Neonatal and pediatric cardiac surgery supplies | University clinic of pediatric surgery | Јавна набавка во Северна Македонија

Arterial perfusion cannula for children, kink-resistant -enhanced wire, introducer which can be adjusted with pegs and plug in depth markings on the body of the cannula so its precise positioning, size 6.

Arterial perfusion cannula for children, kink-resistant -enhanced wire, introduser which can be adjusted with pegs and plug in depth markings on the body of the cannula so its precise positioning, size 8.

Arterial perfusion cannula for children, kink-resistant -enhanced wire, introduser which can be adjusted with pegs and plug in depth markings on the body of the cannula so its precise positioning, size 10.

Arterial perfusion cannula for children, kink-resistant -enhanced wire, introduser which can be adjusted with pegs and plug in depth markings on the body of the cannula so its precise positioning, size 12.

Arterial perfusion cannula for children, kink-resistant -enhanced wire, introduser which can be adjusted with pegs and plug in depth markings on the body of the cannula so its precise positioning, size 14.

Arterial perfusion cannula for children, kink-resistant -enhanced wire, introduser which can be adjusted with pegs and plug in depth markings on the body of the cannula so its precise positioning, size 16.

Arterial cannula elongated body enhanced wire, dilator, tags depth and outer ring for easy positioning of the cannula, length 30,5cm, size 18.

Arterial cannula elongated body enhanced wire, dilator, tags depth and outer ring for easy positioning of the cannula, length 30,5cm, size 20.

Датум	Документ
2016-02-03	Оглас за договор

Venous perfusion cannula for children, curved and angled metal tip and an additional lateral opening for increased flow of blood; thin wall enhanced wire — kink-resistant, with the peak marked line orientation when positioning the cannula in the SVC or IVC, 35.6cm length, size 12 Fr.

Venous perfusion cannula for children, curved and angled metal tip and an additional lateral opening for increased flow of blood; thin wall enhanced wire — kink-resistant, with the peak marked line orientation when positioning the cannula in the SVC or IVC, 35.6cm length, size 14 Fr.

Venous perfusion cannula for children, curved and angled metal tip and an additional lateral opening for increased flow of blood; thin wall enhanced wire — kink-resistant, with the peak marked line orientation when positioning the cannula in the SVC or IVC, 35.6cm length, size 16 Fr.

Venous perfusion cannula for children, curved and angled metal tip and an additional lateral opening for increased flow of blood; thin wall enhanced wire — kink-resistant, with the peak marked line orientation when positioning the cannula in the SVC or IVC, 35.6cm length, size 18 Fr.

Venous perfusion cannula for children, curved and angled metal tip and an additional lateral opening for increased flow of blood; thin wall enhanced wire — kink-resistant, with the peak marked line orientation when positioning the cannula in the SVC or IVC, 35.6cm length, size 20 Fr.

Venous perfusion cannula for children, curved and angled metal tip and an additional lateral opening for increased flow of blood; thin wall enhanced wire — kink-resistant, with the peak marked line orientation when positioning the cannula in the SVC or IVC, 35.6cm length, size 22.

Venous perfusion cannula for children, curved and angled metal tip and an additional lateral opening for increased flow of blood; thin wall enhanced wire — kink-resistant, with the peak marked line orientation when positioning the cannula in the SVC or IVC, 35.6cm length, size 22 Fr.

Venous perfusion cannula for children, curved and angled metal tip and an additional lateral opening for increased flow of blood; thin wall enhanced wire — kink-resistant, with the peak marked line orientation when positioning the cannula in the SVC or IVC, 35.6cm length, size 28 Fr.

One — pieced venous perfusion cannula for children, straight, wall enhanced wire — kink-resistant, top with more open with depth markings on the body of the cannula so its precise positioning, size 12.

One — pieced venous perfusion cannula for children, straight, wall enhanced wire — kink-resistant, top with more open with depth markings on the body of the cannula so its precise positioning, size 14 Fr.

One — pieced venous perfusion cannula for children, straight, wall enhanced wire — kink-resistant, top with more open with depth markings on the body of the cannula so its precise positioning, size 16 Fr.

