Medical implants

Medical consumables ePTFE straight prosthesis reinforced with a ring along the entire length, with dimensions, minimum length of 40cm and diameter: 7mm, 8mm.; made of expanded polytetrafluoroethylene (ePTFE) Vascular graft for thoracic aorta, woven fabric, polyester, impregnated with collagen, resistant to dilation with a minimum diameter range of 20-38mm and …

CPV: 33140000 Materiały medyczne
Termin:
26 maja 2025 13:00
Rodzaj terminu:
Złożenie oferty
Miejsce wykonania:
Medical implants
Miejsce udzielenia zamówienia:
PHI University Clinic for State Cardiac Surgery Skopje
Numer nagrody:
07431/2025

1. Buyer

1.1 Buyer

Official name : PHI University Clinic for State Cardiac Surgery Skopje
Legal type of the buyer : Body governed by public law
Activity of the contracting authority : Health

2. Procedure

2.1 Procedure

Title : Medical implants
Description : Medical consumables
Procedure identifier : cc07f0e4-c088-4931-8fc6-f2a409e5a697
Internal identifier : 07431/2025
Type of procedure : Open
The procedure is accelerated : no
Justification for the accelerated procedure :
Main features of the procedure :

2.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33140000 Medical consumables

2.1.2 Place of performance

Postal address : Majka Tereza 17/building no. 8
Town : Skopje
Postcode : 1000
Country subdivision (NUTS) : Скопски ( MK008 )
Country : North Macedonia

2.1.3 Value

Estimated value excluding VAT : 10 000 000 Denar

2.1.4 General information

Legal basis :
Directive 2014/24/EU

2.1.5 Terms of procurement

Terms of submission :
Maximum number of lots for which one tenderer can submit tenders : 16
Terms of contract :
Maximum number of lots for which contracts can be awarded to one tenderer : 16

2.1.6 Grounds for exclusion

Sources of grounds for exclusion : Notice
Bankruptcy : certificate stating that no bankruptcy procedure has been initiated by a competent body
Grave professional misconduct : 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
Assets being administered by liquidator : certificate stating that no liquidation procedure has been initiated by a competent body
Breaching obligation relating to payment of taxes : certificate of paid taxes, contributions and other public duties issued by a competent body in the country where the economic operator is registered
Business activities are suspended : certificate from the Register of penalties for committed criminal offenses of legal entities proving that no secondary penalty - temporary or permanent ban on performing particular activity has been pronounced;

5. Lot

5.1 Lot technical ID : LOT-0001

Title : ePTFE straight prosthesis
Description : ePTFE straight prosthesis reinforced with a ring along the entire length, with dimensions, minimum length of 40cm and diameter: 7mm, 8mm.; made of expanded polytetrafluoroethylene (ePTFE)
Internal identifier : Lot 1

5.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33140000 Medical consumables
Quantity : 12 piece

5.1.2 Place of performance

Country subdivision (NUTS) : Скопски ( MK008 )
Country : North Macedonia
Additional information : /

5.1.3 Estimated duration

Duration : 12 Month

5.1.6 General information

Reserved participation : Participation is not reserved.
Procurement Project not financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : yes

5.1.9 Selection criteria

Sources of selection criteria : Notice
Criterion : Certificates by independent bodies about quality assurance standards
Description : Decision for placing ready medicine on the market, or a temporary or permanent decision for parallel import issued by the Agency for Medicines and Medical Devices must be submitted for all registered medicines.
Criterion : Enrolment in a trade register
Description : - 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.
Criterion : Enrolment in a relevant professional register
Description : Certificate for wholesale of medical devices pursuant to the Law on Medicines and Medical Devices.
Criterion : Samples, descriptions, or photographs with certification of authenticity for supply contracts
Description : Original catalogues and/or brochures with detailed descriptions and accurately marked items which are offered

5.1.11 Procurement documents

Languages in which the procurement documents are officially available : Macedonian
Deadline for requesting additional information : 18/05/2025 15:30 +02:00

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Allowed
Address for submission : https://www.e-nabavki.gov.mk/
Languages in which tenders or requests to participate may be submitted : Macedonian
Electronic catalogue : Not allowed
Variants : Not allowed
Deadline for receipt of tenders : 26/05/2025 13:00 +02:00
Deadline until which the tender must remain valid : 90 Day
Information about public opening :
Opening date : 26/05/2025 13:00 +02:00
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No
Electronic invoicing : Not allowed
Electronic ordering will be used : no
Electronic payment will be used : no

5.1.15 Techniques

Framework agreement :
No framework agreement
Information about the dynamic purchasing system :
No dynamic purchase system

5.1.16 Further information, mediation and review

Review organisation : State Commission for Public Procurement Appeals -
Information about review deadlines : 18.05.2025

5.1 Lot technical ID : LOT-0002

Title : Vascular graft
Description : Vascular graft for thoracic aorta, woven fabric, polyester, impregnated with collagen, resistant to dilation with a minimum diameter range of 20-38mm and a minimum length of 20cm.
Internal identifier : Lot 2

5.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33140000 Medical consumables
Quantity : 40 piece

5.1.2 Place of performance

Country subdivision (NUTS) : Скопски ( MK008 )
Country : North Macedonia
Additional information : /

5.1.3 Estimated duration

Duration : 12 Month

5.1.6 General information

Reserved participation : Participation is not reserved.
Procurement Project not financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : yes

