Poland - Miscellaneous medical devices and products

Description

Difficult intubation guides described in detail in Appendix 1 package no. 1 For all packagesW In order to confirm that the deliveries offered meet the requirements specified by the Ordering Party, the Ordering Party shall require that the offer be accompanied by the following: a) A certificate allowing the subject of the order to be marketed and used in Poland - in accordance with the current provisions of the Act on Medical Devices. If the subject of the contract described in the ToR has not been classified as a medical device and in accordance with the European directives and the Act on Medical Devices is not covered by declarations of conformity and is not subject to any entry, the Ordering Party shall be required to submit an appropriate statement. b) Catalogues, leaflet folders or technical data sheet/forms regarding the offered subject of the contract, confirming the Ordering Party's requirements included in Annex 1 (packages no. 1-12) to the ToR. c) Free samples of the offered product - in the quantity indicated in Annexes 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 to the ToR. The samples shall be described exactly which package and item they refer to.Moreover, the Economic Operator shall submit the offer together with the offer:a) Authorization (original) to sign the offer and tender documents, as well as to provide explanations, if the signatory is not a person authorized on the basis of an extract from the national court register or a certificate from the central register and information on business activity of the Republic of Poland (it is required to submit the authorization in the original or a copy certified by a notary public);b) Completed price form (description of the subject of the contract) - attachment No. 1 (packages No. 1-12) to the ToR; c) Completed offer form - attachment No. 2 to the ToR; d) Proof of deposit; Delivery of single use medical devices is specified in detail in attachment No. 1 to the ToR for all packages in order to confirm that the offered deliveries meet the requirements specified by the Contracting Authority; the Contracting Authority requires submission together with the offer:a) Certificates allowing the subject matter of the contract to be traded and used in Poland - in accordance with the current provisions of the Act on Medical Devices. If the subject of the contract described in the ToR has not been classified as a medical device and in accordance with the European directives and the Act on Medical Devices is not covered by declarations of conformity and is not subject to any entry, the Ordering Party shall be required to submit an appropriate statement. b) Catalogues, leaflet folders or technical data sheet/forms regarding the offered subject of the contract, confirming the Ordering Party's requirements included in Annex 1 (packages no. 1-12) to the ToR. c) Free samples of the offered product - in the quantity indicated in appendices No. 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 to the ToR. The samples shall be described exactly which package and item they refer to.Moreover, the Economic Operator shall submit the offer together with the offer:a) Authorization (original) to sign the offer and tender documents, as well as to provide explanations, if the signatory is not a person authorized on the basis of an extract from the national court register or a certificate from the central register and information on business activity of the Republic of Poland (it is required to submit the authorization in the original or a copy certified by a notary public);b) Completed price form (description of the subject of the contract) - attachment no. 1 (packages no. 1-12) to the ToR; c) Completed offer form - attachment no. 2 to the ToR; d) Proof of deposit; Transal ports, laparoscopic staplers for laparoscopic procedures are specified in detail in attachment no. 1 to the ToR; package no. 3D concerns all packages in order to confirm that the deliveries offered meet the requirements specified by the Ordering Party; the Ordering Party requires submission together with the offer:a) Certificates allowing the subject matter of the contract to be traded and used in Poland - in accordance with the current provisions of the Act on Medical Devices. If the subject of the contract described in the ToR has not been classified as a medical device and in accordance with the European directives and the Act on Medical Devices is not covered by declarations of conformity and is not subject to any entry, the Ordering Party shall be required to submit an appropriate statement. b) Catalogues, leaflet folders or technical data sheet/forms regarding the offered subject of the contract, confirming the Ordering Party's requirements included in Annex 1 (packages no. 1-12) to the ToR. c) Free samples of the offered product - in the quantity indicated in appendices No. 