Singapore HSA registration DE0509908
Boston Scientific LithoVue™ Elite Digital Flexible Ureteroscope System
Singapore·CLASS B·Boston Scientific Corporation·Registered October 11, 2024Device 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 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.
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
About this record
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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