Yuwell products authorized by US FDA for emergency use

Yuwell, or Yuyue Medical (002223.SZ), announced that it had received an email from the US Food and Drug Administration (FDA) that the non-invasive ventilator products of Suzhou Yuyue Medical Technology Co., Ltd., a wholly owned subsidiary of the company, had obtained Emergency Use Authorization (EUA) issued by FDA, on the evening of April 1st.

Yuwell, or Yuyue Medical (002223.SZ), announced that it had received an email from the US Food and Drug Administration (FDA) that the non-invasive ventilator products of Suzhou Yuyue Medical Technology Co., Ltd., a wholly owned subsidiary of the company, had obtained Emergency Use Authorization (EUA) issued by FDA, on the evening of April 1st.

According to the announcement, the EUA, obtained by Yuyue Medical is a temporary emergency authorization for clinical treatment of patients during the outbreak, and if the company still wants to sell the product in the US market after the emergency is terminated, it needs to complete the corresponding FDA registration work that is already in progress

Disclaimer: This is an article created by Michael Liang for Chinasdg.org. You can find the original article here: https://chinasdg.org/2020/04/16/yuwell-products-authorized-by-us-fda-for-emergency-use/.

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