Indian-built device to contain Covid infectivity gets US, EU nod
“In the US, Emergo, the notified body under US-FDA that clears medical devices, has given us permission for production and marketing,” said the inventor of the machine, Rajah Vijay Kumar
Regulatory agencies in the US and EU have given clearance to a device designed by an Indian scientist to contain the infectivity of SARS-CoV-2 - Scalene Hypercharge Corona Canon (SHYCOCAN), for production under emergency use against Covid-19.
"In the US, Emergo, the notified body under US-FDA that clears medical devices, has given us permission for production and marketing," said the inventor of the machine, Rajah Vijay Kumar, reports the Times of India.
"We have also successfully completed extensive European Union CE- mandated safety testing undertaken by the Underwriters Laboratories and obtained the class-I CE Mark, enabling expedited manufacture, distribution, and sales in all CE-compliant countries, including India," he added.
Conformité Européene (CE) means European Conformity; a mandatory certification required for any product to be sold in the EU.