堃博医疗-B午后涨超4% 自研BroncTru®途扩®取得欧盟MDR CE认证

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Jul 28
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  堃博医疗-B(02216)午后涨超4%,截至发稿,股价上涨4.62%,现报0.68港元,成交额23.40万港元。

  堃博医疗-B发布公告,近日,公司自主研发的 BroncTru®途扩®一次性使用经支气管镜扩张导管(BroncTru®途扩®)取得欧盟医疗器械法规(欧盟MDR)CE认证,标志着公司国际化注册及全球产品布局取得重要进展。截至本公告发布日期,BroncTru®途扩®已取得中国国家药品监督管理局 (NMPA)、美国食品药品监督管理局(FDA)及欧盟MDR CE注册批准,并已在中国台湾地区、印度尼西亚、泰国及马来西亚批准上市。

  据介绍,BroncTru®途扩®的应用场景包括但不限于:配用目前各式经支气管镜活检取样,如经支气管扩张导管纵隔病灶冷冻活检术(EBUS-TTCB)、超声引导一次性使用经支气管镜扩张导管定位活检(EBUS-GS-TBLB)、经支气管镜针吸活检术(TBNA)、经支气管镜下肺空洞穿刺活检及灌洗;经支气管镜扩张导管靶向给药;经支气管镜消融术及经支气管镜辅助定位等,可充分满足临床多元诊疗需求。

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