Singapore HSA registration DE0506462
Micro Therapeutics Rist™ Radial Access Selective Catheter
Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- Neurology
Registration information
- Registration Number
- DE0506462
- Registration Date
- December 09, 2021
- Change Notification Approval Date
- October 06, 2023
- Retention Due Date
- December 08, 2025
Product description
The Rist™ Radial Access Selective Catheter is indicated for the introduction of interventional devices into the peripheral, coronary and neurovasculature. It can be used to facilitate introduction of diagnostic agents in the neurovasculature. It is not intended to facilitate introduction of diagnostic agents in coronary or peripheral arteries.
Product Owner
- Short Name
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Address
- 9775 Toledo Way, Irvine CA 92618, UNITED STATES, UNITED STATES
Registrant
- Address
- 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Importer
- Name
- COVIDIEN PRIVATE LIMITED MEDTRONIC INTERNATIONAL TRADING PTE. LTD. MEDTRONIC INTERNATIONAL, LTD.
- Address
- 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384 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)
- Rist™ Radial Access Selective Catheter Rist™ Radial Access Selective Catheter Rist™ Radial Access Selective Catheter Rist™ Radial Access Selective Catheter
- Model Identifier(s)
- 105F-BER-120 105F-BER-130 105F-SIM-120 105F-SIM-130
About this record
Access comprehensive regulatory information for Micro Therapeutics Rist™ Radial Access Selective Catheter in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0506462 and owned by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The device was registered on December 09, 2021.
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS D