圣湘生物(688289.SH)产品取得医疗器械注册证及欧盟CE认证

智通财经
Nov 07, 2025

智通财经APP讯,圣湘生物(688289.SH)发布公告,公司于近日获得三项产品认证及注册,其中两项为国家三类医疗器械注册证,一项为欧盟CEIVDR认证。

诺如病毒、轮状病毒及肠道腺病毒均为引发病毒性腹泻的常见病原体,传染性极强、分布广泛,尤其在儿童和老年人群中易引发感染。公司此次推出的诺如病毒单检与A组轮状病毒/诺如病毒/F组肠道腺病毒三联检两款新品,将极大提升临床对腹泻病原体的快速鉴别与精准诊断能力,为我国儿童与老年人等重点人群的肠道健康构筑坚实防线。

EB病毒在人群中感染极为普遍,不仅是传染性单核细胞增多症的元凶,更与器官移植后淋巴增生性疾病(PTLD)以及鼻咽癌、霍奇金淋巴瘤、胃癌等多种肿瘤的发生发展密切相关。本次EB病毒检测试剂获得欧盟CEIVDR认证,进一步丰富了公司疱疹病毒检测产品线,亦标志着公司在产品质量、技术性能及管理体系上全面符合国际严格标准,是公司分子诊断战略和国际化战略的重要成果之一。

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