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Implantable Cardioverter Defibrillators Unify Assura - ARCSA Registration a8f513c196f6096e8c64847f54dfb31d

Access comprehensive regulatory information for Implantable Cardioverter Defibrillators Unify Assura in the Ecuador medical device market through Pure Global AI's free database. This IV medical device is registered under ARCSA ID a8f513c196f6096e8c64847f54dfb31d and manufactured by ABBOTT MEDICAL. The device was registered on May 06, 2023.

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
IV
a8f513c196f6096e8c64847f54dfb31d
Implantable Cardioverter Defibrillators Unify Assura
ARCSA ID: a8f513c196f6096e8c64847f54dfb31d
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Device Classification
Risk Class
IV
Product Type
Active
Brand Name
ABBOTT
Commercial Name
Defibrillators/Cardioverters/Pacemakers, Implantable, for Resynchronization
Registration Information
Analysis ID
a8f513c196f6096e8c64847f54dfb31d
Registration Date
May 06, 2023
Expiration Date
May 06, 2028
Product Use

DEVICE INTENDED PRIMARILY FOR USE WITH COMPATIBLE LEADS FOR THE PURPOSE OF DETECTING AND TREATING LIFE-THREATENING VENTRICULAR ARRHYTHMIAS BY PROVIDING VENTRICULAR ANTITACHYCARDIAL PACING AS WELL AS VENTRICULAR CARDIOVERSION/DEFIBRILLATION

Manufacturer
City
SYLMAR
Country
UNITED STATES
Address
15900 VALLEY VIEW COURT, SYLMAR CA 91342, USA
Product Owner
Name
ABBOTT MEDICAL
Country
UNITED STATES
Authorized Representative
Address
510 AVE. DE LAS AMERICAS AND CALLE PUBLICA
Phone
2627377