Infectious diseasesBacteriology (infect. immunology/NAT)Mycobacteria genus + species
Mycobacterial antibody assays
EMDN code W0105010702
Manufacturers registered in Europe (EUDAMED) 17
- 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 |
|---|---|---|---|---|
| BeijingModern GaoDa Biotechnology EU representative : Medunion S.L. (Spain) | China | – 98/79 | EUDAMED record Report an error | |
| Hangzhou Alltest Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) | China | – 98/79 | info@alltests.com.cn EUDAMED record Report an error | |
| Anhui Deepblue Medical Technology FDA EU representative : Luxus Lebenswelt GmbH (Germany) | China | – 98/79 | sales@dbluemedical.com EUDAMED record Report an error | |
| Dynamiker EU representative : Lotus NL B.V. (Netherlands) | China | – 98/79 | Website marketing@dynamiker.com 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 | |
| Vitrosens | Türkiye | C IVDR, 98/79 | Website info@vitrosens.com EUDAMED record Report an error | |
| Zhejiang Greylynx Biotech EU representative : Lotus NL B.V. (Netherlands) | China | – 98/79 | info@vivachek.com EUDAMED record Report an error | |
| Beijing Applied Biological Technologies EU representative : Luxus Lebenswelt GmbH (Germany) | China | – 98/79 | EUDAMED record Report an error | |
| Beijing Jinwofu Bioengineering Technology EU representative : CMC Medical Devices & Drugs SL (Spain) | China | – 98/79 | EUDAMED record Report an error | |
| Diagreat EU representative : Medunion S.L. (Spain) | China | C IVDR | Website info@diagreat.com EUDAMED record Report an error | |
| Encode EU representative : CMC Medical Devices & Drugs SL (Spain) | China | – 98/79 | Website EUDAMED record Report an error | |
| Hangzhou Immuno Biotech EU representative : CMC Medical Devices & Drugs SL (Spain) | China | – 98/79 | info@jgbiotech.com EUDAMED record Report an error | |
| HEALSTONE Biotech FDA EU representative : CMC Medical Devices & Drugs SL (Spain) | Canada | – 98/79 | sales@orientgene.com EUDAMED record Report an error | |
| Hightopbio FDA EU representative : MedNet EC-REP GmbH (Germany) | China | – 98/79 | Website EUDAMED record Report an error | |
| Labsystems Diagnostics FDA | Finland | – 98/79 | Website EUDAMED record Report an error | |
| Nexlab EU representative : MedNet EC-REP GmbH (Germany) | China | – 98/79 | EUDAMED record Report an error | |
| Zetmedikal | Türkiye | – 98/79 | Website info@zetmedikal.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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