Medical / medical grade silicone*

Medical silicone is understood to mean silicone types that have been tested for their quality / purity in the manufacture of medical devices and that have been classified as harmless. Conversely, this does not necessarily mean that the products made from them must be medical devices - With the introduction of the new Ordinance on Medical Devices (Medical Device Regulation, MDR), the requirements are increased - So far, someone who processed a classified as harmless silicone claim that his product was made of medical grade silicone - Now also the final product, so the silicone molded part itself according to ISO 10993-5 / 10993-10 tested and classified as harmless, so that this statement will continue.
Our products containing the addition of medical grade silicone have been tested and found to be safe according to ISO 10993-5 / 10993-10 - There are also test protocols that we can provide on demand - Such tests quickly add up to a mid-range four-digit euro amount - So do not be fooled by statements from some manufacturers and dealers who claim to offer erotic toys "medically tested" or "medical grade silicone". Ask for a written certification of the product according to ISO 10993-5 / 10993-10 - If this can not be presented, these statements are questionable and the provider moves on very thin ice.