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Singapore HSA registration DE0016553

Biosense Webster PENTARAY NAV and NAV eco High-Density Mapping Catheter

Singapore flagSingapore·CLASS D·Biosense Webster, Inc.·Registered November 20, 2014
Device classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
HSA Product Code
HSAMDD00110
HS Code
90183910
Registration information
Registration Number
DE0016553
Registration Date
November 20, 2014
Change Notification Approval Date
April 24, 2025
Retention Due Date
November 19, 2025
Product description
The Biosense Webster PENTARAY® NAV and NAV eco High-Density Mapping Catheters are indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. The catheters are intended to obtain electrograms in the atrial and ventricular regions of the heart. The catheters provide location information when used with compatible CARTO® 3 EP Navigation Systems.
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 International (Singapore) Pte Ltd
Address
2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Model information
Model Name(s)
PENTARAY NAV High-Density Mapping Catheter PENTARAY NAV High-Density Mapping Catheter PENTARAY NAV High-Density Mapping Catheter PENTARAY NAV High-Density Mapping Catheter PENTARAY NAV High-Density Mapping Catheter PENTARAY NAV High-Density Mapping Catheter PENTARAY NAV eco High-Density Mapping Catheter PENTARAY NAV eco High-Density Mapping Catheter PENTARAY NAV eco High-Density Mapping Catheter PENTARAY NAV eco High-Density Mapping Catheter PENTARAY NAV eco High-Density Mapping Catheter PENTARAY NAV eco High-Density Mapping Catheter
Model Identifier(s)
D128201 D128202 D128203 D128204 D128205 D128206 D128207 D128208 D128209 D128210 D128211 D128212
About this record

Access comprehensive regulatory information for Biosense Webster PENTARAY NAV and NAV eco High-Density Mapping 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 DE0016553 and owned by Biosense Webster, Inc.. The device was registered on November 20, 2014.

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