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Official European notification/registration of devices

Since the installment of the European Databank for MD and IVD products in May 2011, we notify the French Competent Authority on a special bilingual form with English and French Instructions for Use. Then the French Competent Authority transmits the information to the European Data Bank. We fill in the notification form per each product group having the same designation and same European nomenclature number. Then we receive a registration reference number from ANSM. It is important that you inform us about any addition to a product family because the designation and GMDN number can be different and could request another registration.

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