All flow-med dry and hygiene products meet the high requirements for medical devices (Class I) of the Medical Devices Regulation (EU) 2017/745.
From May 26, 2021, only accessory products for hearing aids with this certificate are allowed to be imported into EU. In addition to the CE mark, the MD symbol and other marks must be visibly displayed.
This gives our dealers, customers and end users the guarantee of receiving high-quality medical products with proven efficacy and maximum safety. At the same time, the “grey market” is cleared of products with dubious efficacy and often lacking safety.
The UDI registration of our care products with EUDAMED will ensure compliance with and fulfillment of all EU standards throughout the entire product life cycle in the future. Already now all products and manufacturing data are clearly identifiable via the GS1 codes on all packaging levels.
Since its foundation in 2010, flow-med GmbH has been developing and producing high-tech quality products and the MDR certificates are an incentive and confirmation of our actions.