SugenTech Receives EU-Wide Personal Use Approval for COVID-19 Self-Test Kits... "Available at Pharmacies, Convenience Stores, and Online Malls"

[Asia Economy Reporter Yoo Hyun-seok] SuzenTech announced on the 11th that it has become the first domestic company to successfully obtain the European personal use authorization (Certificate of Conformity, CoC) for both COVID-19 antigen rapid diagnostic and antibody rapid self-diagnostic kits.

With this CoC certification, SuzenTech's COVID-19 rapid self-diagnostic kits can be supplied to distribution channels across Europe where self-diagnostic devices can be sold, such as pharmacies and convenience stores. Since distribution is also possible through online malls specialized in selling self-diagnostic products like Amazon, the products are expected to have a wide-reaching impact through extensive distribution platforms.

The German certification body ‘T?V S?D’ approved the ‘CE self-testing CoC’ after a formal review process of SuzenTech’s COVID-19 antigen and antibody self-diagnostic product certification. Since T?V S?D certification is an official certification effective throughout Europe, SuzenTech’s products can be distributed across the entire European region.

A SuzenTech official stated, “Most diagnostic kits from competitors who have previously obtained certification only have ‘Declaration of Conformity (DoC)’ without external verification procedures or ‘short-term conditional approvals’ granted by some individual European countries, so SuzenTech’s formal CoC certification represents a significant differentiation.”

He added, “Once SuzenTech’s rapid self-diagnostic kits are distributed throughout Europe, it will be easy to check not only for infection but also for immune formation status. The antigen self-diagnostic kit is used to easily confirm COVID-19 infection, while the antibody self-diagnostic kit is used to test immune formation and immune persistence due to infection or vaccination, so demand for diagnostic kits is expected to be substantial.”

SuzenTech has been recognized for its outstanding technology and product capabilities in major countries worldwide, having obtained the U.S. ‘FDA EUA POC’ authorization for its COVID-19 antibody product as the first domestic company after performance evaluation by the U.S. ‘NIH/NCI’ institution, and having passed evaluation by the reputable German ‘PEI’ institution to acquire ‘BfArM’ self-diagnostic product authorization.

This content was produced with the assistance of AI translation services.