Congrats! YanengBIO received IVDR certification
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2022-06-09
In June 2022, YanengBIO proudly announced that we have received 10 CE-IVDR Certificates, which covered:
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.
| MNP | Nucleic Acid Extraction Reagent |
| 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.