One — pieced venous perfusion cannula for children, straight, wall enhanced wire — kink-resistant, top with more open with depth markings on the body of the cannula so its precise positioning, size 18 Fr.

Forming once-pieced venous cannula, enhanced wire with a pointed tip with multiple holes with depth markings on the top of the cannula, 26 Fr.

Forming once-pieced venous cannula, enhanced wire with a pointed tip with multiple holes with depth markings on the top of the cannula, 28 Fr.

Femoral one — pieced arterial cannula with a thin wall of urethane (0.38mm) enhanced wire — kink-resistant with a curved top, with introduser and depth markings on the body of the cannula so its precise placement, length 19cm, size 10 fr.

Femoral one — pieced arterial cannula with a thin wall of urethane (0.38mm) enhanced wire — kink-resistant with a curved top, with introduser and depth markings on the body of the cannula so its precise placement, length 19cm, size 12 Fr.

Femoral arterial cannula, with a thin wall (0.48mm) elongated one — pieced body enhanced wire — kink-resistant with a peak with more open, with markings introduser and depth of the body of the cannula so its precise placement, length 43.2cm, size 15 Fr.

Femoral arterial cannula, with a thin wall (0.48mm) elongated one — pieced body enhanced wire — kink-resistant with a peak with more open, with markings introduser and depth of the body of the cannula so its precise placement, length 43.2cm, size 19 Fr.

Femoral arterial cannula, with a thin wall elongated one — pieced body enhanced wire — kink-resistant with a peak with more open, with markings introduser and depth of the body of the cannula so its precise placement, length 19cm, size 12 Fr.

Femoral arterial cannula, with a thin wall elongated one — pieced body enhanced wire — kink-resistant with a peak with more open, with markings introduser and depth of the body of the cannula so its precise placement, length 19cm, size 14 Fr.

Femoral arterial cannula, with a thin wall elongated one — pieced body enhanced wire — kink-resistant with a peak with more open, with markings introduser and depth of the body of the cannula so its precise placement, length 76.2cm, size15 Fr.

Femoral arterial cannula, with a thin wall elongated one — pieced body enhanced wire — kink-resistant with a peak with more open, with markings introduser and depth of the body of the cannula so its precise placement, length 76.2cm, size15.

Femoral arterial cannula, with a thin wall elongated one — pieced body enhanced wire — kink-resistant with a peak with more open, with markings introduser and depth of the body of the cannula so its precise placement, length 76.2cm, size19 Fr.

Femoral arterial cannula, with a thin wall elongated one — pieced body enhanced wire — kink-resistant with a peak with more open, with markings introduser and depth of the body of the cannula so its precise placement, length 76.2cm, size21 Fr.

Pericardial suction catheter (sump), the tongue and soft tube connector 1/4 LL or 1 / 8LL, size of 20 Fr., length 38,1 cm (+/-10 %).

Intracardiac catheters suction (sump), with atraumatic tip with a minimum 10 holes, connector 1/4 LL, size 12 Fr. 20 Fr., length 30,5 cm / 38,1 cm (+/-10 %).

Forming vent tube of PVC — preformed or forming with depth markings and side vents at the top, connector 1/4 LL, 38,1cm length, size 10 fr.

Forming vent tube of PVC — preformed or forming with depth markings and side vents at the top, connector 1/4 LL, 38,1cm length, size 13 Fr.

Forming vent tube of PVC — preformed or forming with depth markings and side vents at the top, connector 1/4 LL, 38,1cm length, size 15 Fr.

Cardioplegia adapter length 5,1 cm with 1/4 LL edge connector with threaded male connector on the other side.

Adapter for pressure monitoring line, length 183cm, with male connector on one and a female connector on the other side or male connector on both sides.

Perfusion connectors, straight, Y, and non-LL, with different sizes (1 / 4x3 / 8, 3 / 16x1 / 4, 1 / 4x1 / 4x1 / 4, 3 / 8x3 / 8x3 / 8, 1 / 4x3 / 8x3 / 8, etc.); for connections within the tubing system, perfusion cannulas.

Sets of displaying pressure silicone membrane attached to tubing which ends or male or stopcock.

