Brighter - CE marks for Actiste device received
Brighter recently announced that it has received CE marking for the Actiste device. In fact, it has received two CE marks as Actiste is regulated under both the EU Medical Devices Directive and the In Vitro Diagnostics Directive due to the multiple functions of the device. Initially, the company will focus on establishing service in the Gulf Cooperation Council (GCC), especially the United Arab Emirates (UAE), Sweden and South-East Asia (in particular Thailand and Indonesia).Brighter publ AB is a Sweden-based company active in the healthcare sector. It is primarily engaged in the development of Brighter One, a self-care device dedicated for type 1 and type 2 diabetes patients. Brighter One integrates a lancet, blood glucose meter for test strips, dosing and injection mechanism, and storage of glucose level and dosing history data. The Company cooperates with partners such as Almi Foretagspartner AB and Innovationsbron, as well as a distributor Rubin Medical.
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