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IVD instrumentsNucleic acid testing instrumentsNucleic acid testing instruments except micro-arrays

Nucleic acid testing instruments except micro-arrays - IVD medical device software

EMDN code W02050192

41 manufacturers, 83 models including 80 on the market, 21 countries

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Manufacturers registered in Europe (EUDAMED) 41
  • On the market
  • No longer marketed
  • 93/42 Former directive, not yet certified under the MDR
  • Click a manufacturer to see its full range, a model to open its EUDAMED record.
ManufacturerCountryRegistered modelsClassContact
Ablsa Luxembourg
3 others
– 98/79 Website contact@ablsa.com EUDAMED record Report an error
Serosep FDA Ireland
2 others
B IVDR, 98/79 Website info@serosep.com EUDAMED record Report an error
Genome Diagnostics Netherlands
1 other
C IVDR, 98/79 Website info@gendx.com EUDAMED record Report an error
Genemind EU representative : Medunion S.L. (Spain) and 1 other China – 98/79 regulatoryaffairs@genemind.com EUDAMED record Report an error
Antegenes Estonia – 98/79 Website info@antegenes.com EUDAMED record Report an error
bioMérieux FDA France A IVDR, 98/79 EUDAMED record Report an error
Bgi Denmark – 98/79 Website EUDAMED record Report an error
Hain Lifescience Germany A IVDR EUDAMED record Report an error
Seqone France C IVDR Website contact@seqone.com EUDAMED record Report an error
Sistemas Genomicos Spain – 98/79 Website EUDAMED record Report an error
3D Biomedicine Science & Technology FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 EUDAMED record Report an error
Life Technologies EU representative : Life Technologies Europe B.V. (Netherlands) United States – 98/79 EUDAMED record Report an error
Omixon Hungary C IVDR, 98/79 Website support@omixon.com EUDAMED record Report an error
One Lambda FDA EU representative : MDSS GmbH (Germany) United States C IVDR Website EUDAMED record Report an error
Progenika Biopharma FDA Spain C IVDR RegulatoryAffairs_DxBU@grifols.com EUDAMED record Report an error
Vela Operations Singapore Pte FDA EU representative : Vela Diagnostics Germany GmbH (Germany) Singapore – 98/79 Website infoAPAC@veladx.com EUDAMED record Report an error
ADmit Therapeutics Spain C IVDR EUDAMED record Report an error
Alifax FDA Italy A IVDR Website regulatory@alifax.com EUDAMED record Report an error
Amoy Diagnostics EU representative : QbD RepS BV (Belgium) China C IVDR Website EUDAMED record Report an error
Atila Biosystems EU representative : SUNGO Europe B.V. (Netherlands) United States C IVDR info@atilabiosystems.com EUDAMED record Report an error
Azure Vault EU representative : Obelis s.a. (Belgium) Israel A IVDR info@diagnostics.ai EUDAMED record Report an error
Beijing USCI Medical Devices EU representative : Wellkang Ltd (Northern Ireland) China – 98/79 office@usci-ivd.cn EUDAMED record Report an error
Breakthrough Genomics EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) United States A IVDR Info@btgenomics.com EUDAMED record Report an error
Congenica EU representative : Acorn Regulatory Consultancy Services Ltd (Ireland) United Kingdom (ex Northern Ireland) – 98/79 Website quality@congenica.com EUDAMED record Report an error
Genexpath France – 98/79 Website EUDAMED record Report an error
GenomeUp Italy A IVDR EUDAMED record Report an error
Hangzhou New Horizon Health Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China A IVDR Website compliance@nhbio.com.cn EUDAMED record Report an error
Intlab EU representative : INTLAB Deutschland GmbH (Germany) Switzerland – 98/79 Website info@intlab.online EUDAMED record Report an error
Medicover Cyprus C IVDR Website EUDAMED record Report an error
Microbio EU representative : Qualrep Services B.V. (Netherlands) Australia – 98/79 Website info@microbio.com.au EUDAMED record Report an error
OncoDNA Belgium – 98/79 Website QA@oncodna.com EUDAMED record Report an error
Qiagen FDA Germany C IVDR Website info@qiagen.com EUDAMED record Report an error
Qlucore Sweden A IVDR info@qlucore.com EUDAMED record Report an error
Sequentia Biotech Spain B IVDR Website quality@sequentiabiotech.com EUDAMED record Report an error
Tetracore FDA EU representative : Emergo Europe B.V. (Netherlands) United States A IVDR EUDAMED record Report an error
UgenTec Belgium – 98/79 Website quality@ugentec.com EUDAMED record Report an error
Veracyte FDA EU representative : Veracyte Global BV (Netherlands) United States – 98/79 Website EUDAMED record Report an error
Ziwig France C IVDR service@ziwig.com EUDAMED record Report an error
Mobidiag No model still on the market Finland – 98/79 Website sales.mob@hologic.com EUDAMED record Report an error
Molecular Health No model still on the market Germany C IVDR Website EUDAMED record Report an error
Noscendo No model still on the market Germany C IVDR Website info@noscendo.com EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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