Pure Global

Edwards Fogarty Thru Lumen Catheter - HSA Registration DE0011664

Access comprehensive regulatory information for Edwards Fogarty Thru Lumen Catheter in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0011664 and owned by Edwards Lifesciences LLC. The device was registered on November 27, 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.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS B
DE0011664
Edwards Fogarty Thru Lumen Catheter
HSA Registration Number: DE0011664
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

The Fogarty Thru-Lumen Embolectomy Catheters are intended to be used for the removal of fresh, soft emboli and thrombi from vessels in the arterial system. They can also be used for temporary occlusion of blood vessels, infusion of fluids, and blood sampling.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General & Plastic Surgery
HSA Product Code
HSAMDB00110
HS Code
90183910
Registration Information
Registration Number
DE0011664
Registration Date
November 27, 2012
Change Notification Approval Date
August 22, 2020
Retention Due Date
November 26, 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 Thru Lumen Catheters Fogarty Thru Lumen Catheters Fogarty Thru Lumen Catheters Fogarty Thru Lumen Catheters Fogarty Thru Lumen Catheters Fogarty Thru Lumen Catheters Fogarty Thru Lumen Catheters Fogarty Thru Lumen Catheters Fogarty Thru Lumen Catheters Fogarty Thru Lumen Catheters
Model Identifier(s)
12TLW1203F 12TLW403F 12TLW404F 12TLW405F35 12TLW406F 12TLW803F 12TLW804F 12TLW805F35 12TLW806F 12TLW807F