Kunbo Medical-B (02216): BroncTru® has obtained EU MDR CE certification for single-use bronchoscopic dilatation catheters

Zhitong Finance App News, Kunbo Medical-B (02216) issued an announcement. Recently, the company's self-developed BroncTru® disposable bronchoscopic dilatation catheter (BroncTRU®) obtained CE certification under the EU Medical Device Regulation (EU MDR), marking important progress in the company's international registration and global product layout.

BroncTRU® has a number of patented technologies. Under the guidance of a navigation system, BroncTru® can accurately reach peripheral pulmonary nodules that are difficult to reach with conventional bronchoscopes. Through the steps of puncture, expansion, and tunneling, it establishes a direct working channel for other endoscopic tools to reach target lesions in the lungs. It is the core tool for performing bronchoscopic transparenchymal nodule access (BTPNA). BroncTRU® can be used in combination with diagnostic products to quickly diagnose and treat all lung lesions. Application scenarios of BroncTru® include, but are not limited to: use of various current transbronchoscopic biopsy samples, such as transbronchial dilatation catheter refrigeration biopsy (EBUS-TTCB), ultrasound-guided disposable transbronchoscopic dilatation catheter positioning biopsy (EBUS-GS-TBLB), transbronchoscopic needle aspiration biopsy (TBNA), transbronchoscopic aspiration biopsy (TBNA), transbronchoscopic pulmonary cavity puncture biopsy and irrigation; transbronchoscopic pulmonary cavity puncture biopsy and irrigation; transbronchoscopic aspiration of pulmonary cavity biopsies and lavage Medicine; transbronchoscopic ablation and transbronchoscopic assisted positioning, etc., can fully meet the diverse clinical diagnosis and treatment needs.

Obtaining the EU MDR CE certification this time marks that BroncTRU® is in line with the latest EU medical device regulations, laying the foundation for the company to further expand the European and other approved CE certification markets. EU CE certification is a mandatory qualification certificate for medical devices entering the European market, indicating that the product complies with EU MDR requirements. It has also further enriched the international product portfolio, helping to enhance the company's global commercialization capabilities and competitiveness in the international market.

As of the date of publication of this announcement, BroncTRU® has obtained CE registration approval from the China National Drug Administration (NMPA), the US Food and Drug Administration (FDA), and the European Union MDR, and has been approved for listing in Taiwan, Indonesia, Thailand and Malaysia.