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 to the ToR. The samples shall be described exactly which package and item they refer to.Moreover, the Economic Operator shall submit the offer together with the offer:a) Authorisation (original) to sign the offer and tender documents, as well as to provide explanations, if the signatory is not a person authorised on the basis of an extract from the national court register or a certificate from the central register and information on business activity of the Republic of Poland (it is required to submit the authorisation in the original or a copy certified by a notary public); b) Completed price form (description of the subject of the contract) - Annex no. 1 (packages no. 1-12) to the ToR;c) Completed tender form - Annex 2 to the ToR; d) Proof of payment of the tender security; Package No. 4 - simple concentric samplers are specified in detail in Annex 1 to the ToR:a) Certificates allowing the subject matter of the contract to be traded and used in Poland - in accordance with the current provisions of the Act on Medical Devices. If the subject of the contract described in the ToR has not been classified as a medical device and in accordance with the European directives and the Act on Medical Devices is not covered by declarations of conformity and is not subject to any entry, the Ordering Party shall be required to submit an appropriate statement. b) Catalogues, leaflet folders or technical data sheet/forms regarding the offered subject of the contract, confirming the Ordering Party's requirements included in Annex 1 (packages no. 1-12) to the ToR. c) Free samples of the offered product - in the quantity indicated in appendices No. 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 to the ToR. The samples shall be described exactly which package and item they refer to.Moreover, the Economic Operator shall submit the offer together with the offer:a) Authorization (original) to sign the offer and tender documents, as well as to provide explanations, if the signatory is not a person authorized on the basis of an extract from the national court register or a certificate from the central register and information on business activity of the Republic of Poland (it is required to submit the authorization in the original or a copy certified by a notary public);b) Completed price form (description of the subject of the contract) - attachment No. 1 (packages No. 1-12) to the ToR; c) Completed offer form - attachment No. 2 to the ToR; d) Proof of deposit; Dreny Kehra - detailed period specified in attachment No. 1 - package No. 5For all packages In order to confirm that the deliveries offered meet the requirements specified by the Ordering Party, the Ordering Party must submit together with the offer:a) Certificates allowing the subject matter of the contract to be traded and used in Poland - in accordance with the current provisions of the Act on Medical Devices. If the subject of the contract described in the ToR has not been classified as a medical device and in accordance with the European directives and the Act on Medical Devices is not covered by declarations of conformity and is not subject to any entry, the Ordering Party shall be required to submit an appropriate statement. b) Catalogues, leaflet folders or technical data sheet/forms regarding the offered subject of the contract, confirming the Ordering Party's requirements included in Annex 1 (packages no. 1-12) to the ToR. c) Free samples of the offered product - in the quantity indicated in appendices No. 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 to the ToR. The samples shall be described exactly which package and item they refer to.Moreover, the Economic Operator shall submit the offer together with the offer:a) Authorization (original) to sign the offer and tender documents, as well as to provide explanations, if the signatory is not a person authorized on the basis of an extract from the national court register or a certificate from the central register and information on business activity of the Republic of Poland (it is required to submit the authorization in the original or a copy certified by a notary public);b) Completed price form (description of the subject of the contract) - attachment No. 1 (packages No. 1-12) to the ToR; c) Completed offer form - attachment No. 2 to the ToR; d) Proof that the deposit has been paid; Automatic blood lancets - detailed in attachment No. 1 to the ToR; package No. 6 For all packages in order to confirm that the deliveries offered meet the requirements specified by the Contracting Authority, the Contracting Authority requires submission together with the offer:a) Certificates allowing the subject matter of the contract to be traded and used in Poland - in accordance with the current provisions of the Act on Medical Devices. If the subject of the contract described in the ToR has not been classified as a medical device and in accordance with the European directives and the Act on Medical Devices is not covered by declarations of conformity and is not subject to any entry, the Ordering Party shall be required to submit an appropriate statement. b) Catalogues, leaflet folders or technical data sheet/forms regarding the offered subject of the contract, confirming the Ordering Party's requirements included in Annex 1 (packages no. 1-12) to the ToR. c) Free samples of the offered product - in the quantity indicated in appendices No. 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 to the ToR. The samples shall be described exactly which package and item they refer to.Moreover, the Economic Operator shall submit the offer together with the offer:a) Authorization (original) to sign the offer and tender documents, as well as to provide explanations, if the signatory is not a person authorized on the basis of an extract from the national court register or a certificate from the central register and information on business activity of the Republic of Poland (it is required to submit the authorization in the original or a copy certified by a notary public);b) Completed price form (description of the subject of the contract) - Annex no. 1 (packages no. 1-12) to the ToR; c) Completed offer form - Annex no. 2 to the ToR; d) Proof of deposit; Flexible 5 mm hooks for a multiple hook - specified in detail in Annex no. 1 to the ToR - Package no. 7 For all packages In order to confirm that the deliveries offered meet