Delivery of ultrasound machines. A detailed description and method of execution of the order is included in the assortment and price table of Annex No. 2 to SWZ and description of the subject of the contract – List of required parameters ("OPZ") of Annex No. 3 to SWZ and model contract of Annex 7 to SWZ. The contracting authority does not provide for the award of contracts referred to in Article 214(1)(8) of the Public Procurement Law. The contracting authority does not require a tendering security. The Ordering Party declares that, being a data controller and taking into account the provisions of the Act of 10.5.2018 on the protection of personal data (hereinafter referred to as GDPR), it has implemented security measures adequate to the risks identified by it and guaranteeing proper protection of personal data provided as part of the proceedings. A detailed information clause from Article 13 of the GDPR is included in the SWZ. Order. does not require a deposit. Order. does not provide for the possibility of awarding contracts referred to in Article 214 paragraph 1 point 8.The contracting authority does not provide for an on-site inspection.

The subject of the contract is the supply of ultrasound machines. A detailed description and method of execution of the order is included in the assortment and price table of Annex No. 2 to SWZ and description of the subject of the contract – List of required parameters ("OPZ") of Annex No. 3 to SWZ and model contract of Annex 7 to SWZ. Order. provides for the application of the so-called reverse procedure referred to in Article 139(1) of the PPL. 1. 1. The Ordering Party requests that the offer be accompanied by the said means of proof to confirm that the offered supplies meet the requirements specified by the Ordering Party:

1) Current documents and statements confirming marketing authorization and for use as a medical device meeting the requirements within the meaning of the Act

of 07 April 2022 on medical devices (consolidated text: Journal of Laws of 2022, item 974), i.e.

a) the declaration/certificate of conformity (issued by the manufacturer or an authorised/authorised representative) confirming that the product complies with the essential requirements (for parts 1, 2 and 3).

b) a statement of the Contractor confirming that the offered assortment is approved for marketing and use as a medical device in the Polish (applies to parts No. 1, 2 and 3).

(c) a document certifying that the conformity assessment procedure has been carried out

with a notified body (notified body certificate), if applicable.

2) Declaration of the Contractor confirming that the offered products meet the requirements specified by the Contracting Entity, submitted if the described

in SWZ the subject of the contract was not classified as a medical device.

3) Information materials containing a description of the offered subject of the contract (prospectus, catalogue, leaflet, technical data sheet issued by the manufacturer of the product, etc.), confirming the requirements contained in Annex 3 to the SWZ

(with indication of the required parameters, position of the offered subject of the contract) – applies to parts No. 1, 2 and 3.

2. If the Contractor does not submit the means of evidence in question or the evidence submitted in question are incomplete, the Contracting Authority shall call for them to be lodged or supplemented within the deadline set.

The subject of the contract is the supply of ultrasound machines. A detailed description and method of execution of the order is included in the assortment and price table of Annex No. 2 to SWZ and description of the subject of the contract – List of required parameters ("OPZ") of Annex No. 3 to SWZ and model contract of Annex 7 to SWZ. Order. provides for the application of the so-called reverse procedure referred to in Article 139(1) of the PPL. 1. 1. The Ordering Party requests that the offer be accompanied by the said means of proof to confirm that the offered supplies meet the requirements specified by the Ordering Party:

1) Current documents and statements confirming marketing authorization and for use as a medical device meeting the requirements within the meaning of the Act

of 07 April 2022 on medical devices (consolidated text: Journal of Laws of 2022, item 974), i.e.

a) the declaration/certificate of conformity (issued by the manufacturer or an authorised/authorised representative) confirming that the product complies with the essential requirements (for parts 1, 2 and 3).

b) a statement of the Contractor confirming that the offered assortment is approved for marketing and use as a medical device in the Polish (applies to parts No. 1, 2 and 3).

(c) a document certifying that the conformity assessment procedure has been carried out

with a notified body (notified body certificate), if applicable.

2) Declaration of the Contractor confirming that the offered products meet the requirements specified by the Contracting Entity, submitted if the described

in SWZ the subject of the contract was not classified as a medical device.

3) Information materials containing a description of the offered subject of the contract (prospectus, catalogue, leaflet, technical data sheet issued by the manufacturer of the product, etc.), confirming the requirements contained in Annex 3 to the SWZ

(with indication of the required parameters, position of the offered subject of the contract) – applies to parts No. 1, 2 and 3.

2. If the Contractor does not submit the means of evidence in question or the evidence submitted in question are incomplete, the Contracting Authority shall call for them to be lodged or supplemented within the deadline set.

The subject of the contract is the supply of ultrasound machines. A detailed description and method of execution of the order is included in the assortment and price table of Annex No. 2 to SWZ and description of the subject of the contract – List of required parameters ("OPZ") of Annex No. 3 to SWZ and model contract of Annex 7 to SWZ. Order. provides for the application of the so-called reverse procedure referred to in Article 139(1) of the PPL. 1. 1. The Ordering Party requests that the offer be accompanied by the said means of proof to confirm that the offered supplies meet the requirements specified by the Ordering Party:

1) Current documents and statements confirming marketing authorization and for use as a medical device meeting the requirements within the meaning of the Act

of 07 April 2022 on medical devices (consolidated text: Journal of Laws of 2022, item 974), i.e.

a) the declaration/certificate of conformity (issued by the manufacturer or an authorised/authorised representative) confirming that the product complies with the essential requirements (for parts 1, 2 and 3).

b) a statement of the Contractor confirming that the offered assortment is approved for marketing and use as a medical device in the Polish (applies to parts No. 1, 2 and 3).

(c) a document certifying that the conformity assessment procedure has been carried out

with a notified body (notified body certificate), if applicable.

2) Declaration of the Contractor confirming that the offered products meet the requirements specified by the Contracting Entity, submitted if the described

in SWZ the subject of the contract was not classified as a medical device.

3) Information materials containing a description of the offered subject of the contract (prospectus, catalogue, leaflet, technical data sheet issued by the manufacturer of the product, etc.), confirming the requirements contained in Annex 3 to the SWZ

(with indication of the required parameters, position of the offered subject of the contract) – applies to parts No. 1, 2 and 3.

2. If the Contractor does not submit the means of evidence in question or the evidence submitted in question are incomplete, the Contracting Authority shall call for them to be lodged or supplemented within the deadline set.