{"bekendtgoerelseNoegle":{"noticeId":{"value":"94e2c1c8-7c27-4d39-9ea3-f0509ce5c6e1"},"noticeVersion":{"value":"01"},"noticePublicationNumber":{}},"htmlDA":"\n\n \n
1 Køber
1.1 Køber
Officielt navn: Statens Serum Institut
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Køberens retlige status: Offentligretligt organ
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2 Procedure
2.1 Procedure
Titel: ADVERTISEMENT OF PKU CARDS in accordance with IVD regulation FOR STATENS SERUM INSTITUT/2025
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Beskrivelse: 1. Purpose
Statens Serum Institut, hereafter ‘the contracting authority’, requests\n the performance of a task concerning PKU CARDS for Statens Serum Institut in accordance\n with Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April\n 2017 on in-vitro diagnostic medical devices, hereafter IVD regulation.
The contracting\n authority hereby invites interested suitable companies to submit tenders for the performance\n of this task. The contracting authority’s suitability requirements and a description\n of which information and documents the companies shall submit in regard to the suitability\n assessment can be found in section 4.2 below and in the advertisement at www.udbud.dk.
1.1\n General description of the purchase
Statens Serum Institute (SSI) carries out\n screening of 25 serious congenital diseases in the national newborn screening program.\n
All newborns in Denmark, Faroe Islands and Greenland are offered a heel prick\n test, where blood is spotted on a dried blood spot card (also called PKU card).
The\n Danish PKU card consists of a filter-paper part for spotting the blood and a demographics\n part for information about mother and child.
The Danish PKU card must be an IVD\n device and intended for use in newborn screening.
\n
Identifikator for proceduren: 5c2fa76f-6b8b-4c63-83e9-287145b1d221
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Intern ID: 25/04836
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2.1.1 Formål
Kontraktens hovedformål: Varer
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Primær klassifikation (cpv): 48500000 Programpakke til kommunikations- og multimedieformål
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Supplerende klassifikation (cpv): 79810000 Trykning
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Supplerende klassifikation (cpv): 79811000 Digital trykning
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Supplerende klassifikation (cpv): 79821000 Færdigbearbejdning af trykt materiale
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Supplerende klassifikation (cpv): 79821100 Korrekturlæsning
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Supplerende klassifikation (cpv): 79823000 Trykning og levering
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2.1.2 Udførelsessted
Postadresse: Artillerivej 5  
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By: København S
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Postnummer: 2300
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Landsdel (NUTS): Byen København (DK011)
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Land: Danmark
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2.1.3 Værdi
Anslået værdi eksklusiv moms: 1.000.000 Dansk krone
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2.1.4 Generelle oplysninger
Retsgrundlag:
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Indkøb under tærskelværdien med grænseoverskridende interesse
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5 Delkontrakt
5.1 Teknisk ID for delkontrakten: LOT-0000
Titel: ADVERTISEMENT OF PKU CARDS in accordance with IVD regulation FOR STATENS SERUM INSTITUT/2025
\n
Beskrivelse: 1. Purpose
Statens Serum Institut, hereafter ‘the contracting authority’, requests\n the performance of a task concerning PKU CARDS for Statens Serum Institut in accordance\n with Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April\n 2017 on in-vitro diagnostic medical devices, hereafter IVD regulation.
The contracting\n authority hereby invites interested suitable companies to submit tenders for the performance\n of this task. The contracting authority’s suitability requirements and a description\n of which information and documents the companies shall submit in regard to the suitability\n assessment can be found in section 4.2 below and in the advertisement at www.udbud.dk.
1.1\n General description of the purchase
Statens Serum Institute (SSI) carries out\n screening of 25 serious congenital diseases in the national newborn screening program.\n
All newborns in Denmark, Faroe Islands and Greenland are offered a heel prick\n test, where blood is spotted on a dried blood spot card (also called PKU card).
The\n Danish PKU card consists of a filter-paper part for spotting the blood and a demographics\n part for information about mother and child.
The Danish PKU card must be an IVD\n device and intended for use in newborn screening.
