CE approval to Embryo Monitoring System
CE approval has been given to Unisense FertiliTech A/S for EmbryoScope(TM) Embryo Monitoring System and EmbryoSlide(TM) tray, as class IIa medical devices for use in IVF. The organisation claimed for the DS/EN ISO13485:2003 and AC: 2007 quality system certificate for production, installation and servicing of IVF incubators and related accessories. The EmbryoScope(TM) Monitoring System allows uninterrupted observation of embryo development in a stable environment.
Francesca Bahr, sales manager at Unisense FertiliTech A/S told that the approval will allow us to market the instrument the Assisted Reproduction clinics across Europe with aim of improving embryo assessment facilitating the goal of elective single embryo transfer.
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