IVD generic use consumablesDEVICES FOR SAMPLES ANALYSES (no laboratory generic products)Devices for samples analyses - various
Devices for samples analyses - other accessories
EMDN code W05039080
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.
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) 15
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 |
|---|---|---|---|
| Siemens Healthcare Diagnostics, Inc. Present in Europe in other categories | United States | ADVIA Centaur® CEA Atellica IM CEA Dimension Vista® Flex® reagent cartridge CEA ADVIA Centaur® CEA Diluent Atellica IM CEA DIL | registered |
| MONOBIND, INC. Present in Europe in other categories | United States | CEA-NG AccuLite CLIA Test System - 96 Wells CEA AccuBind ELISA Test System - 96 Wells CEA AccuLite CLIA Test System - 96 Wells CEA AccuLite CLIA Test System - 192 Wells CEA-NG AccuBind ELISA Test System - 96 Wells CEA-NG AccuBind ELISA Test System - 192 Wells | registered |
| Beckman Coulter, Inc. Present in Europe in other categories | United States | Access CEA Access CEA Diluent Access CEA Calibrators Access CEA QC | K223921 (2023) |
| Ortho-Clinical Diagnostics, Inc. Present in Europe in other categories | United States | VITROS | K231517 (2023) |
| Siemens Healthcare Diagnostics Products GmbH Present in Europe in other categories | Germany | IMMULITE®/IMMULITE® 1000 Systems CEA CEA Sample Diluent IMMULITE® 2000 Systems CEA | registered |
| Ge Medical Systems Information Technologies Present in Europe in other categories | United States | MAC | registered |
| Bio-Rad Present in Europe in other categories | United States | – | registered |
| Diafarma Ecza Deposu ve Medikal Dis Ticaret Dis Tic Ltd Sti | Türkiye | – | registered |
| Diagnostic Automation /Cortez Diagnostics Inc. | United States | – | registered |
| Diamond Diagnostics Inc. Present in Europe in other categories | United States | – | registered |
| QuidelOrtho Corporation | United States | – | registered |
| Roche Diagnostics Operations Inc. | United States | – | registered |
| SST International Inc. | United States | – | registered |
| Siemens Healthcare Disgnostics, Inc. | United States | – | K200215 (2020) |
| Tosoh Bioscience, Inc. | United States | – | registered |
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