Pediatric Oxygenator with electrochant max. flow to 2L / min., static 48ml priming volume and surface area of 0.67m2 membrane radial flow; 1200ml container and suitable pediatric 1 / 4x1 / 4 or 3 / 16x1 / 4 set of lines of cardiopulmonary bypass.

Oksygenator max. flow to 5L / min., static priming volume 175ml to 4200ml and suitable tank 3 / 8x1 / 4 set of lines of cardiopulmonary bypass.

Oksygenator with electrochant and flow to 7L / min. and integrated arterial filter, static priming volume and 260ml tank with radial flow and adequate 4500ml 3 / 8x3 / 8 set of lines for cardiopulmonary bypass.

Pediatric 1 / 4x1 / 4; 3 / 8h1 / 4; 3 / 8h3 / 8 set of lines for cardiopulmonary bypass.

Hemoconcentrator with polysulfone membrane surface 0,09m2 and priming volume 8ml to 10 ml; ‘no-rinse’.

Hemoconcentrator with polysulfone membrane surface 0,3m2 and priming volume 27ml, or 0,71m2 and priming volume58ml; ‘no-rinse’.

Biological conduit composed of biological aortic valve sewn in conduit without stent for improved relationship between the inner and outer diameter of the biological valve with external ring which amplifies conduit and allows radiographic visualization. The possibility of application of the right side of the heart size from 12 to 25mm and the application and the left and right side of the heart size of 12 to 26mm, are used in the reconstruction of congenital heart and venous malformations or pathologies.

Aortic and mitral mechanical heart valve, bi-leaflet, with extended effective valve area, construction of the sewing ring for Supra-Annular setting, rotable, open pivot system with hanging petals, 100 % pyrolitic carbon, size-16-28mm.

Cartridge for determination of circulating heparin compatible with the appliance HMS Plus.

Cartridge for evaluation of individual response of heparin compatible with the apparatus HMS Plus.

High range ACT cartridge kaolin (x50) for the ACT Plus camera or Cartridge down the activation of coagulation with a wide range equivalent to the ACT Plus Camera.

Steroid epicardial unipolar preventricular / ventricular electrodes with body diameter of up to 1.5mm, fixation with surgical thread, optional tuning of minimum 3 lengths.

Biventricular pacemaker DDDR, IS-1 connector, automatic adjustment of voltage and sensitivity to stimulation, recording and storing the IEGM, the opportunity for independent programming of frequency adaptability in at least two zones and switching from bipolar to unipolar stimulation in damage to the electrode, volume ≤ 11.1cm3.

Double chambered temporary pacemaker with the following…

… characteristics:— Select the way of stimulation: DDD, DDI, DOO, VVI, VOO, AAI, AOO— Continuous adjustment of the frequency of stimulation from 30-200 beats / min.— Upper cut-off frequency up to 230 beats / min.— Automatic adjustment of the AV interval, the upper frequency and post ventricular refractory period while changing the frequency of stimulation in stimulation double chambered— Ability to change the battery without interruption of pacing— Possibility of fast atriska stimulation frequency up to 800 beats / min.— LCD display with backlight— Safety switch for immediate passage of DOO mode of stimulationcomplete with— Cable Stitch patient electrodes temporary pacing the heart, the atria, compatible with said pacemaker— Cable Stitch patient electrodes temporary pacing the heart, ventricular pacemaker compatible stated.

… characteristics:

— Select the way of stimulation: DDD, DDI, DOO, VVI, VOO, AAI, AOO

— Continuous adjustment of the frequency of stimulation from 30-200 beats / min.

— Upper cut-off frequency up to 230 beats / min.

— Automatic adjustment of the AV interval, the upper frequency and post ventricular refractory period while changing the frequency of stimulation in stimulation double chambered

— Ability to change the battery without interruption of pacing

— Possibility of fast atriska stimulation frequency up to 800 beats / min.

— LCD display with backlight

— Safety switch for immediate passage of DOO mode of stimulation

complete with

— Cable Stitch patient electrodes temporary pacing the heart,…

… the atria, compatible with said pacemaker

… ventricular pacemaker compatible stated.

