TeMeCo supplies high-quality and innovative medical devices for cardio-diagnostic examinations at the patient’s home. Patient safety is essential. The starting point for TeMeCo is that its solutions meet the legal requirements and guidelines.
Under the Medical Device Regulation 2017/745 (MDR), we carry out various activities to continuously monitor the safety and performance of our medical devices. Post-market surveillance (PMS) takes place throughout the equipment lifecycle.
TeMeCo is also registered in EUDAMED (European Database on Medical Devices) as “manufacturer of medical device”s with the following SRN: NL-MF-000011503.
The SenseLink technology is certified as medical device and holds a CE certification. The certification is issued by DEKRA Certification B.V. (0344) as Notified Body.