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eV3 Navienโ„ข Intracranial Support Catheter - HSA Registration DE0016725

Access comprehensive regulatory information for eV3 Navienโ„ข 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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CLASS D
DE0016725
eV3 Navienโ„ข Intracranial Support Catheter
HSA Registration Number: DE0016725
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Product Description

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

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 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 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