The Ministry of Health has ordered the prohibition of placing on the market and the simultaneous provision of withdrawal from the market of the U-Mask Model 2.1, the new version of the well-known masks, which in recent months ended up at the center of an investigation by the Milan Public Prosecutor’s Office for fraud in the exercise of trade. The carabinieri of the Nas of Trento have seized over 3 tons of goods, for an estimated commercial value of 5 million euros. The company announces that to appeal against the provision.
Withdrawal from the market
The prohibition of sale and withdrawal from the market been decided, as stated in the provision, in consideration of the intended use of the product, that is as a medical device, as well as the potential significant health risks deriving fromabsence 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 filtration capabilities
With regard to the new model of the U-Mask, on the market for a few weeks, the ministry also pointed out that the results of the tests that the manufacturer has made available as an attachment to the technical file they do not provide scientific evidence on the ability to maintain filter performance unaltered for up to 200 hours of use. As stated in the provision, in fact, no test reports are available that give evidence that the characteristics of bacterial filtration efficiency, breathability and splash resistance are maintained. The product was then deleted from the database of medical devices.
Strip the news: Confirm our tests on U-Mask
Our tests quickly revealed that U-Mask 2.1’s breathability was having problems and did not appear to be compliant, he told the ‘Ansa the envoy of Strip the news,Moreno Morello, commenting on the decision of the Ministry of Health. It was Antonio Ricci’s satirical news, we read in a note, a start investigating the U-Mask affair in December 2020, mask compared by the company that produces it to personal protective equipment (FFP2 or FFP3), but which would actually have a filtration capacity below the threshold required by law and lower than that of a 50 cent surgical standard.
The company: All regular, we will appeal
But from the company that produces U-Mask comes the replica in a note specifying that the new 2.1 mask has been duly registered as a new medical device at the Ministry of Health and, as highlighted in the technical file, has all the requirements required by rules for being registered as a medical device. It is also specified that the conformity tests were carried out at an Accredia certified international laboratory (the only Italian body that certifies the laboratories). For this, the note states, the company will proceed with an appeal to the TAR against the provision.
March 27, 2021 (change March 27, 2021 | 18:21)
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