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SONOLITH®I-SYS - ARCSA Registration 7ef45d36b73a4d902c81ca69cb2e3c2f

Access comprehensive regulatory information for SONOLITH®I-SYS in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID 7ef45d36b73a4d902c81ca69cb2e3c2f and manufactured by EDAP TMS FRANCE. The device was registered on May 06, 2019.

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
7ef45d36b73a4d902c81ca69cb2e3c2f
SONOLITH®I-SYS
ARCSA ID: 7ef45d36b73a4d902c81ca69cb2e3c2f
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Device Classification
Risk Class
III
Product Type
Active
Brand Name
EDAPT TMS
Commercial Name
Modular, Mobile Medical Facilities for Urology/Lithotripsy
Registration Information
Analysis ID
7ef45d36b73a4d902c81ca69cb2e3c2f
Registration Date
May 06, 2019
Expiration Date
May 06, 2024
Product Use

SONOLITH® I-SYS IS DESIGNED FOR THE DISINTEGRATION OF STONES LOCATED IN THE URINARY TRACT, THAT IS, THE KIDNEYS (RENAL PELVIS AND CALICES) AND URETER (UPPER, MIDDLE AND LOWER). CAN ALSO BE USED FOR ENDOUROLOGICAL PROCEDURES

Manufacturer
City
VAULX-EN-VELIN, FRANCIA
Country
FRENCH
Address
4 RUE DU DAUPHINE, 69120 VAULX-EN-VELIN, FRANCIA
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