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                           <cbc:Name languageID="ENG">PHI University Clinic for State Cardiac Surgery Skopje</cbc:Name>
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                           <cbc:Name>Ivica Ristevski</cbc:Name>
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                           <cbc:Name languageID="ENG">State Commission for Public Procurement Appeals</cbc:Name>
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                           <cbc:Name languageID="ENG">Publications Office of the European Union</cbc:Name>
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                           <cbc:CityName>Luxembourg</cbc:CityName>
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         <cbc:Name languageID="ENG">Aortic annuloplasty device</cbc:Name>
         <cbc:Description languageID="ENG">Aortic annuloplasty device, three-dimensional for intraannular implantation in the aortic valve in patients with tricuspid valve morphology. It shall have a precisely defined geometry that allows for a standard and symmetrical annuloplasty repair to improve leaflet coaptation and valve functionality. With fixation posts for accurate orientation in relation to the commissures, Available in different dimensions for adaptation to the aortic annulus, with sizes of 19mm, 21mm, 23mm and 25mm.. To provide long-term stability, improved hemodynamics and minimizing the risk of valvular regurgitation, allowing biomechanically compatible repair of the aortic valve. A set of measuring and placement instruments shall be delivered with the device. Permissible deviation shall be up to ±5%.</cbc:Description>
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         <cbc:EstimatedOverallContractQuantity unitCode="H87">5</cbc:EstimatedOverallContractQuantity>
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            <cbc:ItemClassificationCode listName="cpv">33140000</cbc:ItemClassificationCode>
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            <cbc:Description languageID="ENG">/</cbc:Description>
            <cac:Address>
               <cbc:CountrySubentityCode listName="nuts">MK008</cbc:CountrySubentityCode>
               <cac:Country>
                  <cbc:IdentificationCode listName="country">MKD</cbc:IdentificationCode>
               </cac:Country>
            </cac:Address>
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            <cbc:DurationMeasure unitCode="MONTH">12</cbc:DurationMeasure>
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                        <cbc:Description languageID="ENG">Decision for placing ready medicine on the market, or a temporary or permanent decision for parallel import issued by the Agency for Medicines and Medical Devices must be submitted for all registered medicines.</cbc:Description>
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                        <cbc:TendererRequirementTypeCode listName="selection-criterion">slc-suit-reg-trade</cbc:TendererRequirementTypeCode>
                        <cbc:Description languageID="ENG">- Document for registered activity as proof that it had been registered as a natural person or legal entity to perform the activity related to the subject of the contract for public procurement; or proof that it belongs to a suitable association pursuant to the regulations of the country where it has been registered.</cbc:Description>
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                     <efac:SelectionCriteria>
                        <cbc:TendererRequirementTypeCode listName="selection-criterion">slc-suit-reg-prof</cbc:TendererRequirementTypeCode>
                        <cbc:Description languageID="ENG">Certificate for wholesale of medical devices pursuant to the Law on Medicines and Medical Devices.</cbc:Description>
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                        <cbc:TendererRequirementTypeCode listName="selection-criterion">slc-abil-qual-smp-w-autent</cbc:TendererRequirementTypeCode>
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                              <cbc:ID>MKD</cbc:ID>
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            <cbc:ID>07431/2025</cbc:ID>
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            <cbc:DurationMeasure unitCode="DAY">90</cbc:DurationMeasure>
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               <cbc:Description languageID="ENG">18.05.2025</cbc:Description>
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                  <cbc:ID>ORG-0002</cbc:ID>
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            <cbc:ID>MKD</cbc:ID>
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            <cbc:ElectronicOrderUsageIndicator>false</cbc:ElectronicOrderUsageIndicator>
            <cbc:ElectronicPaymentUsageIndicator>false</cbc:ElectronicPaymentUsageIndicator>
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         <cbc:GovernmentAgreementConstraintIndicator>true</cbc:GovernmentAgreementConstraintIndicator>
         <cac:TenderSubmissionDeadlinePeriod>
            <cbc:EndDate>2025-05-26+02:00</cbc:EndDate>
            <cbc:EndTime>13:00:00+02:00</cbc:EndTime>
         </cac:TenderSubmissionDeadlinePeriod>
         <cac:AdditionalInformationRequestPeriod>
            <cbc:EndDate>2025-05-18+02:00</cbc:EndDate>
            <cbc:EndTime>15:30:00+02:00</cbc:EndTime>
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            <cbc:OccurrenceDate>2025-05-26+02:00</cbc:OccurrenceDate>
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         <cbc:ID schemeName="InternalID">Lot 15</cbc:ID>
