Singapore HSA registration DE0010475
Edwards Lifesciences Fogarty Biliary Balloon Catheters
Singapore·CLASS B·Edwards Lifesciences LLC·Registered September 10, 2012Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Gastroenterology & Urology
- HSA Product Code
- HSAMDB00110
- HS Code
- 90183910
Registration information
- Registration Number
- DE0010475
- Registration Date
- September 10, 2012
- Change Notification Approval Date
- March 23, 2020
- Retention Due Date
- September 09, 2025
Product description
The catheter is indicated for the removal of stones and ductal debris and exploration.
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 Biliary Balloon Catheter Fogarty Biliary Balloon Catheter Fogarty Biliary Balloon Catheter
- Model Identifier(s)
- 410235F 410236F 410405F
About this record
Access comprehensive regulatory information for Edwards Lifesciences Fogarty Biliary Balloon 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 DE0010475 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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