Singapore HSA registration DE0013161
Biosense Webster SMARTABLATE Irrigation Tubing Set
Singapore·CLASS B·Biosense Webster, Inc.·Registered June 17, 2013Device 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 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.
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
About this record
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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