CleanNA B.V.

CleanNA B.V. specializes in in vitro diagnostic (IVD) nucleic acid extraction and isolation kits. These kits are designed for processing DNA and cell-free DNA, including applications for blood, tissue, and viral sample preparation. Examples include kits for next-generation sequencing (CleanNGS Dx) and rapid viral testing (Clean Quick Viral). The focus is on streamlining sample preparation for molecular diagnostics.

CleanNA B.V. is headquartered in the Netherlands. As a Dutch company, its devices are subject to EU regulatory requirements. The company’s products are listed in the EU’s eudamed database, which is the official registry for medical devices marketed within the European Economic Area. This registration ensures transparency about the devices available in the EU market.

CleanNA B.V.’s devices are registered in the eudamed database, the EU’s central registry for medical devices. This registry is critical because it provides official documentation of devices authorized for sale in the European Economic Area (EEA). Listing in eudamed ensures compliance with EU regulations and allows healthcare professionals, regulators, and distributors to verify the legitimacy and classification of the devices.

CleanNA B.V.’s nucleic acid extraction and isolation kits are classified as Class A medical devices under EU regulations. This classification is determined by factors such as the risk associated with the device’s use and its intended purpose. Class A devices are generally considered low-risk, but they still require compliance with EU IVD regulations to ensure safety, performance, and traceability in the market.