HSA · registration DE0510244Shenzhen HugeMed Single-use Ureterorenoscope
- Registration number
- DE0510244
- Model name
- Single-use Ureterorenoscope; Single-use Ureterorenoscope; Medical Image Processor
- Model identifier
- HU30; HU30S; HUV-01
- Registration date
- January 16, 2025
- Risk class
- Class B
- Registrant / registration holder
- ANDAMAN MEDICAL PTE. LTD.
The Flexible Video Ureterorenoscope System consists of Single use Ureterorenoscope, and Medical Image Processor. Single use Ureterorenoscope is introduced within the urinary tract and Medical Image Processor for clinical image processing. The Flexible Video Ureterorenoscope System is indicated for endoscopic examination in the urinary tract and can be used to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures.
- Product owner address
- 401,501,Bldg 4, Haizhi Tech Park, Fortis, No. 17, Bulan Road, Xialilang Community, Nanwan Street, Longgang District, Shenzhen, Guangdong, 518112, China
- Registrant address
- 300 TAMPINES AVENUE 5, #09-02, INCOME AT TAMPINES JUNCTION, Singapore 529653
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.