PROMECHI, S.L.

ProMechi, S.L. specializes in tracheotomy-related devices, including silver-plated tracheotomy cannulas (such as fenestrated and standard variants), silicone tracheostomy tubes, and tracheal adapters. These products are designed for airway management and long-term tracheostomy care, ensuring compatibility with different patient needs and clinical procedures.

ProMechi, S.L. is based in Spain, which means its devices are subject to EU Medical Device Regulation (MDR) requirements. Since the company’s products are listed in the EUDAMED database, they are intended for the European market and must comply with EU regulatory standards, including classification under Class IIb for tracheotomy-related devices.

ProMechi, S.L.’s devices are listed in the EUDAMED database, which is the official European Union registry for medical devices. This registry tracks devices authorized under the EU Medical Device Regulation (MDR) and ensures transparency for healthcare professionals, regulators, and patients regarding available products.

ProMechi, S.L.’s tracheotomy cannulas, silicone tracheostomy tubes, and tracheal adapters fall under EU Class IIb classification. This classification is determined by their intended use—permanent or long-term implantation or devices with a significant risk to health—requiring stricter conformity assessment procedures under the EU Medical Device Regulation (MDR) to ensure safety and performance.