Instruments and materials for open and laparoscopic surgery and titanium clips

Public Health Institute University Urology Clinic, Skopje

Instruments and materials for open and laparoscopic surgery and titanium clips.

Рок

Рокот за прием на понудите беше 2015-07-02. Набавката беше објавена на 2015-05-18.

Добавувачи

Следните добавувачи се споменати во одлуките за доделување или други документи за набавка:

Кој?

• Public Health Institute University Urology Clinic, Skopje

Што?

Каде?

• Северна Македонија

Историја на набавките

Датум	Документ
2015-05-18	Оглас за договор
2015-10-06	Оглас за доделување договор

Оглас за договор (2015-05-18)
Предмет
Опсег на набавката
Наслов: Surgical instruments
Количина или опсег: 5 700 000
Вкупна вредност на набавката: 5 700 000 💰
Метаподатоци на огласот
Оригинален јазик: англиски 🗣️
Вид на документ: Оглас за договор
Природа на договорот: Стоки
Регулатива: Друго
Заеднички речник на набавки (CPV)
Шифра: Хируршки инструменти 📦

Постапка
Вид на постапка: Отворена постапка
Вид на понуда: Поднесување за еден или повеќе делови
Критериуми за доделување
Најниска цена

Договорен орган
Идентитет
Земја: Северна Македонија 🇲🇰
Вид на органот кој доделува: Друго
Име на органот кој доделува: Public Health Institute University Urology Clinic, Skopje
Поштенска адреса: Vodnjanska br. 17
Поштенски број: 1000
Поштенско место: Skopje
Контакт
Е-пошта: urologijaklinika@yahoo.com 📧
Телефон: +389 23147032 📞
Факс: +389 23147233 📠

Референца
Датуми
Датум на испраќање: 2015-05-18 📅
Рок за поднесување: 2015-07-02 📅
Датум на објавување: 2015-05-22 📅
Идентификатори
Број на огласот: 2015/S 098-178203
OJ-S издание: 98
Дополнителни информации

https://www.e-nabavki.gov.mk/PublicAccess/home.aspx#/dossie/bd548ea4-347c-4d3c-af7b-f056aa5b02ba/Open

Предмет
Опсег на набавката
Краток опис: Instruments and materials for open and laparoscopic surgery and titanium clips.
Број на дел: 1
Наслов на делот: Laparoscopic instruments and Trocars with an opaque cannula and with the possibility of separating the convector from the body of the trocar with a blade — Trocar system
Краток опис:

Trocar system comprised of black ribbed fixating cannula, obturator with a linear blade V-shaped and safety parabolic shield that covers the knife blade. Knife is revealed only when applied pressure penetration through the abdominal wall and brake release. To possess optical and auditory click indicator when the knife blade is uncovered. To possess two-leaflets valve and insufflation port with three positions. — Trocar System composed of black ribbed fixation cannula with self-adaptive universal convector 5-11 mm (2-leaflets and round valve) and the possibility of placing instruments from 5 to 11 mm without losing the pneumoperitoneum. Obturator with linear blade V-shaped and safety parabolic shield covering the knife blade. Knife is revealed only when applied pressure penetration through the abdominal wall and brake release. To possess optical and auditory click indicator when the knife blade is uncovered. To possess insufflation port with 3 positions. —Trocar System composed of black ribbed fixation cannula with self-adaptive universal convector 5-12 mm (2-leaflets and round valve) and the possibility of placing instruments from 5 to 12 mm without losing the pneumoperitoneum. Obturator with a linear blade V-shaped and safety parabolic shield covering the blade. Knife is revealed only when applied pressure penetration through abdominal wall and brake release. To possess optical and auditory click indicator when the knife blade is uncovered. To possess insufflation port with 3 positions.

Број на дел: 2
Наслов на делот: Laparoscopic instruments and Trocars with an opaque cannula and with the possibility of separating of the convector from the body of the trocar without a blade
Краток опис:

