Singapore HSA registration DE0506419
Biosense Webster CARTO OCTARAY Mapping Catheter with TRUERef Technology
Singapore·CLASS D·Biosense Webster, Inc.·Registered November 26, 2021Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- Cardiovascular
Registration information
- Registration Number
- DE0506419
- Registration Date
- November 26, 2021
- Change Notification Approval Date
- September 29, 2024
- Retention Due Date
- November 25, 2025
Product description
The CARTO® OCTARAY™ Mapping Catheter with TRUEref™ Technology is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e. recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The catheter provides location information only when used with compatible versions of the CARTO® 3 EP Navigation System.
Product Owner
- Short Name
- Biosense Webster, Inc.
- Address
- 31 Technology Drive, Suite 200, Irvine, CA 92618, UNITED STATES
Registrant
- Address
- 2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Importer
- Address
- 2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222 2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Model information
- Model Name(s)
- CARTO OCTARAY Mapping Catheter with TRUEref Technology 2-2-2-2-2 CARTO OCTARAY Mapping Catheter with TRUEref Technology 2-5-2-5-2 CARTO OCTARAY Mapping Catheter with TRUEref Technology 3-3-3-3-3 CARTO OCTARAY Mapping Catheter with TRUEref Technology 2-2-2-2-2 CARTO OCTARAY Mapping Catheter with TRUEref Technology 2-5-2-5-2 CARTO OCTARAY Mapping Catheter with TRUEref Technology 3-3-3-3-3
- Model Identifier(s)
- D160901 D160902 D160903 D160904 D160905 D160906
About this record
Access comprehensive regulatory information for Biosense Webster CARTO OCTARAY Mapping Catheter with TRUERef Technology in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0506419 and owned by Biosense Webster, Inc.. The device was registered on November 26, 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