Devicare granted authorization to market product for patients with renal lithiasis in Europe
<p>CEO Rosendo Garganta believes the company has met all of the milestones proposed for 2015</p>
Devicare’s Lit-Control pH Meter, a medical device for patients with chronic renal lithiasis, has received CE marking from the British Standards Institution in the United Kingdom, allowing it to go on the market in Europe.
CE marking, which is valid for 5 years, ensures the product meets the European Community’s directives regarding the safety, quality and performance of healthcare devices for in vitro diagnosis. This means the device can now be distributed in more than 20 countries in the European Economic Area.
Devicare CEO Rosendo Garganta believes that, by obtaining this certification, the company has reached all of the milestones set for 2015 in terms of quality and regulatory issues. “And this is on top of Devicare’s ISO certification,” says Garganta.
Lit-Control pH Meter is part of a portfolio of products the company has developed to prevent renal lithiasis, a metabolic disease characterized by the formation of kidney stones or deposits in the urinary tract that lead to episodes of intense pain known as “nephritic colic”. The device that has obtained CE marking is designed specifically to control patients’ risk of lithogenesis by measuring the pH of their urine.