HSA · registration DE0510598Shenzhen HugeMed Single-use Bronchoscope
- Registration number
- DE0510598
- Model name
- Single-use Bronchoscope; Single-use Bronchoscope; Single-use Bronchoscope; Single-use Bronchoscope; Single-use Bronchoscope; Single-use Bronchoscope; Single-use Bronchoscope; Single-use Bronchoscope; Single-use Bronchoscope; Single-use Bronchoscope
- Model identifier
- BR-M22; BR-M25; BR-M32; BR-M40; BR-M40H; BR-M50; BR-M52; BR-M52H; BR-M58; BR-M58H
- Registration date
- April 15, 2025
- Risk class
- Class B
- Registrant / registration holder
- ANDAMAN MEDICAL PTE. LTD.
The product is a single-use sterile flexible endoscope for endoscopic surgery and examination in the anatomy of nasal cavity and upper respiratory tract. The endoscope is used to provide images through an endoscopy video processor manufactured by HugeMed. The single-use flexible bronchoscope is connected to an endoscopy video processor manufactured by HugeMed, and used in conjunction with other endoscopic accessories for the examination and treatment of trachea and bronchus in adults. The endoscope in indicated for use in a hospital, and for the treatment of adults.
- 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.