News
EmbryoScope(TM) Embryo Monitoring System receives CE Mark of approval
Aaruhs, Denmark
Jul 6, 2009
Unisense FertiliTech A/S has received CE approval for EmbryoScope(TM) Embryo Monitoring System and EmbryoSlide(TM) tray, as class IIa medical devices for use in IVF. The organisation has also claimed 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 says, "The CE mark will allow us to market the instrument to Assisted Reproduction clinicsacross Europe, with the goal of improving embryo assessment facilitating the goal of elective single embryo transfer".
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