c50a7edcd8b20b3c4f588e255a8a7b88

PREFACE™ GUIDING SHEATH

CARDINAL HEALTH MEXICO 244 S DE RL DE CV·II·Ecuador ARCSA·Registered August 18, 2021
Device classification
Risk class
II
Product type
Invasive
Brand name
PREFACE™ GUIDING SHEATH
Commercial name
Catheter Introducers
Registration information
Analysis ID
c50a7edcd8b20b3c4f588e255a8a7b88
Registration date
August 18, 2021
Expiration date
August 18, 2026
Manufacturer
Country
MEXICO
Address
SANTIAGO TRONCOSO # 808, PARQUE INDUSTRIAL SALVARCAR 32574
Product owner
Name
BIOSENSE WEBSTER, INC.
Country
UNITED STATES
Authorized representative
Address
AV. CORUÑA N28-14 Y MANUEL ITURREY, EDIFICIO SANTA FE, OF 11, DIAGONAL A DOMINOS PIZZA
Phone
983350955
Product use

THE INTENDED USE OF THE PREFACE REINFORCED GUIDE INTRODUCER PERCUTANEOUS EXCHANGE SYSTEM IS THE INTRODUCTION OF INTRAVASCULAR CATHETERS FOR ELECTROPHYSIOLOGY INTO THE CARDIAC CHAMBER.

About this record

Access comprehensive regulatory information for PREFACE™ GUIDING SHEATH in the Ecuador medical device market through Pure Global AI's free database. This II medical device is registered under ARCSA ID c50a7edcd8b20b3c4f588e255a8a7b88 and manufactured by CARDINAL HEALTH MEXICO 244 S DE RL DE CV. The device was registered on August 18, 2021.

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.