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MYVAL Transcatheter Heart Valve - ARCSA Registration 7b5982ccebcc71e49d10fc5999e07c1b

Access comprehensive regulatory information for MYVAL Transcatheter Heart Valve in the Ecuador medical device market through Pure Global AI's free database. This IV medical device is registered under ARCSA ID 7b5982ccebcc71e49d10fc5999e07c1b and manufactured by MERIL LIFE SCIENCES PVT LTD. The device was registered on February 21, 2020.

This page provides complete registration details including product type (Invasive), 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
IV
7b5982ccebcc71e49d10fc5999e07c1b
MYVAL Transcatheter Heart Valve
ARCSA ID: 7b5982ccebcc71e49d10fc5999e07c1b
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Device Classification
Risk Class
IV
Product Type
Invasive
Brand Name
CRITERIA
Commercial Name
MYVAL Transcatheter Heart Valve System
Registration Information
Analysis ID
7b5982ccebcc71e49d10fc5999e07c1b
Registration Date
February 21, 2020
Expiration Date
February 21, 2025
Product Use

THE MYVALTM TRANSCATHETER HEART VALVE (THV) AND ACCESSORIES ARE INDICATED FOR RELIEF OF AORTIC STENOSIS IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO SEVERE NATIVE CALCIFIC AORTIC STENOSIS AS JUDGED BY A HEART TEAM (INCLUDING A CARDIAC SURGEON) AND IN PATIENTS WHO ARE AT HIGH RISK FOR OPEN HEART SURGICAL THERAPY

Manufacturer
Country
INDIA
Address
NEAR GM BILAKHIA STADIUM MUKTANAND MARG CHALA VAPI DIST VALSAD GUJARAT
Product Owner
Name
MERIL LIFE SCIENCES PVT LTD
Country
INDIA
Authorized Representative
Address
CALLE BY. LEOPOLDO BENTEZ. INTERSECCIN: OF. JOAQUN ORRANTIA.
Phone
42109097