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Boston Scientific Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device - HSA Registration DE0509417

Access comprehensive regulatory information for Boston Scientific Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509417 and owned by Boston Scientific Corporation. The device was registered on June 20, 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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CLASS B
DE0509417
Boston Scientific Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
HSA Registration Number: DE0509417
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Product Description

The Acquire Fine Needle Biopsy Device is designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0509417
Registration Date
June 20, 2024
Retention Due Date
June 19, 2026
Product Owner
Short Name
Boston Scientific Corporation
Address
300 Boston Scientific Way, Marlborough, MA 01752, 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)
Acquire S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device Acquire S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device Acquire S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device Acquire S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
Model Identifier(s)
M00555640 M00555641 M00555660 M00555661