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Innova Medical Group Earns CE Mark to Distribute Rapid Antigen Test Throughout Europe

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Innova Medical Group, Inc., a global health screening and diagnostic innovator and world’s largest manufacturer and distributor of lateral flow test kits, today announced it successfully earned its CE mark certification (certificate N° 39032) of the Innova SARS-CoV-2 Antigen Rapid Qualitative Self-Test through GMED LNE Group, a leading certification organization and a distinguished Notified Body of the European Commission covering a vast range of products covered under both Invitro Diagnostic and Medical Device Regulations.

A CE mark is an important distinction that allows the company to now sell its products across Europe. This is a significant milestone in the company’s global mission to advance and expand access to its antigen rapid self tests to more people worldwide. The European CE mark Conformity Assessment reviewed Innova’s clinical support and performance data and evaluated the strength and effectiveness of its Quality Management Systems (QMS).

The Innova brand rapid antigen self test has been widely used, studied, tested, scrutinized and analyzed, and has been approved for distribution in markets around the world including United Kingdom, Israel, Malaysia, Sultanate of Oman, Qatar and now the 27 countries of the EU. The company is furthering its mission by applying for authorization and certifications in countries where rapid antigen self tests are needed most.

“Since the COVID-19 pandemic outbreak in March 2020, our team has delivered more than 1.5 billion lateral flow tests to customers worldwide, and this new European certification only underscores our ongoing commitment to provide effective, high-quality diagnostic products at reasonable prices to more people around the world,” said Robert Kasprzak, CEO of Innova Medical Group.

Numerous scientific studies, along with ongoing public health screening of millions of people on a regular basis, have shown rapid antigen self tests are an important tool for identifying infectious people quickly and equitably, even when they may not have symptoms of COVID-19 in ways that simply are not possible with slower, more expensive lab-based tests.

While the coronavirus continues to morph its genetic ribonucleic acid (“RNA”) to generate new and potentially more contagious or more harmful variants, Innova’s rapid antigen self test – which detects multiple proteins in the virus – can provide an at-home, cost-effective way of helping to control the spread and reduce surges. When coupled with Innova’s expansive production capacity, the wide-ranging detection capabilities of its rapid antigen self tests underline the company’s role as a critical partner to nations and businesses in containing more contagious strains.

Since its founding in 2020, Innova has put countless resources towards ensuring that its quality management system is compliant with ISO 13485:2016 Medical Devices – Quality Management Systems, Requirements for Regulatory, and US 21 CFR Part 820 Quality System Regulation, Requirements for Medical Devices. The company has built a dedicated Quality Assurance and Regulatory Affairs team with expertise in quality and regulatory compliance matters, as it continually expands to keep up with global quality and compliance needs. In addition to conducting consistent internal audits to identify process improvements, the company also has electronic Quality Management Systems in place to ensure quality policies are followed, continually monitoring product performance through diligent testing, providing oversight of manufacturing processes and assessing customers’ experiences. The company also uses Enterprise Resource Planning (ERP) systems to assure it has traceability of its products and that only the products that meet performance

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