\n
Intern ID: 25/04836
\n
5.1.1 Formål
Kontraktens hovedformål: Varer
\n
Primær klassifikation (cpv): 48500000 Programpakke til kommunikations- og multimedieformål
\n
Supplerende klassifikation (cpv): 79810000 Trykning
\n
Supplerende klassifikation (cpv): 79811000 Digital trykning
\n
Supplerende klassifikation (cpv): 79821000 Færdigbearbejdning af trykt materiale
\n
Supplerende klassifikation (cpv): 79821100 Korrekturlæsning
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Supplerende klassifikation (cpv): 79823000 Trykning og levering
\n
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5.1.2 Udførelsessted
Postadresse: Artillerivej 5  
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By: København S
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Postnummer: 2300
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Landsdel (NUTS): Byen København (DK011)
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Land: Danmark
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Yderligere oplysninger: 
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5.1.3 Anslået varighed
Startdato: 18-03-2026
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Varigheds slutdato: 18-03-2029
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5.1.5 Værdi
Anslået værdi eksklusiv moms: 1.000.000 Dansk krone
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5.1.10 Tildelingskriterier
Kriterium:
Type: Pris
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Navn: Pris
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Beskrivelse: The contracting authority will award the contract to the tenderer with the lowest\n price.
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5.1.11 Udbudsdokumenter
Frist for anmodning om yderligere oplysninger: 09-12-2025 22:55 +00:00
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Adresse på udbudsdokumenterne: https://eu.eu-supply.com/app/rfq/rwlentrance_s.asp?PID=446099&TID=407326&B=
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5.1.12 Udbudsvilkår
Vilkår for indgivelse:
Tilbudsgivere kan indgive mere end ét tilbud: Ikke tilladt
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5.1.16 Yderligere oplysninger, mægling og gennemgang
Organisation med ansvar for klager: Klagenævnet for Udbud
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Organisation, der leverer supplerende oplysninger om udbudsproceduren: Statens Serum Institut
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Organisation, der sikrer adgang til udbudsdokumenterne offline: Statens Serum Institut
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Organisation, der leverer yderligere oplysninger om klageprocedurerne: Konkurrence og forbrugerstyrelsen
\n
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8 Organisationer
8.1 ORG-0001
Officielt navn: Statens Serum Institut
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Registreringsnummer: 46837428
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Postadresse: Artillerivej 5  
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By: København S
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Postnummer: 2300
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Landsdel (NUTS): Byen København (DK011)
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Land: Danmark
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Enhed: Henrik Bækby Graversen
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E-mail: hebb@ssi.dk
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Telefon: +45 32688917
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Internetadresse: https://www.ssi.dk
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Køberprofil: https://eu.eu-supply.com/ctm/company/companyinformation/index/244516
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Denne organisations roller:
Køber
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Organisation, der leverer supplerende oplysninger om udbudsproceduren
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Organisation, der sikrer adgang til udbudsdokumenterne offline
\n
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8.1 ORG-0002
Officielt navn: Klagenævnet for Udbud
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Registreringsnummer: 37795526
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Postadresse: Nævnenes Hus, Toldboden 2  
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By: Viborg
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Postnummer: 8800
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Landsdel (NUTS): Østjylland (DK042)
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Land: Danmark
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E-mail: klfu@naevneneshus.dk
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Telefon: +45 35291000
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Internetadresse: https://naevneneshus.dk/naevnsoversigt/klagenaevnet-for-udbud/
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Denne organisations roller:
Organisation med ansvar for klager
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8.1 ORG-0003
Officielt navn: Konkurrence og forbrugerstyrelsen
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Registreringsnummer: 10294819
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Postadresse: Carl Jacobsens Vej 35  
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By: Valby
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Postnummer: 2500
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Landsdel (NUTS): Byen København (DK011)
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Land: Danmark
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Enhed: 10 29 48 19
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E-mail: kfst@kfst.dk
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Telefon: +4541715000
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Internetadresse: https://www.kfst.dk/
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Denne organisations roller:
Organisation, der leverer yderligere oplysninger om klageprocedurerne
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11 Oplysninger om bekendtgørelsen
11.1 Oplysninger om bekendtgørelsen
Bekendtgørelsens ID: 94e2c1c8-7c27-4d39-9ea3-f0509ce5c6e1 - 01
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Formulartype: Konkurrencevilkår
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Bekendtgørelsestype: Annoncering
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Afsendelsesdato for bekendtgørelsen: 21-11-2025 14:45 +01:00
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Dato for afsendelse af bekendtgørelsen (eSender): 21-11-2025 14:45 +01:00
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Bekendtgørelsens officielle sprog: engelsk 
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11.2 Oplysninger om offentliggørelsen
Offentliggørelsesdato: 21-11-2025 14:45 +01:00
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\n
\n \n","htmlEN":"\n\n \n
1 Buyer
1.1 Buyer
Official name: Statens Serum Institut
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Legal type of the buyer: Body governed by public law
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\n
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2 Procedure
2.1 Procedure
Title: ADVERTISEMENT OF PKU CARDS in accordance with IVD regulation FOR STATENS SERUM INSTITUT/2025
\n
Description: 1. Purpose
Statens Serum Institut, hereafter ‘the contracting authority’, requests\n the performance of a task concerning PKU CARDS for Statens Serum Institut in accordance\n with Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April\n 2017 on in-vitro diagnostic medical devices, hereafter IVD regulation.
