EU CE3018 Self-Test Certification, Bioteke 5 In 1 Respiratory Pathogen Panel

Bioteke's 5-in-1 Respiratory Antigen Test Kit Nears EU CE3018 Certification for Self-Testing

       We are proud to announce that Bioteke's 5-in-1 Respiratory Pathogen Antigen Rapid Test Kit is in the final stages of acquiring the EU CE3018 certificate for self-testing. This major regulatory milestone affirms the test kit's safety, accuracy, and usability for at-home diagnosis in the European Union.

       This 5-in-1 rapid test kit is designed to simultaneously detect five major respiratory viruses in a single test within 15 minutes, making it an essential tool for personal health monitoring, early infection control, and public health management.

What Does CE3018 Self-Test Certification Mean?

The CE3018 mark is an EU declaration of conformity under Regulation (EU) 2017/746 (IVDR), specifically for self-testing in vitro diagnostic medical devices. It ensures the product can be safely used by laypersons without professional supervision. This certification enhances consumer confidence and facilitates legal market access across EU and EEA member states.

Learn more about the CE certification process on the European Commission’s official website.

Key Features of Bioteke's 5-in-1 Antigen Rapid Test Kit

• Targets 5 common respiratory viruses:

• SARS-CoV-2 (COVID-19)

• Influenza A

• Influenza B

• Respiratory Syncytial Virus (RSV)

• Adenovirus

• Results in 15 minutes – no equipment required

• User-friendly design for at-home use

• Three drops of sample for accurate detection

• CE-compliant design, manufactured under ISO13485 standards

• Shelf life: 24 months

• Storage conditions: 2°C–30°C

Global Access and Public Health Impact

       Once CE3018 certification is officially granted, Bioteke's 5-in-1 test kit will be eligible for sale in EU countries, EEA regions, and other international markets recognizing CE marking for IVD self-tests. It is a vital step toward expanding the accessibility of high-quality diagnostic tools for home users, pharmacies, and distributors across Europe.

       Distributors and retailers interested in early access and bulk purchasing opportunities are invited to contact our BioTeke team via our inquiry form.

Bioteke Corporation(Wuxi) Co., Ltd

Official Website: www.bioteke.cn

Email: zr@bioteke.cn

Phone: +86 133-5792-7939

Whatsapp: +86 133-5792-7939

Address: No.90 Huiming Road, Huishan, Wuxi 2141000, China