Medically implanted material

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

Medically implanted material
-Medical consumables
-Medical equipment, pharmaceuticals and personal care products

Рок

Рокот за прием на понудите беше 2023-06-15. Набавката беше објавена на 2023-05-18.

Кој?

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

Што?

• Медицинска опрема › Медицински потрошен материјал

Каде?

• Северна Македонија › Скопски

Историја на набавките

Датум	Документ
2023-05-18	Оглас за договор

Оглас за договор (2023-05-18)
Предмет
Опсег на набавката
Наслов: Medical consumables
Краток опис:

Medically implanted material -Medical consumables -Medical equipment, pharmaceuticals and personal care products

Метаподатоци на огласот
Оригинален јазик: англиски 🗣️
Вид на документ: Оглас за договор
Природа на договорот: Стоки
Регулатива: Друго
Заеднички речник на набавки (CPV)
Шифра: Медицински потрошен материјал 📦
Дополнителен CPV: Медицинска опрема, фармацевтски производи и производи за лична нега 📦
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: 2023-05-18 📅
Рок за поднесување: 2023-06-15 📅
Датум на објавување: 2023-05-23 📅
Идентификатори
Број на огласот: 2023/S 098-305969
OJ-S издание: 98
Дополнителни информации

- Vasil Papestiev - Dejan Dimitrovski - Kujtim Xhelili

Предмет
Опсег на набавката
Краток опис:

Medically implanted material

-Medical consumables

-Medical equipment, pharmaceuticals and personal care products

Проценета вкупна вредност: 10 000 000 MKD 💰
Краток опис:

Vascular graft for thoracic aorta powder (woven), polyester, impregnated with collagen, MRI safe, water permeability < 5ml/cm2/min, dilation resistant with minimum diameter range from 6-38mm and a minimum length span of 15-60cm.

ePTFE straight prosthesis reinforced with a ring along the entire length, with dimensions, minimum length of 80cm and diameter: 6mm, 7mm, 8mm.; made of expanded polytetrafluoroethylene (ePTFE)

Thromboembolectomy cath. 2Fr FOGARTY, with shaft of polyurethane with latex balloon 0.2ml, graduated, color coded, with atraumatic tip, single lumen, X-ray visible, with rigid stylet, length 67.5cm, sterile packed in hard packaging, with a tolerance of +/- 3%

Thromboembolectomy cath. 3Fr FOGARTY, (same as above) 0.6ml, graduated, color coded, with atraumatic tip, single lumen, X-ray visible, with rigid stylet, length 82cm, to be sterile packed in hard packaging, with a tolerance of +/- 3%

Thromboembolectomy catheter 4Fr FOGARTY, (same as above) 1.2ml, graduated, color coded, with atraumatic tip, single lumen, X-ray visible, with rigid stylet, length 82cm, to be sterile packed in hard packaging, with a tolerance of +/- 3%

Thromboembolectomy catheter 5Fr FOGARTY, (same as above) 3ml, graduated, color coded, with atraumatic tip, single lumen, X-ray visible, with rigid stylet, length 82cm, to be sterile packed in hard packaging, with a tolerance of +/- 3%

Thromboembolectomy catheter 6Fr FOGARTY, (same as above) 4.5ml, graduated, color coded, with atraumatic tip, single lumen, X-ray visible, with rigid stylet, length 82cm, to be sterile packed in hard packaging, with a tolerance of +/- 3%

Thromboembolectomy catheter 7Fr FOGARTY, (same as above) 5ml, graduated, color coded, with atraumatic tip, single lumen, X-ray visible, with rigid stylet, length 82cm, to be sterile packed in hard packaging, with a tolerance of +/- 3%

Thromboembolectomy catheter 8Fr FOGARTY, (same as above) 5.5ml, graduated, color coded, with atraumatic tip, single lumen, X-ray visible, with rigid stylet, length 82cm, to be sterile packed in hard packaging, with a tolerance of +/- 3%

Carotid shunts TYPE 3 Carotid shunt with "T" side branch for aspiration and irrigation; conical, with a wider end on one side of 12-15Fr., and a narrower end on the other side of 6-9Fr.; with length of 12-15 cm.

Mitral mechanical valve for mitral valve replacement. Constructed of an annular body and outside coated with polyester and Teflon. On the ring body there are two valves made of pyrolytic carbon or titanium; ring diameter size 25mm, 27mm, 29mm, 31mm, 33mm, 35mm, 37mm.; transvalvular gradient across valves of different sizes to be delivered. Valves to be with low transvalvular gradient. On the ring there should be a marker for the placement of the sutures. The valves should have the possibility to rotate (to correct the position of the discs after implantation) i.e. to be rotatable,in situ”,

Composite Ascending Aorta and Valve Replacement Graft composed of an aortic mechanical valve for intraannular implantation and vascular graft. Annular body with two valves, to be built from pyrolytic carbon. Valve ring diameter size to be 19 cm, 21cm, 23cm, 25cm, 27cm, 29cm, 31cm, the graft should be 12cm +/-10% in length, made of double woven tri-marker collagen coated suede.

Complete mitral annulus. Complete annulus for mitral valve repair; complete ring with flexible anterior part of silico/polyester and semi-rigid posterior part of cobalt/chromium; enables physiological movement of the mitral valve in the ratio 3:4; 4:4; diameter of the ring 24mm, 26mm, 28mm, 30mm, 32mm, 34mm, 36mm, 38mm, 40mm.

Tricuspid 3D Ring. Three-dimensional anatomically shaped incomplete ring for repair of tricuspid valve with a silicon and polyester coated titanium core for easing the insertion of the needle; height profile 3.3mm; diameter 26mm, 28mm, 30mm, 32mm, 34mm, 36mm

Pericardial patch from bovine pericardium, treated with glutaraldehyde, which increases durability and prevents collection etc.

Проценета вредност без ДДВ: 10 000 000 MKD 💰
Времетраење: 90 дена
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 st. 17/8, Skopje

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 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.

Техничка и професионална способност:

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

Минимално ниво(а) на стандарди:

For the registered medical devices, the economic operator must submit an approval for placing a medical device on the market or a temporary or permanent approval for parallel import, according to the Law on Medicines and Medical Devices - For the unregistered medical devices, the economic operator must submit a document allowing import (approval for intervention import) in accordance with the Law on Medicines and Medical Devices or a Certificate issued by MALMED, with which they will confirm that if they are selected in the procedure, they will be issued an import permit. - During the evaluation of the offers, if the bidder has a registration solution, it is taken as an advantage due to an already registered product

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: 2023-06-15 📅
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: 07.06.2023; 15:30
Орган од каде што може да се добијат информации за постапката за ревизија
Исто како: Тело за преглед
Извор: OJS 2023/S 098-305969 (2023-05-18)

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