Singapore HSA registration DE0015710

ev3 Axium™ Prime Detachable Coil System

Singapore·CLASS D·Micro Therapeutics, Inc. d/b/a EV3 Neurovascular·Registered June 16, 2014

Device classification

Device Class: CLASS D
Medical Speciality Area: Neurology

Registration information

Registration Number: DE0015710
Registration Date: June 16, 2014
Change Notification Approval Date: November 08, 2024
Retention Due Date: June 15, 2025

Product description

The eV3 AXIUM™ PRIME Detachable Coils are intended for the endovascular embolization of intracranial aneurysms. The AXIUM™ PRIME Detachable Coils are also intended for the embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.

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): Axium Prime Bare Helix Configuration Axium Prime Bare 3D Configuration Axium Prime Bare Helix Configuration Axium Prime Bare 3D Configuration Axium Prime Bare Helix Configuration Axium Prime Bare 3D Configuration Axium Prime Bare Helix Configuration Axium Prime Bare 3D Configuration Axium Prime Bare Helix Configuration Axium Prime Bare 3D Configuration Axium Prime Bare Helix Configuration Axium Prime Bare 3D Configuration Axium Prime Bare Helix Configuration Axium Prime Bare Helix Configuration Axium Prime Bare 3D Configuration Axium Prime Bare Helix Configuration Axium Prime Bare 3D Configuration Axium Prime Bare Helix Configuration Axium Prime Bare 3D Configuration Axium Prime Bare Helix Configuration Axium Prime Bare Helix Configuration Axium Prime Bare Helix Configuration Axium Prime Bare Helix Configuration Axium Prime Bare 3D Configuration Axium Prime Bare Helix Configuration Axium Prime Bare 3D Configuration Axium Prime Bare Helix Configuration Axium Prime Bare Helix Configuration Axium Prime Bare Helix Configuration Axium Prime Bare 3D Configuration Axium Prime Bare Helix Configuration Axium Prime Bare 3D Configuration Axium Prime Bare Helix Configuration Axium Prime Bare 3D Configuration Axium Prime Bare Helix Configuration Axium Prime Bare 3D Configuration Axium Prime Bare 3D Configuration Axium Prime Bare 3D Configuration Axium Prime Bare 3D Configuration Axium Prime Bare Helix Configuration Axium Prime Bare 3D Configuration Axium Prime Bare Helix Configuration Axium Prime Bare 3D Configuration Axium Prime Bare Helix Configuration Axium Prime Bare 3D Configuration Axium Prime Bare Helix Configuration Axium Prime Bare 3D Configuration Axium Prime Bare Helix Configuration Axium Prime Bare 3D Configuration Axium Prime Bare Helix Configuration Axium Prime Bare Helix Configuration Axium Prime Bare 3D Configuration Axium Prime Bare 3D Configuration Axium Prime Bare Helix Configuration Axium Prime Bare 3D Configuration Axium Prime Bare 3D Configuration Axium Prime Bare Helix Configuration Axium Prime Frame Axium Prime Frame Axium Prime Frame Axium Prime Frame Axium Prime Frame Axium Prime Frame Axium Prime Frame Axium Prime Frame Axium Prime Frame Axium Prime Frame Axium Prime Frame Axium Prime Frame Axium Prime Frame Axium Prime Frame Axium Prime Frame Axium Prime Frame Axium Prime Frame Axium Prime Frame Axium Prime Frame Axium Prime Frame Axium Prime Frame Axium Prime Frame Axium Prime Frame Axium Prime Frame Axium Prime Frame Axium Prime Frame Axium Prime Frame Axium Prime Frame Axium Prime Frame Axium Prime Frame Axium Prime Frame Axium Prime Frame Axium Prime Frame Axium Prime Frame Axium Prime Frame Axium Prime Frame Axium Prime Frame Axium Prime Frame Axium Prime Frame Axium Prime Frame Axium Prime Frame Axium Prime Frame Axium Prime Frame Axium Prime Frame Instant Detacher
Model Identifier(s): APB-1-1-HX-ES* APB-1-2-3D-ES APB-1-2-HX-ES APB-1-3-3D-ES APB-1-3-HX-ES APB-1-4-3D-ES APB-1.5-1-HX-ES APB-1.5-2-3D-ES APB-1.5-2-HX-ES APB-1.5-3-3D-ES APB-1.5-3-HX-ES APB-1.5-4-3D-ES APB-1.5-4-HX-ES APB-2-1-HX-ES APB-2-2-3D-ES APB-2-2-HX-ES APB-2-3-3D-ES APB-2-3-HX-ES APB-2-4-3D-ES APB-2-4-HX-ES APB-2-6-HX-ES APB-2-8-HX-ES APB-2.5-3-HX-ES APB-2.5-4-3D-ES APB-2.5-4-HX-ES APB-2.5-6-3D-ES APB-2.5-6-HX-ES APB-2.5-8-HX-ES APB-3-10-HX-ES APB-3-4-3D-ES APB-3-4-HX-ES APB-3-6-3D-ES APB-3-6-HX-ES APB-3-8-3D-ES APB-3-8-HX-ES APB-3.5-10-3D-ES APB-3.5-6-3D-ES APB-3.5-8-3D-ES APB-4-10-3D-SS APB-4-10-HX-SS APB-4-12-3D-SS APB-4-12-HX-SS APB-4-6-3D-SS APB-4-6-HX-SS APB-4-8-3D-SS APB-4-8-HX-SS APB-5-10-3D-SS APB-5-10-HX-SS APB-5-15-3D-SS APB-5-15-HX-SS APB-5-20-HX-SS APB-5-8-3D-SS APB-6-10-3D-SS APB-6-12-HX-SS APB-6-15-3D-SS APB-6-20-3D-SS APB-6-20-HX-SS FC-10-20-3D FC-10-30-3D FC-10-40-3D FC-12-30-3D FC-12-40-3D FC-12-50-3D FC-14-30-3D FC-14-40-3D FC-14-50-3D FC-16-40-3D FC-16-50-3D FC-18-40-3D FC-18-50-3D FC-20-50-3D FC-22-50-3D FC-25-50-3D FC-3-10-3D FC-3-6-3D FC-3-8-3D FC-3.5-10-3D FC-3.5-6-3D FC-3.5-8-3D FC-4-10-3D FC-4-12-3D FC-4-15-3D FC-4-6-3D FC-4-8-3D FC-5-10-3D FC-5-15-3D FC-5-20-3D FC-5-8-3D FC-6-10-3D FC-6-15-3D FC-6-20-3D FC-6-25-3D FC-7-12-3D FC-7-15-3D FC-7-20-3D FC-7-30-3D FC-8-15-3D FC-8-20-3D FC-8-30-3D FC-9-20-3D FC-9-30-3D ID-1-5

About this record

Access comprehensive regulatory information for ev3 Axium™ Prime Detachable Coil System in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0015710 and owned by Micro Therapeutics, Inc. d/b/a EV3 Neurovascular. The device was registered on June 16, 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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