Infarmed. Disposable swab withdrawn from the market for improperly bearing the CE mark
A disposable sample collection swab, branded Icleam, was withdrawn from the market at the request of Infarmed, for improperly bearing the CE mark, since there is no evidence of compliance with European legal requirements. It is the model “Nasopharyngeal Swab \Flocked\” from the “iclean” brand, from the manufacturer Shenzhen Cleanmo Technology.
At issue is the fact that the product is improperly qualified by the manufacturer as a “medical device for in vitro diagnostics”, when the appropriate qualification is that of a medical device, explains the health authority.
“Consequently, there is no evidence of the device having been subject to the respective conformity assessment by a Notified Body assessing, namely the aspects related to obtaining, guaranteeing and maintaining the sterility conditions”.
The National Authority for Medicines and Health Products, the distributor Vacuette Portugal SA is “developing the necessary actions for the collection of said medical device”. Thus, those who have units of this medical device should not make it available.
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Source: Jornal i by ionline.sapo.pt.
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