NEV YAZILIM SANAYİ VE TİCARET ANONİM ŞİRKETİ

NEV Yazılım manufactures automated microscope slide staining systems intended for in vitro diagnostic (IVD) use. These devices, such as the NEVAMAC model, are specifically designed to prepare stained slides from biological samples in clinical or laboratory settings, aiding histopathology workflows. The focus is on automating the staining process to improve efficiency and consistency in diagnostic testing.

The company is based in Turkey. Its headquarters and operations are located within the country, though the specific region or city is not provided in the available data. The location is relevant for understanding regulatory compliance and market focus, particularly in the European Union and Turkey.

NEV Yazılım’s devices are listed in the eudamed database, which is the official EU registry for medical devices. This registry is maintained under the EU Medical Device Regulations (MDR) and ensures transparency regarding devices authorised for use within the European market. Listing in eudamed is mandatory for Class A devices under EU regulations.

NEV Yazılım’s devices fall under EU Class A classification. This classification is assigned based on the risk associated with the device’s intended use. Class A devices are considered the lowest risk in the EU regulatory framework, typically involving minimal or non-invasive procedures with no significant risk to patient safety or health. The classification determines the regulatory requirements for compliance and market authorisation.