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Singapore HSA registration DE0010471

Edwards Lifesciences Fogarty Graft Thrombectomy Catheters

Singapore flagSingapore·CLASS B·Edwards Lifesciences LLC·Registered September 10, 2012
Device classification
Device Class
CLASS B
Medical Speciality Area
General & Plastic Surgery
HSA Product Code
HSAMDB00110
HS Code
90183910
Registration information
Registration Number
DE0010471
Registration Date
September 10, 2012
Change Notification Approval Date
March 23, 2020
Retention Due Date
September 09, 2025
Product description
The Fogarty Graft Thrombectomy Catheter is designed to remove organized thrombus and adherent thrombotic material from synthetic bypass grafts, specifically AV fistulas for dialysis access and grafts for iliofemoral bypass.
Product Owner
Name
Edwards Lifesciences LLC
Short Name
Edwards Lifesciences
Address
One Edwards Way, Irvine, CA 92614, UNITED STATES
Registrant
Name
EDWARDS LIFESCIENCES (ASIA) PTE. LTD.
Address
238B THOMSON ROAD, NOVENA SQUARE, #18-01/08, SINGAPORE 307685
Importer
Name
EDWARDS LIFESCIENCES (SINGAPORE) PTE. LTD. MLS LOGISTIC SERVICES PTE. LTD. ZUELLIG PHARMA PTE LTD
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 Graft Thrombectomy Catheter Fogarty Graft Thrombectomy Catheter
Model Identifier(s)
160245F 160246F
About this record

Access comprehensive regulatory information for Edwards Lifesciences Fogarty Graft Thrombectomy 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 DE0010471 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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