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Singapore HSA registration DE0015270

Biosense Webster DECANAV™ Electrophysiology Catheter

Singapore flagSingapore·CLASS D·Biosense Webster, Inc.·Registered April 30, 2014
Device classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
HSA Product Code
HSAMDD00110
HS Code
90183910
Registration information
Registration Number
DE0015270
Registration Date
April 30, 2014
Change Notification Approval Date
September 29, 2024
Retention Due Date
April 29, 2026
Product description
The Biosense Webster DECANAV™ Catheter is indicated for electrophysiological mapping of cardiac structure i.e., recording and stimulation, including in the coronary sinus. In addition, DECANAV catheter is used with compatible CARTO® 3 EP Navigation systems to provide catheter tip location information.
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)
Biosense Webster DECANAV™ Electrophysiology Catheter Biosense Webster DECANAV™ Electrophysiology Catheter
Model Identifier(s)
D-1285-01 , R7D282CT D-1285-02, R7F282CT
About this record

Access comprehensive regulatory information for Biosense Webster DECANAV™ 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 DE0015270 and owned by Biosense Webster, Inc.. The device was registered on April 30, 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.

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