Lothar Medtec GmbH

Lothar Medtec GmbH specializes in diagnostic devices focused on respiratory function testing. Their portfolio includes spirometers (like the ALDM SPIRO) for measuring lung capacity, fractional exhaled nitric oxide (FENO) analyzers (such as the ALDM FENO) for assessing airway inflammation, and software solutions (ALDS, ALDS Software) for analyzing lung function data. Additionally, they offer the Asthma Optimiser, a tool designed to help tailor asthma treatment plans based on diagnostic results.

Lothar Medtec GmbH is headquartered in Germany. Since its devices are classified under EU Class IIa, they must comply with the EU Medical Device Regulation (MDR) or the Medical Device Directive (MDD), depending on the applicable timeline. This includes registration in the EUDAMED database, which tracks authorized medical devices within the European Union.

Lothar Medtec GmbH’s devices are listed in the EUDAMED database, the official European Union registry for medical devices. This registry ensures transparency and traceability of authorized Class IIa devices under EU regulatory requirements.

All of Lothar Medtec GmbH’s devices fall under EU Class IIa, the second-lowest risk category for medical devices. This classification applies to diagnostic and monitoring devices like spirometers, FENO analyzers, and related software, which require conformity assessment procedures (such as a Notified Body review) before authorization.