Both our smart mini ECG ‘ritmo’ and the AI-supported analysis software are certified and approved throughout the EU as fully-fledged Class IIa medical devices.
Below you will find the respective certifications from a notified body.
Certificate for the scope of application ‘Development, manufacture and final inspection of long-term ECG evaluation units’ as a Class IIA medical device in accordance with Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as well as confirmation that the product may continue to be → marked in accordance with Art. 120 MDR to continue to be placed on the market after 26 May 2024.
Certificate confirming the introduction and application of a quality management system for the development, manufacture, distribution and operation of software for the analysis of vital data in accordance with DIN EN ISO 13485.
Certificate for the scope of application ‘Development, production and final inspection of devices for monitoring and ECG recording’ in accordance with Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as well as confirmation that the product may continue to be → marked after 26 May 2024 in accordance with Art. 120 MDR, even after 26 May 2024, from the supplier ‘livetec Ingenieurbüro’.
Certificate for classification as a Class IIa medical device in accordance with Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices and the introduction and application of a quality assurance system at the supplier ‘Medset Medizintechnik’ in accordance with DIN EN ISO 13485.
