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Medtronic React 68 and React 71 Catheters - HSA Registration DE0503787

Access comprehensive regulatory information for Medtronic React 68 and React 71 Catheters in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0503787 and owned by Micro Therapeutics, Inc. d/b/a EV3 Neurovascular. The device was registered on November 01, 2019.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS D
DE0503787
Medtronic React 68 and React 71 Catheters
HSA Registration Number: DE0503787
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Product Description

The Reactโ„ข 68 Catheter and Reactโ„ข 71 Catheter are indicated for the introduction of interventional/diagnostic devices into the peripheral and neurovasculature. The Reactโ„ข 68 Catheter and Reactโ„ข 71 Catheter are also indicated for the removal/aspiration of emboli and thrombi from selected blood vessels in the arterial system, including the neurovasculature.

Device Classification
Device Class
CLASS D
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0503787
Registration Date
November 01, 2019
Change Notification Approval Date
July 11, 2024
Retention Due Date
October 31, 2025
Product Owner
Short Name
ev3 Neurovascular
Address
9775 Toledo Way,, Irvine, CA. 92618, UNITED STATES
Registrant
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Importer
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Model Information
Model Name(s)
React 68 Catheter React 71 Catheter
Model Identifier(s)
React-68 React-71