5.1.9 Selection criteria

Sources of selection criteria : Notice
Criterion : Certificates by independent bodies about quality assurance standards
Description : Decision for placing ready medicine on the market, or a temporary or permanent decision for parallel import issued by the Agency for Medicines and Medical Devices must be submitted for all registered medicines.
Criterion : Enrolment in a trade register
Description : - 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.
Criterion : Enrolment in a relevant professional register
Description : Certificate for wholesale of medical devices pursuant to the Law on Medicines and Medical Devices.
Criterion : Samples, descriptions, or photographs with certification of authenticity for supply contracts
Description : Original catalogues and/or brochures with detailed descriptions and accurately marked items which are offered

5.1.11 Procurement documents

Languages in which the procurement documents are officially available : Macedonian
Deadline for requesting additional information : 18/05/2025 15:30 +02:00

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Allowed
Address for submission : https://www.e-nabavki.gov.mk/
Languages in which tenders or requests to participate may be submitted : Macedonian
Electronic catalogue : Not allowed
Variants : Not allowed
Deadline for receipt of tenders : 26/05/2025 13:00 +02:00
Deadline until which the tender must remain valid : 90 Day
Information about public opening :
Opening date : 26/05/2025 13:00 +02:00
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No
Electronic invoicing : Not allowed
Electronic ordering will be used : no
Electronic payment will be used : no

5.1.15 Techniques

Framework agreement :
No framework agreement
Information about the dynamic purchasing system :
No dynamic purchase system

5.1.16 Further information, mediation and review

Review organisation : State Commission for Public Procurement Appeals -
Information about review deadlines : 18.05.2025

5.1 Lot technical ID : LOT-0003

Title : Thromboembolectomy catheter
Description : Thromboembolectomy catheter 2Fr FOGARTY, with polyurethane shaft with latex balloon 0.2ml, graduated, color coded, with atraumatic tip, single lumen, radiopaque, with rigid stylet, length 67.5cm, sterile to be packed in hard packaging, with a tolerance of +/- 3%
Internal identifier : Lot 3

5.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33140000 Medical consumables
Quantity : 10 piece

5.1.2 Place of performance

Country subdivision (NUTS) : Скопски ( MK008 )
Country : North Macedonia
Additional information : /

5.1.3 Estimated duration

Duration : 12 Month

5.1.6 General information

Reserved participation : Participation is not reserved.
Procurement Project not financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : yes

5.1.9 Selection criteria

Sources of selection criteria : Notice
Criterion : Certificates by independent bodies about quality assurance standards
Description : Decision for placing ready medicine on the market, or a temporary or permanent decision for parallel import issued by the Agency for Medicines and Medical Devices must be submitted for all registered medicines.
Criterion : Enrolment in a trade register
Description : - 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.
Criterion : Enrolment in a relevant professional register
Description : Certificate for wholesale of medical devices pursuant to the Law on Medicines and Medical Devices.
Criterion : Samples, descriptions, or photographs with certification of authenticity for supply contracts
Description : Original catalogues and/or brochures with detailed descriptions and accurately marked items which are offered

5.1.11 Procurement documents

Languages in which the procurement documents are officially available : Macedonian
Deadline for requesting additional information : 18/05/2025 15:30 +02:00

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Allowed
Address for submission : https://www.e-nabavki.gov.mk/
Languages in which tenders or requests to participate may be submitted : Macedonian
Electronic catalogue : Not allowed
Variants : Not allowed
Deadline for receipt of tenders : 26/05/2025 13:00 +02:00
Deadline until which the tender must remain valid : 90 Day
Information about public opening :
Opening date : 26/05/2025 13:00 +02:00
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No
Electronic invoicing : Not allowed
Electronic ordering will be used : no
Electronic payment will be used : no

5.1.15 Techniques

Framework agreement :
No framework agreement
Information about the dynamic purchasing system :
No dynamic purchase system

5.1.16 Further information, mediation and review

Review organisation : State Commission for Public Procurement Appeals -
Information about review deadlines : 18.05.2025

5.1 Lot technical ID : LOT-0004

Title : Thromboembolectomy catheter
Description : Thromboembolectomy catheter 3Fr FOGARTY, with polyurethane shaft with latex balloon 0.2ml, graduated, color coded, with atraumatic tip, single lumen, radiopaque, with rigid stylet, length 82cm, sterile to be packed in hard packaging, with a tolerance of +/- 3%
Internal identifier : Lot 4

5.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33140000 Medical consumables
Quantity : 10 piece

5.1.2 Place of performance

Country subdivision (NUTS) : Скопски ( MK008 )
Country : North Macedonia
Additional information : /

5.1.3 Estimated duration

Duration : 12 Month

5.1.6 General information

Reserved participation : Participation is not reserved.
Procurement Project not financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : yes

5.1.9 Selection criteria

Sources of selection criteria : Notice
Criterion : Certificates by independent bodies about quality assurance standards
Description : Decision for placing ready medicine on the market, or a temporary or permanent decision for parallel import issued by the Agency for Medicines and Medical Devices must be submitted for all registered medicines.
Criterion : Enrolment in a trade register
Description : - 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.
Criterion : Enrolment in a relevant professional register
Description : Certificate for wholesale of medical devices pursuant to the Law on Medicines and Medical Devices.
Criterion : Samples, descriptions, or photographs with certification of authenticity for supply contracts
Description : Original catalogues and/or brochures with detailed descriptions and accurately marked items which are offered