The contracting\n authority hereby invites interested suitable companies to submit tenders for the performance\n of this task. The contracting authority’s suitability requirements and a description\n of which information and documents the companies shall submit in regard to the suitability\n assessment can be found in section 4.2 below and in the advertisement at www.udbud.dk.
1.1\n General description of the purchase
Statens Serum Institute (SSI) carries out\n screening of 25 serious congenital diseases in the national newborn screening program.\n
All newborns in Denmark, Faroe Islands and Greenland are offered a heel prick\n test, where blood is spotted on a dried blood spot card (also called PKU card).
The\n Danish PKU card consists of a filter-paper part for spotting the blood and a demographics\n part for information about mother and child.
The Danish PKU card must be an IVD\n device and intended for use in newborn screening.
\n
Procedure identifier: 5c2fa76f-6b8b-4c63-83e9-287145b1d221
\n
Internal identifier: 25/04836
\n
2.1.1 Purpose
Main nature of the contract: Supplies
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Main classification (cpv): 48500000 Communication and multimedia software package
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Additional classification (cpv): 79810000 Printing services
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Additional classification (cpv): 79811000 Digital printing services
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Additional classification (cpv): 79821000 Print finishing services
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Additional classification (cpv): 79821100 Proofreading services
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Additional classification (cpv): 79823000 Printing and delivery services
\n
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2.1.2 Place of performance
Postal address: Artillerivej 5  
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Town: København S
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Postcode: 2300
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Country subdivision (NUTS): Byen København (DK011)
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Country: Denmark
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2.1.3 Value
Estimated value excluding VAT: 1.000.000 Danish krone
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2.1.4 General information
Legal basis:
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Procurement below threshold with cross-border interest
\n
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5 Lot
5.1 Lot technical ID: LOT-0000
Title: ADVERTISEMENT OF PKU CARDS in accordance with IVD regulation FOR STATENS SERUM INSTITUT/2025
\n
Description: 1. Purpose
Statens Serum Institut, hereafter ‘the contracting authority’, requests\n the performance of a task concerning PKU CARDS for Statens Serum Institut in accordance\n with Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April\n 2017 on in-vitro diagnostic medical devices, hereafter IVD regulation.
The contracting\n authority hereby invites interested suitable companies to submit tenders for the performance\n of this task. The contracting authority’s suitability requirements and a description\n of which information and documents the companies shall submit in regard to the suitability\n assessment can be found in section 4.2 below and in the advertisement at www.udbud.dk.
1.1\n General description of the purchase
Statens Serum Institute (SSI) carries out\n screening of 25 serious congenital diseases in the national newborn screening program.\n
All newborns in Denmark, Faroe Islands and Greenland are offered a heel prick\n test, where blood is spotted on a dried blood spot card (also called PKU card).
The\n Danish PKU card consists of a filter-paper part for spotting the blood and a demographics\n part for information about mother and child.
The Danish PKU card must be an IVD\n device and intended for use in newborn screening.
