Beyond fékk FDA(EUA) samþykki!
Congratulations to Beyond Medical: received FDA(EUA) approval!
Hvað er EUA?
The United States FDA has made certain ventilators, anaesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as ventilators (collectively referred to as “ventilators”), ventilator tubing connectors, and ventilator accessories available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of medical devices, including alternative devices used as medical devices, due to shortages during the COVID-19 pandemic.
Did Beyond Medical get the FDA(EUA) certification?
Yes, we got the FDA(EUA) certification of our B-30 P and C-20A ventilator, please check it as followed!
From now, Beyond Medical became a professional company which own FDA certification, CE certification and ISO certification, Besides that, we were also included in the white list of ventilator export of the State Drug Administration. We all believe that we will do better and better in the coming day.