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RESTORE DEB Paclitaxel Releasing PTCA Balloon Dilatacion Catheter - ARCSA Registration 72410fe02e110ba0238f4330e06080d3

Access comprehensive regulatory information for RESTORE DEB Paclitaxel Releasing PTCA Balloon Dilatacion Catheter in the Ecuador medical device market through Pure Global AI's free database. This IV medical device is registered under ARCSA ID 72410fe02e110ba0238f4330e06080d3 and manufactured by CARDIONOVUM GMBH. The device was registered on December 17, 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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IV
72410fe02e110ba0238f4330e06080d3
RESTORE DEB Paclitaxel Releasing PTCA Balloon Dilatacion Catheter
ARCSA ID: 72410fe02e110ba0238f4330e06080d3
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Device Classification
Risk Class
IV
Product Type
Invasive
Brand Name
CARDIONOVUM GmbH
Commercial Name
CATHETERS, VASCULAR, ANGIOPLASTY, BALLOON
Registration Information
Analysis ID
72410fe02e110ba0238f4330e06080d3
Registration Date
December 17, 2020
Expiration Date
December 17, 2025
Product Use

IT IS INDICATED FOR PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE CAUSED BY ISOLATED LESIONS OF THE CORONARY ARTERIES WITH A REFERENCE VASCULAR DIAMETER OF 1.5 TO 4.00 MM TO IMPROVE THE DIAMETER OF THE CORONARY LUMEN.

Manufacturer
City
BONN
Country
GERMANY
Address
AM BONNER BOGEN 2, 53227 BONN
Product Owner
Name
HEALTH SPHERE LLC
Country
UNITED STATES
Authorized Representative
Address
AV DE LOS SHYRIS N9-38 AND BELGICA STREET
Phone
23800917