\n
Internal identifier: 25/04836
\n
5.1.1 Purpose
Main nature of the contract: Supplies
\n
Main classification (cpv): 48500000 Communication and multimedia software package
\n
Additional classification (cpv): 79810000 Printing services
\n
Additional classification (cpv): 79811000 Digital printing services
\n
Additional classification (cpv): 79821000 Print finishing services
\n
Additional classification (cpv): 79821100 Proofreading services
\n
Additional classification (cpv): 79823000 Printing and delivery services
\n
\n
5.1.2 Place of performance
Postal address: Artillerivej 5  
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Town: København S
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Postcode: 2300
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Country subdivision (NUTS): Byen København (DK011)
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Country: Denmark
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Additional information: 
\n
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5.1.3 Estimated duration
Start date: 18-03-2026
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Duration end date: 18-03-2029
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5.1.5 Value
Estimated value excluding VAT: 1.000.000 Danish krone
\n
\n
5.1.10 Award criteria
Criterion:
Type: Price
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Name: Pris
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Description: The contracting authority will award the contract to the tenderer with the lowest\n price.
\n
\n
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5.1.11 Procurement documents
Deadline for requesting additional information: 09-12-2025 22:55 +00:00
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Address of the procurement documents: https://eu.eu-supply.com/app/rfq/rwlentrance_s.asp?PID=446099&TID=407326&B=
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5.1.12 Terms of procurement
Terms of submission:
Tenderers may submit more than one tender: Not allowed
\n
\n
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5.1.16 Further information, mediation and review
Review organisation: Klagenævnet for Udbud
\n
Organisation providing additional information about the procurement procedure: Statens Serum Institut
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Organisation providing offline access to the procurement documents: Statens Serum Institut
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Organisation providing more information on the review procedures: Konkurrence og forbrugerstyrelsen
\n
\n
\n
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8 Organisations
8.1 ORG-0001
Official name: Statens Serum Institut
\n
Registration number: 46837428
\n
Postal address: Artillerivej 5  
\n
Town: København S
\n
Postcode: 2300
\n
Country subdivision (NUTS): Byen København (DK011)
\n
Country: Denmark
\n
Contact point: Henrik Bækby Graversen
\n
Email: hebb@ssi.dk
\n
Telephone: +45 32688917
\n
Internet address: https://www.ssi.dk
\n
Buyer profile: https://eu.eu-supply.com/ctm/company/companyinformation/index/244516
\n
Roles of this organisation:
Buyer
\n
Organisation providing additional information about the procurement procedure
\n
Organisation providing offline access to the procurement documents
\n
\n
\n
8.1 ORG-0002
Official name: Klagenævnet for Udbud
\n
Registration number: 37795526
\n
Postal address: Nævnenes Hus, Toldboden 2  
\n
Town: Viborg
\n
Postcode: 8800
\n
Country subdivision (NUTS): Østjylland (DK042)
\n
Country: Denmark
\n
Email: klfu@naevneneshus.dk
\n
Telephone: +45 35291000
\n
Internet address: https://naevneneshus.dk/naevnsoversigt/klagenaevnet-for-udbud/
\n
Roles of this organisation:
Review organisation
\n
\n
\n
8.1 ORG-0003
Official name: Konkurrence og forbrugerstyrelsen
\n
Registration number: 10294819
\n
Postal address: Carl Jacobsens Vej 35  
\n
Town: Valby
\n
Postcode: 2500
\n
Country subdivision (NUTS): Byen København (DK011)
\n
Country: Denmark
\n
Contact point: 10 29 48 19
\n
Email: kfst@kfst.dk
\n
Telephone: +4541715000
\n
Internet address: https://www.kfst.dk/
\n
Roles of this organisation:
Organisation providing more information on the review procedures
\n
\n
\n
\n
11 Notice information
11.1 Notice information
Notice identifier/version: 94e2c1c8-7c27-4d39-9ea3-f0509ce5c6e1 - 01
\n
Form type: Competition
\n
Notice type: Contract notice
\n
Notice dispatch date: 21-11-2025 14:45 +01:00
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Notice dispatch date (eSender): 21-11-2025 14:45 +01:00
\n
Languages in which this notice is officially available: English 
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11.2 Publication information
Publication Date: 21-11-2025 14:45 +01:00
\n
\n
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