樂心醫療(300562.SZ):申請電子血壓計醫療器械註冊證事宜將予以終止
格隆匯4月7日丨樂心醫療(300562.SZ)公佈,此前披露,公司申請電子血壓計醫療器械註冊證事宜已獲得FDA受理。近日,公司收到相關通知,公司上述申請醫療器械註冊證事宜(提交號:K223571)將予以終止。
上述電子血壓計醫療器械註冊證首次申請註冊受理後,FDA調整了醫療器械註冊申請審核相關要求,公司此前提交的申請註冊審核材料需根據新的審核要求予以調整,該次醫療器械註冊證申請註冊事宜將予以終止。後續公司將根據最新的註冊申請審核要求重新提交申請材料。
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