Trocar system composed of ribbed fixating cannula and obturator without a blade with a plastic tip for directing, side wings for dissection and retractable dilatation shield. To possess 2-leaflets valve and insufflation port with 3 positions. Trocar system composed of ribbed fixating cannula and obturator without blade with a plastic tip for directing, side wings for dissection and retractable dilatation shield. To possess universal self-adaptive convector 5-11 mm (two-leaflets and round valve) and the possibility of placing instruments from 5 to 11 mm without losing the pneumoperitoneum and insufflation port with three positions. Trocar system composed of ribbed fixating cannula and obturator without blade with a plastic tip for directing, side wings for dissection and retractable dilatation shield. To possess universal self-adaptive convector 5-12 mm ( two-leaflets and round valve) and the possibility of placing instruments from 5 to 12 mm without losing the pneumoperitoneum and insufflation port with three positions. - Trocar system composed of ribbed fixating cannula and obturator without blade with a plastic tip for directing, side wings for dissection and retractable dilatation shield. Possess universal self-adaptive convector 10-15 mm (two-leaflets and round valve) and the possibility of placing the instruments from 5 to 15 mm without losing the pneumoperitoneum with additional valve and insufflation port with three positions.

Број на дел: 3
Наслов на делот: Endoscopic Staplers and cartridges with integrated knife blade in the cartridge, with equal variable dimension of the clips, tissue reinforcement and diameter of 12 mm
Краток опис:

Laparoscopic articular rotating stapler, only the instrument with 360 ° rotating body of the instrument and a button for 5 positions of articulation in each direction. Ability to use the straight and articulated cartridge length 30 mm, 45 mm and 60 mm. Possibility of use of cartridge with equal dimensions of clips, cartridges with growing clips, and cartridge with integrated strengthening of tissue - Articulated cartridge with two triple rows of titanium clips with dimensions that grow from medial to lateral, curved top and new blade knife between them for articulated and rotary stapler from lot 1 - Straight cartridge with two triple rows of titanium clips and a new knife between them, for articulated and rotary stapler from lot 1 - Articulated cartridge two triple rows of titanium clip dimensions that grow from medial to laterally and new knife blade between them, for articulated and rotary stapler from lot 1 - Straight cartridge with two triple rows of titanium clips and a new blade knife between them,for articulated and rotary stapler from Lot 1.

Број на дел: 4
Наслов на делот: Endoscopic staplers with 12 mm diameter and cartridges without a blade knife for laparoscopic interventions
Краток опис:

Laparoscopic vascular stapler consisting of instrument and cartridge with three rows of titanium clips - Cartridge with three rows of titanium clips for laparoscopic vascular stapler from Lot 1.

Број на дел: 5
Наслов на делот: Instrument- electrode compatible to Force Triad and Ligasure generators or equivalent
Краток опис:

For open surgery with electrode with length of 22 mm, with 20 mm knife blade and manual activation.

Број на дел: 6
Краток опис:

For open surgery with electrode length 18 mm, knife blade 12 mm, manual activation and dolphin top.

Број на дел: 7
Краток опис:

For open surgery with electrode, length 19,5 mm, knife blade 18 mm, manual activation and blunt tip.

Број на дел: 8
Краток опис:

For open surgery with a hand grip, curved jaw with length 16,5 mm and length of knife blade 15 mm, with manual automatic activation.

Број на дел: 9
Краток опис:

For open surgery with a curved jaw, length 36 mm and knife blade length 34 mm, with manual activation.

Број на дел: 10
Краток опис:

For laparoscopic surgery with electrode, length 22 mm with 20 mm knife blade and manual activation.

Број на дел: 11
Краток опис:

For laparoscopic surgery with electrode, length 18 mm, blade 12 mm, manual activation and dolphin top.

Број на дел: 12
Краток опис:

For laparoscopic surgery with electrode, length 19,5 mm, knife blade 18 mm, manual activation and blunt tip and unilateral jaw opening.

Број на дел: 13
Краток опис:

For laparoscopic surgery with electrode, length 19,5 mm, knife blade 18 mm, manual activation and blunt, rounded tip and double-sided jaw opening.

Број на дел: 14
Краток опис:

For laparoscopic surgery with bilateral curved electrode, length 18 mm, with a knife blade 15,5 mm, with monopolar pin and manual activation.

Број на дел: 15
Наслов на делот: Endoscopic Automatic Clip Applier, 360 ° rotating body with a diameter of 5 mm and a working length 9-33 cm
Краток опис:

Pre-filled with 15-20 locking titanium clips and LCD screen that shows the number of clips. The Clip Applier to have a mechanism for leveling of the jaws to prevent their crossing. Closing the clips to be towards the head. Jaw to be empty, with the option of putting down the clips in the jaw before closing, front and side opening of the jaw. To have a safety locking mechanism for the handle after firing all the clips.

