Delivery of an integrated coloring and covering center and microscopes. A detailed description and method of execution of the order is included in the assortment and price table of Annex 2 to SWZ and description of the subject of the contract – List of required parameters ("OPZ") of Annex 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 bid bond. 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) 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.
Integrated colouring and covering centreThe subject of the contract is the delivery of an integrated coloring and covering center. 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. 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 by an authorised/authorised representative) confirming that the product complies with the essential requirements (for parts 1 and 2).
b) the Contractor's statement confirming that the offered assortment is approved for marketing and use as a medical device in the Polish (applies to parts No. 1 and 2).
(c) a document certifying that the conformity assessment procedure with a notified body (notified body certificate) has been carried out, if applicable.
2) Contractor's statement confirming that the offered products meet the requirements specified by the Contracting Entity, submitted if the subject of the contract described in the SWZ has not been classified as a medical device.
3) Information materials containing a description of the offered subject of the contract (prospectus, catalog, leaflet, technical data sheet issued by the manufacturer of the product, etc.), confirming the requirements contained in Annex 3 to the SWZ (with an indication of the required parameters, position of the offered subject of the contract) – applies to parts No. 1 and 2.
2. If the Contractor does not submit the evidence in question or the measures of evidence submitted are incomplete, the Contracting Authority shall call for submission or supplement them within the time limit set.
Microscope type IThe subject of the contract is the delivery of a microscope type I. 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 a description of the subject of the contract – List of required parameters ("OPZ") of Annex 3 to SWZ and model contract of Annex No. 7 to SWZ. Order. provides for the application of the so-called reverse procedure referred to in Article 139(1) of the PPL. 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 by an authorised/authorised representative) confirming that the product complies with the essential requirements (for parts 1 and 2).
b) the Contractor's statement confirming that the offered assortment is approved for marketing and use as a medical device in the Polish (applies to parts No. 1 and 2).
(c) a document certifying that the conformity assessment procedure with a notified body (notified body certificate) has been carried out, if applicable.
2) Contractor's statement confirming that the offered products meet the requirements specified by the Contracting Entity, submitted if the subject of the contract described in the SWZ has not been classified as a medical device.
3) Information materials containing a description of the offered subject of the contract (prospectus, catalog, leaflet, technical data sheet issued by the manufacturer of the product, etc.), confirming the requirements contained in Annex 3 to the SWZ (with an indication of the required parameters, position of the offered subject of the contract) – applies to parts No. 1 and 2.
2. If the Contractor does not submit the evidence in question or the measures of evidence submitted are incomplete, the Contracting Authority shall call for submission or supplement them within the time limit set.
Microscope type IIThe subject of the contract is the supply of a type II microscope. 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. 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 by an authorised/authorised representative) confirming that the product complies with the essential requirements (for parts 1 and 2).
b) the Contractor's statement confirming that the offered assortment is approved for marketing and use as a medical device in the Polish (applies to parts No. 1 and 2).
(c) a document certifying that the conformity assessment procedure with a notified body (notified body certificate) has been carried out, if applicable.
2) Contractor's statement confirming that the offered products meet the requirements specified by the Contracting Entity, submitted if the subject of the contract described in the SWZ has not been classified as a medical device.
3) Information materials containing a description of the offered subject of the contract (prospectus, catalog, leaflet, technical data sheet issued by the manufacturer of the product, etc.), confirming the requirements contained in Annex 3 to the SWZ (with an indication of the required parameters, position of the offered subject of the contract) – applies to parts No. 1 and 2.
2. If the Contractor does not submit the evidence in question or the measures of evidence submitted are incomplete, the Contracting Authority shall call for submission or supplement them within the time limit set.