HSA · registration DE0509908Boston Scientific LithoVue™ Elite Digital Flexible Ureteroscope System
SingaporeGastroenterology & UrologyClass BBoston Scientific Corporation
Official record identity
- Registration number
- DE0509908
- Model name
- 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
- M0067932300; M0067933000; M006793300R0 (refurbished); M0067940000; M0067940500; M0067941000; M0067941500
- Registration date
- October 11, 2024
Classification
- Risk class
- Class B
Official value: CLASS B
Published parties
- Product owner
- Boston Scientific Corporation
- Registrant / registration holder
- BOSTON SCIENTIFIC ASIA PACIFIC PTE. LTD.
Official 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.
Additional source fields
- Product owner address
- 300 Boston Scientific Way, Marlborough, MA01752, UNITED STATES
- Registrant address
- 9 NORTH BUONA VISTA DRIVE, #20-01, THE METROPOLIS, Singapore 138588
About this record
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.