Breathcare PAP Certified by NMPA/CE/FDA

2020-04-17

Up to 9:44 a.m. EST on the 15th, more than 2 million people in the world have been diagnosed with COVID-19. Amid the rise in the cases, Breathcare PAPs are still badly needed. According to the study of The Lancet, more than 50 percent of the COVID-19 patients had trouble breathing, which can be improved by using the noninvasive ventilation Breathcare PAPs.

On March 30th, the US FDA started to issue the Emergency Use Authorization (EUA) targeting the noninvasive Breathcare PAP. On March 31th (April 1st, Beijing time), yuwell obtained the authorization, becoming the first noninvasive Breathcare PAP manufacturer in China to acquire this qualification. This marks that yuwell has acquired a pass to help the U.S. fight the epidemic.

Yuwell received the EUA authorization confirmation letter from US FDA

Accelerated Approval Process With Unchanged Thresholds

During the COVID-19 chaos, China has made great efforts to cover the shortage of medical supplies in the whole world. For the export of the Breathcare PAP, the Conformite Europeenne (CE) certification and US FDA certification, as the two most important passes, represent the access thresholds for global mainstream markets. According to the statistics from the Ministry of Industry and Information Technology (MIIT), among the 21 Breathcare PAP manufacturers, only eight of them have acquired the CE certification.

Yuwell had acquired the medical instrument registration certificate presented by the NMPA and the CE certification before obtaining the US FDA-issued EUA. Therefore, yuwell has become one of the few medical brands with "three certificates” in the field of noninvasive Breathcare PAPs in China.

Production lines of yuwell Breathcare PAPs

It is known that the US FDA registration of the Breathcare PAP usually takes at least 6-9 months. To fill the gap of the Breathcare PAP as soon as possible, US FDA accelerated the approval, but it did not reduce the requirements for reporting enterprises and still has strict standards for enterprise scales and quality management.

This sharp weapon is used to fight the pandemic in the world

The noninvasive Breathcare PAP has played a crucial role in China's victory over the COVID-19 pandemic. Multiple experts pointed out that most patients must be treated by using the noninvasive Breathcare PAP or high-flow oxygen therapy if they have hypoxemia in the early or middle stage of the disease to prevent patients from entering critical illness to a great extent.

Doctors in the Wuhan hospital using yuwell Breathcare PAP

According to the statistics of the MIIT, during February this year, China produced about 15,000 Breathcare PAPs. As an important global supplier for the noninvasive Breathcare PAP, yuwell provided the whole country with 7,000 noninvasive Breathcare PAPs, accounting for half of China's noninvasive Breathcare PAPs and providing strong support for winning the defense war in Hubei Province.

A doctor who rushed to the front line of anti-epidemic in Wuhan said that the yuwell noninvasive Breathcare PAP is easy to operate: “10 parameters are displayed on the same screen and the blood oxygen and pulse rate are recorded synchronously, which greatly reduces our workload and saves patients’ lives.”

So far, more than 10,000 yuwell noninvasive Breathcare PAPs have been exported to Italy, Spain, Russia, Britain, and other countries.

To put the exported Breathcare PAPs into use as soon as possible, they are also illustrated with the English user manual, installation guidance video, FAQ, and other auxiliary materials to help international doctors get familiar with the equipment quickly and race against the clock to save patients’ lives.