MEDA receives CE marking for its MD-6000P Bladder Scanner
The CE marking approval paves way for entry into European markets
MEDA Co., Ltd. has received CE marking approval for its MD-6000P Bladder Scanner, the latest flagship of its bladder scanner portfolio.
The MD-6000P Bladder Scanner is a hand-held device based on ultrasonic distance measuring principles to calculate urine volume in the bladder and to determine the correct opportunity to apply catheterization in order to reduce the frequency of catheterization and risk of UTI. It also comes with an Android tablet as an option for higher visibility for bladder scanning results.
CE marking indicates a product's compliance with EU Directives -- among which, 93/42/EEC is the directive for ultrasound products -- to meet specific standards of performance, quality, safety, and efficacy, which enables the commercialization of the product in the European markets.
MEDA’s new bladder scanner was assessed and certified by TÜV SÜD, a Germany-based global certification body for medical devices. This approval paves the way for the product’s entry into European markets.