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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 smallest portable EP lab with an integrated stimulator, our device sets the standard for signal quality and portability. To date, over 1,400 EP systems from Schwarzer Cardiotek have been successfully deployed worldwide.

Our unwavering commitment to maintaining the highest quality standards underscores our dedication to excellence. We proudly hold MDR stage 1 and stage 2 as well as MDSAP certifications (USA, Brazil, Canada, Australia) for our quality management system  and for our products in accordance with EN ISO 13485:2016 and Annex II of the Medical Device Directive 93/42/EEC. 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.