the requirements specified by the Contracting Authority, the Contracting Authority requires submission together with the offer:a) Certificates allowing the subject matter of the contract to be traded and used in Poland - in accordance with the current provisions of the Act on Medical Devices. If the subject of the contract described in the ToR has not been classified as a medical device and in accordance with the European directives and the Act on Medical Devices is not covered by declarations of conformity and is not subject to any entry, the Ordering Party shall be required to submit an appropriate statement. b) Catalogues, leaflet folders or technical data sheet/forms regarding the offered subject of the contract, confirming the Ordering Party's requirements included in Annex 1 (packages no. 1-12) to the ToR. c) Free samples of the offered product - in the quantity indicated in appendices No. 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 to the ToR. The samples shall be described exactly which package and item they refer to.Moreover, the Economic Operator shall submit the offer together with the offer:a) Authorization (original) to sign the offer and tender documents, as well as to provide explanations, if the signatory is not a person authorized on the basis of an extract from the national court register or a certificate from the central register and information on business activity of the Republic of Poland (it is required to submit the authorization in the original or a copy certified by a notary public);b) Completed price form (description of the subject of the order) - attachment No. 1 (packages No. 1-12) to the ToR; c) Completed offer form - attachment No. 2 to the ToR; d) Proof of deposit; Accessories for the uterus manipulator prod. Richard Wolf- set out in detail in Appendix No. 1 to the ToR. The package No. 8 applies to all packages in order to confirm that the deliveries offered meet the requirements specified by the Ordering Party. The Ordering Party shall call for the submission of the Economic Operator whose offer has been assessed the highest in accordance with the provisions of the ToR: a) Certificates allowing the subject of the contract to be marketed and used in Poland - in accordance with the current provisions of the Act on Medical Devices. If the subject of the contract described in the ToR has not been classified as a medical device and in accordance with the European directives and the Act on Medical Devices is not covered by declarations of conformity and is not subject to any entry, the Ordering Party shall be required to submit an appropriate statement. b) Catalogues, leaflet folders or technical data sheet/forms regarding the offered subject of the contract, confirming the Ordering Party's requirements included in Annex 1 (packages no. 1-12) to the ToR. c) Free samples of the offered product - in the quantity indicated in appendices No. 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 to the ToR. The samples shall be described exactly which package and item they refer to.Moreover, the Economic Operator shall submit the offer together with the offer:a) Authorization (original) to sign the offer and tender documents, as well as to provide explanations, if the signatory is not a person authorized on the basis of an extract from the national court register or a certificate from the central register and information on business activity of the Republic of Poland (it is required to submit the authorization in the original or a copy certified by a notary public);b) Completed price form (description of the subject of the contract) - attachment No. 1 (packages No. 1-12) to the ToR; c) Completed offer form - attachment No. 2 to the ToR; d) Proof of deposit; Package No. 9 sclerotherapy needles, polypectomy loops - specified in detail in attachment No. 1 to the ToR; Package No. 9 For all packages In order to confirm that the deliveries offered meet the requirements specified by the Contracting Authority, the Contracting Authority requires submission together with the offer:a) Certificates allowing the subject matter of the contract to be traded and used in Poland - in accordance with the current provisions of the Act on Medical Devices. If the subject of the contract described in the ToR has not been classified as a medical device and in accordance with the European directives and the Act on Medical Devices is not covered by declarations of conformity and is not subject to any entry, the Ordering Party shall be required to submit an appropriate statement. b) Catalogues, leaflet folders or technical data sheet/forms regarding the offered subject of the contract, confirming the Ordering Party's requirements included in Annex 1 (packages no. 1-12) to the ToR. c) Free samples of the offered product - in the quantity indicated in appendices No. 