5.1.11 Procurement documents

Languages in which the procurement documents are officially available : Macedonian
Deadline for requesting additional information : 18/05/2025 15:30 +02:00

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Allowed
Address for submission : https://www.e-nabavki.gov.mk/
Languages in which tenders or requests to participate may be submitted : Macedonian
Electronic catalogue : Not allowed
Variants : Not allowed
Deadline for receipt of tenders : 26/05/2025 13:00 +02:00
Deadline until which the tender must remain valid : 90 Day
Information about public opening :
Opening date : 26/05/2025 13:00 +02:00
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No
Electronic invoicing : Not allowed
Electronic ordering will be used : no
Electronic payment will be used : no

5.1.15 Techniques

Framework agreement :
No framework agreement
Information about the dynamic purchasing system :
No dynamic purchase system

5.1.16 Further information, mediation and review

Review organisation : State Commission for Public Procurement Appeals -
Information about review deadlines : 18.05.2025

5.1 Lot technical ID : LOT-0005

Title : Thromboembolectomy catheter
Description : Thromboembolectomy catheter 4Fr FOGARTY, with polyurethane shaft with latex balloon 1.2ml, graduated, color coded, with atraumatic tip, single lumen, radiopaque, with rigid style, length 82cm, sterile to be packed in hard packaging, with a tolerance of +/- 3%
Internal identifier : Lot 5

5.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33140000 Medical consumables
Quantity : 15 piece

5.1.2 Place of performance

Country subdivision (NUTS) : Скопски ( MK008 )
Country : North Macedonia
Additional information : /

5.1.3 Estimated duration

Duration : 12 Month

5.1.6 General information

Reserved participation : Participation is not reserved.
Procurement Project not financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : yes

5.1.9 Selection criteria

Sources of selection criteria : Notice
Criterion : Certificates by independent bodies about quality assurance standards
Description : Decision for placing ready medicine on the market, or a temporary or permanent decision for parallel import issued by the Agency for Medicines and Medical Devices must be submitted for all registered medicines.
Criterion : Enrolment in a trade register
Description : - 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.
Criterion : Enrolment in a relevant professional register
Description : Certificate for wholesale of medical devices pursuant to the Law on Medicines and Medical Devices.
Criterion : Samples, descriptions, or photographs with certification of authenticity for supply contracts
Description : Original catalogues and/or brochures with detailed descriptions and accurately marked items which are offered

5.1.11 Procurement documents

Languages in which the procurement documents are officially available : Macedonian
Deadline for requesting additional information : 18/05/2025 15:30 +02:00

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Allowed
Address for submission : https://www.e-nabavki.gov.mk/
Languages in which tenders or requests to participate may be submitted : Macedonian
Electronic catalogue : Not allowed
Variants : Not allowed
Deadline for receipt of tenders : 26/05/2025 13:00 +02:00
Deadline until which the tender must remain valid : 90 Day
Information about public opening :
Opening date : 26/05/2025 13:00 +02:00
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No
Electronic invoicing : Not allowed
Electronic ordering will be used : no
Electronic payment will be used : no

5.1.15 Techniques

Framework agreement :
No framework agreement
Information about the dynamic purchasing system :
No dynamic purchase system

5.1.16 Further information, mediation and review

Review organisation : State Commission for Public Procurement Appeals -
Information about review deadlines : 18.05.2025

5.1 Lot technical ID : LOT-0006

Title : Thromboembolectomy catheter
Description : Thromboembolectomy catheter 5Fr FOGARTY, with polyurethane shaft with latex balloon 3ml, graduated, color coded, with atraumatic tip, single lumen, radiopaque, with rigid style, length 82cm, sterile to be packed in hard packaging, with a tolerance of +/- 3%
Internal identifier : Lot 6

5.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33140000 Medical consumables
Quantity : 15 piece

5.1.2 Place of performance

Country subdivision (NUTS) : Скопски ( MK008 )
Country : North Macedonia
Additional information : /

5.1.3 Estimated duration

Duration : 12 Month

5.1.6 General information

Reserved participation : Participation is not reserved.
Procurement Project not financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : yes

5.1.9 Selection criteria

Sources of selection criteria : Notice
Criterion : Certificates by independent bodies about quality assurance standards
Description : Decision for placing ready medicine on the market, or a temporary or permanent decision for parallel import issued by the Agency for Medicines and Medical Devices must be submitted for all registered medicines.
Criterion : Enrolment in a trade register
Description : - 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.
Criterion : Enrolment in a relevant professional register
Description : Certificate for wholesale of medical devices pursuant to the Law on Medicines and Medical Devices.
Criterion : Samples, descriptions, or photographs with certification of authenticity for supply contracts
Description : Original catalogues and/or brochures with detailed descriptions and accurately marked items which are offered

5.1.11 Procurement documents

Languages in which the procurement documents are officially available : Macedonian
Deadline for requesting additional information : 18/05/2025 15:30 +02:00

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Allowed
Address for submission : https://www.e-nabavki.gov.mk/
Languages in which tenders or requests to participate may be submitted : Macedonian
Electronic catalogue : Not allowed
Variants : Not allowed
Deadline for receipt of tenders : 26/05/2025 13:00 +02:00
Deadline until which the tender must remain valid : 90 Day
Information about public opening :
Opening date : 26/05/2025 13:00 +02:00
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No
Electronic invoicing : Not allowed
Electronic ordering will be used : no
Electronic payment will be used : no

