Singapore HSA registration DE0010474
Edwards Lifesciences Fogarty Arterial Embolectomy catheters
Singapore·CLASS B·Edwards Lifesciences LLC·Registered September 10, 2012Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General & Plastic Surgery
- HSA Product Code
- HSAMDB00110
- HS Code
- 90183910
Registration information
- Registration Number
- DE0010474
- Registration Date
- September 10, 2012
- Change Notification Approval Date
- December 01, 2020
- Retention Due Date
- September 09, 2025
Product description
The Arterial Embolectomy Catheters are intended to be used for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.
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 Arterial Embolectomy Catheter, Tube Pack Fogarty Arterial Embolectomy Catheter, Pouch Fogarty Arterial Embolectomy Catheter, Tube Pack Fogarty Arterial Embolectomy Catheter, Pouch Fogarty Arterial Embolectomy Catheter, Tube Pack Fogarty Arterial Embolectomy Catheter, Pouch Fogarty Arterial Embolectomy Catheter, Tube Pack Fogarty Arterial Embolectomy Catheter, Pouch Fogarty Arterial Embolectomy Catheter, Tube Pack Fogarty Arterial Embolectomy Catheter, Pouch Fogarty Arterial Embolectomy Catheter, Tube Pack Fogarty Arterial Embolectomy Catheter, Pouch Fogarty Arterial Embolectomy Catheter, Tube Pack Fogarty Arterial Embolectomy Catheter, Pouch Fogarty Arterial Embolectomy Catheter, Tube Pack Fogarty Arterial Embolectomy Catheter, Pouch Fogarty Arterial Embolectomy Catheter, Tube Pack Fogarty Arterial Embolectomy Catheter, Pouch Fogarty Arterial Embolectomy Catheter, Tube Pack Fogarty Arterial Embolectomy Catheter, Pouch Fogarty Arterial Embolectomy Catheter, Flat Pack with Syringe Fogarty Arterial Embolectomy Catheter, Flat Pack with Syringe Fogarty Arterial Embolectomy Catheter, Flat Pack with Syringe Fogarty Arterial Embolectomy Catheter, Flat Pack with Syringe Fogarty Arterial Embolectomy Catheter, Flat Pack with Syringe Fogarty Arterial Embolectomy Catheter, Flat Pack with Syringe Fogarty Arterial Embolectomy Catheter, Flat Pack with Syringe Fogarty Arterial Embolectomy Catheter, Flat Pack with Syringe Fogarty Arterial Embolectomy Catheter, Flat Pack with Syringe Fogarty Embolectomy Catheter with Gate Valve Accessory Set
- Model Identifier(s)
- 120403F 120403FP 120403FS 120403FSP 120404F 120404FP 120602F 120602FP 120803F 120803FP 120803FS 120803FSP 120804F 120804FP 120805F 120805FP 120806F 120806FP 120807F 120807FP 12A0403F 12A0404F 12A0602F 12A0803F 12A0804F 12A0805F 12A0806F 12A0807F 12A1004F CV3200
About this record
Access comprehensive regulatory information for Edwards Lifesciences Fogarty Arterial Embolectomy 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 DE0010474 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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