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Singapore HSA registration DE0507749

Boston Scientific Agile™ Esophageal Partially Covered Stent System

Singapore flagSingapore·CLASS C·Boston Scientific Corporation·Registered February 06, 2023
Device classification
Device Class
CLASS C
Medical Speciality Area
Gastroenterology & Urology
Registration information
Registration Number
DE0507749
Registration Date
February 06, 2023
Retention Due Date
February 05, 2026
Product description
The stent is intended to be used in patients with malignant (cancerous) esophageal strictures (narrowing of the food pipe) and is not intended to be removed. The stent is designed as a device to improve dysphagia (difficulty swallowing) and maintain esophageal patency (opening of the esophagus) to allow for passage of food and liquids.
Product Owner
Name
Boston Scientific Corporation
Short Name
Boston Scientific Corporation
Address
300 Boston Scientific Way, Marlborough, MA 01752, UNITED STATES
Registrant
Name
BOSTON SCIENTIFIC ASIA PACIFIC PTE. LTD.
Address
9 NORTH BUONA VISTA DRIVE, THE METROPOLIS TOWER ONE, #20-01, SINGAPORE 138588
Importer
Name
BOSTON SCIENTIFIC ASIA PACIFIC PTE. LTD.
Address
9 NORTH BUONA VISTA DRIVE, THE METROPOLIS TOWER ONE, #20-01, SINGAPORE 138588
Model information
Model Name(s)
Agile™ Esophageal Partially Covered Agile™ Esophageal Partially Covered Agile™ Esophageal Partially Covered Agile™ Esophageal Partially Covered Agile™ Esophageal Partially Covered Agile™ Esophageal Partially Covered Agile™ Esophageal Partially Covered Agile™ Esophageal Partially Covered
Model Identifier(s)
M00517200 M00517210 M00517220 M00517230 M00517240 M00517250 M00517260 M00517270
About this record

Access comprehensive regulatory information for Boston Scientific Agile™ Esophageal Partially Covered 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 DE0507749 and owned by Boston Scientific Corporation. The device was registered on February 06, 2023.

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