I also noted this on the BfArM website... "The person...

I also noted this on the BfArM website...

"The person responsible for the first placing on the market of the device is the manufacturer or his or her authorised representative. If the manufacturer does not have his/her registered place of business in the European Economic Area and if an authorised representative has not been designated, or if medical devices are not being imported into the European Economic Area under the responsibility of the authorised representative, the importer shall be the person responsible. The name or the firm and the address of the person responsible must appear on the label or in the instructions for the use of the medical devices."

https://www.bfarm.de/EN/MedicalDevices/MarketAccess/_node.html