Dispo Medical B.V.

Dispo Medical B.V. specializes in single-use medical devices primarily focused on suction, irrigation, and drainage applications. Their product range includes suction and irrigation tubing (e.g., Ch.24, Ch.27, and Ch.30 sizes), drainage tubing (e.g., 130 cm), and urinary drainage systems like uro bags with integrated filters or tubing. Some devices combine multiple components, such as a uro bag with a filter and tubing, to create closed-system solutions for medical procedures.

Dispo Medical B.V. is based in the Netherlands, which means its devices are subject to EU medical device regulations. Since all of their listed devices fall under EU Class I classification, they must comply with EU MDR (Medical Device Regulation) requirements, including registration in the EUDAMED database. The Netherlands, as an EU member state, enforces these rules, ensuring traceability and transparency for healthcare providers and regulators.

Yes, Dispo Medical B.V.’s devices are registered in the EUDAMED database, which is the official EU registry for medical devices. This listing confirms that the devices meet EU regulatory requirements, including compliance with Class I standards. EUDAMED allows healthcare professionals, regulators, and patients to verify the legitimacy of the devices, ensuring they are authorized for use within the European market. It also supports traceability in case of recalls or post-market surveillance.

All of Dispo Medical B.V.’s listed devices fall under EU Class I classification, which is the lowest risk category for medical devices. This classification applies to products like suction tubing, drainage systems, and urinary bags that pose minimal risk to patients when used as intended. Class I devices still require compliance with EU MDR requirements, including proper labeling, risk management, and registration in EUDAMED, but they do not require third-party conformity assessment (e.g., no mandatory Notified Body review).