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Biosense Webster Celsius FLTR Catheter - HSA Registration DE0015039

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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CLASS D
DE0015039
Biosense Webster Celsius FLTR Catheter
HSA Registration Number: DE0015039
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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.

Device 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 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