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Stop the sale of masks U-Mask 2.1. The prohibition of marketing and simultaneous withdrawal from the market of this type of masks, for reasons related to the safety of the product, was established by the provision issued by the General Directorate of Health Products and the Pharmaceutical Service of the Ministry of Health as a result of the controls made from the Nas de Trento. The ministry’s decision is based “on a detailed examination of the documentation that does not demonstrate the actual possession by the product of the necessary and essential technical requirements, such as the ability to maintain the performance of the interchangeable filter (recharge) unaltered for up to 200 hours. of use., biocompatibility and microbial cleaning of the product “.
The product was registered by the company U-Earth Biotech Ltd through the presentation of a new technical file, replacing the 2.0 model that on February 19 was the subject of a similar ministerial provision. The Model 2.1 was registered as a Category I Type 2R medical device, so it could also be used in healthcare settings to limit the transmission of infectious agents between operators and patients.
The provision of the Department of Health goes hand in hand with the findings of the investigation of the Nas Carabinieri of Trento, carried out with the coordination of the Milan Prosecutor’s Office. During the last weeks, the military, based on the examination of the new technical file, have verified the production chain of the new mask model, relocated in several companies in northern Italy, each of which carried out a partial processing of the product.
It was found that, compared to the previous model, despite having replaced one of the interchangeable filter internal tissues to obtain better bacterial filtration performance, the product had not actually passed the microbial cleanliness test, which the company had referenced. to a certificate issued by the University of Bologna on the previous mask model. Last week, in addition, during a search delegated by the Public Ministry of Milan, an anonymous warehouse on the outskirts of that capital and not indicated among the company’s production units was identified, in the availability of a Romanian citizen, finding e seizing more than 3 tons of merchandise, for an estimated commercial value of 5 million euros, including 50 thousand complete packages of U-Mask mod. 2 and 2.1, 100 thousand spare parts and various materials for packaging (envelopes, labels, warranty seals).
In light of the material found, the research hypothesis that the old product (model 2.0) was repackaged with the new outer packaging of the U-Mask 2.1 model is being investigated. The ministerial provision gives the company U-Earth Biotech Ltd 5 days to comply with the prescriptions on the withdrawal of model 2.1 masks. which, in the meantime, have been removed from the national database of notified medical devices.
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