IVD instrumentsNucleic acid testing instruments
Nucleic acid testing instruments - rapid and point of care tests
EMDN code W020503
Manufacturers registered in Europe (EUDAMED) 29
- 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 |
|---|---|---|---|---|
| Ustar Biotechnologies (Hangzhou) EU representative : Lotus NL B.V. (Netherlands) | China | A IVDR | Website service@bioustar.com EUDAMED record Report an error | |
| Targetingone EU representative : SUNGO Europe B.V. (Netherlands) | China | A IVDR | EUDAMED record Report an error | |
| igenetech EU representative : CMC Medical Devices & Drugs SL (Spain) | South Korea | A IVDR | Website EUDAMED record Report an error | |
| Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇ | Türkiye | A IVDR | Website info@visionbiotechnology.com EUDAMED record Report an error | |
| Bioteke FDA EU representative : SUNGO Europe B.V. (Netherlands) | China |
|
A IVDR | Website info@bioteke.cn EUDAMED record Report an error |
| FlashDx Shenzhen EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) | China | A IVDR | info@flash-dx.com EUDAMED record Report an error | |
| Genes2Me EU representative : Obelis s.a. (Belgium) | India | A IVDR | Website EUDAMED record Report an error | |
| Guangzhou Deaou Gene Technology EU representative : SUNGO Europe B.V. (Netherlands) | China | A IVDR | EUDAMED record Report an error | |
| Shanghai Chuangkun Biotech EU representative : SUNGO Europe B.V. (Netherlands) | China | A IVDR | EUDAMED record Report an error | |
| Wuxi Qitian Biological Science Instrument EU representative : SUNGO Europe B.V. (Netherlands) | China | A IVDR | EUDAMED record Report an error | |
| Baybio EU representative : SUNGO Europe B.V. (Netherlands) | China | A IVDR | EUDAMED record Report an error | |
| Cowingene EU representative : MedPath GmbH (Germany) | China | A IVDR | Website EUDAMED record Report an error | |
| Genedrive EU representative : Advena Limited (Malta) | United Kingdom (ex Northern Ireland) |
|
A IVDR | Website EUDAMED record Report an error |
| Geneus Technologies (Chengdu) EU representative : SUNGO Europe B.V. (Netherlands) | China | A IVDR | EUDAMED record Report an error | |
| Guangzhou Four E’s Scientific FDA EU representative : Humiss Beratung GmbH (Germany) | China | A IVDR | EUDAMED record Report an error | |
| Hangzhou Bigfish Bio-tech EU representative : SUNGO Europe B.V. (Netherlands) | China |
|
A IVDR | EUDAMED record Report an error |
| Healgen FDA EU representative : CMC Medical Devices & Drugs SL (Spain) | United States |
|
– 98/79 | quality@healgen.com EUDAMED record Report an error |
| Hysenbiotech EU representative : Medunion S.L. (Spain) | South Korea | A IVDR | EUDAMED record Report an error | |
| Infitek FDA EU representative : Kingsmead Service B.V. (Netherlands) | China | A IVDR | info@infitek.com EUDAMED record Report an error | |
| Lifereal EU representative : SUNGO Europe B.V. (Netherlands) | China | A IVDR | EUDAMED record Report an error | |
| Ortho-Clinical Diagnostics Dba Quidel EU representative : MDSS GmbH (Germany) | United States | A IVDR | Website PRRC@quidelortho.com EUDAMED record Report an error | |
| Pluslife EU representative : SUNGO Europe B.V. (Netherlands) | China | A IVDR | Website ra@pluslife.com EUDAMED record Report an error | |
| Qingdao MGI Tech EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | A IVDR | EUDAMED record Report an error | |
| Rocgene FDA EU representative : SUNGO Europe B.V. (Netherlands) | China | A IVDR | sale@rocgene.com EUDAMED record Report an error | |
| Sense Biodetection EU representative : Emergo Europe B.V. (Netherlands) | United Kingdom (ex Northern Ireland) | – 98/79 | Website info@sense-bio.com EUDAMED record Report an error | |
| Suzhou Changhe Biotech EU representative : SUNGO Europe B.V. (Netherlands) | China | A IVDR | EUDAMED record Report an error | |
| Toroivd Technology EU representative : SUNGO Europe B.V. (Netherlands) | China | A IVDR | EUDAMED record Report an error | |
| Winnoz EU representative : MedNet EC-REP GmbH (Germany) | Taiwan | A IVDR | Website service@winnoz.com 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 |
A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.
Other manufacturers known in the United States (FDA) 3
Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| QIAGEN GmbH Present in Europe in other categories | Germany | QIAcuityDx® Four QIAcuityDx® Nanoplate 26k 24-well | registered |
| Bio-Rad Present in Europe in other categories | United States | – | registered |
| Suzhou Sniper Medical Technologies Co., Ltd Present in Europe in other categories | China | – | registered |
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