5.1.15 Techniques

Framework agreement :
No framework agreement
Information about the dynamic purchasing system :
No dynamic purchase system

5.1.16 Further information, mediation and review

Review organisation : State Commission for Public Procurement Appeals -
Information about review deadlines : 18.05.2025
Organisation providing more information on the review procedures : State Commission for Public Procurement Appeals -

5.1 Lot technical ID : LOT-0007

Title : Thromboembolectomy catheter
Description : Thromboembolectomy catheter 6Fr FOGARTY, with polyurethane shaft with latex balloon 4.5ml, graduated, color coded with atraumatic tip, single lumen, radiopaque, with rigid style, length 82cm, sterile to be packed in hard packaging, with a tolerance of +l- 3%
Internal identifier : Lot 7

5.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33140000 Medical consumables
Quantity : 15 piece

5.1.2 Place of performance

Country subdivision (NUTS) : Скопски ( MK008 )
Country : North Macedonia
Additional information : /

5.1.3 Estimated duration

Duration : 12 Month

5.1.6 General information

Reserved participation : Participation is not reserved.
Procurement Project not financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : yes

5.1.9 Selection criteria

Sources of selection criteria : Notice
Criterion : Certificates by independent bodies about quality assurance standards
Description : Decision for placing ready medicine on the market, or a temporary or permanent decision for parallel import issued by the Agency for Medicines and Medical Devices must be submitted for all registered medicines.
Criterion : Enrolment in a trade register
Description : - 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.
Criterion : Enrolment in a relevant professional register
Description : Certificate for wholesale of medical devices pursuant to the Law on Medicines and Medical Devices.
Criterion : Samples, descriptions, or photographs with certification of authenticity for supply contracts
Description : Original catalogues and/or brochures with detailed descriptions and accurately marked items which are offered

5.1.11 Procurement documents

Languages in which the procurement documents are officially available : Macedonian
Deadline for requesting additional information : 18/05/2025 15:30 +02:00

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Allowed
Address for submission : https://www.e-nabavki.gov.mk/
Languages in which tenders or requests to participate may be submitted : Macedonian
Electronic catalogue : Not allowed
Variants : Not allowed
Deadline for receipt of tenders : 26/05/2025 13:00 +02:00
Deadline until which the tender must remain valid : 90 Day
Information about public opening :
Opening date : 26/05/2025 13:00 +02:00
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No
Electronic invoicing : Not allowed
Electronic ordering will be used : no
Electronic payment will be used : no

5.1.15 Techniques

Framework agreement :
No framework agreement
Information about the dynamic purchasing system :
No dynamic purchase system

5.1.16 Further information, mediation and review

Review organisation : State Commission for Public Procurement Appeals -
Information about review deadlines : 18.05.2025

5.1 Lot technical ID : LOT-0008

Title : Thromboembolectomy catheter
Description : Thromboembolectomy catheter 7Fr FOGARTY, with polyurethane shaft with 5ml latex balloon, graduated, color coded with atraumatic tip, single lumen, radiopaque, with rigid stylet, length 82cm, sterile to be packed in hard packaging, with a tolerance of +/- 3%
Internal identifier : Lot 8

5.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33140000 Medical consumables
Quantity : 15 piece

5.1.2 Place of performance

Country subdivision (NUTS) : Скопски ( MK008 )
Country : North Macedonia
Additional information : /

5.1.3 Estimated duration

Duration : 12 Month

5.1.6 General information

Reserved participation : Participation is not reserved.
Procurement Project not financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : yes

5.1.9 Selection criteria

Sources of selection criteria : Notice
Criterion : Certificates by independent bodies about quality assurance standards
Description : Decision for placing ready medicine on the market, or a temporary or permanent decision for parallel import issued by the Agency for Medicines and Medical Devices must be submitted for all registered medicines.
Criterion : Enrolment in a trade register
Description : - 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.
Criterion : Enrolment in a relevant professional register
Description : Certificate for wholesale of medical devices pursuant to the Law on Medicines and Medical Devices.
Criterion : Samples, descriptions, or photographs with certification of authenticity for supply contracts
Description : Original catalogues and/or brochures with detailed descriptions and accurately marked items which are offered

5.1.11 Procurement documents

Languages in which the procurement documents are officially available : Macedonian
Deadline for requesting additional information : 18/05/2025 15:30 +02:00

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Allowed
Address for submission : https://www.e-nabavki.gov.mk/
Languages in which tenders or requests to participate may be submitted : Macedonian
Electronic catalogue : Not allowed
Variants : Not allowed
Deadline for receipt of tenders : 26/05/2025 13:00 +02:00
Deadline until which the tender must remain valid : 90 Day
Information about public opening :
Opening date : 26/05/2025 13:00 +02:00
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No
Electronic invoicing : Not allowed
Electronic ordering will be used : no
Electronic payment will be used : no

5.1.15 Techniques

Framework agreement :
No framework agreement
Information about the dynamic purchasing system :
No dynamic purchase system

5.1.16 Further information, mediation and review

Review organisation : State Commission for Public Procurement Appeals -
Information about review deadlines : 18.05.2025

