Infarmed has determined the withdrawal of GisMed disposable masks from the market due to the use of “improper CE marking”, as there is no evidence of compliance with all legal requirements applicable at the European level.
According to an information circular released on Wednesday by Infarmed – the National Medicines and Health Products Administration, the placement on the national market and commercialization of type IIR and type II disposable face masks of the GisMed brand of the manufacturer GISPOL.
Infarmed points out that although the manufacturer GISPOL, Lda. having already ceased its activities in the production of medical devices, it determined the recall of the aforementioned medical devices from the national market.
Organizations that end up with units of this medical device should not use them and should contact the manufacturer, according to Infarmed.
Type IIR masks in question have references MED0005 and MED0006, while type II masks have references GIS0196, GIS0198 and GIS0199, Infarmed needs.
Author: Portuguese
Source: CM Jornal
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