DName-iT Holdings Ltd

DName-iT Holdings Ltd specialises in DNA barcoding-based specimen labels. These labels are designed to uniquely identify patient samples during Next Generation Sequencing (NGS) analysis, helping to prevent misidentification or sample mix-up in genetic testing workflows.

DName-iT Holdings Ltd is headquartered in the United Kingdom. This location is relevant for regulatory and compliance purposes, particularly when considering the company’s involvement with EU-based registries.

DName-iT Holdings Ltd’s devices are listed in the eudamed database, which is the official EU registry for medical devices. This inclusion ensures transparency and compliance with EU regulatory requirements for Class I devices.

DName-iT Holdings Ltd’s devices fall under EU Class I classification. This classification is determined based on their intended use—specifically, their role in specimen identification for NGS workflows—and their associated risk profile, which is deemed low under EU medical device regulations.