5.1 Lot technical ID : LOT-0009

Title : Thromboembolectomy catheter
Description : Thromboembolectomy catheter 8Fr FOGARTY, with polyurethane shaft with 5.5ml latex balloon, graduated, color coded, with atraumatic tip, single lumen, radiopaque, with rigid stylet, length 82cm, sterile to be packed in hard packaging, with a tolerance of +/- 3%
Internal identifier : Lot 9

5.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33140000 Medical consumables
Quantity : 10 piece

5.1.2 Place of performance

Country subdivision (NUTS) : Скопски ( MK008 )
Country : North Macedonia
Additional information : /

5.1.3 Estimated duration

Duration : 12 Month

5.1.6 General information

Reserved participation : Participation is not reserved.
Procurement Project not financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : yes

5.1.9 Selection criteria

Sources of selection criteria : Notice
Criterion : Certificates by independent bodies about quality assurance standards
Description : Decision for placing ready medicine on the market, or a temporary or permanent decision for parallel import issued by the Agency for Medicines and Medical Devices must be submitted for all registered medicines.
Criterion : Enrolment in a trade register
Description : - 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.
Criterion : Enrolment in a relevant professional register
Description : Certificate for wholesale of medical devices pursuant to the Law on Medicines and Medical Devices.
Criterion : Samples, descriptions, or photographs with certification of authenticity for supply contracts
Description : Original catalogues and/or brochures with detailed descriptions and accurately marked items which are offered

5.1.11 Procurement documents

Languages in which the procurement documents are officially available : Macedonian
Deadline for requesting additional information : 18/05/2025 15:30 +02:00

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Allowed
Address for submission : https://www.e-nabavki.gov.mk/
Languages in which tenders or requests to participate may be submitted : Macedonian
Electronic catalogue : Not allowed
Variants : Not allowed
Deadline for receipt of tenders : 26/05/2025 13:00 +02:00
Deadline until which the tender must remain valid : 90 Day
Information about public opening :
Opening date : 26/05/2025 13:00 +02:00
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No
Electronic invoicing : Not allowed
Electronic ordering will be used : no
Electronic payment will be used : no

5.1.15 Techniques

Framework agreement :
No framework agreement
Information about the dynamic purchasing system :
No dynamic purchase system

5.1.16 Further information, mediation and review

Review organisation : State Commission for Public Procurement Appeals -
Information about review deadlines : 18.05.2025

5.1 Lot technical ID : LOT-0010

Title : Biological aortic valve
Description : Biological aortic valve made from porcine aortic valve cusp, with flexible, low-profile, shell-shaped stent made of acetal copolymer covered with knitted polyester fabric, with a sewing cuff shaped to provide a double layer of fabric, and containing three sewing marks for easy placement of the valve, with a steel wire to provide radiopacity, with a bovine pericardium strip at the outlet end of the valve, with a size range of 19, 21, 23, 25, 27
Internal identifier : Lot 10

5.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33140000 Medical consumables
Quantity : 8 piece

5.1.2 Place of performance

Country subdivision (NUTS) : Скопски ( MK008 )
Country : North Macedonia
Additional information : /

5.1.3 Estimated duration

Duration : 12 Month

5.1.6 General information

Reserved participation : Participation is not reserved.
Procurement Project not financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : yes

5.1.9 Selection criteria

Sources of selection criteria : Notice
Criterion : Certificates by independent bodies about quality assurance standards
Description : Decision for placing ready medicine on the market, or a temporary or permanent decision for parallel import issued by the Agency for Medicines and Medical Devices must be submitted for all registered medicines.
Criterion : Enrolment in a trade register
Description : - 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.
Criterion : Enrolment in a relevant professional register
Description : Certificate for wholesale of medical devices pursuant to the Law on Medicines and Medical Devices.
Criterion : Samples, descriptions, or photographs with certification of authenticity for supply contracts
Description : Original catalogues and/or brochures with detailed descriptions and accurately marked items which are offered

5.1.11 Procurement documents

Languages in which the procurement documents are officially available : Macedonian
Deadline for requesting additional information : 18/05/2025 15:30 +02:00

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Allowed
Address for submission : https://www.e-nabavki.gov.mk/
Languages in which tenders or requests to participate may be submitted : Macedonian
Electronic catalogue : Not allowed
Variants : Not allowed
Deadline for receipt of tenders : 26/05/2025 13:00 +02:00
Deadline until which the tender must remain valid : 90 Day
Information about public opening :
Opening date : 26/05/2025 13:00 +02:00
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No
Electronic invoicing : Not allowed
Electronic ordering will be used : no
Electronic payment will be used : no

5.1.15 Techniques

Framework agreement :
No framework agreement
Information about the dynamic purchasing system :
No dynamic purchase system

5.1.16 Further information, mediation and review

Review organisation : State Commission for Public Procurement Appeals -
Information about review deadlines : 18.05.2025

5.1 Lot technical ID : LOT-0011

Title : Supraannular aortic mechanical valve
Description : Mechanical valve for replacing the aortic valve in the supraannular position. Constructed of an annular body and externally coated with polyester and Teflon. The annular body should have two valves made of pyrolytic carbon or titanium; ring diameter sizes: 17mm, 19mm, 21mm, 23mm, 25mm, 27mm; the transvalvular gradient should be delivered through the valves of different sizes. The valves should have a low transvalvular gradient. The valve leaflet opening angle should be 85˚ in systole. The ring should have a marker for placing the sutures. The valves should have the ability to rotate (to correct the position of the discs after implantation) i.e. To be rotatable "in situ"
Internal identifier : Lot 11

