Public procurement notice: Contract Notice
Published: 2024-04-23
Region: MK008
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33182000
Estimated value: 10000000 MKD
Submission deadline: 2024-05-17

Technical requirements: Part 1
Stent graft system - Stent graft system (hybrid prosthesis) indicated for the treatment of aneurysms, dissections and specific lesions of the thoracic aorta, for the treatment of acute aortic dissections extending deep into the descending aorta, acute aortic dissections combined with Marfan syndrome, extensive aortic dissection aneurysm of the ascending aorta or of the aortic arch extending to the descending aorta (also mycotic aneurysm), complex aortic dissections and chronic extensive aortic dissections which consists of two components: a self-expanding stent-graft with an embedded polyester vascular adapter and a system for delivery with a cuff - (collar) between the stent graft and the vascular adapter.
The delivery system must be able to position and mount on the system for delivery.
Proximal configuration – Aortic Cuff, Straight
Open, Twin Stent
Distal configuration - Straight Cut, Twin Stent,
Straight open
Variations with and without cuff.
Stent graft length: 130mm - 160mm
Graft length: 50mm - 70mm
Proximal diameter: 20 mm - 40 mm
Distal diameter: 20 mm - 40 mm
Covered length: 80 mm - 240 mm
Cuff diameter: 20 mm - 40 mm
Cuff length: 10 mm - 150 mm
Collar width: 2 mm - 40 mm
Part 2
Diameter of Delivery System of the catheter: 36 mm- 48 mm
Stent graft diameter 20 mm-40 mm
A special hybrid stent graft for the treatment of ascending and descending aorta and aortic arch reconstruction.
Made of woven polyester sealed with gelatin.
The hybrid graft consists of a proximal surgical graft and a distal endovascular stent graft component supported by nitinol rings and positioning markers.
In a set with a delivery and positioning system.
Available in 2 configurations: Plexus and Ante-Flo
Diameter of the proximal graft: 22 - 32mm,
Diameter of branches: 8mm, 10mm and 12mm length
150mm
Diameter of stent graft: 24 - 40mm
Stent graft length: 100 and 150mm
statement of the economic operator that no effective verdict has been pronounced against the economic operator within the past five years for a committed crime stated in Art. 88, paragraph 1 of the LPP; 
- certificate stating that no bankruptcy procedure has been initiated by a competent body; 
- certificate stating that no liquidation procedure has been initiated by a competent body; 
- certificate of paid taxes, contributions and other public duties issued by a competent body in the country where the economic operator is registered; 
- certificate from the Register of penalties for committed criminal offenses of legal entities proving that no secondary penalty - ban on participating in open call procedures, awarding public procurement contracts and contracts on public - private partnership has been pronounced; 
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- certificate stating that no misdemeanor sanction - ban on the performance of the profession, activity or duty, i.e. temporary ban on the performance of a particular activity has been pronounced with an effective verdict.
- Original catalogues and/or brochures with detailed descriptions and accurately marked items which are offered
- Decision for placing medical device on the market, with correctly marked positions that are subject to procurement, pursuant to the Law on Medicines and Medical Devices
- 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. 
– Certificate for wholesale of medical devices pursuant to the Law on Medicines and Medical Devices.
PHI University Clinic for State cardiac Surgery – Skopje, Majka Tereza 17/8