Yes! We take your safety and the reliability of the product at the very core of everything we do. Don't just take our word for it, we are quality driven and regulated. This means that we have taken all steps necessary (and more), since the very early stages of design up until the last details in manufacturing and shipping to ensure that the product you receive conforms with health, safety and environmental protection standards set by the European Commission to be traded on the extended Single Market in the European Economic Area (EEA).
The collector part of the inne strip consists of a filtration paper manufactured from raw cellulose pulp that is Generally Recognized As Safe (GRAS - according to FDA Regulation 21 CFR 186.1673). This means the product is safe enough to be added to food.
The biocompatibility of the collector part of the inne STRIP has also been evaluated according to Directive ISO 10993.
Additionally, all the components of the inne MINILAB are certified under the Directive 98/79/EC (IVDD).
The inne MINILAB has been on the market and classified as a self-testing in-vitro diagnostic device with the intended use of fertility monitoring since April 2020. No incidents have been reported so far.
Comments
0 comments
Please sign in to leave a comment.