Il-Polonja – Reaġenti tal-laboratorju – DZ/30/2026 Sukcesywne dostawy odczynników z dzierżawą analizatorów do badań laboratoryjnych w okresie 36 miesięcy dla SZPZOZ im. Dzieci Warszawy w Dziekanowie Leśnym

1. **Part 1** – Supply of reagents and consumable materials for the performance of immunological parameter determinations together with the lease of an analyser for their performance. **Part 2** – Supply of reagents and consumable materials for the performance of critical parameter determinations together with the lease of an analyser for their performance. **Part 3** – Supply of reagents and consumable materials for the performance of tests for IgE-dependent component allergy diagnosis together with the lease of devices for their performance. **Part 4** – Supply of reagents and consumable materials for the performance of peripheral blood morphology determinations on the Yumizen H500 analyser. **Part 5** – Supply of reagents and consumable materials for the performance of biochemical parameter determinations together with the lease of an analyser for their performance. **Part 6** – Supply of reagents and consumable materials for the performance of blood group and compatibility tests together with the lease of an analyser for their performance. A detailed description of the subject of the order includes the SWZ and: Annex No. 1 – Offer Form, Annex No. 2 – Product Price Form; Annex No. 2A – Part 1 Analyser Technical Specification, Annex No. 2B – Part 2 Analyser Technical Specification, Annex No. 2C – Part 5 Analyser Technical Specification, Annex No. 2D – Part 6 Analyser Technical Specification, Annex No. 3 – Draft contract provisions Part 1-3, 5-6, Annex No. 3A - Draft contract provisions Part 4.

1. The offered subject of the order must comply with the requirements of the Purchaser described in this SWZ and the applicable laws in Poland; moreover, it must have current documents and declarations confirming its admission to trade and use as a medical device meeting the requirements in accordance with the Act of 7 April 2022 on medical devices, i.e.: a. a declaration of conformity (issued by the manufacturer or authorized (authorized) representative) confirming that the product complies with the essential requirements; b. a statement from the Contractor, confirming that the offered assortment is admitted to trade and use as a medical device in Poland; c. a certificate from the notified body (identifying the manufacturer and the type of product), if the assessment was carried out with the participation of the notified body (if the assessment of the notified body was required).

2. The Purchaser requires that the Contractor submits with the offer a declaration of possession of the documents required by law regarding the offered assortment according to the pattern constituting Annex No. 7 to the SWZ. In the event of selecting the Contractor's offer as the most advantageous and concluding a contract for the public order, the Purchaser may throughout the period of implementation of the contract require the Contractor to provide certified copies of the documents required by law.

3. The marking of the delivered products must be made in the Polish language together with readable UDI (EAN) codes (if the product has them); instructions for use, leaflets, product description must be made in the Polish language, external labels (original) - in Polish or English. The Purchaser requires the inclusion of a translation of the labels, descriptions or leaflets into Polish.

4. The delivered reagents must have at least a 5-month validity period for use from the date of delivery to the Purchaser's headquarters.

5. The maximum deadline for the implementation of orders for successive deliveries – 7 calendar days.

6. The delivery deadline for leased devices and the conduct of initial training – within 10 working days from the date of conclusion of the contract.

7. In the case of Part No. 6 - approval of the validity periods of blood samples and control materials allowing for the continuity of determinations with the possibility of cyclic deliveries of the entire assortment, no less than once a month – according to the delivery schedule for the given calendar year, enclosed with the offer/delivered once a year, with the simultaneous assurance of the possibility of urgent deliveries.

8. The devices must be free of defects, and their quality parameters not lower than those presented.

INFORMATION ON SUBJECT MATTERS OF EVIDENCE are in Section VI of the SWZ. INFORMATION ON EXCLUSION BASIS are in Section VIII of the SWZ.