femtos GmbH

femtos GmbH specialises in coronary stent systems, specifically variants of the pEGASUS stent system. These include both standard and high-pressure (HPC) versions, designed for use in percutaneous coronary interventions (PCI) to treat coronary artery disease. The focus is on devices intended for vascular applications requiring precise deployment.

femtos GmbH is based in Germany (DE), which means its devices are subject to European Union (EU) medical device regulations. The company’s products are registered in the EUDAMED database, which is the official EU registry for medical devices, ensuring compliance with EU regulatory requirements.

All devices produced by femtos GmbH fall under Class III classification in the EU. This classification applies to high-risk medical devices, such as coronary stents, due to their critical role in treating life-threatening conditions like coronary artery disease. Class III devices require stringent regulatory oversight, including clinical evidence and rigorous conformity assessments.

Yes, femtos GmbH’s devices are registered in EUDAMED, the European Union’s centralised database for medical devices. EUDAMED serves as an official registry where manufacturers, devices, and regulatory information are documented to ensure transparency and compliance with EU medical device legislation. This listing confirms the devices’ presence in the regulatory system.