Poland – Dressings; clip, suture, ligature supplies – SUPPLY OF SUTURE MATERIALS, STAPLERS AND LOADS USED FOR SURGICAL PROCEDURES, SETS FOR THE TREATMENT OF PELVIC FLOOR STATIC DISORDERS AND VARIOUS MEDICAL DEVICES

Opportunity description

The subject matter of the contract is the supply of suture materials, staplers and loads used for surgical procedures, sets for the treatment of pelvic floor static disorders and various medical devices (CPV: 33.10.00.00-1, 33.14.11.11-1, 33.14.11.21-4, 33.14.11.27-6, 33.15.82.10-7) for the needs of Copernicus Podmiot Leczniczy Sp. z o.o. in Gdańsk, the detailed description, assortment and estimated quantities of which are contained in the Assortment and Pricing Form – Annex No. 1 to the SWZ (parts 1-50). By completing the items in the “State yes/no” column, the Contractor confirms compliance with the requirements specified by the Contracting Authority – if applicable. The offered items covered by the contract must be complete, of a high standard in terms of both quality and functionality, and free from material, design and legal defects. The offered subject matter of the contract must be authorized for marketing and use in accordance with the applicable provisions of law. The subject matter of the contract must comply with the Act of 7 April 2022 on medical devices (Journal of Laws 2022, item 974 of 2022.05.09). In all provisions of the SWZ and its annexes in which the Contracting Authority refers to standards, approvals, technical specifications or reference systems, or where trademarks, parameters or sources of origin (names of manufacturers or devices) are indicated, pursuant to Art. 99(5) and Art. 101(4) of the Pzp Act, the Contracting Authority permits equivalent solutions. The Contracting Authority does not reserve the possibility of applying for the contract exclusively to Contractors referred to in Art. 94 of the Pzp Act. The Contracting Authority does not impose the requirements referred to in Art. 96 of the Pzp Act. For the purpose of submitting a tender, the Contracting Authority does not envisage the Contractor conducting a site visit or inspecting documents necessary for the performance of the contract that are available on the Contracting Authority’s premises. In order to confirm that the offered supplies meet the requirements specified by the Contracting Authority, the Contracting Authority requires the following means of evidence relating to the subject matter to be submitted with the tender: the product manufacturer’s technical data sheets or the product manufacturer’s catalogue sheets for the offered part and item. Each page of the sheets must be marked to indicate the scope and item to which it relates, samples of the offered assortment (described in a manner enabling identification): - applies to: part No. 1 item 1 – 2 sachets, part No. 2 item 14 – 2 sachets, item 20 – 2 sachets, part No. 3 item 1 – 2 sachets, part No. 4 item 9 – 2 sachets, item 11 – 2 sachets, part No. 7 item 10 – 2 sachets, item 13 – 2 sachets, part No. 10 item 30 – 2 sachets, item 31 – 2 sachets, item 34 – 2 sachets, - part No. 11 item 1 – 2 sachets, part No. 12 item 2 – 2 sachets, item 3 – 2 sachets, item 4 – 2 sachets, part No. 19 item 2 – 3 sachets. The submitted samples must comply with the description contained in Annex No. 1 – the Assortment and Pricing Form. Submission of samples in accordance with the provisions of § XII of the SWZ. With regard to the requirement to submit samples, the Contracting Authority waives the requirement to use electronic means of communication. If equivalent solutions other than those specified in the SWZ are offered, documents confirming that the equivalent solutions used meet the Contracting Authority’s requirements (e.g. descriptions, catalogue sheets, technical data sheets) must be attached to the tender. Before selecting the most advantageous tender, the Contracting Authority will call upon the Contractor whose tender received the highest score to submit, within a specified period of no less than 10 days, the current entity-related means of evidence specified in § X of the SWZ, valid as of the date of submission. The Contracting Authority does not require a performance bond. The manner of performance of the subject matter of the contract is specified in the draft contracts contained in Annex No. 5 to the SWZ. The controller of your personal data is Copernicus Podmiot Leczniczy Sp. z o.o., with its registered office at ul. Nowe Ogrody 1-6, 80-803 Gdańsk. The subject matter of the contract is the supply of suture materials, staplers and loads used for surgical procedures, sets for the treatment of pelvic floor static disorders and various medical devices (CPV: 33.10.00.00-1, 33.14.11.11-1, 33.14.11.21-4, 33.14.11.27-6, 33.15.82.10-7) for the needs of Copernicus Podmiot Leczniczy Sp. z o.o. in Gdańsk, the detailed description, assortment and estimated quantities of which are contained in the Assortment and Pricing Form – Annex No. 1 to the SWZ. The offered items covered by the contract must be complete, of a high standard in terms of both quality and functionality, and free from material, design and legal defects. The offered subject matter of the contract must be authorized for marketing and use in accordance with the applicable provisions of law. The subject matter of the contract must comply with the Act of 7 April 2022 on medical devices (Journal of Laws 2022, item 974 of 2022.05.09). In all provisions of the SWZ and its annexes in which the Contracting Authority refers to standards, approvals, technical specifications or reference systems, or where trademarks, parameters or sources of origin (names of manufacturers or devices) are indicated, pursuant to Art. 99(5) and Art. 101(4) of the Pzp Act, the Contracting Authority permits equivalent solutions. The term “equivalence” of a solution is understood in particular to mean an indication that the offered solution has at least the same or better technical parameters and functional quality characteristics—described by a given standard, type or mark—which concern the utility values of the subject matter of the contract and are appropriate for the material, component or product used, such as: functionality, efficiency, strength, service life, resistance, ease of use, safety, comfort of use, finishing standard, as well as characteristics describing the physical properties of the subject matter of the contract, such as size (length, width, height), volume, density, shape, color scheme, structure, type of material and component. A Contractor relying on equivalent solutions is required to demonstrate that the supplies, services or construction works it offers meet the requirements specified by the Contracting Authority. Procedure: open. Review the original TED notice for the complete requirement, lots, amendments and attachments.