Fish Yue Win -Clean Vecentage obtained NMPA+CE+FDA trio certification
At 9:44 am on November 15, 2020, Eastern Time, there have been more than 2 million people in the world's new crown pneumonia.Behind the rising numbers, the ventilator is still short.According to the "Liuye knife" research, more than 50%of new coronary pneumonia patients will have difficulty breathing, and the use of non -invasive ventilation machines can improve symptoms.
On March 30, 2020, the US Food and Drug Administration (FDA) began to issue emergency use authorization (EUA) for non -invasive ventilator.On March 31, 2020 (April 1, Beijing time), Yuyue Medical was authorized, becoming the first domestic non -invasive ventilator R & D manufacturing enterprise in China, marking that Yuyue has obtained a pass to the United States resistance.
The threshold for approved speed -up is unchanged
Global gaps, Chinese aid.On the road of ventilator exit, the EU CE certification and the US FDA certification are the two most important pass permits, representing the entry threshold of the world's mainstream markets.According to statistics from the Ministry of Industry and Information Technology, only 8 of the 21 ventilator manufacturers across the country have obtained CE certification.
Earlier, Yuyue has obtained medical device registration certificates issued by the China State Drug Administration (NMPA), the EU CE certification, and the FDA urgently authorized authorization, Yuyue Medical has become one of the few "three certificates in hand in hand in hand"Medical brand.
fish Yue Win -clean Vecent Production Line
It is understood that the FDA registration cycle of the ventilator usually takes at least 6-9 months.In order to fill the ventilator gap as soon as possible, the FDA pressed the fast -forward key, but it did not reduce the requirements for applying for enterprises. It still has strict standards in terms of enterprise scale and quality management.
Anti -epidemic weapon again to fight international
Non -invasive ventilator played a key role in the anti -epidemic war in China.Several experts point out that most patients should be treated in a timely or medium period of the disease. If they find hypoxemia, it should be treated with non -invasive ventilator or high -flow oxygen therapy in time, which can greatly prevent patients from entering the critical stage.
Doctors in Wuhan Hospital use fish leapless ventilator
According to statistics from the Ministry of Industry and Information Technology, in February 2020, China's ventilator output was about 15,000 units.As an important supplier of the world's unsecured ventilator, Yu Yue assisted 7,000 units nationwide, which is equivalent to half of the half -wall of China's non -invasive ventilator, which provides strong support for winning the Battle of Hubei and Wuhan's defense war.
A doctor who assisted the front line of Wuhan said that the operation of fish jump non -invasive ventilator is simple: "10 parameters show the same screen, and the blood oxygen pulse rate is simultaneously reducing the burden of fish leaps and opening the life channel for patients."
In order to put it into use as soon as possible, the export ventilator also equipped with auxiliary materials such as English use manuals, installation guidance videos, and common questions answering questions to help international doctors quickly be familiar with the equipment and scramble for patients.
The Tao is not far away, and there is no other country.Under the epidemic, professional, accurate and efficient aids are the wisdom of Chinese wisdom and the role of China under the epidemic.The epidemic will eventually end. After experiencing the test test, the community of human destiny will eventually usher in a better tomorrow!