The Ministry of Health ordered “the ban on the marketing of the U-Mask Model 2 medical device” and “the adoption of the measure of withdrawal of the same product” from the market. Decision taken after the carabinieri of the Nas of Trento reported to the ministry that the U-Mask masks they were found to be medical devices on the basis of certification from an “without authorization” laboratory, signed by a person without a degree. The ministry highlights the “potential significant health risks” deriving from “the absence of a regular evaluation process”.
–
U-Masks ended up in the viewfinder after an investigation by Strip the news which revealed that the filtering was less than 95% compared to that required by law: while costing 35 euros, they would filter less than those of 50 cents. The validation procedure of the Higher Institute of Health is in fact limited to a simple control of documents and not to a control of the effectiveness of the devices. Distributed in 121 countries around the world, the U-Mask has been adopted by various sports federations, and is widespread in Formula One and in Parliament. The carabinieri of the Nas of Trento, who seized the laboratory in Bolzano at the end of January, had written to the Ministry of Health to evaluate the possibility of suspending the qualification of medical devices for the well-known masks. The Bolzano Public Prosecutor’s Office opened an investigation into the matter due to the absence of laboratory authorizations and the illegal exercise of the profession. IS in Milan An investigation is underway in which, at the moment, the director of the company’s Italian branch is being investigated for fraud in the exercise of trade.
–
Also l’Antitrust had initiated proceedings against the promotion and sale of U-Masks. The claims of the product developed by U-Earth Biotech Ltd are targeted by the independent authority, which is responsible for defending competition law and consumer rights. In the advertisements “the effectiveness of these devices would be emphasized in deceptive and aggressive ways, unduly exploiting the current health emergency situation to induce the consumer to buy the advertised product at high prices”.
–
