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ev3 Neurovascular Concerto™ PGLA Enlaced Detachable Coils - HSA Registration DE0017022

Access comprehensive regulatory information for ev3 Neurovascular Concerto™ PGLA Enlaced Detachable Coils in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0017022 and owned by Micro Therapeutics, Inc. d/b/a EV3 Neurovascular. The device was registered on April 16, 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
DE0017022
ev3 Neurovascular Concerto™ PGLA Enlaced Detachable Coils
HSA Registration Number: DE0017022
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Product Description

The ev3 Neurovascular Concerto™ PGLA Enlaced Detachable Coils are intended for arterial and venous embolizations in the peripheral vasculature.

Device Classification
Device Class
CLASS D
Medical Speciality Area
General & Plastic Surgery
HSA Product Code
HSAMDD00107
HS Code
90219000
Registration Information
Registration Number
DE0017022
Registration Date
April 16, 2015
Change Notification Approval Date
November 08, 2024
Retention Due Date
April 15, 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)
Concerto Detachable Coil System Concerto Detachable Coil System Concerto Detachable Coils - PGLA Configurations Concerto Detachable Coil System Concerto Detachable Coils - PGLA Configurations Concerto Detachable Coils - PGLA Configurations Concerto Detachable Coil System Concerto Detachable Coils - PGLA Configurations Concerto Detachable Coil System Concerto Detachable Coils - PGLA Configurations Concerto Detachable Coil System Concerto Detachable Coils - PGLA Configurations Concerto Detachable Coil System Concerto Detachable Coil System Concerto Detachable Coil System Concerto Detachable Coils - PGLA Configurations Concerto Detachable Coil System Concerto Detachable Coil System Concerto Detachable Coil System Concerto Detachable Coil System Concerto Detachable Coil System Concerto Detachable Coil System Concerto Detachable Coil System Concerto Detachable Coil System Concerto Detachable Coil System Concerto Detachable Coil System Concerto Detachable Coil System Concerto Detachable Coil System Concerto Detachable Coil System Concerto Detachable Coil System Concerto Detachable Coil System Concerto Detachable Coil System
Model Identifier(s)
PV-10-20-3D PV-10-30-3D PV-12-30-HELIX PV-12-40-3D PV-12-40-HELIX PV-14-30-HELIX PV-14-40-3D PV-14-40-HELIX PV-16-40-3D PV-16-40-HELIX PV-18-40-3D PV-18-40-HELIX PV-2-2-3D PV-2-4-3D PV-2-6-3D PV-20-50-HELIX PV-3-4-3D PV-3-6-3D PV-3-8-3D PV-4-10-3D PV-4-12-3D PV-4-8-3D PV-5-10-3D PV-5-15-3D PV-6-15-3D PV-6-20-3D PV-7-20-3D PV-7-30-3D PV-8-20-3D PV-8-30-3D PV-9-20-3D PV-9-30-3D