Thoracic drainage system with 4 chambers suitable for gravity or active sukciona thoracic drainage. The system consist of a transparent chamber with pediatric graduacija soft monoprensko (latex) hose samozapechatuvachko sampling and needleless port sampling of the fluids that are drained, manual valve with bacterial filter and a safety cap for controlling excessive negative pressure, automatic valve for regulating excess positive pressure antireflux mechanism, floor stand, hanger fixing the bed, some monitoring of the negative intrapleural pressure, mechanical suction regulator that regulates sukcijata without adding or subtracting water, latex, two drain.

Thoracic drainage system with 4 chambers suitable for gravity or active suction thoracic drainage. The system consist of a transparent chamber with pediatric graduacija soft mono prenic (latex) hose selfsetting sampling and needleless port sampling of the fluids that are drained, manual valve with bacterial filter and a safety cap for controlling excessive negative pressure, automatic valve for regulating excess positive pressure antireflux mechanism, floor stand, hanger fixing the bed, some monitoring of the negative intrapleural pressure, mechanical suction regulator that regulates sukcijata without adding or subtracting water, latex, a drain.

Thoracic / mediastinal catheters for EU, sterile, translucent, atraumatic made of soft thermosensitive PVC with radio detective line and thin walls. Possess at least four side and a distal opening for smooth drainage can be calibrated to each numeric 2cm, possess adaptive funnel proximal end which can be adapted as a cone-shaped connector. Length 50cm ± 1cm 12 Fr/.

Thoracic / mediastinal catheters for EU, sterile, translucent, atraumatic made of soft thermosensitive PVC with radio detective line and thin walls. Possess at least four side and a distal opening for smooth drainage can be calibrated to each numeric 2cm, possess adaptive funnel proximal end which can be adapted as a cone-shaped connector. Length 50cm ± 1cm 16 Fr.

Silicone thoracic catheters — straight, atraumatic, biocompatible, tromboresistant with thin walls and radio detective line. To be soft and resistant to pinching and hold at least 5 side and a distal opening for drainage and smooth tapered end for easy connection to the aspiration/drain hose length 50cm ± 1cm 20 Fr.

Silicone thoracic catheters — straight, atraumatic, biocompatible, tromboresistant with thin walls and radio detective line. To be soft and resistant to pinching and hold at least 5 side and a distal opening for drainage and smooth tapered end for easy connection to the aspiration/drain hose length 50cm ± 1cm 24 Fr.

Thoracic catheters set composed of thoracic catheter made of thermosensitive PVC and aluminum trocar for placing a rounded tip. Possess graduation catheter in every 2cm length. Possess a smooth elliptic holes for reducing the risk of trauma, visible ray line and without latex. 8 Fr.

Thoracic catheters set composed of thoracic catheter made of thermosensitive PVC and aluminum trocar for placing a rounded tip. Possess graduation catheter in every 2cm length. Possess a smooth elliptic holes for reducing the risk of trauma, visible ray line and without latex. 10 Fr.

Thoracic catheters set composed of thoracic catheter made of thermosensitive PVC and aluminum trocar for placing a rounded tip. Possess graduation catheter in every 2cm length. Possess a smooth elliptic holes for reducing the risk of trauma, visible ray line and without latex. 12 Fr.

Thoracic catheters set composed of thoracic catheter made of thermosensitive PVC and aluminum trocar for placing a rounded tip. Possess graduation catheter in every 2cm length. Possess a smooth elliptic holes for reducing the risk of trauma, visible ray line and without latex. 16 Fr.

Y connector restraint thoracic catheters, without latex with imprintable end connector.

The thoracentesis set comprising:safety needle thoracentesis / paracentesis and catheter — 8Fr / 12.5cm50ml luer lock syringeDrain bladder 2000mPossess so-called ball valve that occludes the opening of the catheter when the needle is withdrawn, and so-called Duck Bill valve which prevents the penetration of atmospheric air into the pleural space, port sampling, lateral openings of the catheter and the depth markers.

