Singapore HSA registration DE0010469
Edwards Lifesciences Fogarty Corkscrew Catheters
Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General & Plastic Surgery
Registration information
- Registration Number
- DE0010469
- Registration Date
- September 10, 2012
- Change Notification Approval Date
- February 27, 2020
- Retention Due Date
- September 09, 2025
Product description
The Fogarty Corkscrew Catheters are utilized for removal of emboli and thrombi from either native vessels or synthetic grafts 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 Corkscrew Catheter Fogarty Corkscrew Catheter Fogarty Corkscrew Catheter
- Model Identifier(s)
- 1408010 140806 140808
About this record
Access comprehensive regulatory information for Edwards Lifesciences Fogarty Corkscrew 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 DE0010469 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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