IVD instrumentsGeneral purpose IVD instrumentsVarious general purpose IVD instruments
Various general purpose IVD instruments - other
EMDN code W02079099
Manufacturers registered in Europe (EUDAMED) 33
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
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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) 6
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 |
|---|---|---|---|
| Nova Biomedical Corp. | United States | STAT PROFILE | registered |
| Instrumentation Laboratory CO Present in Europe in other categories | United States | GEM Premier 5000 PAK BG/COOX/TBILI 75 TEST GEM Premier 5000 PAK BG/ISE/COOX/TBILI 75 TEST GEM Premier 5000 PAK BG/ISE/GL/COOX 600 TEST GEM Premier 5000 PAK BG/ISE/GL/COOX 450 TEST GEM Premier 5000 PAK BG/ISE/COOX/TBILI 300 TEST GEM Premier 5000 PAK BG/ISE/COOX 600 TEST | registered |
| Bionostics, Inc. | United States | – | registered |
| Diamond Diagnostics Inc. Present in Europe in other categories | United States | – | registered |
| Roche Diagnostics Operations Inc. | United States | – | registered |
| Sebia Present in Europe in other categories | United States | – | registered |
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