PROSTATE CANCER.

Manufacturer
Country
FRENCH
Address
PARC D ACTIVITES LA POUDRETTE LAMARTINE - 4 RUE DU DAUPHINE- 69120
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