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亞輝龍(688575.SH):取得IVDR CE認證 共包括14個產品
格隆匯 10-22 18:03

格隆匯10月22日丨亞輝龍(688575.SH)公佈,公司於近日收到了由BSI Group The Netherlands B.V.簽發的IVDR CE 證書共包括14個產品,具體信息如下:

新的歐盟體外診斷醫療器械法規(IVDR, EU 2017/746)將替代原歐盟體外診斷醫療器械指令(IVDD, 98/79/EC)對歐盟市場的體外診斷醫療器械進行管理。本次為公司第一次獲得IVDR CE 證書,為公司後續的IVDR 認證切換工作奠定了良好的基礎。

根據歐盟體外診斷醫療器械法規的規定,上述14個產品已經具備進入歐盟市場的必要條件。對公司在歐盟地區的業務推廣將產生積極影響,但產品具體銷售情況受到市場等因素影響,公司尚無法預測上述產品對公司未來業績的影響,敬請廣大投資者理性投資,注意投資風險。

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