Circulatory Assist Device

JZU UK za drzavna kardiohirurgija/ PHI UC for State Cardiac Surgery

Cardiac stimulation devices
Cardiac monitoring devices
Artificial parts of the heart

Рок

Рокот за прием на понудите беше 2023-06-19. Набавката беше објавена на 2023-05-22.

Кој?

• JZU UK za drzavna kardiohirurgija/ PHI UC for State Cardiac Surgery

Што?

Каде?

• Северна Македонија › Скопски

Историја на набавките

Датум	Документ
2023-05-22	Оглас за договор

Оглас за договор (2023-05-22)
Предмет
Опсег на набавката
Наслов: Medical equipments
Краток опис:

Cardiac stimulation devices Cardiac monitoring devices Artificial parts of the heart

Метаподатоци на огласот
Оригинален јазик: англиски 🗣️
Вид на документ: Оглас за договор
Природа на договорот: Стоки
Регулатива: Друго
Заеднички речник на набавки (CPV)
Шифра: Медицинска опрема 📦
Дополнителен CPV: Уреди за следење на срцевата активност 📦
Место на извршување
NUTS регион: Северна Македонија 🏙️

Постапка
Вид на постапка: Отворена постапка
Вид на понуда: Поднесување за сите делови
Критериуми за доделување
Најниска цена

Договорен орган
Идентитет
Земја: Северна Македонија 🇲🇰
Вид на органот кој доделува: Друго
Име на органот кој доделува: JZU UK za drzavna kardiohirurgija/ PHI UC for State Cardiac Surgery
Поштенска адреса: Majka Tereza no. 17/building 8
Поштенски број: 1000
Поштенско место: Skopje
Контакт
Интернет-адреса: https://www.e-nabavki.gov.mk/ 🌏
Е-пошта: f.stoilkovska@yahoo.com 📧
Телефон: +389 75389076 📞
Факс: +389 23113053 📠
URL за документи: https://www.e-nabavki.gov.mk/ 🌏

Референца
Датуми
Датум на испраќање: 2023-05-22 📅
Рок за поднесување: 2023-06-19 📅
Датум на објавување: 2023-05-26 📅
Идентификатори
Број на огласот: 2023/S 101-310317
OJ-S издание: 101
Дополнителни информации

- Vasil Papestiev - Dejan Dimitrovski - Kujtim Xhelili

Предмет
Опсег на набавката
Краток опис:

Cardiac stimulation devices

Cardiac monitoring devices

Artificial parts of the heart

Проценета вкупна вредност: 72 000 000 MKD 💰
Краток опис:

Centrifugal pump for mechanical support of the left ventricle in adolescents and adults, flow from 2.5 l/min to 10 l/min; the operation of the pump is based on full magnetic levitation technology (even at zero speed, i.e. the rotor in the pump is fully supported only by electromagnetic forces) designed for implantation in the pericardial space, to have a pulsating mode of operation and centrifugal flow.

Backup HeartMate 3 system control device or equivalent, an external control unit that uses lights, sounds and written messages on the screen to communicate with the patient the operating mode of the pump itself, as well as the status of alarms, to display an alarm type where it also provides clear instructions on how to solve the problem that triggered the alarm, direct access to the alarm history through the controller without the need for external hardware (monitor), it also contains a memory with the parameters of the pump operation that can be further processed, it also shows charging status of the back up battery

Battery charger for the HeartMate3 system or equivalent, with four slots - pockets for simultaneous charging of HeartMate3 14 V lithium-ion batteries, with the option of battery calibration and diagnostics, with the ability to register battery errors and inform about them via codes on the alarm as well as registering errors on the charger and informing through alarm codes.

14V Li-ion battery connector, (set of 2 connectors) for the HeartMate3 system or equivalent, 80mm long, 92mm wide and 32mm high.

Batteries suitable for the HeartMate3 system or equivalent, 14 V lithium-ion battery, each 4.8Ah or 71 Wh, length 160 mm, width 76 mm, height 25 mm.

Mobile power supply unit for the HeartMate3 system or equivalent, with fault detection and alarm functionality, hazard alarms and warning pressure level (SPL) alarms, power supply 100-240 V AC 50-60 Hz.

