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Biosense Webster QDOT MICRO Uni-Directional and Bi-Directional Navigation Catheter - HSA Registration DE0508491

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.

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CLASS D
DE0508491
Biosense Webster QDOT MICRO Uni-Directional and Bi-Directional Navigation Catheter
HSA Registration Number: DE0508491
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Product Description

The QDOT MICROโ„ข 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 CARTOโ„ข 3 System.

Device 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 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