Број на дел: 16
Наслов на делот: Endoscopic Automatic Clip Applier
Краток опис:

360 ° rotating body diameter and 10 mm, working length 29-33 cm, pre-filled with 15-20 locking titanium clips. Closing of the clips to be from the feet towards the head. The jaw to be empty, with the option of putting down the clips in the jaw before closing, front and side opening of the jaw. To have safety locking mechanism for the handle after firing all the clips and a visible indicator.

Број на дел: 17
Краток опис:

360 ° rotating body with diameter of 10 mm, working length 29-33 cm, pre-filled with 15-20 locking titanium clips. Closing of the clips to be from the feet towards the head. The jaw to be empty, with the option of putting down the clips in the jaw before closing, front and side opening of the jaw, head and side opening of the jaw. To have a safety locking mechanism for the handle after firing all the clips and visible indicator.

Број на дел: 18
Краток опис:

360 ° rotating body with 29-33 mm diameter, pre-filled with 15-20 locking titanium clips. The opening of the jaws is on the side, an angle of 90 ° with the body of the instrument.

Број на дел: 19
Наслов на делот: Automatic Clip Applier for open surgery
Краток опис:

With front opening of the jaw and the jaw angle of 30 ° and a mechanism for automatic closing off of the clip, with a length of 9.5 to 11.5 inches, pre-filled with 15-30 titanium locking clips with rectangular form of section 0,47 mm x 0,76 mm and span of the jaws of 3,5-4 mm.

Број на дел: 20
Наслов на делот: Polyurethane laparoscopic bags for extracting sample
Краток опис:

With circular metal grip, thread for closing the bag and separation of circular metal grip and body of the instrument with a diameter of 15 mm.

Број на дел: 21
Краток опис:

With circular metal grip, thread for closing the bag and separation of the circular grip and metal body of instrument with a diameter of 10 mm.

Број на дел: 22
Наслов на делот: Polyurethane laparoscopic bags for extracting sample with a diameter of the instrument body of 10 mm
Број на дел: 23
Наслов на делот: Memory laparoscopic bag
Краток опис:

For 10 mm trocar with nitinol wire with memory effect vol. 1 200 ml, extronic bag 130 mm.

Број на дел: 24
Наслов на делот: Above the knee pair of cuffs compatible to device for intermittent pneumatic compression SCD express or equivalent
Количина или опсег: Size S; 10 pieces.
Број на дел: 25
Количина или опсег: Size: M 90 pieces.
Број на дел: 26
Количина или опсег: Size: L 20 pieces.
Број на дел: 27
Наслов на делот: Covers for the upper part of the body
Краток опис:

Made of dual-layer light material resistant to breakage, liquid and sting, latex-free, RTG transparent with no influence to RTG rays, for adult patients, suitable (optional) for operating room compatible to already existing heater clinic Warmtouch 6000 or equivalent.

Број на дел: 28
Наслов на делот: Monopolar laparoscopic scissors with curve METZENBAUM or equivalent
Краток опис:

Serrated, and curved peaks to the left, with inserted tungsten carbide steel for greater strength - length 29-33 cm diameter of 5 mm, with the opportunity to disassemble the constituent parts. The handle to be with ergonomic design without braking mechanism, with large contact area for the fingers and to be isolated with a special polymer PEEK (polyether-etherketone), jaw (16mm) to be serrated, to have insulated outer tube 5/5 mm and 29-33 cm length.

