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Singapore HSA registration DE0509160

Boston Scientific Agile™ Esophageal Fully Covered OTW Stent System

Singapore flagSingapore·CLASS C·Boston Scientific Corporation·Registered April 11, 2024
Device classification
Device Class
CLASS C
Medical Speciality Area
Gastroenterology & Urology
Registration information
Registration Number
DE0509160
Registration Date
April 11, 2024
Retention Due Date
April 10, 2026
Product description
The Agile Esophageal Fully 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
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 Fully Covered OTW Agile™ Esophageal Fully Covered OTW Agile™ Esophageal Fully Covered OTW Agile™ Esophageal Fully Covered OTW
Model Identifier(s)
M00517750 M00517760 M00517770 M00517780
About this record

Access comprehensive regulatory information for Boston Scientific Agile™ Esophageal Fully 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 DE0509160 and owned by Boston Scientific Corporation. The device was registered on April 11, 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.

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