Certification of our equipment in the EU

22 Aug

Let us inform you that recently we have finished the certification of our equipment in the European Union according to the latest requirements and standards of the EU.

Now we have Sensitiv Imago equipment modes that has the new CE certification.

This equipment can be used all over the territory of the European Union and does not require any additional certification in Europe.

Current certification was provided with the next models of equipment:

  • Sensitiv Imago 130
  • Sensitiv Imago 530

Sensitiv Imago 130 and Sensitiv Imago 530 device models already can be purchased.

  • Sensitiv Imago 130 and Sensitiv Imago 530 models has European certification as monitoring devices for non-vital physiological parameters of the body. These models can be used throughout the European Union, they do not require additional certification in Europe.
  • Sensitiv Imago 130 and Sensitiv Imago 530 starting from September 2016 are supplied with the new certificates. Certification of these models was performed according the new standards and rules accepted in EU in March 2016.
  • We successfully finished the tests of Sensitiv Imago 130 and Sensitiv Imago 530 devices in the TUV laboratory (Germany). Tests continued during 3 months.
  • We received the conclusion for electromagnetic compatibility of the Sensitiv Imago 130 and Sensitiv Imago 530 model series in the EC Leitc laboratory – TR 16.
  • Our manufacturing facilities have fulfilled the Directive of the European parliament and EU Council dated 08.06.2011 – 2011/65/EC – concerning the limitation of specific substances in the electronic equipment (RoHS).
  • ALFA-MED LLC is the author and the rights owner of the programs of Frequency-wave diagnostics. The source data and programs databases for the devices are the property of ALFA-MED holding.

Models description:

  • Equipment models 130, 135 and 120 are identical in the reliability and the possibilities.
  • Equipment models 530, 535 and 520 are identical in the reliability and the possibilities.

Sensitiv Imago 530 device is being assembled according the new European standards of the quality management ISO 9001 full accepted in EU in 2014.

This model is a logical successor of the 500 Sensitiv Imago series devices. The basis is taken from the Sensitiv Imago 500 algorithm.

Sensitiv Imago 130 device is being assembled according the new European standards of the quality management ISO 9001 full accepted in EU in 2014.

This model is a logical successor of the 100 Sensitiv Imago of professional class. The basis is taken from the Sensitiv Imago 100 algorithm.

Device models Sensitiv Imago 130 and Sensitiv Imago 530 are is technically and technologically more advanced. The newest researches of our scientists and engineers were used during it's creation.

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Models devices

Sensitiv Imago 530 – business class model, certified in the EU.

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Sensitiv Imago 535 – business class model, has FDA registration in the USA.

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Sensitiv Imago 520 – business class model, maximum diagnosis capabilities at an affordable cost.

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Sensitiv Imago 135 – authorized for use on the US territory, conforms with the FDA requirements and standards.

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