Singapore HSA registration DE0015039
Biosense Webster Celsius FLTR Catheter
Singapore·CLASS D·Biosense Webster, Inc.·Registered March 28, 2014Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- Cardiovascular
- HSA Product Code
- HSAMDD00110
- HS Code
- 90183910
Registration information
- Registration Number
- DE0015039
- Registration Date
- March 28, 2014
- Change Notification Approval Date
- September 29, 2024
- Retention Due Date
- March 27, 2026
Product description
The Celsius FLTR Catheter is indicated for cardiac electrophysiological mapping (stimulation and recording) and, when used in conjunction with a radiofrequency generator, for cardiac ablation.
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)
- Celsius™ FLTR Catheter Celsius™ FLTR Catheter Celsius™ FLTR Catheter
- Model Identifier(s)
- D135501 D135502 D135901
About this record
Access comprehensive regulatory information for Biosense Webster Celsius FLTR 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 DE0015039 and owned by Biosense Webster, Inc.. The device was registered on March 28, 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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