Information accompanying the products

Together with the CE Marking, it is a fundamental obligation of the manufacturer to provide information with every device placed on the market. The information necessary to identify the product, to ensure safe use, to allow identification of the manufacturer, to trace the product, is shown on the label and when necessary in the instructions for use. Label and instructions for use are provided by Leone in several languages.

It is of fundamental importance that all the information that the manufacturer has deemed to link to the product, that appearing on the device itself and/or on the unit packaging or, possibly, on the commercial packaging, be maintained during all stages of marketing and reach the end users intact.

Product label symbols

The label on the package of any medical device set on the market will show the symbols in compilance with the harmonized standards. The symbols marked with a single (*) are based on the ISO 21531, ISO 15223-1, EN 980 European Standard and on the 93/42EEC Directive. The symbols marked with double (**) have instead been performed by us.

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