5.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33140000 Medical consumables
Quantity : 10 piece

5.1.2 Place of performance

Country subdivision (NUTS) : Скопски ( MK008 )
Country : North Macedonia
Additional information : /

5.1.3 Estimated duration

Duration : 12 Month

5.1.6 General information

Reserved participation : Participation is not reserved.
Procurement Project not financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : yes

5.1.9 Selection criteria

Sources of selection criteria : Notice
Criterion : Certificates by independent bodies about quality assurance standards
Description : Decision for placing ready medicine on the market, or a temporary or permanent decision for parallel import issued by the Agency for Medicines and Medical Devices must be submitted for all registered medicines.
Criterion : Enrolment in a trade register
Description : - 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.
Criterion : Enrolment in a relevant professional register
Description : Certificate for wholesale of medical devices pursuant to the Law on Medicines and Medical Devices.
Criterion : Samples, descriptions, or photographs with certification of authenticity for supply contracts
Description : Original catalogues and/or brochures with detailed descriptions and accurately marked items which are offered

5.1.11 Procurement documents

Languages in which the procurement documents are officially available : Macedonian
Deadline for requesting additional information : 18/05/2025 15:30 +02:00

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Allowed
Address for submission : https://www.e-nabavki.gov.mk/
Languages in which tenders or requests to participate may be submitted : Macedonian
Electronic catalogue : Not allowed
Variants : Not allowed
Deadline for receipt of tenders : 26/05/2025 13:00 +02:00
Deadline until which the tender must remain valid : 90 Day
Information about public opening :
Opening date : 26/05/2025 13:00 +02:00
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No
Electronic invoicing : Not allowed
Electronic ordering will be used : no
Electronic payment will be used : no

5.1.15 Techniques

Framework agreement :
No framework agreement
Information about the dynamic purchasing system :
No dynamic purchase system

5.1.16 Further information, mediation and review

Review organisation : State Commission for Public Procurement Appeals -
Information about review deadlines : 18.05.2025

5.1 Lot technical ID : LOT-0012

Title : Automatic valve
Description : Automatic valve suturing system consisting of at least 2 applicators of a minimum length of 16 cm, a thickness of 5 to 7 mm, and at least 12 buttons for open and minimally invasive surgery
Internal identifier : Lot 12

5.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33140000 Medical consumables
Quantity : 20 piece

5.1.2 Place of performance

Country subdivision (NUTS) : Скопски ( MK008 )
Country : North Macedonia
Additional information : /

5.1.3 Estimated duration

Duration : 12 Month

5.1.6 General information

Reserved participation : Participation is not reserved.
Procurement Project not financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : yes

5.1.9 Selection criteria

Sources of selection criteria : Notice
Criterion : Certificates by independent bodies about quality assurance standards
Description : Decision for placing ready medicine on the market, or a temporary or permanent decision for parallel import issued by the Agency for Medicines and Medical Devices must be submitted for all registered medicines.
Criterion : Enrolment in a trade register
Description : - 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.
Criterion : Enrolment in a relevant professional register
Description : Certificate for wholesale of medical devices pursuant to the Law on Medicines and Medical Devices.
Criterion : Samples, descriptions, or photographs with certification of authenticity for supply contracts
Description : Original catalogues and/or brochures with detailed descriptions and accurately marked items which are offered

5.1.11 Procurement documents

Languages in which the procurement documents are officially available : Macedonian
Deadline for requesting additional information : 18/05/2025 15:30 +02:00

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Allowed
Address for submission : https://www.e-nabavki.gov.mk/
Languages in which tenders or requests to participate may be submitted : Macedonian
Electronic catalogue : Not allowed
Variants : Not allowed
Deadline for receipt of tenders : 26/05/2025 13:00 +02:00
Deadline until which the tender must remain valid : 90 Day
Information about public opening :
Opening date : 26/05/2025 13:00 +02:00
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No
Electronic invoicing : Not allowed
Electronic ordering will be used : no
Electronic payment will be used : no

5.1.15 Techniques

Framework agreement :
No framework agreement
Information about the dynamic purchasing system :
No dynamic purchase system

5.1.16 Further information, mediation and review

Review organisation : State Commission for Public Procurement Appeals -
Information about review deadlines : 18.05.2025

5.1 Lot technical ID : LOT-0013

Title : Kit
Description : Kit, automated applicator for placing sutures through the valve annulus, suitable for mitral and aortic positions (5 mm min width). The kit shall contain a cassette for the appropriate sutures and corresponding applicators for placing the sutures through the prosthesis. The kit shall contain corresponding sutures and a cassette for organizing the sutures
Internal identifier : Lot 13

5.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33140000 Medical consumables
Quantity : 12

5.1.2 Place of performance

Country subdivision (NUTS) : Скопски ( MK008 )
Country : North Macedonia
Additional information : /

5.1.3 Estimated duration

Duration : 12 Month

5.1.6 General information

Reserved participation : Participation is not reserved.
Procurement Project not financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : yes