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 to the ToR. The samples shall be described exactly which package and item they refer to.Moreover, the Economic Operator shall submit the offer together with the offer:a) Authorization (original) to sign the offer and tender documents, as well as to provide explanations, if the signatory is not a person authorized on the basis of an extract from the national court register or a certificate from the central register and information on business activity of the Republic of Poland (it is required to submit the authorization in the original or a copy certified by a notary public);b) Completed price form (description of the subject of the contract) - attachment No. 1 (packages No. 1-12) to the ToR; c) Completed offer form - attachment No. 2 to the ToR; d) Proof of deposit; Package No. 10 sets for pericardium drainage - specified in detail in attachment No. 1 to the ToR, package No. 10 For all packages To confirm that the deliveries offered meet the requirements specified by the Awarding Entity, the Awarding Entity requires submission together with the offer:a) Certificates allowing the subject matter of the contract to be traded and used in Poland - in accordance with the current provisions of the Act on Medical Devices. If the subject of the contract described in the ToR has not been classified as a medical device and in accordance with the European directives and the Act on Medical Devices is not covered by declarations of conformity and is not subject to any entry, the Ordering Party shall be required to submit an appropriate statement. b) Catalogues, leaflet folders or technical data sheet/forms regarding the offered subject of the contract, confirming the Ordering Party's requirements included in Annex 1 (packages no. 1-12) to the ToR. c) Free samples of the offered product - in the quantity indicated in appendices No. 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 to the ToR. The samples shall be described exactly which package and item they refer to.Moreover, the Economic Operator shall submit the offer together with the offer:a) Authorization (original) to sign the offer and tender documents, as well as to provide explanations, if the signatory is not a person authorized on the basis of an extract from the national court register or a certificate from the central register and information on business activity of the Republic of Poland (it is required to submit the authorization in the original or a copy certified by a notary public);b) Completed price form (description of the subject of the contract) - attachment No. 1 (packages No. 1-12) to the ToR; c) Completed offer form - attachment No. 2 to the ToR; d) Proof of deposit; Package No. 11 - needles for subarms anesthesia - described in detail in attachment No. 1 to the ToR, package No. 11 For all packages To confirm that the deliveries offered meet the requirements specified by the Contracting Authority, the Contracting Authority requires submission together with the offer:a) Certificates allowing the subject matter of the contract to be traded and used in Poland - in accordance with the current provisions of the Act on Medical Devices. If the subject of the contract described in the ToR has not been classified as a medical device and in accordance with the European directives and the Act on Medical Devices is not covered by declarations of conformity and is not subject to any entry, the Ordering Party shall be required to submit an appropriate statement. b) Catalogues, leaflet folders or technical data sheet/forms regarding the offered subject of the contract, confirming the Ordering Party's requirements included in Annex 1 (packages no. 1-12) to the ToR. c) Free samples of the offered product - in the quantity indicated in appendices No. 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 to the ToR. The samples shall be described exactly which package and item they refer to.Moreover, the Economic Operator shall submit the offer together with the offer:a) Authorisation (original) to sign the offer and tender documents, as well as to provide explanations, if the signatory is not a person authorised on the basis of an extract from the national court register or a certificate from the central register and information on business activity of the Republic of Poland (it is required to submit the authorisation in the original or a copy certified by a notary public); b) Completed price form (description of the subject of the contract) - Annex no. 1 (packages no. 1-12) to the ToR;c) Completed tender form - Annex 2 to the ToR; d) Proof of payment of the deposit; Connects low pressure to computer tomography, Salient contrast kits - detailed in Annex 1 to the ToR; Package No. 12 applies to all packages in order to confirm that the deliveries offered meet the requirements specified by the Awarding Entity; the Awarding Entity shall call for submission of the Economic Operator whose tender has been assessed the highest according to the provisions of the ToR::a) Certificates allowing the subject of the order to be traded and used on the territory of Poland - in accordance with the current provisions of the Act on Medical Devices. If the subject of the contract described in the ToR has not been classified as a medical device and in accordance with the European directives and the Act on Medical Devices is not covered by declarations of conformity and is not subject to any entry, the Ordering Party shall be required to submit an appropriate statement. b) Catalogues, leaflet folders or technical data sheet/forms regarding the offered subject of the contract, confirming the Ordering Party's requirements included in Annex 1 (packages no. 1-12) to the ToR. Described which package and items they refer to.Moreover, the Economic Operator shall submit the offer together with the offer:a) Authorisation (original) to sign the offer and tender documents, as well as to provide explanations, if the signatory is not a person authorised on the basis of an extract from the national court register or a certificate from the central register and information on business activity of the Republic of Poland (it is required to submit the authorisation in the original or a copy certified by a notary public); b) Completed price form (description of the subject of the contract) - Annex 1 (packages 1-12) to the ToR; c) Completed offer form - Annex 2 to the ToR; d) Proof that the deposit has been deposited;

Opportunity closing date

07 May 2019

Value of contract

to be confirmed