Medical devices for laboratory for heart electrophysiology and electrical stimulation (electro simulators, defibrillators, electrodes, catheters etc.)

University Clinic of Cardiology

Medical devices for laboratory for heart electrophysiology and electrical stimulation (electro simulators, defibrillators, electrodes, catheters etc.).

Рок

Рокот за прием на понудите беше 2017-01-23. Набавката беше објавена на 2016-12-06.

Кој?

• University Clinic of Cardiology

Што?

Каде?

• Северна Македонија

Историја на набавките

Датум	Документ
2016-12-06	Оглас за договор

Оглас за договор (2016-12-06)
Предмет
Опсег на набавката
Наслов: Parts and accessories for pacemakers
Метаподатоци на огласот
Оригинален јазик: англиски 🗣️
Вид на документ: Оглас за договор
Природа на договорот: Стоки
Регулатива: Друго
Заеднички речник на набавки (CPV)
Шифра: Делови и опрема за пејсмејкери 📦

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: University Clinic of Cardiology
Поштенска адреса: Vodnjanska 17
Поштенски број: 1000
Поштенско место: Skopje
Контакт
Е-пошта: kardiologijaskopje@gmail.com 📧
Телефон: +389 023147576, +389 2 3147181, +389 2 3164134 📞
Факс: +389 023211662 📠

Референца
Датуми
Датум на испраќање: 2016-12-06 📅
Рок за поднесување: 2017-01-23 📅
Датум на објавување: 2016-12-09 📅
Идентификатори
Број на огласот: 2016/S 238-434883
OJ-S издание: 238
Дополнителни информации

I.1) Name, addresses and contact point(s) Contact point(s): medical aids - medical expendables for intervention cardiology (stents, wires, catheters,

Предмет
Опсег на набавката
Краток опис:

Medical devices for laboratory for heart electrophysiology and electrical stimulation (electro simulators, defibrillators, electrodes, catheters etc.).

Број на дел: 1
Наслов на делот: Biventricular pacemaker DDDR-CRT, with ‘normal optimal time’ of 5 years with two electrodes with an active / passive fixation on the right atrium and right ventricle, unipolar or bipolar electrode for coronary sinus
Краток опис:

Biventricular pacemaker DDDR-CRT, with ‘normal optimal time’ of 5 years with two electrodes with an active / passive fixation on the right atrium and right ventricle, unipolar or bipolar electrode for coronary sinus.

Број на дел: 2
Наслов на делот: Biventricular pacemaker DDDR-CRT, with ‘normal optimal time’ of 5 years
Краток опис: Biventricular pacemaker DDDR-CRT, with ‘normal optimal time’ of 5 years.
Број на дел: 3
Наслов на делот: Biventricular pacemaker DDDR, with ‘normal optimal time’ for 10 years with two electrodes with an active / passive fixation on the right atrium and right ventricle
Краток опис:

Biventricular pacemaker DDDR, with ‘normal optimal time’ for 10 years with two electrodes with an active / passive fixation on the right atrium and right ventricle.

Број на дел: 4
Наслов на делот: Biventricular pacemaker DDDR, with ‘normal optimal time’ of 10 years
Краток опис: Biventricular pacemaker DDDR, with ‘normal optimal time’ of 10 years.
Број на дел: 5
Наслов на делот: Biventricular pacemaker DDDR with the possibility of MRI with ‘normal optimal time’ of 10 years, with two electrodes with an active / passive fixation on the right atrium and right ventricle
Краток опис:

Biventricular pacemaker DDDR with the possibility of MRI with ‘normal optimal time’ of 10 years, with two electrodes with an active / passive fixation on the right atrium and right ventricle.

Број на дел: 6
Наслов на делот: Biventricular pacemaker DDD, with ‘normal optimal time’ of 10 years, with two electrodes with an active / passive fixation on the right atrium and right ventricle
Краток опис:

Biventricular pacemaker DDD, with ‘normal optimal time’ of 10 years, with two electrodes with an active / passive fixation on the right atrium and right ventricle.

Број на дел: 7
Наслов на делот: Biventricular pacemaker DDD with ‘normal optimal time’ for 10 years
Краток опис: Biventricular pacemaker DDD with ‘normal optimal time’ for 10 years.
Број на дел: 8
Наслов на делот: Biventricular pacemaker VDD with ‘normal optimal time’ for 10 years, with VDD electrode
Краток опис:

Biventricular pacemaker VDD with ‘normal optimal time’ for 10 years, with VDD electrode.

Број на дел: 9
Наслов на делот: Biventricular pacemaker VDD with ‘normal optimal time’ for 10 years
Краток опис: Biventricular pacemaker VDD with ‘normal optimal time’ for 10 years.
Број на дел: 10
Наслов на делот: Single chamber pacemaker VVI with ‘normal optimal time’ of 10 years, with electrode with active / passive fixation on the right ventricle
Краток опис:

Single chamber pacemaker VVI with ‘normal optimal time’ of 10 years, with electrode with active / passive fixation on the right ventricle.

