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Biosense Webster CARTO OCTARAY Mapping Catheter with TRUERef Technology - HSA Registration DE0506419

Access comprehensive regulatory information for Biosense Webster CARTO OCTARAY Mapping Catheter with TRUERef Technology in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0506419 and owned by Biosense Webster, Inc.. The device was registered on November 26, 2021.

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
DE0506419
Biosense Webster CARTO OCTARAY Mapping Catheter with TRUERef Technology
HSA Registration Number: DE0506419
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Product Description

The CARTOยฎ OCTARAYโ„ข Mapping Catheter with TRUErefโ„ข Technology is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e. recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The catheter provides location information only when used with compatible versions of the CARTOยฎ 3 EP Navigation System.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0506419
Registration Date
November 26, 2021
Change Notification Approval Date
September 29, 2024
Retention Due Date
November 25, 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)
CARTO OCTARAY Mapping Catheter with TRUEref Technology 2-2-2-2-2 CARTO OCTARAY Mapping Catheter with TRUEref Technology 2-5-2-5-2 CARTO OCTARAY Mapping Catheter with TRUEref Technology 3-3-3-3-3 CARTO OCTARAY Mapping Catheter with TRUEref Technology 2-2-2-2-2 CARTO OCTARAY Mapping Catheter with TRUEref Technology 2-5-2-5-2 CARTO OCTARAY Mapping Catheter with TRUEref Technology 3-3-3-3-3
Model Identifier(s)
D160901 D160902 D160903 D160904 D160905 D160906