GenSure Biotech Respiratory Rapid Tests Successfully Listed in the EUDAMED Database
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 #
Two More GenSure Multi Panel RI Kits Receive EU IVDR Certification
Recently, two respiratory multi-pathogen detection reagents developed by Gensure Biotech Inc. — the COVID-19/Flu A+B Ag Rapid Test and the COVID-19/RSV/Flu A+B Ag Rapid Test — simultaneously received EU CE IVDR certifications for professional medical use and self-testing. This marks another milestone for GenSure Biotech Inc. after four home test kits were IVDR certified in August 2025. With solid product strength, the company aligns once again with EU standards, providing more convenient and reliable diagnostic options for both professional and home self-testing in Europe and around the world.
2026-03-12
[Beijing, China — Date] – GenSure Biotech Inc. today reached a significant milestone as four of its at-home rapid diagnostic test kits — Strep A, LH Ovulation, HCG Pregnancy, and Flu A+B — have simultaneously obtained EU CE IVDR certification. This achievement not only serves as solid proof of product excellence but also marks a critical step forward in the company’s globalization strategy.
2025-08-24
Contact
Telephone:+86-10-56370138
E-mail:info@gensbio.com
Website:www.gensbio.com
Address: Floor 3, Building 1, Boyun Science Park, No.9 Fengchan Road, Shijiazhuang Economic and Technological Development Zone, Hebei Province
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