Број на дел: 29
Наслов на делот: Laparoscopic instrument with articulation and with range of five fingers
Број на дел: 30
Наслов на делот: Curved scissors for open surgery compatible to the existing Harmonic Generator with manual activation 14 cm / 5 mm, scissors handle grip or equivalent
Број на дел: 31
Наслов на делот: Curved scissors for open surgery compatible to the existing Harmonic generator with manual activation 23 cm / 5 mm, gun scissors or equivalent
Број на дел: 32
Наслов на делот: Curved scissors for endoscopic surgery compatible to the existing Harmonic generator with manual activation 36 cm / 5 mm, gun scissors or equivalent
Број на дел: 33
Наслов на делот: Reabsorptive prosthesis for kidney built from polyglactin 910
Број на дел: 34
Наслов на делот: Special ureteral cystoscope catheter with wire basket for the extraction of stone from the ureter, Metal 4 helical wire from nitinol for extraction of calculus of ureter
Количина или опсег: Length: 60cm-65cm; 2.5-4.6 Fr.
Број на дел: 35
Количина или опсег: Length: 90cm-95cm; 2.5-4.6 Fr.
Број на дел: 36
Количина или опсег: Length: 110cm-120cm; 2.5-4.6 Fr.
Број на дел: 37
Наслов на делот: Special ureteral cystoscope catheter with wire basket for the extraction of stone from the ureter, Metal 3 helical wire from nitinol for extraction calculus of ureter
Број на дел: 38
Наслов на делот: Special ureteral cystoscope catheter with wire basket for the extraction of stone from the ureter, metal wire from nitinol for extraction of ureteric calculus with side adapter handle, type parallel 3-6 wire basket
Број на дел: 39
Наслов на делот: Special ureteral cystoscope catheter with wire basket for the extraction of stone from ureter, metal wire from nitinol for extraction of ureteric calculus with side adapter handle type helical 3-6 wire basket
Број на дел: 40
Наслов на делот: Titanium clips for ligation, placed in warehouse compatible for existing clip applicators Aesculap / Small or equivalent
Број на дел: 41
Наслов на делот: Titanium clips for ligation, placed in warehouse compatible for existing clip applicators Aesculap / Medium or equivalent
Број на дел: 42
Наслов на делот: Titanium clips for ligation, placed in warehouse compatible for existing clip applicators Aesculap / Medium-Large or equivalent
Број на дел: 43
Наслов на делот: Titanium clips for ligation, placed in warehouse compatible for existing clip applicators Aesculap / Large or equivalent
Број на дел: 44
Наслов на делот: Biopsy gun for multiple use with a choice of two depths of penetration of 15 mm and 22 mm
Број на дел: 45
Наслов на делот: Needle biopsy - pink
Број на дел: 46
Наслов на делот: Plastic clips from non-absorptive polymer with secure protection system composed of 1x2 teeth. 5-13 mm, compatible to existing Hem-o-lok Aplaer or equivalent.
Број на дел: 47
Наслов на делот: Plastic clips from non-absorptive polymer with secure protection system composed of 1x2 teeth. 7-16 mm, compatible for existing Hem-o-lok Aplaer or equivalent.
Времетраење: 12 месеци
Референтен број: 04/2015
Место на извршување
Главна локација или место на извршување:

Public Health Institute University Urology Clinic, Skopje, Vodnjanska br. 17, 1000 Skopje, R. Macedonia.

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

— Statement by the economic operator than it has not been sentenced, in the last 5 years, with effective court decision for participation in criminal organization, corruption, fraud or money laundering.

— Certificate that it is not subject to bankruptcy procedure issued by competent authority.

— Certificate that it is not subject to liquidation procedure issued by competent authority.

— Certificate for paid taxes, contributions and other public duties by the competent authority in the country where that economic operator is established.

— Certificate from the Legal Entities Penal Registry that it is not being imposed a side sanction —…

… prohibition to participate in public competitions, public procurement contract award and public-private partnership contract award procedures.

… temporary or permanent prohibition to perform certain professional activity.

— Certificate that it is not being sanctioned for misdemeanor with an effective court decision, resulting in prohibition for pursuing professional activity or duty, i.e. temporary prohibition for performing certain activity.

To prove its ability for performing professional activity the economic operator must submit:

— Document for registered activity;

Document for registered activity as evidence that it is registered as a physical or legal entity for performing the activity related to the subject of the contract or proof that it belongs to a relevant professional association in accordance with the regulations of the country where it is registered.

— To be able to wholesale medical devices the legal entity needs to submit — Permission for wholesale of medical devices issued by the Ministry of Health (in accordance with the Law of of drugs and medical devices).

Економска и финансиска состојба:

Given the value of the procurement economic operators need to have a positive financial result in the last three years or for the period for which records exist.

Минимално ниво(а) на стандарди:

— Balance sheet report certified by a competent authority, i.e. audited balance sheets or extracts from the balance sheets report in case when publication of the balance sheet is required under the law of the country in which the economic operator is registered.

— Statement of the total company turnover (data from the income statement issued by a competent authority, i.e. audited income statement) and, where appropriate, of turnover in the area covered by the contract of public procurement for the latest three financial years the most for which such data is available depending on the date on which the company was set up or started operating.

— Balance sheet report and report of the income statement certified by a competent authority, i.e. audited balance sheets or extracts from the balance sheets in cases when publication of the balance sheet is required under the law of the country in which the economic operator is registered.

Техничка и професионална способност:

— Successful delivery of goods identical or closely related to the object of public procurement.

