Singapore HSA registration DE0016725

eV3 Navien™ Intracranial Support Catheter

Singapore·CLASS D·Micro Therapeutics, Inc. d/b/a EV3 Neurovascular·Registered January 08, 2015

Device classification

Device Class: CLASS D
Medical Speciality Area: Neurology

Registration information

Registration Number: DE0016725
Registration Date: January 08, 2015
Change Notification Approval Date: July 11, 2024
Retention Due Date: January 07, 2026

Product description

The Navien Intracranial Support Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

Product Owner

Name: Micro Therapeutics, Inc. d/b/a EV3 Neurovascular
Short Name: ev3 Neurovascular
Address: 9775 Toledo Way,, Irvine, CA. 92618, UNITED STATES

Registrant

Name: COVIDIEN PRIVATE LIMITED
Address: 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384

Importer

Name: COVIDIEN PRIVATE LIMITED MEDTRONIC INTERNATIONAL, LTD.
Address: 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384

Model information

Model Name(s): Navien Intracranial Support Catheter Navien Intracranial Support Catheter Navien Intracranial Support Catheter Navien Intracranial Support Catheter Navien Intracranial Support Catheter Navien Intracranial Support Catheter Navien Intracranial Support Catheter Navien Intracranial Support Catheter Navien Intracranial Support Catheter Navien Intracranial Support Catheter Navien Intracranial Support Catheter Navien Intracranial Support Catheter Navien Intracranial Support Catheter Navien Intracranial Support Catheter
Model Identifier(s): RFX058-105-08 RFX058-115-08 RFX058-125-08 RFX058-130-08 RFX072-105-08 RFX072-105-08MP RFX072-115-08 RFX072-115-08MP RFX072-125-08 RFX072-125-08MP RFX072-130-08 RFX072-130-08MP RFX072-95-08 RFX072-95-08MP

About this record

Access comprehensive regulatory information for eV3 Navien™ Intracranial Support Catheter in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0016725 and owned by Micro Therapeutics, Inc. d/b/a EV3 Neurovascular. The device was registered on January 08, 2015.

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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