The harmonized standard UNI CEI EN ISO 13485:2016 requires documented procedures to identify products using appropriate means starting from their receipt through all the treatment phases up to delivery and installation at the end user. To this end, all the products manufactured and/or marketed by LUMED S.r.l. have a Batch Number indicated on the package in order to allow their traceability in compliance with the regulations in force on medical devices.

The Batch Number is also indicated on the DELIVERY NOTE and the accompanying INVOICE. It is essential that your internal organization ensure that the information necessary for product traceability towards your customers is maintained in order to allow effective corrective actions in the field in the event of incidents in compliance with the requirements of the medical device standard and MEDDEV 2.12-1 rev.8.

In order to act in the best interest of the customer, we therefore ask you to market our products in such a way that the information necessary for their proper use, traceability and origin is always maintained.

Furthermore, LUMED must be notified of any technical or commercial problem relating to the Medical Device as required by the regulations and the laws in force. Should you need further clarification and information, please contact us.


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