Regulatory Affairs

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COSMED is strongly committed in the constant improvement of products. Original design is continuously updated to meet the different requirements, quality and safety standards needed to market products worldwide. COSMED meets the CE mark, IEC 60 601-1/EN 60 601-1 and FDA 510(K) clearance market and many other certifications throughout the world (Japan, China, Korea, Brazil, Australia etc.).

COSMED products comply and meet with the latest recommendations issued by the most important scientific organizations in the field, such as the ATS (American Thoracic Society) and ERS (European Respiratory Society) and more.

Download Certification:

CMD/CAS ISO 13485:2003
Scope: Design, Manufacturing, Sales and Servicing of Spirometers and Ergospirometers for Analysis of Respiratory Functionality and Metabolic Rate
CE Certificate
For the following medical devices: Devices for evaluation of the respiratory, cardiac and metabolic function; disposable accessories; disposable devices for pulmonary test; electrocardiographs; papers for medical use with function of measure
UNI EN ISO 13485:2012
For the following products/services: design, manufacturing and marketing of equipment and accessories for cardio pulmonary function testing and for measurement of metabolism
UNI EN ISO 9001:2008
For the following products/services: Design, manufacturing and marketing of equipment and accessories for cardio pulmonary function testing and for measurement of metabolism