“Supply of consumables for automatic injector and dispenser to PET/CT at University Hospital “Alexandrovska” EAD”

… months 1. Set of syringes - 10 ml sterile with extension tube, compatible with standard tungsten protection of 10 ml- Number - 10000 2. Sterile disposable kit - for infusion of saline NaCl to patients and connection to the syringe with radiopharmaceuticals- Number-10000 3. Base kit, sterile, single-use- Number- 1000 4. Set for transfer of radiopharmaceuticals from the manufacturer's vial to the distributor's system- Number- 1500 The condition of completeness of the proposal is mandatory, the participant bids all nomenclature units. • Wherever the Specification indicates a specific pattern, source, process, trademark, type, origin or production that would result in the benefit or elimination of certain persons or products, read and understand “or equivalent”. 1. The proposed medical devices shall comply with the requirements of the Medical Devices Act; 2. Medical devices must hold a Declaration of Conformity of the proposed medical devices, in accordance with Article 120 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices or equivalent with a translation into Bulgarian; 3. The medical device must have an EU certificate for affixed CE marking on the device or an equivalent document in accordance with the requirements of Articles 8 and 15 of the MIA with a translation into Bulgarian; 4. The shelf life of medical devices should be not less than 6 (six) months from the date of acceptance - transmission protocol for their delivery; 5. The participant should submit catalogues, brochures, information sheets or equivalent with the proposed medical devices, in which there is detailed information about them with a translation into Bulgarian, showing all indicators and production characteristics, which indisputably demonstrate the quality of the proposed device and its compliance with the technical specifications. 6. The quantities indicated by the individual nomenclature units are estimated and should not be interpreted as an obligation of the Contracting Authority for a minimum or maximum total quantity (within the scope of the contract) of the mentioned medical devices. If necessary, the quantities applied for may be exceeded. Delivery time – no more than 50 /fifty/ working days, after a delivery request has been made. Place of performance: Hospital pharmacy of UMHAT “Alexandrovska” EAD, at: Sofia, 1 Georgi Sofiyski Str. The term of execution of the order is 24 /twenty-four/ months from the date of conclusion of the contract, but not earlier than 24.01.2027, through periodic deliveries according to preliminary requests by type and quantity, depending on the needs of the Assignor.