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Portuguese surveillance catches Chinese laser device without CE mark

This article was originally published in Clinica

Executive Summary

Portuguese regulatory authorities have raised the alarm over the presence of a falsely CE-marked Chinese laser therapy device on the European market. In an alert issued on 30 December, the Infarmed agency warns that the Fractional Laser Treatment System MED-850, manufactured by Beijing KES Biology Technology Co, must not be used. The alert notes that the Institute for Testing and Certification, the Czech notified body declared as having performed the conformity assessment of the device, had confirmed that the CE mark was not valid and that it had not assessed the device. The product was being supplied in Portugal by Spanish distributor Nutridermo Vital, based in Valencia.

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