Infarmed points out that no records of commercialisation of medical devices by this manufacturer were identified in Portugal, but recommends that the devices mentioned above are not purchased or used, because in the European Economic Area, there is free commercial movements.

In a note posted on the it website, Infarmed states that the competent German authority has ordered a ban on the marketing and collection of medical devices for clinical use, from the manufacturer Shantou T&K Medical equipment factory Co., Lda, since those do not comply with the requirements set out in Regulation (EU) 2017/745 on medical devices.

If these mask are found in Portugal, of these devices must be reported to the Infarmed Health Products Department.