Singapore HSA registration DE0011664
Edwards Fogarty Thru Lumen Catheter
Singapore·CLASS B·Edwards Lifesciences LLC·Registered November 27, 2012Device 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 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.
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
- 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 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
About this record
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.
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