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Boston Scientific LithoVue™ Elite Digital Flexible Ureteroscope System - HSA Registration DE0509908

Access comprehensive regulatory information for Boston Scientific LithoVue™ Elite Digital Flexible Ureteroscope System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509908 and owned by Boston Scientific Corporation. The device was registered on October 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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CLASS B
DE0509908
Boston Scientific LithoVue™ Elite Digital Flexible Ureteroscope System
HSA Registration Number: DE0509908
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Product Description

It is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0509908
Registration Date
October 11, 2024
Retention Due Date
October 10, 2025
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)
StoneSmart Power Cord - UK StoneSmart™ Connect Console StoneSmart™ Connect Console LithoVue™ Elite Single-Use Digital Flexible Ureteroscope – Standard Deflection with Pressure Monitoring LithoVue™ Elite Single-Use Digital Flexible Ureteroscope – Reverse Deflection with Pressure Monitoring LithoVue Elite™ Single-Use Digital Flexible Ureteroscope – Standard Deflection LithoVue Elite™ Single-Use Digital Flexible Ureteroscope – Reverse Deflection
Model Identifier(s)
M0067932300 M0067933000 M006793300R0 (refurbished) M0067940000 M0067940500 M0067941000 M0067941500