Pure Global
Singapore HSA registration DE0008475

Biosense Webster WEBSTER® Duo‐Decapolar Electrophysiology Catheter

Singapore flagSingapore·CLASS D·Biosense Webster, Inc.·Registered February 10, 2012
Device classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
HSA Product Code
Refer to CRPNS
HS Code
90181900
Registration information
Registration Number
DE0008475
Registration Date
February 10, 2012
Change Notification Approval Date
September 29, 2024
Retention Due Date
February 09, 2026
Product description
The catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only. In addition, the WEBSTER® Duo-Decapolar Catheter is designed to facilitate electrogram mapping in the atrial region of the heart and the coronary sinus.
Product Owner
Name
Biosense Webster, Inc.
Short Name
Biosense Webster, Inc.
Address
31 Technology Drive, Suite 200, Irvine, CA 92618, UNITED STATES
Registrant
Name
Johnson & Johnson International (Singapore) Pte Ltd
Address
2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Importer
Name
JOHNSON & JOHNSON PTE LTD Johnson & Johnson International (Singapore) Pte Ltd
Address
2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222 2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Model information
Model Name(s)
Webster® Duo-Decapolar Electrophysiology Catheter
Model Identifier(s)
D728260RT
About this record

Access comprehensive regulatory information for Biosense Webster WEBSTER® Duo‐Decapolar Electrophysiology 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 DE0008475 and owned by Biosense Webster, Inc.. The device was registered on February 10, 2012.

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