Singapore HSA registration DE0509232
Boston Scientific Agile™ Esophageal Partially Covered OTW Stent System
Singapore·CLASS C·Boston Scientific Corporation·Registered April 25, 2024Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Gastroenterology & Urology
Registration information
- Registration Number
- DE0509232
- Registration Date
- April 25, 2024
- Retention Due Date
- April 24, 2026
Product description
The Agile Esophageal Partially Covered OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.
Product Owner
- Short Name
- Boston Scientific Corporation
- Address
- 300 Boston Scientific Way, Marlborough, MA01752, UNITED STATES
Registrant
- Address
- 9 NORTH BUONA VISTA DRIVE, THE METROPOLIS TOWER ONE, #20-01, SINGAPORE 138588
Importer
- Address
- 9 NORTH BUONA VISTA DRIVE, THE METROPOLIS TOWER ONE, #20-01, SINGAPORE 138588
Model information
- Model Name(s)
- Agile™ Esophageal Partially Covered OTW Agile™ Esophageal Partially Covered OTW Agile™ Esophageal Partially Covered OTW Agile™ Esophageal Partially Covered OTW
- Model Identifier(s)
- M00517710 M00517720 M00517730 M00517740
About this record
Access comprehensive regulatory information for Boston Scientific Agile™ Esophageal Partially Covered OTW Stent System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0509232 and owned by Boston Scientific Corporation. The device was registered on April 25, 2024.
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C