Certificates and licenses

CE-certificate

ISO 13485

International Protocol of the European Society of Hypertension (ESH-2001)

BPLab ambulatory blood pressure monitor accuracy was confirmed by clinical tests in accordance with ESH-protocol (European Society of Hypertension) in general group of patients in 2003 and in pregnant women in 2006. The test results were published in Russian peer-reviewed magazines:

  • Rogoza A.N. "To the question about measurement accuracy of automatic devices" // "Functional diagnostics" 2003.- 3 (in Russian);
  • Bartosh L.F., Dorogova I.V., Kuznetsova T.N., Krylova A.V. "Validation of 24-hour blood pressure monitor BPLab in pregnant female in accordance with ESH-2001 protocol"// "Arterial hypertension". - T12.-2006.-3 (in Russian).

International BHS-protocol (British Hypertension Society, UK)

In 2011 BPLab 24-hour blood pressure monitoring system was validated according to the European standard BS EN 1060-4:2004 and British Hypertension Society protocol.

Pattern approval certificate of measuring instruments

License for manufacturing and maintenance of measuring devices

Sanitary epidemiological report

Extract from the minutes N 5 of the New Medical Equipment Committee


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