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ev3 Avigo Hydrophilic Guidewire - HSA Registration DE0015651

Access comprehensive regulatory information for ev3 Avigo Hydrophilic Guidewire in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0015651 and owned by Micro Therapeutics, Inc. d/b/a EV3 Neurovascular. The device was registered on June 09, 2014.

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
DE0015651
ev3 Avigo Hydrophilic Guidewire
HSA Registration Number: DE0015651
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Product Description

The ev3 Avigo Hydrophilic Guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the peripheral and cerebral vasculature during diagnostic and/or therapeutic procedures. The device is not intended for use in the coronary arteries. The Guidewire Torque Device is intended to facilitate guidewire manipulation during interventional procedures. The Guidewire Introducer is intended to facilitate guidewire insertion into a catheter hub or through a hemostasis valve.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Neurology
HSA Product Code
HSAMDZ00100
HS Code
90183990
Registration Information
Registration Number
DE0015651
Registration Date
June 09, 2014
Retention Due Date
June 08, 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 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Model Information
Model Name(s)
Avigo Hydrophilic Guidewire
Model Identifier(s)
103-0606-200