5.1.9 Selection criteria

Sources of selection criteria : Notice
Criterion : Certificates by independent bodies about quality assurance standards
Description : Decision for placing ready medicine on the market, or a temporary or permanent decision for parallel import issued by the Agency for Medicines and Medical Devices must be submitted for all registered medicines.
Criterion : Enrolment in a trade register
Description : - 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.
Criterion : Enrolment in a relevant professional register
Description : Certificate for wholesale of medical devices pursuant to the Law on Medicines and Medical Devices.
Criterion : Samples, descriptions, or photographs with certification of authenticity for supply contracts
Description : Original catalogues and/or brochures with detailed descriptions and accurately marked items which are offered

5.1.11 Procurement documents

Languages in which the procurement documents are officially available : Macedonian
Deadline for requesting additional information : 18/05/2025 15:30 +02:00

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Allowed
Address for submission : https://www.e-nabavki.gov.mk/
Languages in which tenders or requests to participate may be submitted : Macedonian
Electronic catalogue : Not allowed
Variants : Not allowed
Deadline for receipt of tenders : 26/05/2025 13:00 +02:00
Deadline until which the tender must remain valid : 90 Day
Information about public opening :
Opening date : 26/05/2025 13:00 +02:00
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No
Electronic invoicing : Not allowed
Electronic ordering will be used : no
Electronic payment will be used : no

5.1.15 Techniques

Framework agreement :
No framework agreement
Information about the dynamic purchasing system :
No dynamic purchase system

5.1.16 Further information, mediation and review

Review organisation : State Commission for Public Procurement Appeals -
Information about review deadlines : 18.05.2025

5.1 Lot technical ID : LOT-0014

Title : Aortic annuloplasty device
Description : Aortic annuloplasty device, three-dimensional for intraannular implantation in the aortic valve in patients with tricuspid valve morphology. It shall have a precisely defined geometry that allows for a standard and symmetrical annuloplasty repair to improve leaflet coaptation and valve functionality. With fixation posts for accurate orientation in relation to the commissures, Available in different dimensions for adaptation to the aortic annulus, with sizes of 19mm, 21mm, 23mm and 25mm.. To provide long-term stability, improved hemodynamics and minimizing the risk of valvular regurgitation, allowing biomechanically compatible repair of the aortic valve. A set of measuring and placement instruments shall be delivered with the device. Permissible deviation shall be up to ±5%.
Internal identifier : Lot 14

5.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33140000 Medical consumables
Quantity : 5 piece

5.1.2 Place of performance

Country subdivision (NUTS) : Скопски ( MK008 )
Country : North Macedonia
Additional information : /

5.1.3 Estimated duration

Duration : 12 Month

5.1.6 General information

Reserved participation : Participation is not reserved.
Procurement Project not financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : yes

5.1.9 Selection criteria

Sources of selection criteria : Notice
Criterion : Certificates by independent bodies about quality assurance standards
Description : Decision for placing ready medicine on the market, or a temporary or permanent decision for parallel import issued by the Agency for Medicines and Medical Devices must be submitted for all registered medicines.
Criterion : Enrolment in a trade register
Description : - 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.
Criterion : Enrolment in a relevant professional register
Description : Certificate for wholesale of medical devices pursuant to the Law on Medicines and Medical Devices.
Criterion : Samples, descriptions, or photographs with certification of authenticity for supply contracts
Description : Original catalogues and/or brochures with detailed descriptions and accurately marked items which are offered

5.1.11 Procurement documents

Languages in which the procurement documents are officially available : Macedonian
Deadline for requesting additional information : 18/05/2025 15:30 +02:00

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Allowed
Address for submission : https://www.e-nabavki.gov.mk/
Languages in which tenders or requests to participate may be submitted : Macedonian
Electronic catalogue : Not allowed
Variants : Not allowed
Deadline for receipt of tenders : 26/05/2025 13:00 +02:00
Deadline until which the tender must remain valid : 90 Day
Information about public opening :
Opening date : 26/05/2025 13:00 +02:00
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No
Electronic invoicing : Not allowed
Electronic ordering will be used : no
Electronic payment will be used : no

5.1.15 Techniques

Framework agreement :
No framework agreement
Information about the dynamic purchasing system :
No dynamic purchase system

5.1.16 Further information, mediation and review

Review organisation : State Commission for Public Procurement Appeals -
Information about review deadlines : 18.05.2025

5.1 Lot technical ID : LOT-0015

Title : Balloon-expandable covered peripheral stent
Description : Balloon-expandable covered peripheral stent, with double ePTFE layer external and internal. Made of CoCr alloy, with open cells, with 3 radiovisible markers at the ends of the stent and 2 markers on the balloon. Diameters: 5 – 10mm, lengths: 17 – 57mm, compatible with 0.035” wire. Catheter lengths: 80 and 140cm.
Internal identifier : Lot 15

5.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33140000 Medical consumables
Quantity : 10 piece

5.1.2 Place of performance

Country subdivision (NUTS) : Скопски ( MK008 )
Country : North Macedonia
Additional information : /

5.1.3 Estimated duration

Duration : 12 Month

5.1.6 General information

Reserved participation : Participation is not reserved.
Procurement Project not financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : yes

5.1.9 Selection criteria

Sources of selection criteria : Notice
Criterion : Certificates by independent bodies about quality assurance standards
Description : Decision for placing ready medicine on the market, or a temporary or permanent decision for parallel import issued by the Agency for Medicines and Medical Devices must be submitted for all registered medicines.
Criterion : Enrolment in a trade register
Description : - 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.
Criterion : Enrolment in a relevant professional register
Description : Certificate for wholesale of medical devices pursuant to the Law on Medicines and Medical Devices.
Criterion : Samples, descriptions, or photographs with certification of authenticity for supply contracts
Description : Original catalogues and/or brochures with detailed descriptions and accurately marked items which are offered

