Singapore HSA registration DE0017022
ev3 Neurovascular Concerto™ PGLA Enlaced Detachable Coils
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 description
The ev3 Neurovascular Concerto™ PGLA Enlaced Detachable Coils are intended for arterial and venous embolizations in the peripheral vasculature.
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
About this record
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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