EV3™ HYPERGLIDE™ OCCLUSION BALLOON SYSTEM - FDA Registration MDR-01768

Access comprehensive regulatory information for EV3™ HYPERGLIDE™ OCCLUSION BALLOON SYSTEM in the Philippines medical device market through Pure Global AI's free database. This device is registered under FDA registration number MDR-01768 and manufactured by Covidien Private Limited-50 Pasir Panjang Road, #04-51 Mapletree Business City, Singapore Mfd by: Micro Therapeutics, Inc - D.B.A. EV3 Neuro Vascular - 9775 Toledo Way, Irvine, CA, USA in USA. The device was registered on February 19, 2025.

This page provides complete registration details including manufacturer information, importer/distributor details (Medtronic Philippines, Inc), and regulatory compliance data from the official Philippines FDA medical device database. Pure Global AI offers free access to Philippines' complete medical device registry, helping global MedTech companies navigate FDA regulations efficiently.