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Edwards Lifesciences Fogarty Biliary Balloon Catheters - HSA Registration DE0010475

Access comprehensive regulatory information for Edwards Lifesciences Fogarty Biliary Balloon Catheters in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0010475 and owned by Edwards Lifesciences LLC. The device was registered on September 10, 2012.

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
DE0010475
Edwards Lifesciences Fogarty Biliary Balloon Catheters
HSA Registration Number: DE0010475
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Product Description

The catheter is indicated for the removal of stones and ductal debris and exploration.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Gastroenterology & Urology
HSA Product Code
HSAMDB00110
HS Code
90183910
Registration Information
Registration Number
DE0010475
Registration Date
September 10, 2012
Change Notification Approval Date
March 23, 2020
Retention Due Date
September 09, 2025
Product Owner
Short Name
Edwards Lifesciences
Address
One Edwards Way, Irvine, CA 92614, UNITED STATES
Registrant
Address
238B THOMSON ROAD, NOVENA SQUARE, #18-01/08, SINGAPORE 307685
Importer
Address
35 CHANGI NORTH CRESCENT, SINGAPORE 499641 5 TAI SENG DRIVE, SCA CREATIVE CENTRE, #02-01, SINGAPORE 535217 15 CHANGI NORTH WAY, #01-00, SINGAPORE 498770
Model Information
Model Name(s)
Fogarty Biliary Balloon Catheter Fogarty Biliary Balloon Catheter Fogarty Biliary Balloon Catheter
Model Identifier(s)
410235F 410236F 410405F