IVD instrumentsNucleic acid testing instrumentsNucleic acid testing instruments except micro-arrays
Nucleic acid testing instruments except micro-arrays - other
EMDN code W02050199
Manufacturers registered in Europe (EUDAMED) 39
- 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.
| Manufacturer | Country | Registered models | Class | Contact |
|---|---|---|---|---|
| Addcare FDA EU representative : Lepu Medical (Europe) Cooperatief U.A. (Netherlands) | China | A IVDR | Website sales@addcare.cn EUDAMED record Report an error | |
| Geneproof | Czechia | A IVDR | Website support@geneproof.com EUDAMED record Report an error | |
| Life Technologies Holdings Pte EU representative : Life Technologies Europe B.V. (Netherlands) | Singapore | A IVDR | EUDAMED record Report an error | |
| Certest | Spain | A IVDR | Website quality@certest.es EUDAMED record Report an error | |
| Hain Lifescience | Germany | A IVDR | EUDAMED record Report an error | |
| Vitrosens | Türkiye | A IVDR | Website info@vitrosens.com EUDAMED record Report an error | |
| Wallac | Finland | A IVDR | Website regulatoryaffairs.turku@revvity.com EUDAMED record Report an error | |
| Aperbio Technologies (Suzhou) EU representative : Medunion S.L. (Spain) | China | A IVDR | EUDAMED record Report an error | |
| Bifour EU representative : SUNGO Europe B.V. (Netherlands) | United States | A IVDR | EUDAMED record Report an error | |
| Genes2Me EU representative : Obelis s.a. (Belgium) | India | A IVDR | Website EUDAMED record Report an error | |
| Institute Of Applied Biotechnologies | Czechia | A IVDR | Website EUDAMED record Report an error | |
| Ningbo HEALTH Gene Technologies EU representative : Lotus NL B.V. (Netherlands) | China | A IVDR | EUDAMED record Report an error | |
| Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain) | China |
|
– 98/79 | EUDAMED record Report an error |
| Qiagen FDA EU representative : QIAGEN GmbH (Germany) | Germany, United States | A IVDR | Website info@qiagen.com EUDAMED record Report an error | |
| Abbott FDA EU representative : Abbott GmbH (Germany) | United States | A IVDR | EUDAMED record Report an error | |
| Aconbio EU representative : MedNet EC-REP GmbH (Germany) | China | A IVDR | Website EUDAMED record Report an error | |
| Bio-Molecular Systems EU representative : mdi Europa GmbH (Germany) | Australia |
|
A IVDR | regulatory@biomolecularsystems.com EUDAMED record Report an error |
| bioMérieux FDA | France | A IVDR | EUDAMED record Report an error | |
| Bioperfectus FDA EU representative : MedNet EC-REP GmbH (Germany) | China | A IVDR | EUDAMED record Report an error | |
| Biopix Dna Technology | Greece | A IVDR | Website EUDAMED record Report an error | |
| BioTNS EU representative : Advena Limited (Malta) | South Korea | A IVDR | EUDAMED record Report an error | |
| Boditech FDA EU representative : Obelis s.a. (Belgium) | South Korea | A IVDR | Website marketing@boditech.co.kr EUDAMED record Report an error | |
| Cepheid FDA EU representative : Cepheid AB (Sweden) | United States | A IVDR | Website EUDAMED record Report an error | |
| Dermagnostix | Germany | A IVDR | Website info@dermagnostix.com EUDAMED record Report an error | |
| Fluxergy FDA EU representative : CMC Medical Devices & Drugs SL (Spain) | United States | A IVDR | Website info@fluxergy.com EUDAMED record Report an error | |
| Genecast EU representative : Medunion S.L. (Spain) | China | A IVDR | info.wuhan@genecast.com.cn EUDAMED record Report an error | |
| Genemind EU representative : Umedwings Netherlands B.V. (Netherlands) | China | A IVDR | regulatoryaffairs@genemind.com EUDAMED record Report an error | |
| inno-train Diagnostik | Germany |
|
A IVDR | Website info@inno-train.de EUDAMED record Report an error |
| Jiangsu Macro & Micro-Test Med-Tech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | A IVDR | marketing@hongweitest.com EUDAMED record Report an error | |
| KH Medical EU representative : Medical Technology Promedt Consulting GmbH (Germany) | South Korea | A IVDR | Website info@khmedical.co.kr EUDAMED record Report an error | |
| Lifotronic FDA EU representative : Umedwings Netherlands B.V. (Netherlands) | China | A IVDR | Website EUDAMED record Report an error | |
| Oacp | Ireland |
|
– 98/79 | Website EUDAMED record Report an error |
| Oxford Nanopore Diagnostics EU representative : MedEnvoy Global BV (Netherlands) | United Kingdom (ex Northern Ireland) | A IVDR | support@nanoporetech.com EUDAMED record Report an error | |
| Sentinel FDA | Italy | A IVDR | Website EUDAMED record Report an error | |
| Shanghai YJMED BioTechnology EU representative : Medunion S.L. (Spain) | China | A IVDR | EUDAMED record Report an error | |
| Shenzhen Huisong Technology Development EU representative : Lotus NL B.V. (Netherlands) | China | A IVDR | EUDAMED record Report an error | |
| Vazyme EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | A IVDR | EUDAMED record Report an error | |
| Xi An Tianlong Science Technology FDA EU representative : SUNGO Europe B.V. (Netherlands) | China | A IVDR | EUDAMED record Report an error | |
| Zybio FDA EU representative : Lotus NL B.V. (Netherlands) | China | A IVDR | PMS@zy-ivd.com EUDAMED record Report an error |
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