Into the EU and Switzerland with SANOVIO as the importer. We are registered in EUDAMED and swissdamed and take on the obligations that come with the role.
How it works
Registered, checked, marketable
Importer under the MDR
For manufacturers outside the EU we take on the role of importer under Art. 13 MDR: we check the CE marking, declaration of conformity, labelling and UDI, keep the register of complaints and recalls, and report what has to be reported.
Market accessImporter: SANOVIO
ProductEUSwitzerland
Marketable
Marketable
Under review
Marketable
EU and Switzerland from one source
Registration in EUDAMED and swissdamed is in place. For Switzerland we take care of linking your products to our registration. Your products are marketable in both markets without you needing two partners.
Product A, market access
Declaration of conformity and CE
Importer on the label
EUDAMED
swissdamed
Your benefit
What changes for you
Role
Importer or distributor
Depending on where your products come from, we take on the fitting role under the MDR.
Registers
EUDAMED and swissdamed
Registered as an importer in the EU and in Switzerland.
Checks
Every batch at goods-in
UDI, batch number, expiry date and condition are checked.
What you can ask your AI agents
What is missing for sales in Switzerland?Which of my products are linked in swissdamed?Which documents does SANOVIO need from me as the importer?Are there complaints about batch 2418?Which products are still under review?When does the certificate for product A expire?Show me the importer details on the label.Which reports has SANOVIO made to authorities?What is missing for sales in Switzerland?Which of my products are linked in swissdamed?Which documents does SANOVIO need from me as the importer?Are there complaints about batch 2418?Which products are still under review?When does the certificate for product A expire?Show me the importer details on the label.Which reports has SANOVIO made to authorities?
Which products are still under review?When does the certificate for product A expire?Show me the importer details on the label.Which reports has SANOVIO made to authorities?What is missing for sales in Switzerland?Which of my products are linked in swissdamed?Which documents does SANOVIO need from me as the importer?Are there complaints about batch 2418?Which products are still under review?When does the certificate for product A expire?Show me the importer details on the label.Which reports has SANOVIO made to authorities?What is missing for sales in Switzerland?Which of my products are linked in swissdamed?Which documents does SANOVIO need from me as the importer?Are there complaints about batch 2418?