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Biosense Webster SMARTABLATE Irrigation Tubing Set - HSA Registration DE0013161

Access comprehensive regulatory information for Biosense Webster SMARTABLATE Irrigation Tubing Set in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0013161 and owned by Biosense Webster, Inc.. The device was registered on June 17, 2013.

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 B
DE0013161
Biosense Webster SMARTABLATE Irrigation Tubing Set
HSA Registration Number: DE0013161
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Product Description

The Biosense Webster SMARTABLATE™ Irrigation Tubing Set is designed for use with the SMARTABLATE™ Irrigation Pump to deliver irrigation solution at specified flow rates to Celsius® ThermoCool®, NaviStar® ThermoCool®, or other irrigated devices for cooling purposes.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Cardiovascular
HSA Product Code
HSAMDB00110
HS Code
90183990
Registration Information
Registration Number
DE0013161
Registration Date
June 17, 2013
Change Notification Approval Date
January 24, 2025
Retention Due Date
June 16, 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)
SMARTABLATE Irrigation Tubing Set
Model Identifier(s)
SAT001