[News]SML Genetree Obtains CE-IVDR Certification for NamuPlex™ Molecular Diagnostic Products for Sexually Transmitted Infections, Gastrointestinal Infections, and Respiratory Infection

SML Genetree's NamuPlex™ molecular diagnostic product portfolio has received certification under the European Union’s In Vitro Diagnostic Medical Devices Regulation (CE-IVDR).

The certification was issued through BSI Group, a European notified body. The certified portfolio includes molecular diagnostic assays for the detection of sexually transmitted infection pathogens, gastrointestinal bacteria and viruses, and respiratory viruses and bacteria.

The NamuPlex™ STD 12 Real-time PCR Kit is a multiplex real-time PCR assay designed for the qualitative detection of 12 pathogens associated with sexually transmitted infections.
The NamuPlex™ GI Virus and GI Bacteria product lines detect pathogens associated with gastrointestinal infections, while the NamuPlex™ Respiratory Pathogen Real-time PCR Kit detects respiratory viruses and pneumonia-related bacterial pathogens.

The EU IVDR imposes more stringent requirements than the previous IVDD, covering product safety and performance, quality management systems, technical documentation, clinical evidence, and post-market surveillance. The certification demonstrates that SML Genetree meets the enhanced quality and regulatory standards required in the European market.

SML Genetree has developed and commercialized real-time PCR-based molecular diagnostic products for a wide range of infectious diseases. Through this CE-IVDR certification, the company plans to strengthen product credibility in Europe, expand international partnerships, and accelerate its global regulatory and market-entry strategies.

Dong-Soo Lee, CEO of SML Genetree, mentioned “This certification confirms that our molecular diagnostic technologies and quality management system comply with Europe’s strengthened regulatory standards. We will continue to strengthen the NamuPlex™ brand and expand our presence in the global molecular diagnostics market.”

Source: NewsWire | 2026.06.18

https://www.newswire.co.kr/newsRead.php?no=1036793