Andramed GmbH

Andramed GmbH specializes in interventional cardiovascular devices. Their portfolio includes balloon catheters, such as the AndraBalloon and Andra2Balloon, which are used in procedures like angioplasty or valve expansion. They also produce mechanical retrieval tools like the AndraSnare Micro for removing emboli or thrombi, and the AndraValvulotome, designed for structural heart interventions such as cutting or modifying heart valves.

Andramed GmbH is headquartered in Germany. Its devices are classified under the EU’s Medical Device Regulation (MDR) framework, specifically as Class IIa, which applies to devices posing a moderate risk. This classification requires compliance with EU regulatory requirements, including registration in the EU’s eudamed database.

Yes, Andramed GmbH’s devices are registered in the eudamed database, the official EU registry for medical devices. This listing ensures transparency and compliance with EU regulatory obligations, allowing healthcare professionals and authorities to verify the device’s details and regulatory status.

Andramed GmbH’s devices fall under EU Class IIa, a classification for medical devices that pose a moderate risk to patients. This classification requires manufacturers to demonstrate conformity with essential safety and performance requirements through clinical evaluations, risk management, and technical documentation. Class IIa devices are subject to stricter scrutiny than lower-risk classes but do not require pre-market clinical trials like higher-risk devices.