(ANSA) - MILAN, MARCH 27 - The Ministry of Health has issued a "ban on the placing on the market and simultaneous withdrawal from the market" of the "U-Mask Model 2.1", the new version of the well-known masks, which ended up in the an investigation by the Milan Public Prosecutor's Office for fraud in the exercise of commerce.
The previous model, the "Model2", had been the subject of a similar provision again by the Directorate General of Medical Devices and the Pharmaceutical Service of the Ministry, at the end of February.
The ban on sale and withdrawal from the market 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 risks to human health deriving from the absence of a regular evaluation process in terms of safety and efficacy and the consequent lack of guarantee on the actual adequacy as an instrument for the prevention of infections ".
The Command of the Carabinieri for the Protection of Health will verify compliance with the provision and the company may appeal to the same Ministry within 30 days or to the Tarentro 60 days.
At the end of January, among other things, the carabinieri of the Nas of Trento had seized a laboratory in Bolzano that had carried out certifications on the previous model of the mask.
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