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Kateetri kaudu implanteeritav aordiklapp

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Fristen for indsendelse er overskredet

Fristen for indsendelse af dette udbud er overskredet, og der modtages ikke længere ansøgninger. Oplysningerne nedenfor er gemt til referenceformål.

Gennemse aktive udbud
Frist
Udløbet
Oktober 24, 2025
Kontrakt detaljer
Kategori
Leverancer
Reference
291592
Værdi
€10,327,000
Lokation
Estonia, Estland
Udgivet
September 23, 2025
CPV-kode
Projekttidslinje

Udbud offentliggjort

September 23, 2025

Frist for spørgsmål

Oktober 17, 2025

Frist for tilbud

Oktober 24, 2025

Åbning af udbud

Oktober 24, 2025

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Budget
€10,327,000
Varighed
Ikke angivet
Lokation
Estonia
Type
Leverancer
Markedsbenchmark
Gns. Vindende Pris
€92,792
Gns. Tilbud
2.2
Konkurrence
Lav
SMV Vindere
86%
3,220 udbud analyseret

Original udbudsbeskrivelse

Kateetri kaudu implanteeritavaid aordiklappide, edaspidi TAVI (Transcatheter aortic valve implantation) ja TAVI klappide paigaldamiseks vajalike vahendite ostmine
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Vinderstrategi

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Konkurrenter

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Krav og kvalifikationer

21 krav på tværs af 5 kategorier

Indsendelse (4)
Obligatorisk (3)
Overholdelse (4)
Teknisk (8)
Finansiel (2)
SUBMISSION REQUIREMENTS4
--Complete and upload electronic ESPD (European Single Procurement Document) via procurement portal
--Fill every column of the Excel price template: product codes, GTIN/TARIC codes, technical parameters, unit prices, shelf life, manufacturer, country of origin
--Attach manufacturer authorisation letter, CE documentation, and “Hankemenetluses osalemise avaldus” (declaration of having read and accepted all documents)
MANDATORY QUALIFICATIONS3
--Be the valve manufacturer OR hold written authorisation from the manufacturer to distribute TAVI products in Estonia
--Possess valid CE-marking documentation: Declaration of Conformity, EC Certificate, Instructions for Use for every offered valve/delivery system
--Demonstrate that Russian-owned or Russian-controlled subcontractors account for ≤ 10 % of contract value
COMPLIANCE REQUIREMENTS4
--Accept all obligations and risks stated in the tender pack and keep the offer binding for 3 months after submission deadline
--Use only the Excel “Maksumuse vorm” template for pricing; no alternative price formats accepted
--Deliver physical product samples within 7 days when requested; failure = automatic disqualification
TECHNICAL REQUIREMENTS8
--Offer at least one complete TAVI system in each required configuration:
--– balloon-expandable
--– self-expanding supra-annular
FINANCIAL REQUIREMENTS2
--Total 2-year framework value must not exceed €420 000 (ex-VAT) for cerebral embolic-protection devices; no stated cap for TAVI valves but overall tender estimate is €10.3 M
--Submit updated annual accounts or ESPD section proving sufficient economic/financial standing (no minimum threshold stated, but authority may reject if evidence insufficient)

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Dokumenter

7 dokumenter tilgængelige med AI-resuméer

VastavustingimusedPDF
291592_vastavustingimused.pdf -- 76.4 KB

This mandatory-compliance document for North Estonia Regional Hospital’s TAVI-heart-valve procurement requires bidders to prove manufacturer/authorised-distributor representation rights, supply full CE-marked technical dossier (IFU, DoC, EC Certificate) for every product, submit prices only on the provided Excel template, and certify that no Russian-owned/controlled subcontractors account for >10 % of contract value.

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Ettevõtja esitab täidetud maksumuse vormiXLS
291592 maksumuse vorm.xlsx -- 48.8 KB

This document is merely a blank price-schedule template that the tenderer must complete with product codes, technical parameters, GTIN/TARIC codes, shelf-life and manufacturer details for cerebral embolic-protection devices (6F, ≥95 cm, 160 units) and any offered TAVI valves, so the only mandatory requirement is to fill in every column accurately and stay below the €420 000 ceiling for the 2-year frame contract.

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Ettevõtja esitab täidetud pakkumuse vormiDOC
291592 tehniline kirjeldus.docx -- 61.0 KB

Tender requires supply of balloon-catheter TAVI heart valves and accessories that strictly meet Table 1 technical specifications (mandatory), with bidders obliged to deliver samples for 7-day functional testing and to reference exact document pages proving equivalence to any cited standards—failure in on-time sample delivery or technical non-conformance disqualifies the offer.

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Ettevõtja kinnitab, et täidab kõik hankemenetluse osalemise avalduses toodud tin...DOC
Hankemenetluses osalemise avaldus (raamleping... -- 50.7 KB

This document is merely a mandatory declaration form requiring bidders to confirm they have reviewed all tender documents, accept every obligation and risk, and keep their offer binding for 3 months—no technical, financial or qualification details are provided here.

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Hindamiskriteeriumid ja hinnatavad näitajadPDF
291592_hindamiskriteeriumid.pdf -- 18.4 KB

North Estonia Regional Hospital is buying TAVI heart valves and delivery systems in three configurations—balloon-expandable, self-expanding supra-annular and self-expanding intra-annular—priced ex-VAT (90–95 % of 100 points) and awarded 5 bonus points only to the bid offering the largest valve diameter and widest size range, so suppliers must already stock the broadest European-approved portfolio at the lowest total cost.

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Hankepass täiendatavate selgitustegaPDF
291592_hankepass_taiendavate_selgitustega.pdf -- 63.9 KB

This open-procurement notice by North Estonia Regional Hospital simply invites suppliers to submit an electronic ESPD (European Single Procurement Document) declaring their general company data and technical/financial capability; it contains no mandatory qualification thresholds, technical specifications, delivery terms or award criteria, so firms cannot yet assess whether to bid on the upcoming TAVI-heart-valve tender.

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Raamlepingu projektDOC
291592 raamlepingu projekt.docx -- 50.1 KB

This draft framework-agreement template for Põhja-Eesti Regionaalhaigla simply sets the 01.12.2025-30.11.2027 supply period for transcatheter aortic valves and their implantation accessories without stating any mandatory technical, qualification or award criteria, so bidders must check the separate procurement documents (RHAD 291592) to decide whether to tender.

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Kvalitetsscore

Omfattende kvalitetsanalyse af dette udbud, der scorer juridisk overholdelse, klarhed, fuldstændighed, retfærdighed, praktisk anvendelighed, datakonsistens og bæredygtighed på en skala fra 0-100 med detaljeret opdeling og anbefalinger.

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