IVD instrumentsGeneral purpose IVD instruments
Various general purpose IVD instruments
EMDN code W020790
Manufacturers registered in Europe (EUDAMED) 38
- 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.
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) 20
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 | K980646 (1998) |
| Draeger Medical Systems, Inc. Present in Europe in other categories | United States | Drager Jaundice Meter, model JM-105 Drager Jaundice Meter, model JM-103 | K133175 (2014) |
| Siemens Healthcare Diagnostics, Inc. Present in Europe in other categories | United States | ADVIA® Chemistry Total Bilirubin_2 TBIL_2 Reagents RAPIDPoint® 500e Blood Gas System | K110277 (2011) |
| REICHERT, INC. Present in Europe in other categories | United States | UNISTAT® Bilirubinometer Specimen Cuvettes | registered |
| AD Supply Group Limited | United Kingdom | – | registered |
| Bionostics, Inc. | United States | – | registered |
| CBR Enterprise Limited | Hong Kong SAR China | – | registered |
| CEVA Logistics Netherlands BV | Netherlands | – | registered |
| DHL Supply Chain (Netherlands) B.V. | Netherlands | – | registered |
| Diamond Diagnostics Inc. Present in Europe in other categories | United States | – | registered |
| Draegerwerk AG & CO Kgaa | Germany | – | registered |
| IVUS ILAC SANAYI VE TICARET AS | Türkiye | – | registered |
| Katecho, Inc. | United States | – | registered |
| Konica Minolta, Inc. Present in Europe in other categories | Japan | – | registered |
| Platinum Focus Group Ltd. | United Kingdom | – | registered |
| Roche Diagnostics Operations Inc. | United States | – | registered |
| Sanicure BV | Netherlands | – | registered |
| Sebia Present in Europe in other categories | United States | – | registered |
| Sekisui Diagnostics, LLC Present in Europe in other categories | United States | – | registered |
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