Poland - Medical supplies

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Details

Provided by Open Opps
Opportunity closing date
12 November 2021
Opportunity publication date
09 October 2021
Category
33140000
Value of contract
to be confirmed
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Description

Delivery of medical devices (used in central sterilization) from the list of packages, in quantities resulting from the current needs of the Purchaser, by the Contractor's transport or at his expense. Detailed attachment No. 1 to the offer (assortment and price form) 3. If an Economic Operator has a seat or place of residence outside the territory of the Republic of Poland:3.1 instead of documents mentioned in item 2 point 2.3.2 shall submit a document or documents issued in the country in which the Economic Operator has its registered seat or place of residence, confirming that it has not gone into liquidation, that it is not declared bankrupt, that its assets are not being administered by a liquidator or a court, that it has not entered into an arrangement with creditors, that its business activity has not been suspended, and that it is not in any other similar situation arising from a similar procedure provided for in the law of the place where such procedure is to be instituted - issued not earlier than 3 months before submitting the document (Chapter IX, item 3).);
Biological indicator for control of steam sterilization at 121 °C and 134 °C - description appendix no 1 to the offer - price 60%Delivery date "T"- 40%12. Subject matter of the evidence: The Orderer, in order to confirm that offered supplies meet requirements specified by the Orderer, demands the following subject matter of the evidence:1) Samples (number of samples is specified in appendix no 1 to the offer (assortment and price)), in order to check proposed assortment with description of the object. The samples must comply with the parameters given in the detailed description in the assortment-price form. Samples are not returnable. Address for delivery of the required samples: Dolnośląskie Centrum Chorób Płuciu in Wrocław , 105 Grabiszyńska Street , 53-439 Wrocław. Registry Office, room no. 4, high ground floor (samples accepted from Monday to Friday, 7.45 a.m. to 1.30 p.m.) with a description on the package: "samples for proceedings no. BZP 3810.63.2021.TP to package/ow................ (2) Valid and up-to-date documents confirming marketing authorization in the Republic of Poland in accordance with the Medical Devices Act of 20 May 2010, including a. Declaration(s) of conformity, b. Certificate(s) of conformity (issued by a notified body - if required), c. Confirmation that the medical device in question has been notified/registered in the register of medical devices and the entities responsible for their placing on the market or a notification has been made regarding the device pursuant to Art. 58 of the Medical Devices Act (the name of the device notified/registered should correspond to the trade/catalogue name of the device in question). If (in accordance with Article 13 of the Act) the manufacturer does not have its place of residence or seat in a Member State and has not appointed an authorised representative, or if the device is not placed on the market under the responsibility of the manufacturer or authorised representative, it shall inform the Contracting Authority of this fact by attaching an appropriate statement in this respect to the tender. NOTEEach document should be described in which item from Appendix 1 to the SWZ it refers to. Relevant manufacturer's catalogues (containing catalogues numbers of the offered products), brochures or manufacturer's reference materials/manufacturer's declarations in a clear and legible manner confirming compliance with the technical-usage parameters described by the Ordering Party in Appendix 1 to the Offer. Lack of confirmation of the required parameters will be considered as non-compliance of the offered equipment with these parameters and will result in rejection of the offer, unless the premises specified in art. 128 occur. The Contracting Authority reserves the right to verify the reliability of the parameters given by the Economic Operator in all available sources - applies to package no. 1-24 - If the item described in the Terms of Reference is not 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 registration, the Contracting Authority requires a relevant statement.1212.1 The Contractor shall submit the said evidence together with the tender (Article 107, paragraph 1 of PPL).12.2 If the Contractor fails to submit the said evidence or the submitted evidence is incomplete, the Contracting Authority shall call for its submission or supplementation within the prescribed time limit (Article 107, paragraph 2 of PPL). Test for controlling effectiveness of mechanical washing in washer-disinfectors. -Price 60 %Delivery date "T"-40 %12. Subject matter of proof: The Contracting Authority, in order to confirm that the offered supplies meet the requirements specified by the Contracting Authority, demands the following subject matter of proof:1) Samples (the number of samples has been specified in appendix no 1 to the offer (assortment-price list) in order to check the offered assortment against its description. The samples must comply with the parameters given in the detailed description in the assortment-price form. Samples are not returnable. Address for delivery of the required samples: Dolnośląskie Centrum Chorób Płuciu in Wrocław , 105 Grabiszyńska Street , 53-439 Wrocław. Registry Office, room no. 4, high ground floor (samples accepted from Monday to Friday, 7.45 a.m. to 1.30 p.m.) with a description on the package: "samples for proceedings no. BZP 3810.63.2021.TP to package/ow................ (2) Valid and up-to-date documents confirming marketing authorization in the Republic of Poland in accordance with the Medical Devices Act of 20 May 2010, including a. Declaration(s) of conformity, b. Certificate(s) of conformity (issued by a notified body - if required), c. Confirmation that the medical device in question has been notified/registered in the register of medical devices and the entities responsible for their placing on the market or a notification has been made regarding the device pursuant to Art. 58 of the Medical Devices Act (the name of the device notified/registered should correspond to the trade/catalogue name of the device in question). If (in accordance with Article 13 of the Act) the manufacturer does not have its place of residence or seat in a Member State and has not appointed an authorised representative, or if the device is not placed on the market under the responsibility of the manufacturer or authorised representative, it shall inform the Contracting Authority of this fact by attaching an appropriate statement in this respect to the tender. NOTEEach document should be described in which item from Appendix 1 to the SWZ it refers to. Relevant manufacturer's catalogues (containing catalogues numbers of the offered products), brochures or manufacturer's reference materials/manufacturer's declarations in a clear and legible manner confirming compliance with the technical-usage parameters described by the Ordering Party in Appendix 1 to the Offer. Lack of confirmation of the required parameters will be considered as non-compliance of the offered equipment with these parameters and will result in rejection of the offer, unless the premises specified in art. 128 occur. The Contracting Authority reserves the right to verify the reliability of the parameters given by the Economic Operator in all available sources - applies to package no. 1-24 - If the item described in the Terms of Reference is not 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 registration, the Contracting Authority requires a relevant statement.1212.1 The Contractor shall submit the said evidence together with the tender (Article 107, paragraph 1 of PPL).12.2 If the Contractor fails to submit the said evidence or the submitted evidence is incomplete, the Contracting Authority shall call for its submission or supplementation within the prescribed time limit (Article 107, paragraph 2 of PPL). Indicator to control the process of thermal disinfection at 90st.C/5min. -Price 60 %Delivery date "T"-40 %12 Subject matter of evidence: The Contracting Authority, in order to confirm that the offered supplies meet the requirements specified by the Contracting Authority, demands the following subject matter of evidence The samples must comply with the parameters given in the detailed description in the assortment-price form. Samples are not returnable. Address for delivery of the required samples: Dolnośląskie Centrum Chorób Płuciu in Wrocław , 105 Grabiszyńska Street , 53-439 Wrocław. Registry Office, room no. 4, high ground floor (samples accepted from Monday to Friday, 7.45 a.m. to 1.30 p.m.) with a description on the package: "samples for proceedings no. BZP 3810.63.2021.TP to package/ow................ (2) Valid and up-to-date documents confirming marketing authorization in the Republic of Poland in accordance with the Medical Devices Act of 20 May 2010, including a. Declaration(s) of conformity, b. Certificate(s) of conformity (issued by a notified body - if required), c. Confirmation that the medical device in question has been notified/registered in the register of medical devices and the entities responsible for their placing on the market or a notification has been made regarding the device pursuant to Art. 58 of the Medical Devices Act (the name of the device notified/registered should correspond to the trade/catalogue name of the device in question). If (in accordance with Article 13 of the Act) the manufacturer does not have its place of residence or seat in a Member State and has not appointed an authorised representative, or if the device is not placed on the market under the responsibility of the manufacturer or authorised representative, it shall inform the Contracting Authority of this fact by attaching an appropriate statement in this respect to the tender. NOTEEach document should be described in which item from Appendix 1 to the SWZ it refers to. Relevant manufacturer's catalogues (containing catalogues numbers of the offered products), brochures or manufacturer's reference materials/manufacturer's declarations in a clear and legible manner confirming compliance with the technical-usage parameters described by the Ordering Party in Appendix 1 to the Offer. Lack of confirmation of the required parameters will be considered as non-compliance of the offered equipment with these parameters and will result in rejection of the offer, unless the premises specified in art. 128 occur. The Contracting Authority reserves the right to verify the reliability of the parameters given by the Economic Operator in all available sources - applies to package no. 1-24 - If the item described in the Terms of Reference is not 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 registration, the Contracting Authority requires a relevant statement.12.1 The Contractor shall submit the said evidence together with the tender (Article 107(1) of PPL).12.2 If the Contractor fails to submit the said evidence or the submitted evidence is incomplete, the Contracting Authority shall call for its submission or supplementation within the prescribed time limit (Article 107(2) of PPL). Corner protectors for sterilization trays - description appendix no 1 to the offer - price 60%Delivery date "T"- 40%12. Subject matter of evidence:The Ordering Party, in order to confirm that offered supplies meet requirements specified by the Ordering Party, demands the following subject matter of evidence:1) Samples (number of samples is specified in appendix no 1 to the offer (assortment and price list) in order to check proposed assortment with description of the object. The samples must comply with the parameters given in the detailed description in the assortment-price form. Samples are not returnable. Address for delivery of the required samples: Dolnośląskie Centrum Chorób Płuciu in Wrocław , 105 Grabiszyńska Street , 53-439 Wrocław. Registry Office, room no. 4, high ground floor (samples accepted from Monday to Friday, 7.45 a.m. to 1.30 p.m.) with a description on the package: "samples for proceedings no. BZP 3810.63.2021.TP to package/ow................ (2) Valid and up-to-date documents confirming marketing authorization in the Republic of Poland in accordance with the Medical Devices Act of 20 May 2010, including a. Declaration(s) of conformity, b. Certificate(s) of conformity (issued by a notified body - if required), c. Confirmation that the medical device in question has been notified/registered in the register of medical devices and the entities responsible for their placing on the market or a notification has been made regarding the device pursuant to Art. 58 of the Medical Devices Act (the name of the device notified/registered should correspond to the trade/catalogue name of the device in question). If (in accordance with Article 13 of the Act) the manufacturer does not have its place of residence or seat in a Member State and has not appointed an authorised representative, or if the device is not placed on the market under the responsibility of the manufacturer or authorised representative, it shall inform the Contracting Authority of this fact by attaching an appropriate statement in this respect to the tender. NOTEEach document should be described in which item from Appendix 1 to the SWZ it refers to. Relevant manufacturer's catalogues (containing catalogues numbers of the offered products), brochures or manufacturer's reference materials/manufacturer's declarations in a clear and legible manner confirming compliance with the technical-usage parameters described by the Ordering Party in Appendix 1 to the Offer. Lack of confirmation of the required parameters will be considered as non-compliance of the offered equipment with these parameters and will result in rejection of the offer, unless the premises specified in art. 128 occur. The Contracting Authority reserves the right to verify the reliability of the parameters given by the Economic Operator in all available sources - applies to package no. 1-24 - If the item described in the Terms of Reference is not 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 registration, the Contracting Authority requires a relevant statement.12.1 The Contractor shall submit the said evidence together with the tender (Article 107, paragraph 1 of PPL).12.2 If the Contractor fails to submit the said evidence or the submitted evidence is incomplete, the Contracting Authority shall call for its submission or supplementation within the prescribed time limit (Article 107, paragraph 2 of PPL). Multi-parameter test for class 4 steam sterilization - description appendix no.1 to the offer - price 60%Delivery date "T"- 40%12. Subject matter of the evidence: The Ordering Party, in order to confirm that offered supplies meet requirements defined by the Ordering Party, demands the following subject matter of the evidence:1) Samples (number of samples is defined in appendix no.1 to the offer (assortment and price list) in order to check proposed assortment with description of the subject matter. The samples must comply with the parameters given in the detailed description in the assortment-price form. Samples are not returnable. Address for delivery of the required samples: Dolnośląskie Centrum Chorób Płuciu in Wrocław , 105 Grabiszyńska Street , 53-439 Wrocław. Registry Office, room no. 4, high ground floor (samples accepted from Monday to Friday, 7.45 a.m. to 1.30 p.m.) with a description on the package: "samples for proceedings no. BZP 3810.63.2021.TP to package/ow................ (2) Valid and up-to-date documents confirming marketing authorization in the Republic of Poland in accordance with the Medical Devices Act of 20 May 2010, including a. Declaration(s) of conformity, b. Certificate(s) of conformity (issued by a notified body - if required), c. Confirmation that the medical device in question has been notified/registered in the register of medical devices and the entities responsible for their placing on the market or a notification has been made regarding the device pursuant to Art. 58 of the Medical Devices Act (the name of the device notified/registered should correspond to the trade/catalogue name of the device in question). If (in accordance with Article 13 of the Act) the manufacturer does not have its place of residence or seat in a Member State and has not appointed an authorised representative, or if the device is not placed on the market under the responsibility of the manufacturer or authorised representative, it shall inform the Contracting Authority of this fact by attaching an appropriate statement in this respect to the tender. NOTEEach document should be described in which item from Appendix 1 to the SWZ it refers to. Relevant manufacturer's catalogues (containing catalogues numbers of the offered products), brochures or manufacturer's reference materials/manufacturer's declarations in a clear and legible manner confirming compliance with the technical-usage parameters described by the Ordering Party in Appendix 1 to the Offer. Lack of confirmation of the required parameters will be considered as non-compliance of the offered equipment with these parameters and will result in rejection of the offer, unless the premises specified in art. 128 occur. The Contracting Authority reserves the right to verify the reliability of the parameters given by the Economic Operator in all available sources - applies to package no. 1-24 - If the item described in the Terms of Reference is not 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 registration, the Contracting Authority requires a relevant statement.1212.1 The Contractor shall submit the said evidence together with the tender (Article 107, paragraph 1 of PPL).12.2 If the Contractor fails to submit the said evidence or the submitted evidence is incomplete, the Contracting Authority shall call for its submission or supplementation within the prescribed time limit (Article 107, paragraph 2 of PPL). Paper and foil sleeve disposable medical packaging for steam and ethylene oxide sterilization with sterilization process indicators. -Price 60 %Delivery date "T"-40 %12 Subject matter of evidence:The Orderer, in order to confirm that the offered supplies meet the requirements specified by the Orderer, demands the following subject matter of evidence:1) Samples (the number of samples has been specified in appendix no 1 to the offer (assortment-price list) in order to check the offered assortment against its description. The samples must comply with the parameters given in the detailed description in the assortment-price form. Samples are not returnable. Address for delivery of the required samples: Dolnośląskie Centrum Chorób Płuciu in Wrocław , 105 Grabiszyńska Street , 53-439 Wrocław. Registry Office, room no. 4, high ground floor (samples accepted from Monday to Friday, 7.45 a.m. to 1.30 p.m.) with a description on the package: "samples for proceedings no. BZP 3810.63.2021.TP to package/ow................ (2) Valid and up-to-date documents confirming marketing authorization in the Republic of Poland in accordance with the Medical Devices Act of 20 May 2010, including a. Declaration(s) of conformity, b. Certificate(s) of conformity (issued by a notified body - if required), c. Confirmation that the medical device in question has been notified/registered in the register of medical devices and the entities responsible for their placing on the market or a notification has been made regarding the device pursuant to Art. 58 of the Medical Devices Act (the name of the device notified/registered should correspond to the trade/catalogue name of the device in question). If (in accordance with Article 13 of the Act) the manufacturer does not have its place of residence or seat in a Member State and has not appointed an authorised representative, or if the device is not placed on the market under the responsibility of the manufacturer or authorised representative, it shall inform the Contracting Authority of this fact by attaching an appropriate statement in this respect to the tender. NOTEEach document should be described in which item from Appendix 1 to the SWZ it refers to. Relevant manufacturer's catalogues (containing catalogues numbers of the offered products), brochures or manufacturer's reference materials/manufacturer's declarations in a clear and legible manner confirming compliance with the technical-usage parameters described by the Ordering Party in Appendix 1 to the Offer. Lack of confirmation of the required parameters will be considered as non-compliance of the offered equipment with these parameters and will result in rejection of the offer, unless the premises specified in art. 128 occur. The Contracting Authority reserves the right to verify the reliability of the parameters given by the Economic Operator in all available sources - applies to package no. 1-24 - If the item described in the Terms of Reference is not 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 registration, the Contracting Authority requires a relevant statement.1212.1 The Contractor shall submit the said evidence together with the tender (Article 107, paragraph 1 of PPL).12.2 If the Contractor fails to submit the said evidence or the submitted evidence is incomplete, the Contracting Authority shall call for its submission or supplementation within the prescribed time limit (Article 107, paragraph 2 of PPL). Price 60%Delivery date "T"-40%12. Subject matter of evidence: The Contracting Authority, in order to confirm that the offered supplies meet the requirements specified by the Contracting Authority, demands the following subject matter of evidence:1) Samples (the number of samples is specified in appendix no 1 to the offer (assortment and price list) in order to check the offered assortment against its description. The samples must comply with the parameters given in the detailed description in the assortment-price form. Samples are not returnable. Address for delivery of the required samples: Dolnośląskie Centrum Chorób Płuciu in Wrocław , 105 Grabiszyńska Street , 53-439 Wrocław. Registry Office, room no. 4, high ground floor (samples accepted from Monday to Friday, 7.45 a.m. to 1.30 p.m.) with a description on the package: "samples for proceedings no. BZP 3810.63.2021.TP to package/ow................ (2) Valid and up-to-date documents confirming marketing authorization in the Republic of Poland in accordance with the Medical Devices Act of 20 May 2010, including a. Declaration(s) of conformity, b. Certificate(s) of conformity (issued by a notified body - if required), c. Confirmation that the medical device in question has been notified/registered in the register of medical devices and the entities responsible for their placing on the market or a notification has been made regarding the device pursuant to Art. 58 of the Medical Devices Act (the name of the device notified/registered should correspond to the trade/catalogue name of the device in question). If (in accordance with Article 13 of the Act) the manufacturer does not have its place of residence or seat in a Member State and has not appointed an authorised representative, or if the device is not placed on the market under the responsibility of the manufacturer or authorised representative, it shall inform the Contracting Authority of this fact by attaching an appropriate statement in this respect to the tender. NOTEEach document should be described in which item from Appendix 1 to the SWZ it refers to. Relevant manufacturer's catalogues (containing catalogues numbers of the offered products), brochures or manufacturer's reference materials/manufacturer's declarations in a clear and legible manner confirming compliance with the technical-usage parameters described by the Ordering Party in Appendix 1 to the Offer. Lack of confirmation of the required parameters will be considered as non-compliance of the offered equipment with these parameters and will result in rejection of the offer, unless the premises specified in art. 128 occur. The Contracting Authority reserves the right to verify the reliability of the parameters given by the Economic Operator in all available sources - applies to package no. 1-24 - If the item described in the Terms of Reference is not 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 registration, the Contracting Authority requires a relevant statement.1212.1 The Contractor shall submit the said evidence together with the tender (Article 107, paragraph 1 of PPL).12.2 If the Contractor fails to submit the said evidence or the submitted evidence is incomplete, the Contracting Authority shall call for its submission or supplementation within the prescribed time limit (Article 107, paragraph 2 of PPL). Self-adhesive indicator tape for water vapour - description appendix no 1 to the offer - price 60%Delivery date "T"- 40%12. Subject matter of evidence:The Contracting Authority, in order to confirm that the offered supplies meet the requirements specified by the Contracting Authority, demands the following subject matter of evidence:1) Samples (number of samples is specified in appendix no 1 to the offer (assortment and price list) in order to check the offered assortment against its description. The samples must comply with the parameters given in the detailed description in the assortment-price form. Samples are not returnable. Address for delivery of the required samples: Dolnośląskie Centrum Chorób Płuciu in Wrocław , 105 Grabiszyńska Street , 53-439 Wrocław. Registry Office, room no. 4, high ground floor (samples accepted from Monday to Friday, 7.45 a.m. to 1.30 p.m.) with a description on the package: "samples for proceedings no. BZP 3810.63.2021.TP to package/ow................ (2) Valid and up-to-date documents confirming marketing authorization in the Republic of Poland in accordance with the Medical Devices Act of 20 May 2010, including a. Declaration(s) of conformity, b. Certificate(s) of conformity (issued by a notified body - if required), c. Confirmation that the medical device in question has been notified/registered in the register of medical devices and the entities responsible for their placing on the market or a notification has been made regarding the device pursuant to Art. 58 of the Medical Devices Act (the name of the device notified/registered should correspond to the trade/catalogue name of the device in question). If (in accordance with Article 13 of the Act) the manufacturer does not have its place of residence or seat in a Member State and has not appointed an authorised representative, or if the device is not placed on the market under the responsibility of the manufacturer or authorised representative, it shall inform the Contracting Authority of this fact by attaching an appropriate statement in this respect to the tender. NOTEEach document should be described in which item from Appendix 1 to the SWZ it refers to. Relevant manufacturer's catalogues (containing catalogues numbers of the offered products), brochures or manufacturer's reference materials/manufacturer's declarations in a clear and legible manner confirming compliance with the technical-usage parameters described by the Ordering Party in Appendix 1 to the Offer. Lack of confirmation of the required parameters will be considered as non-compliance of the offered equipment with these parameters and will result in rejection of the offer, unless the premises specified in art. 128 occur. The Contracting Authority reserves the right to verify the reliability of the parameters given by the Economic Operator in all available sources - applies to package no. 1-24 - If the item described in the Terms of Reference is not 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 registration, the Contracting Authority requires a relevant statement.1212.1 The Contractor shall submit the said evidence together with the tender (Article 107, paragraph 1 of PPL).12.2 If the Contractor fails to submit the said evidence or the submitted evidence is incomplete, the Contracting Authority shall call for its submission or supplementation within the prescribed time limit (Article 107, paragraph 2 of PPL). Chemical indicator for control of steam sterilization class 5 - description appendix no 1 to the offer - price 60%Delivery date "T"- 40%12. Subject matter of proof: The Orderer, in order to confirm that offered supplies meet requirements specified by the Orderer, demands the following subject matter of proof:1) Samples (number of samples has been specified in appendix no 1 to the offer (assortment and price list) in order to check the offered assortment with description of the subject matter. The samples must comply with the parameters given in the detailed description in the assortment-price form. Samples are not returnable. Address for delivery of the required samples: Dolnośląskie Centrum Chorób Płuciu in Wrocław , 105 Grabiszyńska Street , 53-439 Wrocław. Registry Office, room no. 4, high ground floor (samples accepted from Monday to Friday, 7.45 a.m. to 1.30 p.m.) with a description on the package: "samples for proceedings no. BZP 3810.63.2021.TP to package/ow................ (2) Valid and up-to-date documents confirming marketing authorization in the Republic of Poland in accordance with the Medical Devices Act of 20 May 2010, including a. Declaration(s) of conformity, b. Certificate(s) of conformity (issued by a notified body - if required), c. Confirmation that the medical device in question has been notified/registered in the register of medical devices and the entities responsible for their placing on the market or a notification has been made regarding the device pursuant to Art. 58 of the Medical Devices Act (the name of the device notified/registered should correspond to the trade/catalogue name of the device in question). If (in accordance with Article 13 of the Act) the manufacturer does not have its place of residence or seat in a Member State and has not appointed an authorised representative, or if the device is not placed on the market under the responsibility of the manufacturer or authorised representative, it shall inform the Contracting Authority of this fact by attaching an appropriate statement in this respect to the tender. NOTEEach document should be described in which item from Appendix 1 to the SWZ it refers to. Relevant manufacturer's catalogues (containing catalogues numbers of the offered products), brochures or manufacturer's reference materials/manufacturer's declarations in a clear and legible manner confirming compliance with the technical-usage parameters described by the Ordering Party in Appendix 1 to the Offer. Lack of confirmation of the required parameters will be considered as non-compliance of the offered equipment with these parameters and will result in rejection of the offer, unless the premises specified in art. 128 occur. The Contracting Authority reserves