Measure the difference
Schwarzer Cardiotek GmbH develops, produces and distributes hemodynamic and electrophysiological measurement systems, as well as data management solutions for the interventional cardiology field.
Schwarzer Cardiotek GmbH (Heilbronn, Germany) is a forward-thinking company at the forefront of developing innovative measurement systems for functional diagnostics of left/right-heart catheterization. Our integrated systems boast seamless integration with leading documentation and reporting platforms, while offering interoperability with all major X-ray manufacturers. With an impressive installation base exceeding 2000 systems globally, we have established ourselves as a trusted partner in the cardiology industry.
In the realm of electrophysiology, CardioTek B.V. (Sittard, The Netherlands) has been pioneering the development of the EP-TRACER, a cutting-edge EP system renowned for its advanced technology since the 1980s. As the world’s first smallest portable EP lab with an integrated stimulator, our device sets the standard for signal quality and portability. In the 25 years since its foundation, CardioTek B.V. has successfully installed more than 1,500 EP systems in more than 70 countries worldwide.
Our unwavering commitment to maintaining the highest quality standards underscores our dedication to excellence.We are proud to have received both EN ISO 13485:2016 and MDSAP certification (for the USA, Brazil, Canada and Australia) as well as MDR approval for our hemodynamic measurement system. Moreover, our EP-TRACER system received FDA 510(k) clearance for the first time in 2014 and its US market approval has been kept up-to-date ever since, affirming our commitment to meeting stringent regulatory requirements while delivering innovative solutions to our customers.