Genea Biomedx ISO 13485-2016 Certification Documents

Download the ISO 13485-2016 certification documents below to verify Genea Biomedx’s adherence to quality management and regulatory compliance for medical devices. Your confidence in our credentials is paramount.

Certificate of Registation ISO 13485-2016 (MD 630526) (27 May 2021)
Certificate of Registration ISO 13485-2016 FM 650225 (18 Oct 2024)
Certificate of Registration ISO 13485-2016 (MDSAP 685522) (18 Oct 2024)

Genea Biomedx Products

At Genea Biomedx, we innovate fertility technologies to streamline lab workflows and transform fertility treatments. Our goal is to leverage our extensive expertise to deliver precise, accessible technology that significantly improves both lab performance and patient results.


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