ev3 Axium™ Prime Detachable Coil System - HSA Registration DE0015710
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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CLASS D
DE0015710
ev3 Axium™ Prime Detachable Coil System
HSA Registration Number: DE0015710
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.
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 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)
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