Chemistry / immunochemistry instrumentsImmunochemistry instrumentsAutomated immunochemistry analysers
Automated immunochemistry analysers - IVD medical device software
EMDN code W0201020192
Manufacturers registered in Europe (EUDAMED) 6
- 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 |
|---|---|---|---|---|
| Phadia FDA | Sweden | A, B IVDR | Website RegulatoryAffairs.Uppsala.IDD@thermofisher.com EUDAMED record Report an error | |
| Visia Lab FDA | Italy | B IVDR | Website quality@visialab.com EUDAMED record Report an error | |
| Euroimmun FDA | Germany | B IVDR | Website info@euroimmun.de EUDAMED record Report an error | |
| Human | Germany |
|
– 98/79 | Website EUDAMED record Report an error |
| iSTOC | Finland |
|
– 98/79 | Website EUDAMED record Report an error |
| Shenzhen New Industries Biomedical Engineering FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | C IVDR | Website 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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