The technical regulations on medical products were approved by the Cabinet of Ministers of Ukraine Decree No. 753 of 02.10.2013.
For the products of Concern Dräger Safety AG & Co. KGaA:
received the Certificate of Conformity ¹UA.TR.039.645 of 18.02.2019 for ensuring the functioning of the quality management system for the manufacture of medical products (Technical regulations for medical products, Annex 6)
the Certificate of Conformity ¹UA.TR.039.645 of 18.02.2019 is valid to until 07.06.2023.
The authorized representative of the manufacturer in Ukraine is Saturn Data International.
Requirements for putting into operation:
- The manufacturer or his authorized representative must provide a copy of the Declaration of conformity to the requirements of the Technical Regulation on medical products, prepared in accordance with the requirements of the current legislation.
- The conformity mark of the technical regulations and the identification number of the designated conformity assessment body must be placed on labels, operating instructions, service and warranty books of gas analyzers.
- The operation of the gas analyzers must be carried out in accordance with the manufacturer's operating instructions.
Medical products (including gas analyzers for the measurement of alcohol content in exhaled air of all Dräger Alcotest® models), medical products for in vitro diagnosis and aids to them, as well as active implantable medical products that have passed the procedure for assessing conformity with the requirements of technical regulations , are not subject to sanitary and epidemiological control (including in the form of preliminary documentary control) in accordance with the Resolution of the Cabinet of Ministers of Ukraine No. 1031 of 10.05.2011 "Some issues of the state control of goods, through the customs control of Ukraine" (p.2 abz.19 pp.3 in the wording of Resolution CMU ¹ 44 of 31.01.2018).
Dräger Alcotest® and Dräger Interlock® comply with the Technical Regulation of Legally Regulated Measuring Devices in Ukraine
European standard EN 15964: 2011 (DSTU EN 15964: 2014) is valid in Ukraine)