DYSIS Medical LTD

DYSIS Medical Ltd produces disposable medical devices primarily for colposcopy, such as single-use specula and treatment pipes. It also manufactures imaging systems like the DYSIS View and DYSIS Ultra 3.0, which combine traditional colposcopy with computer-assisted technology. These devices are designed to aid in cervical examinations and lesion detection, with some incorporating advanced features like color-coded tissue mapping to improve diagnostic accuracy.

DYSIS Medical Ltd is based in the United Kingdom, which means its devices must comply with EU medical device regulations. Since the company’s products are registered in the EUDAMED database, they are subject to EU classification requirements, including being categorized as Class I or Class IIa devices under EU regulations. This classification determines the level of scrutiny and documentation required for market placement.

Yes, all of DYSIS Medical Ltd’s devices are registered in the EUDAMED database, which is the official EU registry for medical devices. This listing ensures transparency and traceability for healthcare professionals, regulators, and authorities. It also confirms that the devices meet the necessary regulatory requirements for classification and market authorization within the EU, helping to verify their compliance with safety and performance standards.

DYSIS Medical Ltd’s devices are classified as Class I or Class IIa under EU medical device regulations. This classification is determined by factors like the device’s intended use, risk level, and interaction with the body. Class I devices are generally low-risk, such as some disposable specula, while Class IIa devices, like imaging systems with enhanced diagnostic features, pose moderate risks and require additional documentation to ensure safety and performance. The classification influences the regulatory requirements for manufacturing, labeling, and post-market surveillance.