QA/RA

The probiotic tampon ellen® is a natural way for women to simultaneously strengthen their natural vaginal bacterial flora and have a good sanitary protection. Ellen AB has created a unique way of providing the abdomen with patented lactic acid producing bacteria.

The tampon supplies the patented bacterial strains into the vagina where they mainly produce lactic acid. A natural, healthy vaginal environment is a necessity for protection from unpleasant feeling in the abdomen.

A CE-labeled probiotic tampon may be marketed in all Member States by agreement between EU Member States. There is, however, an exception where probiotic tampons today are sold as consumer products, namely in Sweden. Ellen AB’s probiotic tampon ellen® has the same documentation to verify product safety, biocompatibility, clinical studies and intended use as a CE-labeled product.

Ellen AB is certified and meets current requirements according to ISO 13 485: 2016, Quality Management System for Medical Devices.