The thoracentesis set comprising:

safety needle thoracentesis / paracentesis and catheter — 8Fr / 12.5cm

50ml luer lock syringe

Drain bladder 2000m

Possess so-called ball valve that occludes the opening of the catheter when the needle is withdrawn, and so-called Duck Bill valve which prevents the penetration of atmospheric air into the pleural space, port sampling, lateral openings of the catheter and the depth markers.

Peritoneal dialysis catheter for infant built transparent, medical silicone rubber, angled 180° in Swan Neck shape with rounded one end with numerous input and output vents gently diffusion of dialysate in the patient. Possess 2 CAF made from PTFE fixing the catheter and prevention of entry of infection: a preperitoneal and hypodermic. Possibility of placing the catheter percutaneous and surgical. To have the opportunity for extension and repair if necessary. Sterile length 38cm ± 1cm.

Peritoneal dialysis catheter for infant built transparent, medical silicone rubber, angled 180° in Swan Neck shape with rounded one end with numerous input and output vents gently diffusion of dialysate in the patient. Possess 2 CAF made from PTFE fixing the catheter and prevention of entry of infection: a preperitoneal and hypodermic. Possibility of placing the catheter percutaneous and surgical. To have the opportunity for extension and repair if necessary. Sterile length 42cm ± 1cm.

Expiratory filter EU charter compatible to existing PB840 device for mechanical ventilation.

Expiratory filter EU charter compatible neomode to existing PB840 device for mechanical ventilation.

Inspiratory filter mechanically compatible with the single PB840 device for mechanical ventilation.

Filters with passive humidifier connection with 8M / 15-15, with bacterial and viral filtration> 99.99 %, temperature the output 30,2 ° C, humidity otput Vt = 25ml (27.7mg / l), i.e. VT = 50ml (27.5mg / l), flow resistance of 0.7 cm H2O to 5 l / min, H2O 1.2cm of 7.5L / min, H2O 1.9cm of 10L / min flow rate. Aseptic compatible with PB840.

Tracheostomy cannula for neonatal patients with cone…

… CAF3.0.

… CAF

Tracheostomy cannula for neonatal patients with cone CAF3.5.

3.5.

Tracheostomy cannula for pediatric patients with cone…

… CAF4.0.

… CAF

Tracheostomy cannula for pediatric patients with cone CAF4.5.

4.5.

Tracheostomy cannula for pediatric patients with cone CAF5.0.

5.0.

Tracheostomy cannula for pediatric patients with cone CAF5.5.

5.5.

Closed system for endotracheal aspiration of multiple use of the same patient during the 72 hours, that consists of a double flip connector, Y/L connector aspiration catheter protection valve for access to the lavage port and flushing of the catheter and connectors et tubus.

Blankets of dual-layer lightweight material resistant to breakage, liquid and sting, without latex, RTG transparent without effect to the RTG rays, pediatric salad compatible with existing heater clinic model Warmtouch maker Covidien SAD 6000.

Sensors to measure the index bispectral pediatric compatible camera model BIS from producer Covidien SAD of the clinic.

Sensors neonatal measurement of regional oxygen saturation of the brain-compatible apparatus type INVOS the manufacturer Covidien SAD of the clinic.

Pediatric sensors to measure regional oxygen saturation in brain-compatible camera model INVOS the manufacturer Covidien SAD of the clinic.

Sensors neonatal measurement of regional oxygen saturation somatic compatible INVOS apparatus of the clinic.

ECG gel electrodes made of foam, hydrogel special for a long-term use, connector, monitoring dimension 57x34mm.

ECG gel electrodes made of foam, hydrogel special for a long-term use, connector, monitoring dimension 24mm.

‘ Sensors for measuring the oxygen saturation in the blood by a digital calibration in the sensor and the precision of measurement: Saturation (% SPO2): ± 1…

… SDElder patients: 70 % до 100 % ± 2 digits60 % до 80 % ± 3 digitsNeonatology patients: 70 % до 100 % ± 2 digits60 % до 80 % ± 4 digitsIn low perfusion: 70 % до 100 % ± 3 digitssensors suitable for infants and children 3-20kg Compatible with camera model Nellcor N560 from producer Covidien SAD’.

