Singapore HSA registration DE0008154
ev3 HyperForm™ Occlusion Balloon System
Singapore·CLASS D·Micro Therapeutics, Inc. d/b/a EV3 Neurovascular·Registered December 16, 2011Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- Cardiovascular
- HSA Product Code
- HSAMDD00110
- HS Code
- 90183910
Registration information
- Registration Number
- DE0008154
- Registration Date
- December 16, 2011
- Change Notification Approval Date
- April 12, 2024
- Retention Due Date
- December 15, 2025
Product description
The ev3 Occlusion Balloon Catheters are indicated for use in blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired. These catheters offer a vessel selective technique of temporary vascular occlusion, which is useful in selectively stopping or controlling blood flow; the Occlusion Balloon Catheters may also be used in balloon assisted embolization of intracranial aneurysms.
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)
- HyperForm™ Occlusion Balloon Catheter HyperForm™ Occlusion Balloon Catheter HyperForm™ Occlusion Balloon Catheter HyperForm™ Occlusion Balloon Catheter HyperForm™ Occlusion Balloon Catheter HyperForm™ Occlusion Balloon Catheter HyperForm™ Occlusion Balloon Catheter
- Model Identifier(s)
- 104-4153 104-4370 104-4415 104-4420 104-4470 104-4715 104-4770
About this record
Access comprehensive regulatory information for ev3 HyperForm™ Occlusion Balloon 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 DE0008154 and owned by Micro Therapeutics, Inc. d/b/a EV3 Neurovascular. The device was registered on December 16, 2011.
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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