Број на дел: 11
Наслов на делот: Single chamber pacemaker VVI, with ‘normal optimal time’ for 10 years
Краток опис: Single chamber pacemaker VVI, with ‘normal optimal time’ for 10 years.
Број на дел: 12
Наслов на делот: Single chamber pacemaker VVIR with ‘normal optimal time’ of 10 years with electrode with active / passive fixatio on the right ventricle
Краток опис:

Single chamber pacemaker VVIR with ‘normal optimal time’ of 10 years with electrode with active / passive fixatio on the right ventricle.

Број на дел: 13
Наслов на делот: Single chamber pacemaker VVIR, with ‘normal optimal time’ for 10 years
Краток опис: Single chamber pacemaker VVIR, with ‘normal optimal time’ for 10 years.
Број на дел: 14
Наслов на делот: Epicardial electrodes
Краток опис: Epicardial electrodes.
Број на дел: 15
Наслов на делот: Implantable device for the detection of rhythm disorders and continuous ECG monitoring
Краток опис:

Implantable device for the detection of rhythm disorders and continuous ECG monitoring.

Број на дел: 16
Наслов на делот: Single chamber implantable cardioverter defibrillator (ICD) with a minimum voltage of 3.2V before implantation, and a defibrillation electrode
Краток опис:

Single chamber implantable cardioverter defibrillator (ICD) with a minimum voltage of 3.2V before implantation, and a defibrillation electrode.

Број на дел: 17
Наслов на делот: Single chamber implantable cardioverter defibrillator with complete atrial diagnostics ICD DX + DX with minimum voltage before implantation of 3.2V, and a defibrillation electrode
Краток опис:

Single chamber implantable cardioverter defibrillator with complete atrial diagnostics ICD DX + DX with minimum voltage before implantation of 3.2V, and a defibrillation electrode.

Број на дел: 18
Наслов на делот: Single chamber implantable cardioverter defibrillator (ICD) with a minimum voltage before implantation of 3.2V
Краток опис:

Single chamber implantable cardioverter defibrillator (ICD) with a minimum voltage before implantation of 3.2V.

Број на дел: 19
Наслов на делот: Biventricular implantable cardioverter defibrillator (ICD), with a minimum voltage of 3.2V before implantation, in set with electrodes — atrial with active fixation, ventricular defibrillation electrode with two threads and active or passive fixation with minimum length of 70 cm
Краток опис:

Biventricular implantable cardioverter defibrillator (ICD), with a minimum voltage of 3.2V before implantation, in set with electrodes — atrial with active fixation, ventricular defibrillation electrode with two threads and active or passive fixation with minimum length of 70 cm.

Број на дел: 20
Наслов на делот: Biventricular implantable cardioverter defibrillator (CRT-ICD) with a minimum voltage of 3.2V before implantation, with electrodes — atrial electrode with an active fixation, ventricular defibrillation electrode and electrode for coronary sinus
Краток опис:

Biventricular implantable cardioverter defibrillator (CRT-ICD) with a minimum voltage of 3.2V before implantation, with electrodes — atrial electrode with an active fixation, ventricular defibrillation electrode and electrode for coronary sinus.

Број на дел: 21
Наслов на делот: Ablation catheter 4mm, with gold tip or equivalence proven by clinical studies
Краток опис: Ablation catheter 4mm, with gold tip or equivalence proven by clinical studies.
Број на дел: 22
Наслов на делот: Ablation catheter 8mm, with gold tip or equivalence proven by clinical studies
Краток опис: Ablation catheter 8mm, with gold tip or equivalence proven by clinical studies.
Број на дел: 23
Наслов на делот: Ablation catheter with mechanism for the formation of different curvature of the distal end (sterable)
Краток опис:

Ablation catheter with mechanism for the formation of different curvature of the distal end (sterable).

Број на дел: 24
Наслов на делот: Decapolar catheter (5F or 6F)
Краток опис: Decapolar catheter (5F or 6F).
Број на дел: 25
Наслов на делот: Decapolar catheter for coronary sinus
Краток опис: Decapolar catheter for coronary sinus.
Број на дел: 26
Наслов на делот: Quadripolar catheter (4F, 5F and 6F)
Краток опис: Quadripolar catheter (4F, 5F and 6F).
Број на дел: 27
Наслов на делот: Irrigated ablation catheter with a gold top or equivalence proven by clinical studies
Краток опис:

Irrigated ablation catheter with a gold top or equivalence proven by clinical studies.

