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HE Infamous announced, in a statement published on its website, that “the placing on the national market and the commercialization of type I surgical masks has been identified” by OrbitPlatform, with an improper CE marking, because “there is no evidence (proof) of compliance with all applicable legal requirements and because the technical documentation is incomplete”.
These are “type I surgical masks with references MC10001, MC10001.1, MC10002, MC10003 and type IIR with references MC20001, MC20002 and MC20003 “from OrbitPlatform, a Portuguese company dedicated to the manufacture of surgical masks for protection against COVID-19-19.
HE Infamous it determined “the immediate withdrawal of said devices from the national market.”
According to the drug authority, “the manufacturer voluntarily initiated the necessary mechanisms for the collection and suspension of the marketing of said medical devices.”
At the same time, the simplified process of commercialization of these devices in the national market began in the terms of article 4 of Decree Law No. 14-E / 2020, of 13 April, in your Current test, demonstrating compliance with published regulatory requirements and specifications, Infamous not communicated.
A pandemic of COVID-19-19 has already caused at least 889,498 deaths and infetou more than 27.1 million people in 196 countries and territories, according to a report prepared by the French agency AFP.
In Portugal, 1,843 people died of the 60,507 confirmed as infected, according to the most recent Address-General health.
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