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The ZivEco products are medical devices marked CE (Class I) and 0426 CE (Class IIb and Class IIa) in accordance with the Medical Devices Directive 93/42/EEC and subsequent amendments (Directive 2007/47/EC).
The Quality Management System implemented by ZivEco meets the standards and requirements of the current legislation.

CE Certificate
UNI EN ISO 9001:2008 Certificate
UNI CEI EN ISO 13485:2012 Certificate