5.1.11 Procurement documents

Languages in which the procurement documents are officially available : Macedonian
Deadline for requesting additional information : 18/05/2025 15:30 +02:00

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Allowed
Address for submission : https://www.e-nabavki.gov.mk/
Languages in which tenders or requests to participate may be submitted : Macedonian
Electronic catalogue : Not allowed
Variants : Not allowed
Deadline for receipt of tenders : 26/05/2025 13:00 +02:00
Deadline until which the tender must remain valid : 90 Day
Information about public opening :
Opening date : 26/05/2025 13:00 +02:00
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No
Electronic invoicing : Not allowed
Electronic ordering will be used : no
Electronic payment will be used : no

5.1.15 Techniques

Framework agreement :
No framework agreement
Information about the dynamic purchasing system :
No dynamic purchase system

5.1.16 Further information, mediation and review

Review organisation : State Commission for Public Procurement Appeals -
Information about review deadlines : 18.05.2025

5.1 Lot technical ID : LOT-0016

Title : Fenestrated stent graft system
Description : Fenestrated stent graft system indicated for FEVAR for use as a bridging stent graft for endovascular treatment of abdominal aorta with preservation of visceral artery perfusion. Balloon and stent with different diameters proximal/distal. Made of Cobalt-Chromium (CoCr) stent coated with 203 μm ePTFE layer. Balloon expandable, compatible with 0.035” wire. Diameters distal/proximal 5/8mm, 6/8 mm, 7/10mm, 8/10mm, 9/11 mm, lengths 22, 27, 37mm, Catheter length 120 cm
Internal identifier : Lot 16

5.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33140000 Medical consumables
Quantity : 10 piece

5.1.2 Place of performance

Country subdivision (NUTS) : Скопски ( MK008 )
Country : North Macedonia
Additional information : /

5.1.3 Estimated duration

Duration : 12 Month

5.1.6 General information

Reserved participation : Participation is not reserved.
Procurement Project not financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : yes

5.1.9 Selection criteria

Sources of selection criteria : Notice
Criterion : Certificates by independent bodies about quality assurance standards
Description : Decision for placing ready medicine on the market, or a temporary or permanent decision for parallel import issued by the Agency for Medicines and Medical Devices must be submitted for all registered medicines.
Criterion : Enrolment in a trade register
Description : - 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.
Criterion : Enrolment in a relevant professional register
Description : Certificate for wholesale of medical devices pursuant to the Law on Medicines and Medical Devices.
Criterion : Samples, descriptions, or photographs with certification of authenticity for supply contracts
Description : Original catalogues and/or brochures with detailed descriptions and accurately marked items which are offered

5.1.11 Procurement documents

Languages in which the procurement documents are officially available : Macedonian
Deadline for requesting additional information : 18/05/2025 15:30 +02:00

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Allowed
Address for submission : https://www.e-nabavki.gov.mk/
Languages in which tenders or requests to participate may be submitted : Macedonian
Electronic catalogue : Not allowed
Variants : Not allowed
Deadline for receipt of tenders : 26/05/2025 13:00 +02:00
Deadline until which the tender must remain valid : 90 Day
Information about public opening :
Opening date : 26/05/2025 13:00 +02:00
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No
Electronic invoicing : Not allowed
Electronic ordering will be used : no
Electronic payment will be used : no

5.1.15 Techniques

Framework agreement :
No framework agreement
Information about the dynamic purchasing system :
No dynamic purchase system

5.1.16 Further information, mediation and review

Review organisation : State Commission for Public Procurement Appeals -
Information about review deadlines : 18.05.2025

8. Organisations

8.1 ORG-0001

Official name : PHI University Clinic for State Cardiac Surgery Skopje
Registration number : 6928854
Postal address : Majka Tereza 17/building no. 8
Town : Skopje
Postcode : 1000
Country subdivision (NUTS) : Скопски ( MK008 )
Country : North Macedonia
Contact point : Ivica Ristevski
Telephone : 0038978498901
Roles of this organisation :
Buyer

8.1 ORG-0002

Official name : State Commission for Public Procurement Appeals
Registration number : 6428045
Town : Skopje
Postcode : 1000
Country subdivision (NUTS) : Скопски ( MK008 )
Country : North Macedonia
Telephone : 0038923251260
Roles of this organisation :
Review organisation
Organisation providing more information on the review procedures

8.1 ORG-0000

Official name : Publications Office of the European Union
Registration number : PUBL
Town : Luxembourg
Postcode : 2417
Country subdivision (NUTS) : Luxembourg ( LU000 )
Country : Luxembourg
Telephone : +352 29291
Internet address : https://op.europa.eu
Roles of this organisation :
TED eSender
Notice information
Notice identifier/version : eb978ff3-0230-429b-a7f8-62671bfcb668 - 01
Form type : Competition
Notice type : Contract or concession notice – standard regime
Notice dispatch date : 27/04/2025 20:26 +00:00
Languages in which this notice is officially available : English
Notice publication number : 00274331-2025
OJ S issue number : 83/2025
Publication date : 29/04/2025