HSA · registration DE0510285Shenzhen HugeMed Single-use Cystoscope
- Registration number
- DE0510285
- Model name
- Single-use Cystoscope; Single-use Cystoscope; Single-use Cystoscope; Single-use Cystoscope; Single-use Cystoscope; Single-use Cystoscope
- Model identifier
- CY-M32; CY-M40; CY-M40H; CY-M50; CY-M52; CY-M52H
- Registration date
- January 27, 2025
- Risk class
- Class B
- Registrant / registration holder
- ANDAMAN MEDICAL PTE. LTD.
The single-use cystoscope is a single-use sterile flexible endoscope for endoscopic surgery and examination in lower urinary tract endoscopy. The endoscope is used to provide images by an image processor. The single-use flexible cystoscope is connected to an image processor and used in conjunction with other endoscopic accessories for the purposes of examination and treatment of lower urinary tract in adults, and the endoscope can only be used in a hospital.
- 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.