— The products subject to the procurement are already in use in developed European countries, USA and Republic of Macedonia.

— The offered supplies of all lots to have a document from which it is clear that it can be sold on the territory of Republic of Macedonia. — This means that medical products are produced according to certain quality standards based on relevant European and international standards or equivalent certificates issued form institutions based in the countries members of the EU and are produced in accordance with MDD/93/42/EEC, i.e. the medical device is already in sale in the country of the producer in accordance with ЕN ISO 13485/4,which means compliance of the product with the directive of EU for medical devices, according to the international nomenclature of medical devices. If the bidder is a foreign legal entity because the tender was published in international journal then the bidder must submit proof that the products are produced according to certain quality standards based on relevant European and international standards or equivalent certificates issued form institutions based in the countries members of the EU and are produced in accordance with MDD/93/42/EEC, i.e. the medical device is already in sale in the country of the producer in accordance with ЕN ISO 13485/4,which means compliance of the product with the directive of EU for medical devices, according to the international nomenclature of medical devices.

— The bidder to have available photos or catalogs that match the required medical supplies in the technical specification, in which will be described the offered materials provided with dimensions, characteristics.

Минимално ниво(а) на стандарди:

— List of the main deliveries of the bidders or candidates completed in the last three years, with values, dates, buyers (contracting authorities or economic operators) by providing certificate for realized deliveries issued by the recipients for timely and proper delivery of materials subject to the agreement, or if such certificates can not be provided for reasons beyond the control of the economic operator, then only its statement of the completed deliveries.

— Reference list of users in the EU, USA, RM

— Bidders from the country must submit: Decision/Certificate from the Ministry of Health of RM for each product that is object of the procurement, that are registered on the territory of RM and that have an approval for sale of medical devices on the territory of RM. Foreign bidders should submit photocopies of: 1.Free Sale certificate or equivalent, 2. Declaration of conformity- or equivalent certificate issued by the manufacturer to verify that the product corresponds to the prescribed quality systems, 3. EC / CE certificate or equivalent Certificate that proves that the product corresponds to the standards of the EU.

— To submit catalogs or pictures in which the offered materials are described with dimensions and characteristics and its clear that they match the description given in the technical specifications.

Постапка
Период на важност на понудата: 120 дена
Датум на отворање на понудите: 2015-07-02 📅
Место на отворање: PHI University Urology Clinic, Skopje.
Место: PHI University Urology Clinic, Skopje.
Јазици
Други јазици: Macedonian.

Договорен орган
Идентитет
Друг вид договорен орган: Other
Контакт
Контактна точка: Milena Mitrova
URL за учество: http://www.e-nabavki.gov.mk 🌏

Референца
Идентификатори
Референтен број доделен од договорниот орган: 04/2015

Дополнителни информации
Тело за преглед
Име: State Appeals Commission for Public Procurement
Поштенско место: Skopje
Поштенски број: 1000
Земја: Северна Македонија 🇲🇰
Интернет-адреса: http://www.dkzjn.mk 🌏
Извор: OJS 2015/S 098-178203 (2015-05-18)

Оглас за доделување договор (2015-10-06)
Предмет
Опсег на набавката
Вкупна вредност на набавката: 7 600 000 💰
Метаподатоци на огласот
Вид на документ: Оглас за доделување договор

Постапка
Вид на понуда: Не е применливо

Договорен орган
Идентитет
Поштенска адреса: Vodnjanska br.17

Референца
Датуми
Датум на испраќање: 2015-10-06 📅
Датум на објавување: 2015-10-09 📅
Идентификатори
Број на огласот: 2015/S 196-355762
Се однесува на оглас: 2015/S 98-178203
OJ-S издание: 196

Доделување договор

1️⃣
Датум на склучување на договорот: 2015-09-25 📅
Име: Meditrejd 94
Поштенска адреса: ul. Skupi 3. br. 55
Поштенско место: Skopje
Поштенски број: 1000
Земја: Северна Македонија 🇲🇰

2️⃣
Име: DTU Komed DOOEL
Поштенска адреса: ul. Dame Gruev br. 5/8

3️⃣
Име: AD Dr. Panovski Skopje
Поштенска адреса: Skupi 3 br. 55

4️⃣
Име: Promedika DOOEL Skopje
Поштенска адреса: Sv. Kiril i Metodij br. 50
Информации за понудите
Број на примените понуди: 1
Извор: OJS 2015/S 196-355762 (2015-10-06)

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