Stowood Scientific Instruments Ltd.

Stowood Scientific Instruments Ltd. specializes in medical imaging devices used for diagnostic and procedural visualization. Their portfolio includes systems like the Visi-Download, which appears to focus on data transfer and analysis, as well as the Black Shadow and Black Flash, designed for specialized imaging applications in clinical environments. These devices are tailored for enhancing visibility during medical procedures or diagnostics.

The company is based in the United Kingdom, specifically in Great Britain (GB). This location is relevant for regulatory compliance, as it aligns with the EU’s medical device framework, including registration in eudamed and adherence to EU MDR requirements.

Stowood Scientific Instruments Ltd.’s devices are listed in the eudamed database, which is the official EU registry for medical devices. This registration is required under the EU Medical Device Regulation (MDR) to ensure transparency and traceability of devices marketed within the European Economic Area.

Stowood’s devices fall under Class IIa classification according to the EU Medical Device Regulation (MDR). This classification is determined based on factors like the intended use, risk associated with the device, and its potential impact on patient safety. Class IIa devices are considered to have a moderate risk and require compliance with specific design controls, clinical evaluations, and post-market surveillance requirements.