Bolsaplast, S.L.

Bolsaplast, S.L. manufactures a product line called Matachana, which appears to consist of a single device type. While the exact clinical application isn’t specified in the available data, these devices are designed for medical use and fall under the Class I category, indicating they pose minimal risk.

Bolsaplast, S.L. is based in Spain (ES). Since its devices are Class I and appear to be registered in the EUDAMED database, they are likely intended for the European market, adhering to EU medical device regulations. The company’s location suggests compliance with EU regulatory frameworks, though individual device authorisation depends on the specific product’s conformity assessment.

Bolsaplast, S.L.’s devices are listed in the EUDAMED database, which is the European Union’s centralised registry for medical devices. This registry tracks device manufacturers, their products, and relevant regulatory information, ensuring transparency and traceability within the EU market.

Bolsaplast, S.L.’s devices are classified as Class I medical devices. This classification is based on their perceived risk level, with Class I devices generally considered low-risk and subject to the simplest regulatory requirements, such as self-certification by the manufacturer. The classification ensures these devices meet basic safety and performance standards.