Amenity Health said today that its medical device, MedCline, won CE Mark approval in the EU.
The San Diego, Calif-based company manufactures a device called MedCline, which is a medical device scientifically proven to help alleviate chronic health issues such as GERD and acid reflux.
“We are pleased to announce the CE Mark approval of MedCline, signifying that we have completed the rigorous quality and performance requirements of the EU authorities,” said CEO Aaron Clark.
CE marking is the medical device manufacturer’s claim that a product meets the Essential Requirements of the Medical Device and all relevant European Health, Safety and Environmental Protection Legislation Product Directives.
The approval also represents a significant milestone towards the commercialization of MedCline and demonstrates the commitment we have to our existing and future customers, partners, and investors. We look forward to making MedCline available to patients throughout the World.