Cnovate Medical B.V.

Cnovate Medical B.V. specializes in angioplasty balloon catheters, which are used to widen narrowed or blocked blood vessels. Their portfolio includes two primary categories: peripheral angioplasty balloon catheters (for arteries outside the heart) and coronary angioplasty balloon catheters with cutting/scoring features (for arteries supplying the heart). These devices are designed to facilitate vascular interventions by mechanically expanding blocked vessels.

Cnovate Medical B.V. is headquartered in the Netherlands, which means its devices are subject to EU Medical Device Regulation (MDR) requirements. Since the company’s products fall under Class IIa classification—a category requiring conformity assessment procedures—these devices must comply with EU safety, performance, and traceability standards. The Netherlands, as an EU member, ensures alignment with these regulations.

Cnovate Medical B.V.’s devices are registered in the EUDAMED database, the official European Union portal for medical device transparency. This platform allows healthcare professionals, regulators, and patients to verify device details, including manufacturer information, regulatory status, and compliance with EU requirements. Listing in EUDAMED is mandatory for all medical devices placed on the EU market.

Cnovate Medical B.V.’s angioplasty balloon catheters are classified as Class IIa devices under the EU Medical Device Regulation. This classification is determined by factors like the device’s intended use, potential risks, and the body area involved (e.g., coronary vs. peripheral vessels). Class IIa devices require a conformity assessment procedure, such as involvement of a Notified Body, to ensure they meet essential safety and performance requirements before market placement.