The subject of the contract is a heatsink for irradiation of blood and its components using X-rays together with software, all equipment necessary for the proper functioning of the device and a set of radiant labels – a detailed description of the subject of the contract is included in Annex 1 to the SWZ.
The subject of the contract is a heatsink for irradiation of blood and its components using X-rays together with software, all equipment necessary for the proper functioning of the device and a set of radiant labels (1000 pcs.). The Ordering Party requires a minimum 36-month warranty on the device and removal of device failures 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 notify/notify/transfer data on a medical device to the database of the President of the Office for Registration of Medicinal Products for Medical Devices and Biocidal Products pursuant to the Act of 20 May 2010 on medical devices (i.e. Journal of Laws of 2021, item 1565), a statement of the Contractor is required that the offered devices (listed in the statement) are in the database of the President of the Office for Registration of Medicinal Products for Medical Devices and Biocidal Products (model declaration in Annex 6).
(b) Certificate of the Notified Body that the medical device complies with the essential requirements, if applicable.
c) Declaration of the Manufacturer (Manufacturer) on meeting the essential requirements for medical devices – if applicable.
d) Technical specifications of the offered products confirming compliance with the requirements contained in Annex 1 to the SWZ.
2) If the Contractor does not submit the means of proof listed above in points a) to d) or the evidence in question is incomplete, the Ordering Party, in accordance with Article 107 paragraph 2 of the Act, will call for their submission or supplementation within the prescribed period.