Broncus-B (02216) shares gained more than 4% in afternoon trading, reaching an intraday high of 0.68 Hong Kong dollars, with a trading volume of 234,000 Hong Kong dollars as of press time.

The company recently announced that its self-developed BroncTru® disposable transbronchial dilation catheter has obtained EU Medical Device Regulation (MDR) CE certification. This marks a significant milestone in the company's international registration and global product expansion efforts.

As of the announcement date, the BroncTru® device has received regulatory approvals from China's National Medical Products Administration (NMPA), the U.S. Food and Drug Administration (FDA), and the EU MDR CE certification. It has also been approved for market use in Taiwan (China), Indonesia, Thailand, and Malaysia.

The device's applications include, but are not limited to, compatibility with various transbronchial biopsy sampling procedures, such as endobronchial ultrasound-guided transbronchial needle cryobiopsy (EBUS-TTCB), ultrasound-guided transbronchial lung biopsy (EBUS-GS-TBLB), transbronchial needle aspiration (TBNA), transbronchial lung cavity puncture biopsy and lavage, targeted drug delivery via transbronchial dilation catheter, transbronchial ablation, and assisted localization. These capabilities are designed to meet a wide range of clinical diagnostic and therapeutic needs.