Poland – Medical equipments – Dostawa sprzętu jednorazowego do cewnikowania serca i urządzeń do stymulacji serca dla Szpitala Specjalistycznego w Zabrzu Sp. z o.o.; Nr sprawy DZP/10 PN/2026

Supply of single-use cardiac catheterisation equipment and cardiac stimulation devices for Szpital Specjalistyczny w Zabrzu Sp. z o.o.; Case No. DZP/10 PN/2026. The subject of the order has been divided into 8 Parts - Packages, namely: • Part 1 Package No. 3B - Double Y-connector with double locking mechanism • Part 2 Package No. 11B - Pressure measurement lines with single transducer • Part 3 Package No. 23 - Swan-Ganz catheter • Part 4 Package No. 47B - Measurement cables • Part 5 Package No. 48 - CRTP MRI stimulators, electrode insertion kits • Part 6 Package No. 60A - Wireless catheter for functional measurements FFR/cFRR • Part 7 Package No. 73 - Electrode kit for electrophysiological procedures with pump rental • Part 8 Package No. 76 - Kit for pulmonary vein cryoablation with multi-polar mapping electrode cooperating with a cryoablation balloon in the set with equipment rental. Each package constitutes a separate part depending on the features and applications in order to save the patient's health and life. The detailed description of the subject of the order is Annex No. 3 to SWZ – Product price list and Annex No. 3A – technical parameters. 1) The ordering party requires that the offered medical products meet the requirements of the Act of 7 April 2022 on medical devices (Dz.U.2024.1620 i.e. of 5 November 2024 with amendments), the Regulation of the Minister of Health of 5 November 2010 on the method of classifying medical devices (Dz. U. of 2010 No. 215, item 1416), the Regulation of the Minister of Health of 17 February 2016 on the essential requirements and conformity assessment procedures for medical devices (Dz. U. of 2016, item 211), the Regulation of the European Parliament and of the Council (EU) 2019/1020 of 20 June 2019 on market surveillance and product compliance – to the extent to which it applies, as well as in accordance with Directive 93/42/EEC (OJ L1993, No. 169.1 with amendments) and have certificates allowing for their use on the medical market valid in Poland and in the European Union (e.g. Declaration of CE Conformity, Declaration of WE Conformity) and the Regulation of the European Parliament and of the Council (EU) 2017/745 of 5 April 2017 (MDR). 2) The ordering party requires that medical devices have a UDI code carrier on the label and on all higher levels of packaging in the case of Class III devices and Class IIa and IIb devices if it applies to the selected medical device. 3) The ordering party informs that if the description contains trade names of products, trade marks, patents or source or a special process that characterises the product, supplied by a specific Contractor, they refer only to the quality, type of product, and the ordering party cannot, for objective reasons, describe the subject of the order in a sufficiently precise and understandable manner, in connection with which such an indication is accompanied by the words "type" "or equivalent". 4) In each case of using in the description of the subject of the order features of the material, product, about which is mentioned in art. 101 sec. 1 point 2 of the PZP Act, the ordering party allows the submission of offers containing equivalent goods (materials). All goods (materials) specified in the documentation, coming from specific manufacturers, specify the minimum quality parameters and user features, which the goods must meet in order to meet the requirements set by the ordering party. The Contractor may refer in the offer to the use of equivalent goods (materials) described in the SWZ, by submitting a list of equivalent goods (materials). In such a case, the Contractor is obliged to prove that the goods (materials) offered by him, meet the requirements (equivalence criteria) specified by the ordering party. The Contractor, who will use equivalent materials, will be obliged to prove during the implementation of the order, that the materials used by him, meet the requirements specified by the ordering party.