Public procurement notice: Contract Notice
Published: 2024-04-25
Region: MK008
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33140000: Medical consumables
Estimated value: 12000000 MKD
Submission deadline: 2024-05-20
Award criteria: price

Technical requirements: 1	Hydrophilic transfemoral access set 10cm, 4F-9F RO full length with haemostatic valve and Side tube - introducer with anti-kink coating, dilator, wire 45cm 0.038'' metal needle 18G 7cm or equivalent
2	Tapered Tip Hydrophilic Nitinol Guide Wires Coated with RO Polyurethane with Visibility Tungsten and Hydrophilic Coating Full Length 0.018” - 0.038”, 150cm - 260cm Available in Tip Shapes Straight, J, Angled and Double Angled Bolia
3	Diagnostic angiographic catheter double braided SIM 2,3, Vertebral, J, MP, pig tail, Inner diameter 0.047” for 5F. Diameters from 4F to 6F, lengths from 100 to 125cm.
4	Hybrid hydrophilic guidewires with extra-stiff Nitinol body with PTFE coil for passage through complex lesions and 25 cm atraumatic hydrophilic distal end, coated with RO polyurethane with tungsten for visibility, diameter 0.014", 0.018", 0.035", length 180cm, 260cm, 300cm Available in Straight, and Angled tip shape
5	Peripheral support catheter with double internal mesh and 3 x-ray visible markers spaced 4 and 6 cm from the tip for accurate lesion measurement and stent or balloon positioning. Diameter 2.6 F and 4 F, compatible with 0.018” and 0.035” wire, lengths 65, 90, 135, 150 cm. With straight or 30o curved top.
6	Hydrophilic guiding introducers with stainless steel spiral for greater support, gold x-ray visible marker on tip, and PTFE inner layer, 5F-8F, 45cm-90cm length range. Hydrophilic part 5 - 35cm.
7	Balloon-expandable covered peripheral stent, with double ePTFE layer outer and inner. Made of CoCr alloy, open cell, with 3 radio-visible markers on the ends of the stent and 2 markers on the balloon. Diameters: 5 – 10mm, lengths: 17 – 57mm, compatible with 0.035” wire. Catheter length: 80 and 140cm.
8	PTA balloon, semi-compliant coated with Paclitaxel layer 3μg / mm2, with lipophilic organic ester in the ratio 80/20, multi-layer coated, with extended drug availability for long-term efficacy.
Catheter lengths 80 and 140 cm, tip profile 0.036", 2 tungsten radiopaque markers, compatible with 5-6F introducer and 0.035" wire. Nominal pressure 6 - 7 atm, RBP 16 atm. Dimensions: diameter 5 - 7mm, length 20-150mm.
9	PTA balloon Semi-compliant coated with Paclitaxel layer 3μg / mm2, with lipophilic organic ester in the ratio 80/20, multi-layer coated, with extended drug availability for long-term efficacy. Catheter lengths 100, 140 and 150cm, tip profile 0.019", 2 tungsten radiopaque markers, compatible with 4F introducer and 0.018" wire. Nominal pressure 7 atm, RBP 14-16 atm. Dimensions: diameter 2 - 8mm, length 20-200mm.
10	PTA balloon Semi-compliant coated with Paclitaxel layer 3μg / mm2, with lipophilic organic ester in the ratio 80/20, multi-layer coated, with extended drug availability for long-term efficacy. Catheter lengths 100 and 150cm, tip profile 0.017", 2 tungsten radiopaque markers, compatible with 4F introducer and 0.014" wire. Nominal pressure 7 atm, RBP 16 atm. Dimensions: diameter 1.5 - 4mm, length 40-200mm.
11	OTW balloon catheter made of naylon / pebax material, semi-compliant, catheter length 80 and 140 cm, coated with silicone layer, 2 radiopaque markers, tip profile 0.036'', conical atraumatic design for the most difficult lesions, crossing profile 0.057'' - 0.083'', compatible with 5-6F introducer, 0.035'' wire, nomin. pressure 6-7 atm, RBP 13 - 16 atm. Dimensions: diameter 3 - 12 mm, length 20 -200 mm.
12	OTW balloon catheter made of nylon / pebax material, semi-compliant, catheter length 100, 140 and 150 cm, hydrophilic coating, 2 radioactive markers, tip profile 0.019'' max, conical shape, crossing profile 0.029'' - 0.057'' ', compatible with 4F introducer and 0.018'' wire, nomin. pressure 7 atm, RBP 14-16 atm. Dimensions: diameter 2 - 8 mm, length 20 -200 mm.
13	OTW balloon catheter made of naylon / pebax material, , semi-compliant, catheter length 100 and 150 cm, hydrophilic layer, 1-2 radioactive markers, tip profile 0.017'', conical shape, crossing profile 0.021'' - 0.033'' ', compatible with 4F introducer, 0.014'' wire, nomin. pressure 7 atm, RBP 16 atm. Dimensions: diameter 1.25 - 4 mm, length 10 -200 mm.