Shoulder bag for carrying the control device and batteries with clips, for the HeartMate3 system or equivalent, with pockets suitable for the elements for which it is intended to be carried, with an opening for the exit of the modular cable on the right or left side depending on which shoulder it is worn

Shower bag (set of 2) for the HeartMate3 system or equivalent, impermeable to protect system components from moisture, namely the system control unit, batteries and connectors

for batteries.

Transcatheter aortic valve implantation kit contains: -transcatheter aortic valve with stent made of nitinol which has self-expanding property, intraannular leaflets of bovine pericardium that ensure early functional hemodynamic stability before final release of the valve, with active cuff, size 23 mm up to 29 mm, - introducer catheter with low insertion profile, hydrophilic coating and atraumatic conical extension to minimize vascular injury, possibility of repositioning at 80% expansion, without the use of an introducer and predilatation, with the possibility of 3 ways of access: transfemoral , subclavian or axillary - a system for inserting the valve into the introducer catheter of a size compatible with the size of the valve

A system for reconstruction of mitral valve insufficiency through tissue approximation consisting of: a delivery catheter whose extended length is greater than 65 mm, a steering sleeve with a working length of 109.5 cm and an outer diameter of the distal shaft of the catheter of 5.3 mm, an implantable clip with grip width at 120° is 17mm minimum or 22mm minimum, piston (implant) width at 180° 20mm nominal or 25mm nominal, arm width 4mm minimum - 6mm maximum and arm length 9mm maximum or 12 mm maximum, steering introducer catheter with a working length of 80 cm, dilator with a working length of 122 cm, with the possibility of adjusting the implant in any position from fully open, fully twisted and fully closed, without the need for cardiac arrest or cardiopulmonary bypass.

Проценета вредност без ДДВ: 72 000 000 MKD 💰
Времетраење: 12 месеци
Заеднички речник на набавки (CPV)
Дополнителен CPV код: LA52
Место на извршување
Главна локација или место на извршување: PHI University Clinic for State cardiac Surgery – Skopje, Mother Theresa 17/8

Правни, економски, финансиски и технички информации
Услови за учество
Способност за вршење на стручната дејност:

- 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;

… 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.

Техничка и професионална способност:

- 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.

Минимално ниво(а) на стандарди:

- Decision for placing a medical device on the market, with correctly marked positions that are subject to procurement, in accordance with the Law on Medicines and Medical Devices.

- Original catalogues and/or brochures with detailed descriptions and accurately marked items which are offered must be delivered.

Постапка
Правна основа: 32014L0024
Време за прием на понуди: 13:00
Јазици на кои може да се поднесат понуди или барања за учество: македонски 🗣️
Период на важност на понудата: 3 месеци
Датум на отворање на понудите: 2023-06-19 📅
Време на отворање на понудите: 13:00
Место: PHI University Clinic for State cardiac Surgery – Skopje, Mother Theresa 17/8
Дополнителни информации:

- Vasil Papestiev

- Dejan Dimitrovski

- Kujtim Xhelili

Договорен орган
Идентитет
Друг вид договорен орган: Public Health Institution
Контакт
Контактна точка: Frosina Stoilkovska
Адреса на профилот на купувачот: http://kardiohirurgija.mk/mk/ 🌏
URL на документи: https://www.e-nabavki.gov.mk/ 🌏

Дополнителни информации
Тело за преглед
Име: Ministry of Finance – Public Procurement Bureau
Поштенска адреса: Mother Theresa 17/building no. 8
Поштенско место: Skopje
Поштенски број: 1000
Земја: Северна Македонија 🇲🇰
Телефон: +389 75389076 📞
Е-пошта: f.stoilkovska@yahoo.com 📧
Интернет-адреса: https://www.e-nabavki.gov.mk/ 🌏
Информации за роковите за приговор: 11.06.2023; 15:30
Орган од каде што може да се добијат информации за постапката за ревизија
Исто како: Тело за преглед
Извор: OJS 2023/S 101-310317 (2023-05-22)

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