the right to verify the reliability of the parameters given by the Economic Operator in all available sources - applies to package no. 1-24 - If the item described in the Terms of Reference is not 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 registration, the Contracting Authority requires a relevant statement.12.1 The Contractor shall submit the said evidence together with the tender (Article 107, paragraph 1 of PPL).12.2 If the Contractor fails to submit the said evidence or the submitted evidence is incomplete, the Contracting Authority shall call for its submission or supplementation within the prescribed time limit (Article 107, paragraph 2 of PPL). Disinfectant packs - description appendix no 1 to the offer - price 60%Delivery date "T"- 40%12. Subject matter of evidence: The Contracting Authority, in order to confirm that offered supplies meet requirements specified by the Contracting Authority, demands the following subject matter of evidence:1) Samples (number of samples is specified in appendix no 1 to the offer (assortment-price list)), in order to check proposed assortment with description of the subject matter. The samples must comply with the parameters given in the detailed description in the assortment-price form. Samples are not returnable. Address for delivery of the required samples: Dolnośląskie Centrum Chorób Płuciu in Wrocław , 105 Grabiszyńska Street , 53-439 Wrocław. Registry Office, room no. 4, high ground floor (samples accepted from Monday to Friday, 7.45 a.m. to 1.30 p.m.) with a description on the package: "samples for proceedings no. BZP 3810.63.2021.TP to package/ow................ (2) Valid and up-to-date documents confirming marketing authorization in the Republic of Poland in accordance with the Medical Devices Act of 20 May 2010, including a. Declaration(s) of conformity, b. Certificate(s) of conformity (issued by a notified body - if required), c. Confirmation that the medical device in question has been notified/registered in the register of medical devices and the entities responsible for their placing on the market or a notification has been made regarding the device pursuant to Art. 58 of the Medical Devices Act (the name of the device notified/registered should correspond to the trade/catalogue name of the device in question). If (in accordance with Article 13 of the Act) the manufacturer does not have its place of residence or seat in a Member State and has not appointed an authorised representative, or if the device is not placed on the market under the responsibility of the manufacturer or authorised representative, it shall inform the Contracting Authority of this fact by attaching an appropriate statement in this respect to the tender. NOTEEach document should be described in which item from Appendix 1 to the SWZ it refers to. Relevant manufacturer's catalogues (containing catalogues numbers of the offered products), brochures or manufacturer's reference materials/manufacturer's declarations in a clear and legible manner confirming compliance with the technical-usage parameters described by the Ordering Party in Appendix 1 to the Offer. Lack of confirmation of the required parameters will be considered as non-compliance of the offered equipment with these parameters and will result in rejection of the offer, unless the premises specified in art. 128 occur. The Contracting Authority reserves the right to verify the reliability of the parameters given by the Economic Operator in all available sources - applies to package no. 1-24 - If the item described in the Terms of Reference is not 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 registration, the Contracting Authority requires a relevant statement.1212.1 The Contractor shall submit the said evidence together with the tender (Article 107, paragraph 1 of PPL).12.2 If the Contractor fails to submit the said evidence or the submitted evidence is incomplete, the Contracting Authority shall call for its submission or supplementation within the prescribed time limit (Article 107, paragraph 2 of PPL). Integrated batch control indicators - description appendix no 1 to the offer - price 60%Delivery date "T"- 40%12. Subject matter of evidence: The Contracting Authority, in order to confirm that offered supplies meet requirements specified by the Contracting Authority, demands the following subject matter of evidence:1) Samples (number of samples is specified in appendix no 1 to the offer (assortment and price list)), in order to check proposed assortment with description of the object. The samples must comply with the parameters given in the detailed description in the assortment-price form. Samples are not returnable. Address for delivery of the required samples: Dolnośląskie Centrum Chorób Płuciu in Wrocław , 105 Grabiszyńska Street , 53-439 Wrocław. Registry Office, room no. 4, high ground floor (samples accepted from Monday to Friday, 7.45 a.m. to 1.30 p.m.) with a description on the package: "samples for proceedings no. BZP 3810.63.2021.TP to package/ow................ (2) Valid and up-to-date documents confirming marketing authorization in the Republic of Poland in accordance with the Medical Devices Act of 20 May 2010, including a. Declaration(s) of conformity, b. Certificate(s) of conformity (issued by a notified body - if required), c. Confirmation that the medical device in question has been notified/registered in the register of medical devices and the entities responsible for their placing on the market or a notification has been made regarding the device pursuant to Art. 58 of the Medical Devices Act (the name of the device notified/registered should correspond to the trade/catalogue name of the device in question). If (in accordance with Article 13 of the Act) the manufacturer does not have its place of residence or seat in a Member State and has not appointed an authorised representative, or if the device is not placed on the market under the responsibility of the manufacturer or authorised representative, it shall inform the Contracting Authority of this fact by attaching an appropriate statement in this respect to the tender. NOTEEach document should be described in which item from Appendix 1 to the SWZ it refers to. Relevant manufacturer's catalogues (containing catalogues numbers of the offered products), brochures or manufacturer's reference materials/manufacturer's declarations in a clear and legible manner confirming compliance with the technical-usage parameters described by the Ordering Party in Appendix 1 to the Offer. Lack of confirmation of the required parameters will be considered as non-compliance of the offered equipment with these parameters and will result in rejection of the offer, unless the premises specified in art. 128 occur. The Contracting Authority reserves the right to verify the reliability of the parameters given by the Economic Operator in all available sources - applies to package no. 1-24 - If the item described in the Terms of Reference is not 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 registration, the Contracting Authority requires a relevant statement.1212.1 The Contractor shall submit the said evidence together with the tender (Article 107, paragraph 1 of PPL).12.2 If the Contractor fails to submit the said evidence or the submitted evidence is incomplete, the Contracting Authority shall call for its submission or supplementation within the prescribed time limit (Article 107, paragraph 2 of PPL). Biological indicator for ethylene oxide sterilization control - description appendix no 1 to the offer - price 60%Delivery date "T"- 40%12. Subject matter of the evidence: The Orderer, in order to confirm that offered supplies meet requirements specified by the Orderer, demands the following subject matter of the evidence:1) Samples (number of samples is specified in appendix no 1 to the offer (assortment and price list) in order to check the offered assortment with description of the subject matter. The samples must comply with the parameters given in the detailed description in the assortment-price form. Samples are not returnable. Address for delivery of the required samples: Dolnośląskie Centrum Chorób Płuciu in Wrocław , 105 Grabiszyńska Street , 53-439 Wrocław. Registry Office, room no. 4, high ground floor (samples accepted from Monday to Friday, 7.45 a.m. to 1.30 p.m.) with a description on the package: "samples for proceedings no. BZP 3810.63.2021.TP to package/ow................ (2) Valid and up-to-date documents confirming marketing authorization in the Republic of Poland in accordance with the Medical Devices Act of 20 May 2010, including a. Declaration(s) of conformity, b. Certificate(s) of conformity (issued by a notified body - if required), c. Confirmation that the medical device in question has been notified/registered in the register of medical devices and the entities responsible for their placing on the market or a notification has been made regarding the device pursuant to Art. 58 of the Medical Devices Act (the name of the device notified/registered should correspond to the trade/catalogue name of the device in question). If (in accordance with Article 13 of the Act) the manufacturer does not have its place of residence or seat in a Member State and has not appointed an authorised representative, or if the device is not placed on the market under the responsibility of the manufacturer or authorised representative, it shall inform the Contracting Authority of this fact by attaching an appropriate statement in this respect to the tender. NOTEEach document should be described in which item from Appendix 1 to the SWZ it refers to. Relevant manufacturer's catalogues (containing catalogues numbers of the offered products), brochures or manufacturer's reference materials/manufacturer's declarations in a clear and legible manner confirming compliance with the technical-usage parameters described by the Ordering Party in Appendix 1 to the Offer. Lack of confirmation of the required parameters will be considered as non-compliance of the offered equipment with these parameters and will result in rejection of the offer, unless the premises specified in art. 128 occur. The Contracting Authority reserves the right to verify the reliability of the parameters given by the Economic Operator in all available sources - applies to package no. 1-24 - If the item described in the Terms of Reference is not 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 registration, the Contracting Authority requires a relevant statement.1212.1 The Contractor shall submit the said evidence together with the tender (Article 107, paragraph 1 of PPL).12.2 If the Contractor fails to submit the said evidence or the submitted evidence is incomplete, the Contracting Authority shall call for its submission or supplementation within the prescribed time limit (Article 107, paragraph 2 of PPL). Non-woven fabric for sterilization 120 x 120 cm - description appendix no 1 to the offer - price 60%Delivery date "T"- 40%12. Subject matter of proof: The Orderer, in order to confirm that offered supplies meet requirements specified by the Orderer, demands the following subject matter of proof:1) Samples (number of samples is specified in appendix no 1 to the offer (assortment and price list) in order to verify the offered assortment with description of the subject matter. The samples must comply with the parameters given in the detailed description in the assortment-price form. Samples are not returnable. Address for delivery of the required samples: Dolnośląskie Centrum Chorób Płuciu in Wrocław , 105 Grabiszyńska Street , 53-439 Wrocław. Registry Office, room no. 4, high ground floor (samples accepted from Monday to Friday, 7.45 a.m. to 1.30 p.m.) with a description on the package: "samples for proceedings no. BZP 3810.63.2021.TP to package/ow................ (2) Valid and up-to-date documents confirming marketing authorization in the Republic of Poland in accordance with the Medical Devices Act of 20 May 2010, including a. Declaration(s) of conformity, b. Certificate(s) of conformity (issued by a notified body - if required), c. Confirmation that the medical device in question has been notified/registered in the register of medical devices and the entities responsible for their placing on the market or a notification has been made regarding the device pursuant to Art. 58 of the Medical Devices Act (the name of the device notified/registered should correspond to the trade/catalogue name of the device in question). If (in accordance with Article 13 of the Act) the manufacturer does not have its place of residence or seat in a Member State and has not appointed an authorised representative, or if the device is not placed on the market under the responsibility of the manufacturer or authorised representative, it shall inform the Contracting Authority of this fact by attaching an appropriate statement in this respect to the tender. NOTEEach document should be described in which item from Appendix 1 to the SWZ it refers to. Relevant manufacturer's catalogues (containing catalogues numbers of the offered products), brochures or manufacturer's reference materials/manufacturer's declarations in a clear and legible manner confirming compliance with the technical-usage parameters described by the Ordering Party in Appendix 1 to the Offer. Lack of confirmation of the required parameters will be considered as non-compliance of the offered equipment with these parameters and will result in rejection of the offer, unless the premises specified in art. 128 occur. The Contracting Authority reserves the right to verify the reliability of the parameters given by the Economic Operator in all available sources - applies to package no. 1-24 - If the item described in the Terms of Reference is not 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 registration, the Contracting Authority requires a relevant statement.12.1 The Contractor shall submit the said evidence together with the tender (Article 107, paragraph 1 of PPL).12.2 If the Contractor fails to submit the said evidence or the submitted evidence is incomplete, the Contracting Authority shall call for its submission or supplementation within the prescribed time limit (Article 107, paragraph 2 of PPL). Indicator for thermal disinfection process control at 90 °C/5min - description appendix no 1 to the offer - price 60%Delivery date "T"- 40%12. Subject matter of the evidence: The Contracting Authority, in order to confirm that offered supplies meet requirements defined by the Contracting Authority, demands the following subject matter of the evidence:1) Samples (number of samples is defined in appendix no 1 to the offer (assortment-price list) in order to check proposed assortment with description of the subject matter. The samples must comply with the parameters given in the detailed description in the assortment-price form. Samples are not returnable. Address for delivery of the required samples: Dolnośląskie Centrum Chorób Płuciu in Wrocław , 105 Grabiszyńska Street , 53-439 Wrocław. Registry Office, room no. 4, high ground floor (samples accepted from Monday to Friday, 7.45 a.m. to 1.30 p.m.) with a description on the package: "samples for proceedings no. BZP 3810.63.2021.TP to package/ow................ (2) Valid and up-to-date documents confirming marketing authorization in the Republic of Poland in accordance with the Medical Devices Act of 20 May 2010, including a. Declaration(s) of conformity, b. Certificate(s) of conformity (issued by a notified body - if required), c. Confirmation that the medical device in question has been notified/registered in the register of medical devices and the entities responsible for their placing on the market or a notification has been made regarding the device pursuant to Art. 58 of the Medical Devices Act (the name of the device notified/registered should correspond to the trade/catalogue name of the device in question). If (in accordance with Article 13 of the Act) the manufacturer does not have its place of residence or seat in a Member State and has not appointed an authorised representative, or if the device is not placed on the market under the responsibility of the manufacturer or authorised representative, it shall inform the Contracting Authority of this fact by attaching an appropriate statement in this respect to the tender. NOTEEach document should be described in which item from Appendix 1 to the SWZ it refers to. Relevant manufacturer's catalogues (containing catalogues numbers of the offered products), brochures or manufacturer's reference materials/manufacturer's declarations in a clear and legible manner confirming compliance with the technical-usage parameters described by the Ordering Party in Appendix 1 to the Offer. Lack of confirmation of the required parameters will be considered as non-compliance of the offered equipment with these parameters and will result in rejection of the offer, unless the premises specified in art. 128 occur. The Contracting Authority reserves the right to verify the reliability of the parameters given by the Economic Operator in all available sources - applies to package no. 1-24 - If the item described in the Terms of Reference is not 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 registration, the Contracting Authority requires a relevant statement.1212.1 The Contractor shall submit the said evidence together with the tender (Article 107, paragraph 1 of PPL).12.2 If the Contractor fails to submit the said evidence or the submitted evidence is incomplete, the Contracting Authority shall call for its submission or supplementation within the prescribed time limit (Article 107, paragraph 2 of PPL). Emulsion sterilization test type/class 6 (TST), (T time, S - steam, T - temperature) - description appendix no 1 to the offer - price 60%Delivery date "T"- 40%12. Subject matter of proof: The Orderer, in order to confirm that offered supplies meet requirements specified by the Orderer, demands the following subject matter of proof:1) Samples (number of samples is specified in appendix no 1 to the offer (assortment - price)) in order to check proposed assortment with description of the subject matter. The samples must comply with the parameters given in the detailed description in the assortment-price form. Samples are not returnable. Address for delivery of the required samples: Dolnośląskie Centrum Chorób Płuciu in Wrocław , 105 Grabiszyńska Street , 53-439 Wrocław. Registry Office, room no. 4, high ground floor (samples accepted from Monday to Friday, 7.45 a.m. to 1.30 p.m.) with a description on the package: "samples for proceedings no. BZP 3810.63.2021.TP to package/ow................ (2) Valid and up-to-date documents confirming marketing authorization in the Republic of Poland in accordance with the Medical Devices Act of 20 May 2010, including a. Declaration(s) of conformity, b. Certificate(s) of conformity (issued by a notified body - if required), c. Confirmation that the medical device in question has been notified/registered in the register of medical devices and the entities responsible for their placing on the market or a notification has been made regarding the device pursuant to Art. 58 of the Medical Devices Act (the name of the device notified/registered should correspond to the trade/catalogue name of the device in question). If (in accordance with Article 13 of the Act) the manufacturer does not have its place of residence or seat in a Member State and has not appointed an authorised representative, or if the device is not placed on the market under the responsibility of the manufacturer or authorised representative, it shall inform the Contracting Authority of this fact by attaching an appropriate statement in this respect to the tender. NOTEEach document should be described in which item from Appendix 1 to the SWZ it refers to. Relevant manufacturer's catalogues (containing catalogues numbers of the offered products), brochures or manufacturer's reference materials/manufacturer's declarations in a clear and legible manner confirming compliance with the technical-usage parameters described by the Ordering Party in Appendix 1 to the Offer. Lack of confirmation of the required parameters will be considered as non-compliance of the offered equipment with these parameters and will result in rejection of the offer, unless the premises specified in art. 128 occur. The Contracting Authority reserves the right to verify the reliability of the parameters given by the Economic Operator in all available sources - applies to package no. 1-24 - If the item described in the Terms of Reference is not 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 registration, the Contracting Authority requires a relevant statement.1212.1 The Contractor shall submit the said evidence together with the tender (Article 107, paragraph 1 of PPL).12.2 If the Contractor fails to submit the said evidence or the submitted evidence is incomplete, the Contracting Authority shall call for its submission or supplementation within the prescribed time limit (Article 107, paragraph 2 of PPL). Quick test for detection of protein contamination residues after cleaning and disinfection of instruments and medical equipment - description appendix no 1 to the offer - price 60%Delivery date "T"- 40%12. Subject matter of the evidence: The Contracting Authority, in order to confirm that the offered supplies meet the requirements specified by the Contracting Authority, demands the following subject matter of the evidence:1) Samples (number of samples is specified in appendix no 1 to the offer (assortment and price)) in order to verify the offered assortment with the description of the subject matter. The samples must comply with the parameters given in the detailed description in the assortment-price form. Samples are not returnable. Address for delivery of the required samples: Dolnośląskie Centrum Chorób Płuciu in Wrocław , 105 Grabiszyńska Street , 53-439 Wrocław. Registry Office, room no. 4, high ground floor (samples accepted from Monday to Friday, 7.45 a.m. to 1.30 p.m.) with a description on the package: "samples for proceedings no. BZP 3810.63.2021.TP to package/ow................ (2) Valid and up-to-date documents confirming marketing authorization in the Republic of Poland in accordance with the Medical Devices Act of 20 May 2010, including a. Declaration(s) of conformity, b. Certificate(s) of conformity (issued by a notified body - if required), c. Confirmation that the medical device in question has been notified/registered in the register of medical devices and the entities responsible for their placing on the market or a notification has been made regarding the device pursuant to Art. 58 of the Medical Devices Act (the name of the device notified/registered should correspond to the trade/catalogue name of the device in question). If (in accordance with Article 13 of the Act) the manufacturer does not have its place of residence or seat in a Member State and has not appointed an authorised representative, or if the device is not placed on the market under the responsibility of the manufacturer or authorised representative, it shall inform the Contracting Authority of this fact by attaching an appropriate statement in this respect to the tender. NOTEEach document should be described in which item from Appendix 1 to the SWZ it refers to. Relevant manufacturer's catalogues (containing catalogues numbers of the offered products), brochures or manufacturer's reference materials/manufacturer's declarations in a clear and legible manner confirming compliance with the technical-usage parameters described by the Ordering Party in Appendix 1 to the Offer. Lack of confirmation of the required parameters will be considered as non-compliance of the offered equipment with these parameters and will result in rejection of the offer, unless the premises specified in art. 128 occur. The Contracting Authority reserves the right to verify the reliability of the parameters given by the Economic Operator in all available sources - applies to package no. 1-24 - If the item described in the Terms of Reference is not 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 registration, the Contracting Authority requires a relevant statement.1212.1 The Contractor shall submit the said evidence together with the tender (Article 107, paragraph 1 of PPL).12.2 If the Contractor fails to submit the said evidence or the submitted evidence is incomplete, the Contracting Authority shall call for its submission or supplementation within the prescribed time limit (Article 107, paragraph 2 of PPL). Welding control test in form of a test sheet with a black test field - description appendix no 1 to the offer - price 60%Delivery date "T"- 40%12. Subject matter of the evidence: The Contracting Authority, in order to confirm that the offered supplies meet the requirements specified by the Contracting Authority, demands the following subject matter of the evidence:1) Samples (number of samples is specified in appendix no 1 to the offer (assortment-price list) in order to check the offered assortment against its description. The samples must comply with the parameters given in the detailed description in the assortment-price form. Samples are not returnable. Address for delivery of the required samples: Dolnośląskie Centrum Chorób Płuciu in Wrocław , 105 Grabiszyńska Street , 53-439 Wrocław. Registry Office, room no. 4, high ground floor (samples accepted from Monday to Friday, 7.45 a.m. to 1.30 p.m.) with a description on the package: "samples for proceedings no. BZP 3810.63.2021.TP to package/ow................ (2) Valid and up-to-date documents confirming marketing authorization in the Republic of Poland in accordance with the Medical Devices Act of 20 May 2010, including a. Declaration(s) of conformity, b. Certificate(s) of conformity (issued by a notified body - if required), c. Confirmation that the medical device in question has been notified/registered in the register of medical devices and the entities responsible for their placing on the market or a notification has been made regarding the device pursuant to Art. 58 of the Medical Devices Act (the name of the device notified/registered should correspond to the trade/catalogue name of the device in question). If (in accordance with Article 13 of the Act) the manufacturer does not have its place of residence or seat in a Member State and has not appointed an authorised representative, or if the device is not placed on the market under the responsibility of the manufacturer or authorised representative, it shall inform the Contracting Authority of this fact by attaching an appropriate statement in this respect to the tender. NOTEEach document should be described in which item from Appendix 1 to the SWZ it refers to. Relevant manufacturer's catalogues (containing catalogues numbers of the offered products), brochures or manufacturer's reference materials/manufacturer's declarations in a clear and legible manner confirming compliance with the technical-usage parameters described by the Ordering Party in Appendix 1 to the Offer. Lack of confirmation of the required parameters will be considered as non-compliance of the offered equipment with these parameters and will result in rejection of the offer, unless the premises specified in art. 128 occur. The Contracting Authority reserves the right to verify the reliability of the parameters given by the Economic Operator in all available sources - applies to package no. 1-24 - If the item described in the Terms of Reference is not 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 registration, the Contracting Authority requires a relevant statement.1212.1 The Contractor shall submit the said evidence together with the tender (Article 107, paragraph 1 of PPL).12.2 If the Contractor fails to submit the said evidence or the submitted evidence is incomplete, the Contracting Authority shall call for its submission or supplementation within the prescribed time limit (Article 107, paragraph 2 of PPL). ULTRA-Polyolefin Sleeve for sterilization, polyolefin basis weight 93 g/m2 designed for sterilization, description appendix no 1 to the offer - price 60%Delivery date "T"- 40%12. 1) Samples (the number of samples has been specified in appendix 1 to the offer (assortment and price list) in order to check the offered assortment against its description. The samples must comply with the parameters given in the detailed description in the assortment-price form. Samples are not returnable. Address for delivery of the required samples: Dolnośląskie Centrum Chorób Płuciu in Wrocław , 105 Grabiszyńska Street , 53-439 Wrocław. Registry Office, room no. 4, high ground floor (samples accepted from Monday to Friday, 7.45 a.m. to 1.30 p.m.) with a description on the package: "samples for proceedings no. BZP 3810.63.2021.TP to package/ow................ (2) Valid and up-to-date documents confirming marketing authorization in the Republic of Poland in accordance with the Medical Devices Act of 20 May 2010, including a. Declaration(s) of conformity, b. Certificate(s) of conformity (issued by a notified body - if required), c. Confirmation that the medical device in question has been notified/registered in the register of medical devices and the entities responsible for their placing on the market or a notification has been made regarding the device pursuant to Art. 58 of the Medical Devices Act (the name of the device notified/registered should correspond to the trade/catalogue name of the device in question). If (in accordance with Article 13 of the Act) the manufacturer does not have its place of residence or seat in a Member State and has not appointed an authorised representative, or if the device is not placed on the market under the responsibility of the manufacturer or authorised representative, it shall inform the Contracting Authority of this fact by attaching an appropriate statement in this respect to the tender. NOTEEach document should be described in which item from Appendix 1 to the SWZ it refers to. Relevant manufacturer's catalogues (containing catalogues numbers of the offered products), brochures or manufacturer's reference materials/manufacturer's declarations in a clear and legible manner confirming compliance with the technical-usage parameters described by the Ordering Party in Appendix 1 to the Offer. Lack of confirmation of the required parameters will be considered as non-compliance of the offered equipment with these parameters and will result in rejection of the offer, unless the premises specified in art. 128 occur. The Contracting Authority reserves the right to verify the reliability of the parameters given by the Economic Operator in all available sources - applies to package no. 1-24 - If the item described in the Terms of Reference is not 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 registration, the Contracting Authority requires a relevant statement.1212.1 The Contractor shall submit the said evidence together with the tender (Article 107, paragraph 1 of PPL).12.2 If the Contractor fails to submit the said evidence or the submitted evidence is incomplete, the Contracting Authority shall call for its submission or supplementation within the prescribed time limit (Article 107, paragraph 2 of PPL). Double sided brush for cleaning instruments with a handle - description appendix no 1 to the offer - price 60%Delivery date "T"- 40%12. Subject matter of the evidence: The Contracting Authority, in order to confirm that offered supplies meet requirements specified by the Contracting Authority, demands the following subject matter of the evidence:1) Samples (number of samples is specified in appendix no 1 to the offer (assortment-price list) in order to check the offered assortment against description of the object. The samples must comply with the parameters given in the detailed description in the assortment-price form. Samples are not returnable. Address for delivery of the required samples: Dolnośląskie Centrum Chorób Płuciu in Wrocław , 105 Grabiszyńska Street , 53-439 Wrocław. Registry Office, room no. 4, high ground floor (samples accepted from Monday to Friday, 7.45 a.m. to 1.30 p.m.) with a description on the package: "samples for proceedings no. BZP 3810.63.2021.TP to package/ow................ (2) Valid and up-to-date documents confirming marketing authorization in the Republic of Poland in accordance with the Medical Devices Act of 20 May 2010, including a. Declaration(s) of conformity, b. Certificate(s) of conformity (issued by a notified body - if required), c. Confirmation that the medical device in question has been notified/registered in the register of medical devices and the entities responsible for their placing on the market or a notification has been made regarding the device pursuant to Art. 58 of the Medical Devices Act (the name of the device notified/registered should correspond to the trade/catalogue name of the device in question). If (in accordance with Article 13 of the Act) the manufacturer does not have its place of residence or seat in a Member State and has not appointed an authorised representative, or if the device is not placed on the market under the responsibility of the manufacturer or authorised representative, it shall inform the Contracting Authority of this fact by attaching an appropriate statement in this respect to the tender. NOTEEach document should be described in which item from Appendix 1 to the SWZ it refers to. Relevant manufacturer's catalogues (containing catalogues numbers of the offered products), brochures or manufacturer's reference materials/manufacturer's declarations in a clear and legible manner confirming compliance with the technical-usage parameters described by the Ordering Party in Appendix 1 to the Offer. Lack of confirmation of the required parameters will be considered as non-compliance of the offered equipment with these parameters and will result in rejection of the offer, unless the premises specified in art. 128 occur. The Contracting Authority reserves the right to verify the reliability of the parameters given by the Economic Operator in all available sources - applies to package no. 1-24 - If the item described in the Terms of Reference is not 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 registration, the Contracting Authority requires a relevant statement.1212.1 The Contractor shall submit the said evidence together with the tender (Article 107, paragraph 1 of PPL).12.2 If the Contractor fails to submit the said evidence or the submitted evidence is incomplete, the Contracting Authority shall call for its submission or supplementation within the prescribed time limit (Article 107, paragraph 2 of PPL). Brush for cleaning working channels, length 60-70 cm - description in appendix no 1 to the offer - price 60%Delivery date "T"- 40%12. Subject matter of the evidence: The Contracting Authority, in order to confirm that offered supplies meet requirements specified by the Contracting Authority, demands the following subject matter of the evidence:1) Samples (number of samples is specified in appendix no 1 to the offer (assortment - price)), in order to check proposed assortment with description of the object. The samples must comply with the parameters given in the detailed description in the assortment-price form. Samples are not returnable. Address for delivery of the required samples: Dolnośląskie Centrum Chorób Płuciu in Wrocław , 105 Grabiszyńska Street , 53-439 Wrocław. Registry Office, room no. 4, high ground floor (samples accepted from Monday to Friday, 7.45 a.m. to 1.30 p.m.) with a description on the package: "samples for proceedings no. BZP 3810.63.2021.TP to package/ow................ (2) Valid and up-to-date documents confirming marketing authorization in the Republic of Poland in accordance with the Medical Devices Act of 20 May 2010, including a. Declaration(s) of conformity, b. Certificate(s) of conformity (issued by a notified body - if required), c. Confirmation that the medical device in question has been notified/registered in the register of medical devices and the entities responsible for their placing on the market or a notification has been made regarding the device pursuant to Art. 58 of the Medical Devices Act (the name of the device notified/registered should correspond to the trade/catalogue name of the device in question). If (in accordance with Article 13 of the Act) the manufacturer does not have its place of residence or seat in a Member State and has not appointed an authorised representative, or if the device is not placed on the market under the responsibility of the manufacturer or authorised representative, it shall inform the Contracting Authority of this fact by attaching an appropriate statement in this respect to the tender. NOTEEach document should be described in which item from Appendix 1 to the SWZ it refers to. Relevant manufacturer's catalogues (containing catalogues numbers of the offered products), brochures or manufacturer's reference materials/manufacturer's declarations in a clear and legible manner confirming compliance with the technical-usage parameters described by the Ordering Party in Appendix 1 to the Offer. Lack of confirmation of the required parameters will be considered as non-compliance of the offered equipment with these parameters and will result in rejection of the offer, unless the premises specified in art. 128 occur. The Contracting Authority reserves the right to verify the reliability of the parameters given by the Economic Operator in all available sources - applies to package no. 1-24 - If the item described in the Terms of Reference is not 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 registration, the Contracting Authority requires a relevant statement.1212.1 The Contractor shall submit the said evidence together with the tender (Article 107, paragraph 1 of PPL).12.2 If the Contractor fails to submit the said evidence or the submitted evidence is incomplete, the Contracting Authority shall call for its submission or supplementation within the prescribed time limit (Article 107, paragraph 2 of PPL). Price 60%Delivery date "T"-40%12. Subject matter of proof: The Contracting Authority, in order to confirm that the offered supplies meet the requirements specified by the Contracting Authority, demands the following subject matter of proof:1) Samples (number of samples is specified in appendix no. 1 to the offer (assortment-price list) in order to check the offered assortment against its description. The samples must comply with the parameters given in the detailed description in the assortment-price form. Samples are not returnable. Address for delivery of the required samples: Dolnośląskie Centrum Chorób Płuciu in Wrocław , 105 Grabiszyńska Street , 53-439 Wrocław. Registry Office, room no. 4, high ground floor (samples accepted from Monday to Friday, 7.45 a.m. to 1.30 p.m.) with a description on the package: "samples for proceedings no. BZP 3810.63.2021.TP to package/ow................ (2) Valid and up-to-date documents confirming marketing authorization in the Republic of Poland in accordance with the Medical Devices Act of 20 May 2010, including a. Declaration(s) of conformity, b. Certificate(s) of conformity (issued by a notified body - if required), c. Confirmation that the medical device in question has been notified/registered in the register of medical devices and the entities responsible for their placing on the market or a notification has been made regarding the device pursuant to Art. 58 of the Medical Devices Act (the name of the device notified/registered should correspond to the trade/catalogue name of the device in question). If (in accordance with Article 13 of the Act) the manufacturer does not have its place of residence or seat in a Member State and has not appointed an authorised representative, or if the device is not placed on the market under the responsibility of the manufacturer or authorised representative, it shall inform the Contracting Authority of this fact by attaching an appropriate statement in this respect to the tender. NOTEEach document should be described in which item from Appendix 1 to the SWZ it refers to. Relevant manufacturer's catalogues (containing catalogues numbers of the offered products), brochures or manufacturer's reference materials/manufacturer's declarations in a clear and legible manner confirming compliance with the technical-usage parameters described by the Ordering Party in Appendix 1 to the Offer. Lack of confirmation of the required parameters will be considered as non-compliance of the offered equipment with these parameters and will result in rejection of the offer, unless the premises specified in art. 128 occur. The Contracting Authority reserves the right to verify the reliability of the parameters given by the Economic Operator in all available sources - applies to package no. 1-24 - If the item described in the Terms of Reference is not 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 registration, the Contracting Authority requires a relevant statement.1212.1 The Contractor shall submit the said evidence together with the tender (Article 107, paragraph 1 of PPL).12.2 If the Contractor fails to submit the said evidence or the submitted evidence is incomplete, the Contracting Authority shall call for its submission or supplementation within the prescribed time limit (Article 107, paragraph 2 of PPL). Price 60%Delivery date "T"- 40%12. Subject matter of evidence: The Contracting Authority, in order to confirm that the offered supplies meet the requirements specified by the Contracting Authority, demands the following subject matter of evidence:1) Samples (number of samples is specified in appendix no. 1 to the offer (assortment and price list) in order to check the offered assortment against its description. The samples must comply with the parameters given in the detailed description in the assortment-price form. Samples are not returnable. Address for delivery of the required samples: Dolnośląskie Centrum Chorób Płuciu in Wrocław , 105 Grabiszyńska Street , 53-439 Wrocław. Registry Office, room no. 4, high ground floor (samples accepted from Monday to Friday, 7.45 a.m. to 1.30 p.m.) with a description on the package: "samples for proceedings no. BZP 3810.63.2021.TP to package/ow................ (2) Valid and up-to-date documents confirming marketing authorization in the Republic of Poland in accordance with the Medical Devices Act of 20 May 2010, including a. Declaration(s) of conformity, b. Certificate(s) of conformity (issued by a notified body - if required), c. Confirmation that the medical device in question has been notified/registered in the register of medical devices and the entities responsible for their placing on the market or a notification has been made regarding the device pursuant to Art. 58 of the Medical Devices Act (the name of the device notified/registered should correspond to the trade/catalogue name of the device in question). If (in accordance with Article 13 of the Act) the manufacturer does not have its place of residence or seat in a Member State and has not appointed an authorised representative, or if the device is not placed on the market under the responsibility of the manufacturer or authorised representative, it shall inform the Contracting Authority of this fact by attaching an appropriate statement in this respect to the tender. NOTEEach document should be described in which item from Appendix 1 to the SWZ it refers to. Relevant manufacturer's catalogues (containing catalogues numbers of the offered products), brochures or manufacturer's reference materials/manufacturer's declarations in a clear and legible manner confirming compliance with the technical-usage parameters described by the Ordering Party in Appendix 1 to the Offer. Lack of confirmation of the required parameters will be considered as non-compliance of the offered equipment with these parameters and will result in rejection of the offer, unless the premises specified in art. 128 occur. The Contracting Authority reserves the right to verify the reliability of the parameters given by the Economic Operator in all available sources - applies to package no. 1-24 - If the item described in the Terms of Reference is not 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 registration, the Contracting Authority requires a relevant statement.1212.1 The Contractor shall submit the said evidence together with the tender (Article 107, paragraph 1 of PPL).12.2 If the Contractor fails to submit the said evidence or the submitted evidence is incomplete, the Contracting Authority shall call for its submission or supplementation within the prescribed time limit (Article 107, paragraph 2 of PPL). Unwoven fabric cleaner for removing rust and tarnish - description in appendix no 1 to the offer - price 60%Delivery date "T"- 40%12. Subject matter of the evidence: The Contracting Authority, in order to confirm that offered supplies meet requirements specified by the Contracting Authority, demands the following subject matter of the evidence:1) Samples (number of samples is specified in appendix no 1 to the offer (assortment and price list) in order to check the offered assortment with description of the object. The samples must comply with the parameters given in the detailed description in the assortment-price form. Samples are not returnable. Address for delivery of the required samples: Dolnośląskie Centrum Chorób Płuciu in Wrocław , 105 Grabiszyńska Street , 53-439 Wrocław. Registry Office, room no. 4, high ground floor (samples accepted from Monday to Friday, 7.45 a.m. to 1.30 p.m.) with a description on the package: "samples for proceedings no. BZP 3810.63.2021.TP to package/ow................ (2) Valid and up-to-date documents confirming marketing authorization in the Republic of Poland in accordance with the Medical Devices Act of 20 May 2010, including a. Declaration(s) of conformity, b. Certificate(s) of conformity (issued by a notified body - if required), c. Confirmation that the medical device in question has been notified/registered in the register of medical devices and the entities responsible for their placing on the market or a notification has been made regarding the device pursuant to Art. 58 of the Medical Devices Act (the name of the device notified/registered should correspond to the trade/catalogue name of the device in question). If (in accordance with Article 13 of the Act) the manufacturer does not have its place of residence or seat in a Member State and has not appointed an authorised representative, or if the device is not placed on the market under the responsibility of the manufacturer or authorised representative, it shall inform the Contracting Authority of this fact by attaching an appropriate statement in this respect to the tender. NOTEEach document should be described in which item from Appendix 1 to the SWZ it refers to. Relevant manufacturer's catalogues (containing catalogues numbers of the offered products), brochures or manufacturer's reference materials/manufacturer's declarations in a clear and legible manner confirming compliance with the technical-usage parameters described by the Ordering Party in Appendix 1 to the Offer. Lack of confirmation of the required parameters will be considered as non-compliance of the offered equipment with these parameters and will result in rejection of the offer, unless the premises specified in art. 128 occur. The Contracting Authority reserves the right to verify the reliability of the parameters given by the Economic Operator in all available sources - applies to package no. 1-24 - If the item described in the Terms of Reference is not 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 registration, the Contracting Authority requires a relevant statement.1212.1 The Contractor shall submit the said evidence together with the tender (Article 107 par.1 of PPL).12.2 If the Contractor fails to submit the said evidence or the submitted evidence is incomplete, the Contracting Authority shall call for its submission or supplementation within the prescribed time limit (Article 107 par.2 of PPL). Ethylene oxide cartridges for sterilizer STERIL - VAC 5 XL; 4-100, - description in appendix no 1 to the offer - price 60%Delivery date "T"- 40%12. Subject matter of the evidence: The Orderer, in order to confirm that offered supplies meet requirements specified by the Orderer, demands the following subject matter of the evidence:1) Samples (number of samples is specified in appendix no 1 to the offer (assortment and price)), in order to check proposed assortment with description of the object. The samples must comply with the parameters given in the detailed description in the assortment-price form. Samples are not returnable. Address for delivery of the required samples: Dolnośląskie Centrum Chorób Płuciu in Wrocław , 105 Grabiszyńska Street , 53-439 Wrocław. Registry Office, room no. 4, high ground floor (samples accepted from Monday to Friday, 7.45 a.m. to 1.30 p.m.) with a description on the package: "samples for proceedings no. BZP 3810.63.2021.TP to package/ow................ (2) Valid and up-to-date documents confirming marketing authorization in the Republic of Poland in accordance with the Medical Devices Act of 20 May 2010, including a. Declaration(s) of conformity, b. Certificate(s) of conformity (issued by a notified body - if required), c. Confirmation that the medical device in question has been notified/registered in the register of medical devices and the entities responsible for their placing on the market or a notification has been made regarding the device pursuant to Art. 58 of the Medical Devices Act (the name of the device notified/registered should correspond to the trade/catalogue name of the device in question). If (in accordance with Article 13 of the Act) the manufacturer does not have its place of residence or seat in a Member State and has not appointed an authorised representative, or if the device is not placed on the market under the responsibility of the manufacturer or authorised representative, it shall inform the Contracting Authority of this fact by attaching an appropriate statement in this respect to the tender. NOTEEach document should be described in which item from Appendix 1 to the SWZ it refers to. Relevant manufacturer's catalogues (containing catalogues numbers of the offered products), brochures or manufacturer's reference materials/manufacturer's declarations in a clear and legible manner confirming compliance with the technical-usage parameters described by the Ordering Party in Appendix 1 to the Offer. Lack of confirmation of the required parameters will be considered as non-compliance of the offered equipment with these parameters and will result in rejection of the offer, unless the premises specified in art. 128 occur. The Contracting Authority reserves the right to verify the reliability of the parameters given by the Economic Operator in all available sources - applies to package no. 1-24 - If the item described in the Terms of Reference is not 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 registration, the Contracting Authority requires a relevant statement.1212.1 The Contractor shall submit the said evidence together with the tender (Article 107(1) of PPL).12.2 If the Contractor fails to submit the said evidence or the submitted evidence is incomplete, the Contracting Authority shall call for its submission or completion within the prescribed time limit (Article 107(2) of PPL).

Opportunity closing date
12 November 2021
Value of contract
to be confirmed

About the buyer

Address
Dolnośląskie Centrum Chorób Płuc we Wrocławiu ul. Grabiszynska 105 Wroclaw 53-439 Poland
Contact
t.podsiadlo@dcchp.pl

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