… SD

Elder patients: 70 % до 100 % ± 2 digits

60 % до 80 % ± 3 digits

Neonatology patients: 70 % до 100 % ± 2 digits

60 % до 80 % ± 4 digits

In low perfusion: 70 % до 100 % ± 3 digits

sensors suitable for infants and children 3-20kg Compatible with camera model Nellcor N560 from producer Covidien SAD’.

‘Disc constructed of polyurethane foam with added antimicrobial agent Polyhexamethylene…

… biguanidehydrochloride (PHMB), to prevent input infections incertive places the drains and catheters with a diameter of 2.5cm ± 1 % and the central hole 7 mm. ’.

… biguanide

hydrochloride (PHMB), to prevent input infections incertive places the drains and catheters with a diameter of 2.5cm ± 1 % and the central hole 7 mm. ’.

‘Disc constructed of polyurethane foam with added antimicrobial agent Polyhexamethylene biguanidehydrochloride (PHMB), to prevent input infections incertive places the drains and catheters with a diameter of 2.5cm ± 1 % and the central hole 4 mm. ’.

hydrochloride (PHMB), to prevent input infections incertive places the drains and catheters with a diameter of 2.5cm ± 1 % and the central hole 4 mm. ’.

Prolonged infusion system, a minimum length of 75cm and a maximum diameter of 3.0 mm.

EXTENDED HOSE compatible with the syringe pump B.Braun Perfusor Space, with a minimum length of 200 cm and a diameter 1.5mm.

Three directional luer lock valves for infusion, with blue mark resistant to leaks, contamination and air embolism.

Three directional luer lock valves for infusion, with red mark resistant to leaks, contamination and air embolism.

Bivolumed central cranky polyurethane catheters recognizable of X-rays marked length adhering soft patch in the shape of a teddy bear for fixation of catheter, guide wire resistant to bending, Seldinger needle G21, luer lock syringe 5ml, dilator, scalpel, ECG cable connectivity options, valve for protection from air embolism, wire 0.46mm x 50cm, catheter 4F / 18D, maximum length 8cm, channels 22D / 22D.

Bivolumed central cranky polyurethane catheters recognizable of X-rays marked length adhering soft patch in the shape of a teddy bear for fixation of catheter, guide wire resistant to bending, Seldinger needle G21, luer lock syringe 5ml, dilator, scalpel, ECG cable connectivity options, valve for protection from air embolism, wire 0.46mm x 50cm, catheter 4F / 18D, maximum length 13cm, channels 22D / 22D.

Three volumed central cranky polyurethane catheters recognizable of X-rays marked length adhering soft patch in the shape of a teddy bear for fixation of catheter, guide wire resistant to bending, Seldinger needle G21, luer lock syringe 5ml, dilator, scalpel, ECG cable connectivity options, valve for protection from air embolism, wire 0.46mm x 50cm, catheter 5F / 16G, maximum length 8cm, channels 20G/ 22G/22G.

Three volumed central cranky polyurethane catheters recognizable of X-rays marked length adhering soft patch in the shape of a teddy bear for fixation of catheter, guide wire resistant to bending, Seldinger needle G21, luer lock syringe 5ml, dilator, scalpel, ECG cable connectivity options, valve for protection from air embolism, wire 0.46mm x 50cm, catheter 5F / 16G, maximum length 13cm, channels 20G/ 22G/22G.

Three volumed central cranky polyurethane catheters recognizable of X-rays marked length adhering soft patch in the shape of a teddy bear for fixation of catheter, guide wire resistant to bending, Seldinger needle G21, luer lock syringe 5ml, dilator, scalpel, ECG cable connectivity options, valve for protection from air embolism, wire 0.46mm x 50cm, catheter 5F / 16G, maximum length 15cm, channels 16G/ 18G/18G.

Triple syringe 20ml, luerlock, graduated,equivalent for pumpB.Braun (model Perfusor fm and Space), without latex, made of biocompatible synthetic material,polypropylene clip that prevents leaking under pressure, filter needle aspiration prevention particles.

‘Epidural anesthesia set, a catheter G24 with lateral…

… openingsTuohy epidural needle G18, 50-80mm, 8 ml syringe LOR technique triple luer lock syringe of 2-3m., catheter connector, Velcro fastening and 0.2 microns filter ’.

