We manage the registration of manufacturers, importers, authorised representatives and medical devices on to the Eudamed database. We also secure and support the use of the UDI code (UDI-DI, UDI-PI and basic UDI).
The 2017/745 medical device regulation (MDR) requires the registration of economic operators (manufacturers, importers and authorised representatives) on the Eudamed database.
In addition, each product must be identified by a UDI code registered on the database prior to commercial release, with the guarantee that information will be updated over time.
We secure the UDI code (UDI-DI, UDI-PI and basic UDI) by dealing with the awarding bodies authorised by the European Union and, once secured, we support clients in managing and using codes on labels and packaging.
We manage registration and updating information on the Eudamed database for economic operators (manufacturers, distributors and authorised representatives) and medical devices. In addition, we deal with the publication of all information required for surveillance and vigilance (PSUR).
We manage publication in the Eudamed database of the summary of safety and clinical performance of implantable and class III medical devices.
Use the details in the contact section to get in touch: we can give you more information, organise an initial meeting, create a bespoke service, or put together a dedicated quote.
Services
Sistemir EU S.r.l.
Lecco, LC 23900
Via Ponte Alimasco, 13
segreteria@sistemir.com
+39 0341 1716381
VAT n. 03924150133
Administrative index no. LC-407096
Share capital € 10,000.00 fully paid
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