In August 2022, YHLO received the newest IVDR Certificate from BSI, one of the most reputable notified bodies for medical device CE certifications. The IVDR certificate of YHLO covers additional 58 YHLO chemiluminescent immunoassay (CLIA) detection products including TSH, Cardiolipin IgG, AMH, CA 15-3, CK-MB, HSV-1 IgG etc. Until today, YHLO has obtained IVDR CE Certificate of 72 products, covering the autoimmunity, reproductive health, tumor markers, cardiac markers, infection detection fields and so forth.

The Regulation (EU) 2017/746 on in vitro diagnostic Medical Devices is the new EU legislation applicable to in vitro diagnostic (IVD) medical devices. As of 26 May 2022, the Regulation (EU) 2017/746 (IVDR) fully applied across the EU. The 58 newly certified products of YHLO are proving to the EU market that they are meeting the higher level of requirement to offer safe, high quality and effective diagnostic solutions to patients and healthcare professionals. The rest of YHLO’s other CLIA products are also under the process of obtaining the same certification in a smooth order.

In order to supply reliable products and services to customers, the YHLO team has been working hard to obtain the CE mark in accordance with the IVDR. With the mission of “Focus on healthcare, better life with technology”, YHLO will continue to provide reliable, high-quality healthcare innovations and services worldwide to improve human well-being.