14	Hydrophilic PVA particle microcatheter with tungsten coil for visibility PTFE inner layer for easy particle delivery. RO tip with two PtIr markers. Resistant to 900 psi. Complete with 0.021" wire with locating marker. Diameters from 2.0F to 2.8F, lengths from 110 to 150 cm
15	Coronary Balloon Catheters for Dilatation and STO, semicompliant, hydrophilic coated with low profile 0.41mm tip, with two markers on the balloon and two depth on the shaft, diameter from 1.00mm - 4.00mm, length from 5mm - 40mm, length of shaft 145cm, diameter 1.9F proximally.
16	Guide wire, super stiff, 0.035'' and 0.038'', made of stainless steel and PTFE coating. Atraumatic soft tip, 3cm distal tip. for a contralateral approach. Choice of tip: straight, J-tip. Choice of sizes: 75cm, 145cm, 180cm, 260cm.
17	Hydrophilic guide wire made of Nitinol coated and hydrophilic layer along the entire length 0.018" - 0.038", 80-260 cm. Available in Straight, Angled, J-tip, Long Taper tip shape and a choice of Standard and Stiff shafts
18	Peripheral hydrophilic wire, stainless steel core, 0.014'', with lengths from 185 to 300 cm, with tip load from 3 to 6 grams
19	Peripheral hydrophilic wire, stainless steel core, 0.018'', with lengths from 110 to 300 cm, with a tip load of 6 to 8 grams
20	Guide Wire for Arterial Procedures Below the Knee. 0.014". Nitinol tip (2.9gp), straight or angled, with a choice of lengths 185cm and 300cm.
21	Endoscopic and hard-to-reach procedure wire with high performance and adjustable length for selective cannulation of bile and hepatic ducts. Made of Triton core, with a flexible atraumatic tip 6 cm, X-ray visible, straight 0.18 "diameter length 260 cm and 480 cm.
22	Balloon catheter with choice of Over-the-wire or monorail. RBP: 10ATM, 12ATM and 14ATM. Compatible with 4F,5F and 6F introducer and guide wire 0.018'', minimum balloon diameter range of 2 -10 mm,
- 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; 
- certificate from the Register of penalties for committed criminal offenses of legal entities proving that no secondary penalty - temporary or permanent ban on performing particular activity has been pronounced; 
- certificate stating that no misdemeanour 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.
– 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.
- Original catalogues and/or brochures with detailed descriptions and accurately marked items which are offered
- The economic operator should secure a Decision for placing medical device on the market, with correctly marked positions that are subject to procurement, or temporary or permanent approval for parallel import, pursuant to the Law on Medicines and Medical Devices. \
- For the unregistered medical devices, the economic operator must submit a document allowing import (authorization for interventional import) in accordance with the Law on Medicines and Medical Devices or a Certificate issued by MALMED, which confirms that if they are selected in the procedure, they will be issued a permit for import.
23	Balloon dilatation catheter to RTB:24ATM. Compatible with 5F, 6F and 7F introducer. minimum balloon diameter range of 3 -12 mm, minimum length range of 20 - 200 mm and minimum catheter length 40 - 135 cm
24	Balloon catheter for large blood vessels, with noncompliant balloon. Compatible with and introducer 7F. RBP: 8ATM and 5ATM. minimum balloon diameter range of 12 -18 mm, minimum length range of 20-60 mm and minimum catheter length 75 - 120 cm
25	Peripheral balloon catheter with medication, active ingredient PACLITAXEL maximum of 2 micrograms, minimum balloon diameter range from 2.00mm to 8.00mm and minimum length range from 30mm to 200mm and catheter length 80cm, 90cm, 135cm, 150cm.
26	Angiographic diagnostic catheter, 5F, choice of lengths 40cm, 65cm and 100cm, compatible with 0.035'' and 0.038'' guide wire. Tip shape choices: bern, h1, sim1, sim2, st, chgb, contra 2, c1, c2, mik, shk1.0, rc2, rdc.
27	Coronary Balloon Catheters – NS- (Non Compliant) for predilatation of large coronary arteries with hard calcified lesions and occlusions and for post-dilatation in the LM stent. Compatible with 0.014 inch wire. Diameter ranging from 5.5 and 6mm, and lengths ranging from 8 to 20mm. Rx and OTW wire placement, low pass profile of 0.017 inch or 0.43mm.
28	Peripheral guiding catheter, with choice of 6F, 7F and 8F, with choice of lengths 55cm and 90cm. Tip shape choices: hs, rdc, rdc1, re-s, re-ss, re-l, c1, c2, mp1, mp2, st, crossover 1, crossover 2, lima, bates1, bates 2, 40°.