         <cbc:Name languageID="ENG">Balloon-expandable covered peripheral stent</cbc:Name>
         <cbc:Description languageID="ENG">Balloon-expandable covered peripheral stent, with double ePTFE layer external and internal. Made of CoCr alloy, with open cells, with 3 radiovisible markers at the ends of the stent and 2 markers on the balloon. Diameters: 5 – 10mm, lengths: 17 – 57mm, compatible with 0.035” wire. Catheter lengths: 80 and 140cm.</cbc:Description>
         <cbc:ProcurementTypeCode listName="contract-nature">supplies</cbc:ProcurementTypeCode>
         <cbc:EstimatedOverallContractQuantity unitCode="H87">10</cbc:EstimatedOverallContractQuantity>
         <cac:MainCommodityClassification>
            <cbc:ItemClassificationCode listName="cpv">33140000</cbc:ItemClassificationCode>
         </cac:MainCommodityClassification>
         <cac:RealizedLocation>
            <cbc:Description languageID="ENG">/</cbc:Description>
            <cac:Address>
               <cbc:CountrySubentityCode listName="nuts">MK008</cbc:CountrySubentityCode>
               <cac:Country>
                  <cbc:IdentificationCode listName="country">MKD</cbc:IdentificationCode>
               </cac:Country>
            </cac:Address>
         </cac:RealizedLocation>
         <cac:PlannedPeriod>
            <cbc:DurationMeasure unitCode="MONTH">12</cbc:DurationMeasure>
         </cac:PlannedPeriod>
      </cac:ProcurementProject>
   </cac:ProcurementProjectLot>
   <cac:ProcurementProjectLot>
      <cbc:ID schemeName="Lot">LOT-0016</cbc:ID>
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                        <cbc:TendererRequirementTypeCode listName="selection-criterion">slc-sche-qu-cert-indep</cbc:TendererRequirementTypeCode>
                        <cbc:Description languageID="ENG">Decision for placing ready medicine on the market, or a temporary or permanent decision for parallel import issued by the Agency for Medicines and Medical Devices must be submitted for all registered medicines.</cbc:Description>
                     </efac:SelectionCriteria>
                     <efac:SelectionCriteria>
                        <cbc:TendererRequirementTypeCode listName="selection-criterion">slc-suit-reg-trade</cbc:TendererRequirementTypeCode>
                        <cbc:Description languageID="ENG">- Document for registered activity as proof that it had been registered as a natural person or legal entity to perform the activity related to the subject of the contract for public procurement; or proof that it belongs to a suitable association pursuant to the regulations of the country where it has been registered.</cbc:Description>
                     </efac:SelectionCriteria>
                     <efac:SelectionCriteria>
                        <cbc:TendererRequirementTypeCode listName="selection-criterion">slc-suit-reg-prof</cbc:TendererRequirementTypeCode>
                        <cbc:Description languageID="ENG">Certificate for wholesale of medical devices pursuant to the Law on Medicines and Medical Devices.</cbc:Description>
                     </efac:SelectionCriteria>
                     <efac:SelectionCriteria>
                        <cbc:TendererRequirementTypeCode listName="selection-criterion">slc-abil-qual-smp-w-autent</cbc:TendererRequirementTypeCode>
                        <cbc:Description languageID="ENG">Original catalogues and/or brochures with detailed descriptions and accurately marked items which are offered</cbc:Description>
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            <cbc:ID>07431/2025</cbc:ID>
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            <cbc:DurationMeasure unitCode="DAY">90</cbc:DurationMeasure>
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               <cbc:Description languageID="ENG">18.05.2025</cbc:Description>
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                  <cbc:ID>ORG-0002</cbc:ID>
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            <cbc:ID>MKD</cbc:ID>
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            <cbc:EndDate>2025-05-18+02:00</cbc:EndDate>
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         <cbc:ID schemeName="InternalID">Lot 16</cbc:ID>
         <cbc:Name languageID="ENG">Fenestrated stent graft system </cbc:Name>
         <cbc:Description languageID="ENG">Fenestrated stent graft system indicated for FEVAR for use as a bridging stent graft for endovascular treatment of abdominal aorta with preservation of visceral artery perfusion. Balloon and stent with different diameters proximal/distal. Made of Cobalt-Chromium (CoCr) stent coated with 203 μm ePTFE layer. Balloon expandable, compatible with 0.035” wire. Diameters distal/proximal 5/8mm, 6/8 mm, 7/10mm, 8/10mm, 9/11 mm, lengths 22, 27, 37mm, Catheter length 120 cm</cbc:Description>
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         <cbc:EstimatedOverallContractQuantity unitCode="H87">10</cbc:EstimatedOverallContractQuantity>
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            <cbc:ItemClassificationCode listName="cpv">33140000</cbc:ItemClassificationCode>
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         <cac:RealizedLocation>
            <cbc:Description languageID="ENG">/</cbc:Description>
            <cac:Address>
               <cbc:CountrySubentityCode listName="nuts">MK008</cbc:CountrySubentityCode>
               <cac:Country>
                  <cbc:IdentificationCode listName="country">MKD</cbc:IdentificationCode>
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         <cac:PlannedPeriod>
            <cbc:DurationMeasure unitCode="MONTH">12</cbc:DurationMeasure>
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