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Relying on in-house R&D and design departments, all CA-MI suction devices and compressor nebulizers are manufactured in Italy using state-of-the-art and wear resistant materials, in compliance with UNI EN ISO 9001:2015 and EN ISO 13485:2016 normatives and carry relevant CE 0123 number certified by German Notified Body TÜV SÜD Product Service GmbH.
The high standards of quality recently allowed CA-MI suction units, aerosol delivery systems, hot-steam inhalators and breast pump to meet the requirements of the latest EN 60601-1-11 “for use in the home healthcare environment, regardless of whether the medical electrical equipment or medical electrical system is intended for use by a lay operator or by trained healthcare personnel” and to be classified with IP21 being “the degree of protection provided against the intrusion (including body parts such as hands and fingers), dust, accidental contact, and water in mechanical casings and with electrical enclosures.”