29	Balloon expandable stent for peripheral arteries. Medical grade stainless steel 316 L set, compatible with 0.035" and 6-7F lead wire. Diameter 5-10 mm, balloon length 20-60 mm Stent diameter is 5-10 mm, stent length 17-57 mm.
30	Renal and Biliary Premounted Stent System, Renal Monorail Premounted Stent System for transluminal renal angioplasty, compatible with 0.018" and 5-6F. balloon length 16-20 mm Stent diameter is 4-7 mm, stent length 15-19 mm
31	Open, semi-open or closed (covered) stent from nitinol or other alloy, intended for TIPS (trans yugular portosystemic shunt), biliary stenting or stenting of iliac arteries, diameter 5-24mm, length 20-90mm
32	Self-expanding peripheral stent, profile 6 F, 0.035, combination of open and closed cell design for radial strength and flexibility, diameter 5-14 mm, length 20-120 mm, catheter length 75 cm and 120 cm.
33	Peripheral stent system "drug eluting technology", with proximal opening 2.7F and distal opening 2.1F, with nominal pressure 11ATM and RBP 18ATM, compatible with 4F guide wire. Choice of stent lengths: 20mm, 28mm and 38mm.
34	Inflation pump with pressure gauge with working pressure 26 atm capacity up to 20ccm, with ergonomic handle, Y connector, one touch pressure release mechanism, torque device, insertion tool and stopper
35	Drug-Paclitaxel-coated DES for peripheral arteries, SFA region, catheter length 75 and 130 cm, diameter 6 and 7 mm, stent length 40-150 mm, with polymer, triaxial delivery system. Drug dose density of paclitaxel maximum 0.300 μg/mm2
36	Embolization occlusion coil compatible with 0.021" microcatheters and 0.018" microcoils with highly thrombogenic Dacron fibers for complex and distal peripheral vascularization. Size selection from 2 to 22 mm and length 4 to 60 cm, with 2D helical shape.
37	Balloon catheter with monorail system, compatible with 0.014" guide wire and 4F introducer. RBP: 12ATM and 14ATM. Low lesion entry profile (0.017''/0.43mm), minimum balloon diameter range of 1.5-4mm, minimum length range of 20-220mm and minimum catheter length of 90-150cm
38	Hydrophilic microcatheter for occlusion system. Resistant to 1000 psi. Proximal/distal OD (F) 2.4-3.0F, from 105-155cm with lumen sizes of 0.021" / 0.53mm
39	Platinum Chromium Alloy coronary stent for large proximal vessels, thin profile, non-linear link open cell design, with bioresorbable polymer and cytostatic everolimus (DES), diameter range from 3.50 to 5.00 mm with possibility of over expansion up to 6.00 mm and length from 8 to 32mm compatible with 5F guiding catheter for all sizes.
40	A flexible, low-profile 5F Rapid exchange dual micro-mesh, closed-cell carotid nitinol stent for embolus protection. Self-tapering. With the possibility of withdrawing into the sheath and repositioning - resheatable. Diameter from 5 to 10 mm, lengths from 16 to 43 mm
41	Hybrid PKI guidewires, 0.014", 180 cm long, PTFE-coated stainless steel proximal, Nitinol distal and hydrophilic coated, straight shaping tip with platinum helix for better visibility, varying tip loading from 0.6 gf to 3.6 gf.
42	Pressure hose with rotating adapter (M/F), made of transparent reinforced polyurethane for visual control, to withstand a pressure of at least 84 Bar (1200 psi), length 25 - 100 cm
43	V08AB02-IOHEXOL-Solution for injection-350mgJ/ml Polypropylene bottle
44	Cobalt-planitum iridium alloy coronary stent, continuous sinusoidal wire like stent design, for large diameter coronary arteries and for tortuous lesions, coated with permanent polymer and cytostatic zotarolimus (DES), minimum diameter span of 2, up to 5 mm and minimum length span from at least 12 to 30mm, with the possibility of expansion to a larger diameter without significant shortening, for large coronary arteries, for LM, compatible with 5F guiding catheter for all dimensions.
45	Peripheral microcatheters for support through tortuous vessels and complex lesions, 0.014”; nonbraided; straight top, tapered, low profile; transparent shaft; hydrophilic sheath of a distal part with a length of at least 40 cm; wire 0.014”; compatible with 2.3 F; working length: 90, 135, 150 cm
46	Peripheral microcatheters for support through tortuous vessels and complex lesions, 0.014”, curved; braided, for easier entry through difficult lesions; 25 or 30° curved tip, tapered, low profile; hydrophilic coating on the distal part with a length of at least 40 cm; wire 0.014”; can be placed through a 0.035” catheter to reach more distant lesions; compatible with 2.3 F;