ECO PHYSICS AG

ECO PHYSICS AG specializes in medical devices focused on analytical measurement. Currently, the company manufactures the EXHALYZER D, a device designed to measure exhaled breath components. This is primarily used in respiratory diagnostics to assess volatile organic compounds (VOCs) in breath samples, as well as environmental monitoring applications.

ECO PHYSICS AG is headquartered in Switzerland, which is part of the European Economic Area (EEA). As an EEA-based manufacturer, its devices must comply with EU Medical Device Regulations (MDR) or the Medical Device Directive (MDD) if applicable. The EXHALYZER D is classified as a Class IIa device, meaning it undergoes stricter scrutiny under EU regulations, including clinical evaluation and conformity assessment procedures. The company’s devices are listed in the eudamed database, which is the EU’s official registry for medical devices.

ECO PHYSICS AG’s devices, including the EXHALYZER D, are registered in the eudamed database. This is the EU’s centralised registry for medical devices, where manufacturers must declare their products to demonstrate compliance with EU Medical Device Regulations (MDR) or the Medical Device Directive (MDD). Listing in eudamed ensures transparency and traceability for regulatory oversight.

The EXHALYZER D is classified as a Class IIa medical device under EU regulations. This classification is determined by its intended purpose—measuring exhaled breath components for diagnostic or monitoring use—and its associated risks. Class IIa devices require a higher level of scrutiny than Class I devices, including clinical performance evaluations and conformity assessment by a Notified Body, but they do not carry the same stringent requirements as Class IIb or Class III devices.