Број на дел: 28
Наслов на делот: Decapolar twenty electrode catheter
Краток опис: Decapolar twenty electrode catheter.
Број на дел: 29
Наслов на делот: Long introducer for electrophysiology (8F)
Краток опис: Long introducer for electrophysiology (8F).
Број на дел: 30
Наслов на делот: Ablative quadripolar catheter (thermocouple) (7F)
Краток опис: Ablative quadripolar catheter (thermocouple) (7F).
Број на дел: 31
Наслов на делот: Decapolar decapolar catheter
Краток опис: Decapolar decapolar catheter.
Број на дел: 32
Наслов на делот: Introducer 7 F, 8 F, 9 F and 10 or 10.5 F (peel-away) — needle and wire set
Краток опис: Introducer 7 F, 8 F, 9 F and 10 or 10.5 F (peel-away) — needle and wire set.
Број на дел: 33
Наслов на делот: Introducers (catheters) for subselection tortuous branches of coronary sinus
Краток опис: Introducers (catheters) for subselection tortuous branches of coronary sinus.
Број на дел: 34
Наслов на делот: Introducers m/t SIDE PORT 6F
Краток опис: Introducers m/t SIDE PORT 6F.
Број на дел: 35
Наслов на делот: Introducers m/t SIDE PORT 8F
Краток опис: Introducers m/t SIDE PORT 8F.
Број на дел: 36
Наслов на делот: Transseptal introducer, in set
Краток опис: Transseptal introducer, in set.
Број на дел: 37
Наслов на делот: Self-adhesive electrodes for pacing and defibrillation
Краток опис: Self-adhesive electrodes for pacing and defibrillation.
Број на дел: 38
Наслов на делот: Cable for stimulation of the heart through the tester programmer
Краток опис: Cable for stimulation of the heart through the tester programmer.
Место на извршување
Главна локација или место на извршување: Clinic of Cardiology — Skopje.

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

Statement of economic operator that in the last 5 years there was no effective conviction for participation in criminal organization, corruption, fraud or money laundering.

— Certificate that any competent authority has initiated no open…

… bankruptcy procedure.

… liquidation procedure.

— Certificate for paid taxes, contributions and other public payments by competent authority in the country where the economic operator has been registered in.

— Certificate from the Register of penalties for crimes committed by legal persons that there is no minor penalty that prohibits participation in procedures for public announcement, awarding contracts on public procurements and contract for public-private partnership

— Certificate from Register of penalties for crimes committed by legal persons that there is no effective conviction for temporary or permanent prohibition to perform certain activity

— Certificate that there is no effective conviction by which infringement sanction has been imposed on — interdiction for professional activities, activities or duties, i.e. temporary interdiction of separate activity realization.

Техничка и професионална способност:

Document for registered activity

— Document for registered activity — DRA or Registered Activity Form — Decision for wholesale of medical devices issued by the Agency for Medicines and Medical Devices

Statement by the economic operator that if selected as the best to provide continuous education of physicians during the duration of the contract (education on programming of apparatus, introduction of new techniques, training, etc.) It will be considered that the economic operator hired technical staff whether or not it belongs to the economic operator. Additionally, in support of the statement, in the event the technical staff is employed by the economic operator, an appropriate evidence will be needed, issued by a competent authority, that those persons are employed by him, or if not employed by him, a statement that will be made available to the economic operator if it is selected as the winning bidder shall be submitted. — Statement by the economic operator that he will provide accessible team of medical engineers to consult a doctor about implanted devices — Statement by the economic operator that he will provide service to the programmer if there is an obstacle in its operation, at the request of a doctor within 24 hours. — Statement by the economic operator that if selected as the most favourable, he will provide free use and software upgrades of at least two programmers for electro simulators during the duration of the contract. For the registered medical devices: Decision for marketing a medical device or temporary or permanent approval for parallel import, in accordance with the Law on Medicines and Medical Devices. For unregistered medical devices: — Import Permit (approval for interventional import), in accordance with the Law on Medicines and Medical Devices.

Minimum criteria for determining the technical and professional condition of the economic operator:

For the registered medical devices: Decision for marketing a medical device or temporary or permanent approval for parallel import, in accordance with the Law on Medicines and Medical Devices. For unregistered medical devices: — Import Permit (approval for interventional import), in accordance with the Law on Medicines and Medical Devices. Statement by the economic operator that if selected as the best to provide continuous education of physicians during the duration of the contract (education on programming of apparatus, introduction of new techniques, training, etc.) It will be considered that the economic operator hired technical staff whether or not it belongs to the economic operator. Additionally, in support of the statement, in the event the technical staff is employed by the economic operator, an appropriate evidence will be needed, issued by a competent authority, that those persons are employed by him, or if not employed by him, a statement that will be made available to the economic operator if it is selected as the winning bidder shall be submitted. — Statement by the economic operator that he will provide accessible team of medical engineers to consult a doctor about implanted devices — Statement by the economic operator that he will provide service to the programmer if there is an obstacle in its operation, at the request of a doctor within 24 hours. — Statement by the economic operator that if selected as the most favourable, he will provide free use and software upgrades of at least two programmers for electro simulators during the duration of the contract.

Извршување на договорот
Потребни депозити и гаранции: Offer guarantee: Yes [3.00 %].

Постапка
Јазици
Други јазици: Macedonian.

Договорен орган
Идентитет
Друг вид договорен орган: Other
Име на органот кој доделува: Clinical Hospital ‘Trifun Panovski’
Поштенска адреса: Partizanska bb
Поштенско место: Bitola
Поштенски број: 4000
Контакт
Контактна точка: Meri Mandalova

Референца
Дополнителни информации

I.1) Name, addresses and contact point(s)

Contact point(s): medical aids - medical expendables for intervention cardiology (stents, wires, catheters,

Извор: OJS 2016/S 238-434883 (2016-12-06)

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