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Micro Therapeutics Axium™ Detachable Coil System - HSA Registration DE0510413

Access comprehensive regulatory information for Micro Therapeutics Axium™ 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 DE0510413 and owned by Micro Therapeutics, Inc. d/b/a EV3 Neurovascular. The device was registered on March 03, 2025.

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
DE0510413
Micro Therapeutics Axium™ Detachable Coil System
HSA Registration Number: DE0510413
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Product Description

Axium™ Detachable Coils are intended for the endovascular embolization of intracranial aneurysms. Axium™ 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
DE0510413
Registration Date
March 03, 2025
Retention Due Date
March 02, 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
Model Information
Model Name(s)
Axium™ Detachable Coil System (Nylon Helix) Axium™ Detachable Coil System (Nylon Helix) Axium™ Detachable Coil System (Nylon Helix) Axium™ Detachable Coil System (Nylon Helix) Axium™ Detachable Coil System (Nylon Helix) Axium™ Detachable Coil System (Nylon Helix) Axium™ Detachable Coil System (Nylon Helix) Axium™ Detachable Coil System (Nylon Helix) Axium™ Detachable Coil System (Nylon Helix) Axium™ Detachable Coil System (Nylon Helix) Axium™ Detachable Coil System (Nylon Helix) Axium™ Detachable Coil System (PGLA 3D) Axium™ Detachable Coil System (PGLA Helix) Axium™ Detachable Coil System (PGLA 3D) Axium™ Detachable Coil System (PGLA Helix) Axium™ Detachable Coil System (PGLA 3D) Axium™ Detachable Coil System (PGLA 3D) Axium™ Detachable Coil System (PGLA 3D) Axium™ Detachable Coil System (PGLA 3D) Axium™ Detachable Coil System (PGLA 3D) Axium™ Detachable Coil System (PGLA 3D) Axium™ Detachable Coil System (PGLA Helix) Axium™ Detachable Coil System (PGLA 3D) Axium™ Detachable Coil System (PGLA Helix) Axium™ Detachable Coil System (PGLA Helix) Axium™ Detachable Coil System (PGLA 3D) Axium™ Detachable Coil System (PGLA Helix) Axium™ Detachable Coil System (PGLA 3D) Axium™ Detachable Coil System (PGLA Helix) Axium™ Detachable Coil System (PGLA Helix) Axium™ Detachable Coil System (PGLA 3D) Axium™ Detachable Coil System (PGLA Helix) Axium™ Detachable Coil System (PGLA 3D) Axium™ Detachable Coil System (PGLA Helix) Axium™ Detachable Coil System (PGLA 3D) Axium™ Detachable Coil System (PGLA Helix) Axium™ Detachable Coil System (PGLA 3D) Axium™ Detachable Coil System (PGLA Helix) Axium™ Detachable Coil System (PGLA 3D) Axium™ Detachable Coil System (PGLA Helix) Axium™ Detachable Coil System (PGLA 3D) Axium™ Detachable Coil System (PGLA 3D) Axium™ Detachable Coil System (PGLA Helix) Axium™ Detachable Coil System (PGLA 3D) Axium™ Detachable Coil System (PGLA 3D) Axium™ Detachable Coil System (PGLA Helix) Axium™ Detachable Coil System (PGLA Helix) Axium™ Detachable Coil System (PGLA 3D) Axium™ Detachable Coil System (PGLA 3D) Axium™ Detachable Coil System (PGLA 3D) Axium™ Detachable Coil System (PGLA 3D) Axium™ Detachable Coil System (PGLA Helix) Axium™ Detachable Coil System (PGLA 3D) Axium™ Detachable Coil System (PGLA 3D) Axium™ Detachable Coil System (PGLA Helix) Axium™ Detachable Coil System (PGLA 3D) Axium™ Detachable Coil System (PGLA Helix) Axium™ Detachable Coil System (PGLA 3D) Axium™ Detachable Coil System (PGLA 3D) Axium™ Detachable Coil System (PGLA Helix) Axium™ Detachable Coil System (PGLA 3D) Axium™ Detachable Coil System (PGLA Helix) Axium™ Detachable Coil System (PGLA 3D) Axium™ Detachable Coil System (PGLA Helix) Axium™ Detachable Coil System (PGLA 3D) Axium™ Detachable Coil System (PGLA Helix)
Model Identifier(s)
NC-2-1-HELIX NC-2-2-HELIX NC-2-3-HELIX NC-2-4-HELIX NC-2-6-HELIX NC-2-8-HELIX NC-3-4-HELIX NC-3-6-HELIX NC-3-8-HELIX NC-4-10-HELIX NC-4-8-HELIX PC-10-20-3D PC-10-20-HELIX PC-10-30-3D PC-10-30-HELIX PC-12-30-3D PC-12-40-3D PC-14-30-3D PC-14-40-3D PC-16-40-3D PC-18-40-3D PC-2-1-HELIX PC-2-2-3D PC-2-2-HELIX PC-2-3-HELIX PC-2-4-3D PC-2-4-HELIX PC-2-6-3D PC-2-6-HELIX PC-2-8-HELIX PC-3-4-3D PC-3-4-HELIX PC-3-6-3D PC-3-6-HELIX PC-3-8-3D PC-3-8-HELIX PC-4-10-3D PC-4-10-HELIX PC-4-12-3D PC-4-12-HELIX PC-4-6-3D PC-4-8-3D PC-4-8-HELIX PC-5-10-3D PC-5-15-3D PC-5-15-HELIX PC-5-20-HELIX PC-5-8-3D PC-6-10-3D PC-6-15-3D PC-6-20-3D PC-6-20-HELIX PC-7-15-3D PC-7-20-3D PC-7-20-HELIX PC-7-30-3D PC-7-30-HELIX PC-8-15-3D PC-8-20-3D PC-8-20-HELIX PC-8-30-3D PC-8-30-HELIX PC-9-20-3D PC-9-20-HELIX PC-9-30-3D PC-9-30-HELIX