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I work for a medical device company that sells dental products. We have agreements with distributors that they can sell our products to different countries. Some are located in the EU as well as other countries. Their names are listed at the top of the label as the distributor and ours is located at the bottom as the Manufacturer. We keep the technical files and have a CE mark and 510k for the products. We develop some products exclusively for them and others are universal. We only use our CE mark on the label, but the distributors will sometimes re-name our product and assign new part numbers. We maintain our brand name, but the line of products they offer is given a different name with our products being included in that line. Are they supposed to use their CE mark and are we considered to be a private labeler for them? Some distributors want to place other certifications on their labels that we create to sell in other countries that require them such as Russia, but they are using our CE mark, is that acceptable?