… openings

Tuohy epidural needle G18, 50-80mm, 8 ml syringe LOR technique triple luer lock syringe of 2-3m., catheter connector, Velcro fastening and 0.2 microns filter ’.

‘Epidural anesthesia set, a catheter G24 with lateral openingsTuohy epidural needle G20, 50-80mm, 8 ml syringe LOR technique triple luer lock syringe of 2-3m., catheter connector, Velcro fastening and 0.2 microns filter ’.

Tuohy epidural needle G20, 50-80mm, 8 ml syringe LOR technique triple luer lock syringe of 2-3m., catheter connector, Velcro fastening and 0.2 microns filter ’.

Public Health Institution University Clinic for Pediatric Surgery Ul. Vodnjanska br. 17 1000 Skopje, Republic of Macedonia.

— Statement of the economic operator proving that in the last 5 years has had an effective sentence for participation in a criminal organization, corruption, fraud or money laundering; — Certificate that a bankruptcy procedure has not been initiated by the competent body; — Certificate that a liquidation procedure has not been initiated by the competent body; — Certificate of paid taxes, benefits and other public duties, issued by the competent body in the country where the economic operator is registered; — Certificate from the Registry of penalties for committed acts of crime by legal entities that the economic operator has not been issued an additional penalty of a ban on participating in procedures for public call for bids, for awarding public procurement contracts and for contracts on public — private partnership; — Certificate from the Registry of penalties for committed acts of crime by legal entities that the economic operator has not been issued an additional penalty of a temporary or permanent ban on performing a certain activity.

In order to prove its capability to perform a professional activity, the economic operator needs to submit a document for registered activity, as proof that it is registered as a legal entity for performing the activity related to the subject of the public procurement contract.

— High Professional and technical trained personnel by the manufacturer of the equipment who will be responsible for installation of the equipment, — High Professional and technical trained personnel by the manufacturer of the equipment, who will be responsible for maintenance of the equipment with technical help, — High Professional and technical trained personnel by the manufacturer of the equipment, who will be responsible for the trainings of the personnel who will work with the equipment, -Minimum equipment warranty of 1 (one) year and during that period the economic operator is obliged to perform free service and free replacement of spare parts, -Providing spare parts in the post warranty period at least in the following period of 5 (five ) years -The offered products are corresponding with the required characteristics written in the technical specification -The offered products to be manufactured in accordance with international standards for medical devices, quality standards, are approved for use/sale in the manufacturer country and abroad, the products are safe to use and sale and are approved to be used and sold on the market.

— Statement and attaching a certificate issued by the manufacturer of the equipment providing high — technical educated personnel responsible for installation of the equipment, — Statement and attaching a certificate issued by the manufacturer of the equipment providing high — technical educated personnel responsible for maintenance of the equipment, — Statement and attaching a certificate issued by the manufacturer of the equipment providing high technical educated personnel responsible for trainings of the personnel for usage of the equipment, Statement that will provide a warranty fot the equipment for a period of minimum one (1 ) year, during which the economic operator is obliged to perform free service and free replacement of spare parts, — Statement of the economic operator for delivering spare parts in the post warranty period of minimum 5 (five) years, — The economic operator is obliged to submit catalogues indicating the offered equipment in the same description and photographs of the offered products that are subject of the procurement, — Certificates issued by the competent authorities for quality control, with recognized competence that test the conformity of products clearly identified by references to specifications or standard to these certificates or equivalent: Declaration of conformity, Free sale Certificate, FDA Certificate, EC/CE Certificate. Proof that the company that produces medical products is implementing the ISO standard for quality work. The economic operator shall prove the fulfilment of the standards of subsection 2.6.1 by submitting: -ISO 13485 or equivalent The goods offered by the economic operator to be granted a marketing authorization in accordance with The Law on Medicines and Medical Devices. Approval issued by the Medicines Agency of RM for distribution of required materials or temporary authorization for parallel imports or final approval for parallel imports.

Public Health Institution University Clinic for Pediatric Surgery St Majka Tereza No. 17, 1000 Skopje, R. Macedonia.