Medical devices - Import export

The work of the TempoHeart module is based on the method of scoring the heart rate vegetative regulation. This method is popular due to its high information value and non-invasiveness. Cannot be used without an interface block. The module can: • evaluate the heart rate autonomic regulation; • to predict in advance (to prematurely reveal) the hazards of a myocardial infarction, hypertensive crises and strokes; • to determine the metabolic and electrolyte disorders in the myocardium; • identify risk groups for heart rate increased stability; • to make a cold evaluation of the autonomic nervous system's reaction when exposed to electromagnetic fields, intoxications and other pathogenic factors; • to assess the activity of the respiratory component when measuring heart rate variability, recording the parameters of blood movement in the vessels; • to expose the stress resistance level.

A registration certificate is a document that allows you to legally convert a medical device (hereinafter referred to as a medical device, MI) on the territory of the Russian Federation. A registration certificate is issued on the basis of an Order of the registering authority (Federal Service for Supervision in the Field of Healthcare/Roszdravnadzor) after passing all the mandatory stages of state registration, during which the registration dossier is formed