GenSure Biotech is pleased to announce that its respiratory antigen rapid tests have now been successfully listed in the European Database on Medical Devices (EUDAMED), representing an important milestone in strengthening regulatory transparency and compliance within the European Union.

 Listed Devices
COVID-19 / Flu A+B Antigen Rapid Test 
COVID-19 / RSV / Flu A+B Antigen Rapid Test 
✔ Regulatory Update
Following CE certification under the In Vitro Diagnostic Regulation (IVDR, Regulation (EU) 2017/746) obtained in January 2026, these products are now:
Officially listed in the EUDAMED database 
Accessible within the EU regulatory transparency framework 
The EUDAMED listing enhances device traceability and provides stakeholders—including healthcare professionals, distributors, and regulatory authorities—with access to key product information.
✔ Supporting Reliable Respiratory Diagnostics
Both products are intended for:
Professional use 
Self-testing applications 
They are designed to support the rapid and reliable detection of major respiratory pathogens, enabling:
Faster clinical decision-making 
Broader access to testing in decentralized settings 
Improved management of seasonal respiratory infections 
✔ Commitment to Compliance and Quality
The successful listing in EUDAMED reflects GenSure Biotech’s ongoing commitment to:
Full compliance with IVDR requirements 
Transparency across the product lifecycle 
Delivery of high-quality diagnostic solutions for the European market 
✔ Device Listings (EUDAMED)
https://ec.europa.eu/tools/eudamed/#/screen/search-device/3b7e77c4-7a1b-4bef-81be-2e
✔ Contact Information
For IVDR documentation, product specifications, or distribution inquiries:

Website: www.gensbio.com
Email: info@gensbio.com
Tel: +86 10-56370138
✔ Keywords
#IVDR #EUDAMED #CEIVDR #InVitroDiagnostics #IVD #POCT #RapidTest #RespiratoryInfections #Influenza #RSV #COVID19 #RegulatoryCompliance #