Chemistry / immunochemistry instrumentsChemistry instrumentsChemistry analysers
Chemistry analysers - consumables
EMDN code W0201010185
Manufacturers registered in Europe (EUDAMED) 21
- 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) 22
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 |
|---|---|---|---|
| ASTORIA-PACIFIC, INC. | United States | SPOTCHECK | registered |
| Alere San Diego, Inc. Present in Europe in other categories | United States | Cholestech LDX™ | registered |
| DiaSorin, Inc. Present in Europe in other categories | United States | LIAISON® Easy Starter Kit LIAISON® XL | K052794 (2006) |
| Diamedix Corp. | United States | Diamedix | K973177 (1997) |
| Roche Diagnostics Corp. Present in Europe in other categories | United States | cobas c 311 cobas 6000 core unit | K033734 (2003) |
| Roche Molecular Systems, Inc. | United States | COBAS®TaqMan® 48 Analyzer COBAS® TaqMan® | K012966 (2002) |
| Accuster Technologies Pvt. Ltd. | India | – | registered |
| Autobio Labtec Instruments Co., Ltd. Present in Europe in other categories | China | – | registered |
| Boston Easy Biotech Inc | United States | – | registered |
| Diamond Diagnostics Inc. Present in Europe in other categories | United States | – | registered |
| Furuno Electric Co., Ltd. Present in Europe in other categories | Japan | – | registered |
| Getein Biotech,Inc Present in Europe in other categories | China | – | registered |
| Harvard Bioscience Inc | United States | – | registered |
| INFRARED LABORATORY SYSTEMS LLC | United States | – | registered |
| Innovation Scientific Pty Ltd | Australia | – | registered |
| LABSYSTEMS DIAGNOSTICS Present in Europe in other categories | Finland | – | registered |
| Roche Diagnostics Operations Inc. | United States | – | registered |
| STRATEC SE Present in Europe in other categories | Germany | – | registered |
| STRATEC Switzerland AG c/o STRATEC SE | Germany | – | registered |
| Tecan U.S., Ltd. Present in Europe in other categories | United States | – | registered |
| Wuhan Landing Intelligence Medical Co.,Ltd Present in Europe in other categories | China | – | registered |
| tst Biomedical Electronics Co., Ltd. | Taiwan | – | registered |
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