Poland – Laboratory reagents – Dostawa odczynników do oznaczeń biochemicznych z najmem analizatora na okres 48 miesięcy

The subject of the order is: supply of reagents for immunochemical determinations with the rental of an analyzer for a period of 48 months. 2. The detailed description of the subject of the order includes a price list and a technical specification of the analyzer, which are attachments no. 1A and no. 4 to SWZ. 1.1. The ordering party, in order to confirm the conformity of the offered supplies, requires the submission, together with the offer, of the following subject-specific evidential means: 1) 1) A declaration that the offered assortment has been approved and placed on the market in accordance with the provisions of the Act of 7 April 2022 on medical devices (Journal of Laws of 2022, item 974) and has current declarations of conformity and certificates from the notified body and will be made available upon each request of the ordering party after signing the contract - the content of the declaration is entered in the offer form, which is attachment no. 1 to SWZ 2) The catalog card of the analyzer confirming the parameters indicated in attachment no. 4 to SWZ 3) Brochures for the offered reagents 4) Declaration of conformity of the analyzer – a document issued by the manufacturer of the product or its authorized representative. 5) Catalog cards of the manufacturer and/or user instructions for the analyzer confirming the evaluated parameters (offer evaluation criteria: K2, K3, K4, K5 described in point XV of SWZ) 2. This concerns point VIII.1 ppkt. 1) The ordering party does not envisage the supplementation of the subject-specific evidential means indicated in point VIII.1 ppkt. 1). Offers that do not contain the above documents will be rejected on the basis of art. 226.5 of the PZP Act. 3. This concerns point VIII.1 ppkt. 2), 3), 4) In the event that the Contractor does not submit the documents indicated in point VIII.1 ppkt. 2), 3), 4) with the offer or the submitted subject-specific evidential means are incomplete, the ordering party will call for their submission or supplementation within a specified deadline. 4. This concerns point VIII.1 ppkt. 5) The ordering party does not envisage the supplementation of the documents indicated in point VIII.1 ppkt. 5) confirming the evaluated parameters. In the event of a lack of documents, the Contractor will receive 0 points. 5. Subject-specific evidential means drawn up in a foreign language shall be submitted together with a translation into Polish. 6. The ordering party requires that the subject-specific evidential means be drawn up in electronic form and endorsed with a qualified signature by the Contractor. 7. In the event that the subject-specific evidential means have been drawn up in electronic form and endorsed with a qualified signature by their issuer (authorized entity), they should be submitted in that form. 8. In the case where the subject-specific evidential means have been issued in paper form, a digital copy of the document endorsed with a qualified signature by the contractor should be submitted 9. The ordering party requires that the subject-specific evidential means confirm the actual status as of the date of submission of the offers. 10. The ordering party requires that the subject-specific evidential means be up-to-date as of the date of submission/supplementation. 7. The ordering party requires that the subject-specific evidential means be up-to-date as of the date of submission/supplementation.