Congrats! YanengBIO received IVDR certification

Manufacturers of in-vitro diagnostic instruments and regents must obtain new CE-IVDR certifications after 26 May 2022 to enter the EU market.

In June 2022, YanengBIO proudly announced that we have received 10 CE-IVDR Certificates, which covered: MNP (Nucleic Acid Extraction Reagent) MEB (Nucleic Acid Extraction Reagent) MES (Nucleic Acid Extraction Reagent) MCP (Nucleic Acid Extraction Reagent) CY (Cell Preservation Solution) VPD (Sample preservation Solution) H48 (Automatic Hybridization System) QIA (Nucleic Acid Extraction Reagent) FPS (Stool Collection Tube) BS (Sample Pretreatment Kit for DNA Methylation Test)

Manufacturers of in-vitro diagnostic instruments and regents must obtain new CE-IVDR certifications after 26 May 2022 to enter the EU market. These certifications confirm that the products meet the IVDR’s high-quality standards, which focus on protecting the health of patients and users. Compared to IVDD, IVDR has a risk classification of IVD devices, tightened requirements for post-market surveillance and vigilance, and tightened requirements for clinical evidence and conformity assessment.

YanengBIO will keep working hard to meet the customer’s needs as a responsible enterprise. And we will always put our hearts and souls to chasing life miracles.