Singapore HSA registration DE0508491
Biosense Webster QDOT MICRO Uni-Directional and Bi-Directional Navigation Catheter
Singapore·CLASS D·Biosense Webster, Inc.·Registered September 14, 2023Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- Cardiovascular
Registration information
- Registration Number
- DE0508491
- Registration Date
- September 14, 2023
- Change Notification Approval Date
- February 27, 2025
- Retention Due Date
- September 13, 2025
Product description
The QDOT MICRO™ Uni-Directional Catheter and Bi- Directional Catheter and related accessory devices are indicated for catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used in conjunction with a compatible RF generator, for cardiac ablation. The catheter provides a real-time measurement of temperature and contact force between the catheter tip and heart wall, as well as location information when used with a CARTO™ 3 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)
- QDOT MICRO Uni-Directional Navigation Catheter QDOT MICRO Uni-Directional Navigation Catheter QDOT MICRO Uni-Directional Navigation Catheter QDOT MICRO Bi-Directional Navigation Catheter QDOT MICRO Bi-Directional Navigation Catheter QDOT MICRO Bi-Directional Navigation Catheter QDOT MICRO Bi-Directional Navigation Catheter QDOT MICRO Bi-Directional Navigation Catheter TX eco Cable Kit
- Model Identifier(s)
- D139401 D139402 D139403 D139501 D139502 D139503 D139504 D139505 D140102
About this record
Access comprehensive regulatory information for Biosense Webster QDOT MICRO Uni-Directional and Bi-Directional Navigation 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 DE0508491 and owned by Biosense Webster, Inc.. The device was registered on September 14, 2023.
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