EU DECLARATIONS OF CONFORMITY

Bio/Data Corporation proudly affirms its compliance with the rigorous (EU) In Vitro Diagnostic Regulation (IVDR) 2017/746 and, where applicable, other relevant Union Legislation. This commitment is formally declared through a comprehensive Declaration of Conformity (DoC). In this formal statement, Bio/Data Corporation explicitly states that the devices specified within the declarations meet the essential health, safety, and environmental requirements as stipulated by the pertinent directives.

This declaration stands as a testament to Bio/Data Corporation's unwavering dedication to quality and regulatory adherence. By meeting the stringent standards set forth in the IVDR 2017/746 Regulation, Bio/Data Corporation ensures that its in vitro diagnostic devices not only comply with the essential criteria but also uphold the company's commitment to excellence.

Furthermore, the acknowledgment of adherence to any other applicable Union Legislation underscores Bio/Data Corporation's proactive approach in aligning its products with broader regulatory frameworks. This proactive stance demonstrates the company's commitment to not only meeting the minimum requirements but also exceeding them, fostering a culture of continuous improvement in product safety, performance, and environmental impact.

In essence, the Declaration of Conformity serves as a formal affirmation of Bio/Data Corporation's proactive and comprehensive approach to compliance, reflecting the company's steadfast commitment to delivering high-quality, safe, and environmentally responsible in vitro diagnostic devices that meet or exceed the stringent standards set by the European Union.