EFOP 2.2.22- Purchase of medical equipment Text automatically translated in your browsing language Automatically translated

EKR001951682022

On the basis of EFOP’s tender No 2.2-22-20-2021-00001 for György Gottsegen György, entitled ‘Development of the Onkological and cardiological equipment park’, the supply, installation and commissioning of the equipment specified in the technical specifications, if necessary, as specified in the technical specifications forming part of the Public Procurement Documentation and in accordance with the following sub-tasks: Lot 1 procurement of telemetry system Part 2 Purchase of Additional and gynaecological ultrasound (intrauterin) equipment Lot 3 Procurement of free-standing IVUS (mobile intravascular UH) equipment Part 4 Procurement of mobile C-array detector equipment Part 5 Procurement of electrophysiological diagnostic system Part 6 Part 7 Purchase of blood heaters and chillers (KD) detailed in the Technical Documentation. For each lot submitted, the tenderer must attach in its tender a detailed product specification containing the technical parameters of the product(s) issued by the manufacturer(s) of the product(s) or his authorised representative or, in the case of a foreign manufacturer, the Hungarian distributor, for the product(s) proposed in that part. The contracting authority draws attention to the fact that, in the event of suspicion of non-conformity, their authenticity must be certified by a certified declaration by the manufacturer at the request of the contracting authority. — (under the contracting authority manufacturer 4/2009 on medical devices. (III. The contracting authority refers to a document summarising the functional and technical parameters of the product. The product specification, with a photograph, which must not be an illustration, i.e. it must represent the product offered. The bid submitted by the tenderer in that part is the Public Procurement Act. It shall be invalid under Section 73(1)(e) if the product(s) proposed do not meet one of the characteristics laid down in the technical specifications on the basis of the product specification(s) submitted or if compliance cannot be established beyond reasonable doubt. —For each of the devices offered, the conformity of the medical device shall be demonstrated by the MDR or the manufacturer’s declaration of conformity provided for in the Medical Devices Regulation AND, if required for the placing on the market of the medical device under the MDR (Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC) or the Medical Devices Regulation, respectively, a CE conformity assessment certificate. (16/2012. (II. Section 9(2) of Government Decree No 16)) If the product offered is not among the means for which the CE conformity assessment certificate is required, only the manufacturer’s declaration of conformity (EC Conformity Declaration) is mandatory for those products. Translation of the manufacturer’s declarations of conformity (EC Conformity Declaration), CE certificates and product information in an accepted tenderer’s translation. For BT-625, kilograms means pieces Text automatically translated in your browsing language Automatically translated

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33192230 - Operating tables

33000000 - Medical equipments, pharmaceuticals and personal care products

33100000 - Medical equipments

33124110 - Diagnostic systems

33111000 - X-ray devices

33112000 - Echo, ultrasound and doppler imaging equipment