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Memmert CO2 incubator ICOmed classified as medical device

The Memmert CO2 incubator ICOmed now is a class IIa medical device for in-vitro fertilisation and biosynthesis. The CE label on the appliances includes the mark 0197, denoting TÜV Rheinland LGA Products GmbH as the notified body.

In 2016, Memmert had introduced a new generation of its CO2 incubators at the analytica trade show. Now, about one year later, all products in the ICOmed product range have been classified as medical devices. "Hospitals and medical practices from all around the world that have specialized in in-vitro fertilization are a highly interesting market for Memmert," says Heinz Bayer, Head of Sales at Memmert. In this highly delicate field of application, both medical staff and patients need to be able to fully rely on the precision and reliability of the incubators used. During cultivation, the slightest deviation in the CO2 atmosphere, temperature or humidity can have a negative influence on cell development. "High clinical success rates directly translate to human joy," notes Bayer.

For that reason, Memmert subjected its CO2 incubators ICO to an elaborate risk assessment in cooperation with TÜV Rheinland. The classification as a medical device confirms that all Memmert CO2 incubators ICO comply with the fundamental safety requirements of the European Medical Devices Directive 93/42/EEC.

For many years now, Memmert has had a quality management system in accordance with DIN EN 13485 for the development and manufacturing of medical devices in place. This standard has even more strict requirements on patient and user safety than a certification as per DIN EN 9001. Bayer further points out that "the quality of other products such as heating ovens, incubators, climate chambers and water baths also benefits from these processes that have been especially tailored to our medical devices."