The device IONTO SONO effect has the article number 8432. The article number 8432.1 is the device including its accessories. Among these part numbers we carry the device in our ERP system. The certificates are issued only on the device, so the item number 8432. Relevant for registration is therefore the item number 8432. The instructions we may like to amend.
We cannot change the documents of Wellcomet. The device is an OBL (Own Brand Label) product for us. We do not produce the device ourselves, but according to EU legislation we are manufacturer. The OEM (Original Equipment Maufacturer) is Wellcomet and Wellcomet need for the device also have a medical approval, under its own name and article number.
Therefore, the test reports cannot be changed. To illustrate that the Wellcomet device and our device are identical (except for the labeling), there is the declaration of identity. I´ve already send it to you and here again attached.