HSA · registration MDPR260508D0001Macrolux BubbleView Single-Use Digital Flexible Cystoscope
- Registration number
- MDPR260508D0001
- Model name
- Single-Use Digital Flexible Cystoscope; Single-Use Digital Flexible Cystoscope; Single-Use Digital Flexible Cystoscope; Single-Use Digital Flexible Cystoscope; Single-Use Digital Flexible Cystoscope; Single-Use Digital Flexible Cystoscope
- Model identifier
- C38-CRS; C38-CS; C50-C; C50-CB; C50-CBR; C50-CR
- Registration date
- May 08, 2026
- Risk class
- Class B
- Product owner
- MacroLux Medical Technology Co., Ltd
- Registrant / registration holder
- QST TECHNOLOGIES PTE. LTD.
The BubbleView Single-Use Digital Flexible Cystoscope is a sterile, single-use, flexible endoscope intended to be used for the examination, diagnosis, and treatment of the urethra, bladder, and renal pelvis (percutaneous). The BubbleView is intended to provide visualization via ViewHub video processor and can be used with endoscopic accessories. Medical indication: Endoscopy within the urethra, bladder, and renal pelvis. Intended user: The device is intended to be used by professional. Intended patient population: Adult (including elderly person). Patient selection criteria: patient over 18 years of age. Intended use environment: The endoscope is intended for use in a hospital environment and medical office environment.
- Product owner address
- 301, Building 3, NamTai Inno Park In Guang Ming, Avenue Guangming, 518107 Shenzhen, China
- Registrant address
- 196 PANDAN LOOP, #04-29, PANTECH BUSINESS HUB, Singapore 128384
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.