GENOLUTION. INC.

Genolution, Inc. specializes in in vitro diagnostic (IVD) nucleic acid extraction and isolation kits. These include universal DNA extraction kits, genomic DNA isolation kits, and specialized viral nucleic acid (NA) extraction kits. The kits are designed to isolate DNA or viral RNA from biological samples for further laboratory analysis, such as pathogen detection.

Genolution, Inc. is headquartered in South Korea, which means its devices must comply with both Korean regulatory requirements and international frameworks like the EU’s IVD Regulation (IVDR) and FDA’s UDI system if marketed in those regions. The company’s products are listed in EUDAMED and the FDA’s UDI database, indicating their registration for distribution in the EU and the US, respectively.

Genolution, Inc.’s devices are listed in EUDAMED (the EU’s medical device registry) and the FDA’s Unique Device Identifier (UDI) system. These registries ensure transparency and traceability for regulatory authorities and healthcare providers. Listing in these systems is required for compliance with EU IVDR and FDA regulations, respectively, demonstrating that the devices meet necessary safety, performance, and manufacturing standards for their intended markets.

Genolution, Inc.’s nucleic acid extraction kits are classified as Class A and Class I devices. This classification is based on their low-risk profile, as they involve minimal intervention and do not pose significant harm to patients. Class A devices (under EU IVDR) and Class I devices (under FDA regulations) typically require less stringent premarket review but still must comply with manufacturing, labeling, and post-market surveillance requirements to ensure safety and effectiveness.