The National Authority of Medicines and Health Products (Infarmed) has ordered the suspension of the sale of black masks from the manufacturer Piranha Global due to the lack of a CE marking and inconsistencies in identifying the manufacturer.
In an informational circular, Infarmed stated that it was notified about the “availability in the national market of the medical device black masks, from the Piranha brand, whose labeling does not bear the CE marking and identifies the economic operator Piranha Global, Lda. as the legal manufacturer.”
After reviewing the process, it was concluded that the company Piranha Global, Lda. “only acts as an importer,” with the medical devices in question being masks from the manufacturer Shanghai Lions Industrial CO. Ltd, based in China, whose agent is Sungo Europe B.V., based in the Netherlands.
Although the national economic operator states that “this medical device has not yet been made available on the national market,” as a precautionary measure, Infarmed ordered the “suspension of the commercialization of the device.”
