The subject of the contract is a radiator for irradiation of blood and its components using X-ray X-rays together with software, all equipment necessary for the proper functioning of the device – a detailed description of the subject of the contract is included in Annex 1 to the SWZ.

The subject of the contract is a heat sink for irradiation of blood and its components using X-rays X together with software, all equipment necessary for the proper functioning of the device. The ordering party requires a minimum 24-month warranty on the device and removal of the device failure in a maximum of 7 days.

The order should be completed within 4 months from the date of signing the contract.

To confirm that the offered products meet the requirements of the Ordering Party, subject documents should be submitted, i.e. current ones:

a) for devices subject to the obligation to report/notify/transfer data on a medical device to the database of the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products pursuant to the Act of 7 April 2022 on medical devices (i.e. Journal of Laws 2022.974), a statement of the Contractor is required that the offered products (listed in the statement) are in the database of the President of the Office for Registration of Medicinal Products, Medical Devices and Products Biocidal (model declaration in Annex 6).

(b) EU/EC declaration of conformity(s) confirming the granting of the CE mark.

c) Contractor's statement on compliance with the Ordering Party's requirements by the offered device (Appendix No. 2A)

If the Contractor does not submit the evidence referred to above in points a) to b) or the evidence submitted is incomplete, the Contracting Authority, in accordance with Article 107 paragraph 2 of the Act, shall call for their submission or supplementation within the prescribed period.

The statement mentioned in point c) is not subject to supplementation – Annex 2A should be submitted together with the offer!