怡和嘉業(301367.SZ):作為國內家用無創呼吸機及通氣面罩龍頭企業,於2012年取得美國FDA認證,為唯一一家無創呼吸機產品通過美國FDA認證的國內上市公司
格隆匯7月11日丨有投資者向怡和嘉業(301367.SZ)提問,“美國FDA關於EUA政策出台,對貴公司呼吸機出口是否會造成影響?貴公司目前是否通過EUA方式將呼吸機進入美國市場?”
怡和嘉業回覆稱,公司呼吸機是通過FDA方式而非EUA方式進入美國市場,美國FDA於2023年5月發佈的最新關於EUA明顯收緊的政策,一定程度上對通過FDA認證方式進入美國市場的國內製造商在政策層面具有積極影響,會帶來更穩定且持續的市場環境。公司作為國內家用無創呼吸機及通氣面罩龍頭企業,於2012年取得美國FDA認證,為唯一一家無創呼吸機產品通過美國FDA認證的國內上市公司。
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