U-Mask Model 2.1 stop on sale because of “Health Risks”

“Prohibition of placing on the market “and ” withdrawal from the market “ for the U-Mask Model 2.1 , the new version of the ‘VIP masks’ ended up at the center of an investigation by the Milan Public Prosecutor’s Office for fraud in the exercise of trade. This was established by the Ministry of Health with a provision similar to the one that had affected the previous model, ‘Model 2’, at the end of February.

The stop was decided, as stated in the provision, ” in consideration of the intended use of the product “, ie as a medical device,” as well as the potential significant health risks human deriving from the absence of a regular evaluation process in terms of safety and efficacy and the consequent absence of guarantee on the actual adequacy as a tool for preventing infections “.

The Carabinieri Command for the Protection of Health will verify compliance the provision and the company will be able to appeal to the same Ministry within 30 days or to the TAR within 60 days. At the end of January, among other things, the carabinieri of the Nas of Trento had seized a laboratory in Bolzano which had carried out certifications on previous model of the masks.

U-Mask announces appeal to the Tar . “In confirming that the U-Mask Model 2.1 is fully compliant and obviously does not harm health in any way”, the company announces that “ will act immediately to protect their rights and interests in the competent offices, as already happened for the previous Model Two, most recently with an appeal to the TAR against the provision notified just yesterday “. The company states in a note: “The new U-Mask Model 2.1, which develops and refines the previous U-Mask Model Two, has been duly registered as new medical device at the Ministry of Health and, as highlighted in the technical file, possesses all the requisites required by the En14683 standard which governs, acknowledging the European standards, manufacturing, design, performance requirements and test methods for medical face masks. The materials of the new model do not present any problem of compliance with the aforementioned standards and requirements as the tests were carried out in an international laboratory Accredia certificate and the results obtained are fully within the parameters in force “.