IVD instrumentsChemistry / immunochemistry instrumentsChemistry instruments
Chemistry analysers
EMDN code W02010101
Manufacturers registered in Europe (EUDAMED) 94
- 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) 97
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 |
|---|---|---|---|
| Hycor Biomedical, Inc. Present in Europe in other categories | United States | NOVEOS Cuvette Wash Pack NOVEOS Wheat, Triticum aestivum NOVEOS Egg White, Gallus gallus NOVEOS Diluent A Kit NOVEOS Gal d 2 Ovalbumin, Egg NOVEOS Common Silver Birch, Betula verrucosa | registered |
| Biobase Biodustry(Shandong)Co., Ltd. | China | BIOBASE BIOBASEBK200mini | registered |
| Ortho-Clinical Diagnostics, Inc. Present in Europe in other categories | United States | VITROS | K063144 (2006) |
| EUROIMMUN Medizinische Labordiagnostika AG Present in Europe in other categories | Germany | System liquid concentrate Device Qualification Test Kit EUROIMMUN Analyzer I / I-2P Device Qualification Test Kit EUROLabWorkstation ELISA EUROIMMUN Analyzer I-2P Device Qualification Test Kit EUROLabLiquidHandler EUROLabWorkstation ELISA | registered |
| BIOCHROM LIMITED Present in Europe in other categories | – | Bio30+ Physiological HR Bio30+ Physio W/O A/S HR Bio30+ Physio High Performance Bio30+ System Physio HR Bio30+ System Physio HP Bio30+ Physio Accelerated | registered |
| Immunodiagnostic Systems , Ltd. Present in Europe in other categories | United Kingdom | IDS-iSYS Cuvettes IDS i20 IDS-iSYS D-Sorb Solution IDS Top Cap Set IDS-i10 IDS-iSYS Multi Discipline Automated System | registered |
| Gold Standard Diagnostics Present in Europe in other categories | United States | Bolt Bolt (CLIA) ThunderBolt EIA ThunderBolt EIA (CLIA) Performance Check Dye Kit | registered |
| bioMerieux, Inc. Present in Europe in other categories | United States | VIDAS 3 mini VIDAS® VIDAS® 3 VIDAS® Refurbished VIDAS® 3 ASSAY DILUTION CUP VIDAS® 3 SOFTWARE V1.4 | registered |
| Diamond Diagnostics Inc. Present in Europe in other categories | United States | Reference Electrode Sample Sensor Urine Standard ProLyte Electrolyte Analyzer SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ Reference Electrode Housing | registered |
| TOSOH CORPORATION Present in Europe in other categories | United States | Automated Chemiluminescent Enzyme Immunoassay Analyzer AIA-CL2400 Automated Chemiluminescent Enzyme Immunoassay Analyzer AIA-CL1200 Automated Chemiluminescent Enzyme Immunoassay Analyzer AIA-CL300 Auto-Prep Unit for AIA-CL1200 | registered |
| FUJIREBIO INC. Present in Europe in other categories | – | LUMIPULSE G1200 Lumipulse G Substrate Solution Lumipulse G Wash Solution TENDIGO Disposable Trays TENDIGO | registered |
| MONOBIND, INC. Present in Europe in other categories | United States | Titin ELISA Analyzer Titin ELISA & CLIA Analyzer Titin-s ELISA Analyzer Titin-s ELISA & CLIA Analyzer | registered |
| Phadia AB Present in Europe in other categories | Sweden | Maintenance Solution Kit Phadia Maintenance Solution Large Phadia Maintenance Solution Small Maintenance Solution Kit Large | registered |
| TECO DIAGNOSTICS | United States | Teco Diagnostics TC Matrix Clinical Chemistry Analyzer | K073370 (2008) |
| TOKYO BOEKI MEDISYS INC. | United States | MyeLyte Touch BIOLIS 30i IMMTOX 270 DZ-Lite c270 | registered |
| Inova Diagnostics, Inc. Present in Europe in other categories | United States | QUANTA-Lyser ® 3000 ELISA/IFA+ Incubator QUANTA-Lyser® 3000 ELISA/IFA QUANTA-Lyser® 3000 /IFA | registered |
| Medica Corp. | United States | ISE Reagent Pack EasyRA Analyzer (LIS) EasyRA Analyzer (ISE&LIS) | registered |
| ALFA WASSERMANN, INC. | United States | ACE Axcel® ACE Alera® | registered |
| ASTORIA-PACIFIC, INC. | United States | SPOTCHECK | registered |
| Alere San Diego, Inc. Present in Europe in other categories | United States | Cholestech LDX™ | registered |
| CAROLINA LIQUID CHEMISTRIES CORPORATION | United States | CLC480 Chemistry Analyzer W/ISE CLC720 Chemistry Analyzer w/ISE | K133519 (2014) |
| DIESSE DIAGNOSTICA SENESE SPA Present in Europe in other categories | United States | CHORUS TRIO CHORUS TRIO RAS | registered |
| DREW SCIENTIFIC, INC. | United Kingdom | JAS Diagnostics | 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) |
| STRATEC SE Present in Europe in other categories | Germany | KleeYa® GEMINI | registered |
| Shenzhen New Industries Biomedical Engineering Co., Ltd. Present in Europe in other categories | China | Maglumi 2000 Immunoassay Analyzer MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer | registered |
| Awareness Technology, Inc. | United States | SelectaLyte | registered |
| Bio-Rad Present in Europe in other categories | United States | EVOLIS | registered |
| Fujirebio Diagnostics,Inc. Present in Europe in other categories | United States | Lumipulse G Wash Solution | registered |
| INFRARED LABORATORY SYSTEMS LLC | United States | Synermed® | registered |
| OPTI MEDICAL SYSTEMS, INC. Present in Europe in other categories | United States | OPTI Accessory Kit | registered |
| PHC Corporation Present in Europe in other categories | Japan | PATHFAST | registered |
| SOCIETE ANONYME DE FABRICATION D'APPAREILS SCIENTIFIQUES | Monaco | Spiral Laboratories | registered |
| THE BINDING SITE GROUP LIMITED Present in Europe in other categories | United States | Optilite® Analyser | registered |
| Taidoc Technology Corporation Present in Europe in other categories | Taiwan | URIGHT Hemoglobin A1c Analyzer | registered |
| ARI Medical Technology Co., Ltd. Present in Europe in other categories | China | – | registered |
| Accuster Technologies Pvt. Ltd. | India | – | registered |
| Beijing Hotgen Biotech Co., Ltd. Present in Europe in other categories | China | – | registered |
| Bio-Rad Laboratories (Bio-Rad Services France) Present in Europe in other categories | France | – | registered |
| Boston Easy Biotech Inc | United States | – | registered |
| CARCLO TECHNICAL PLASTICS | United States | – | registered |
| Canon, Inc. Present in Europe in other categories | United States | – | registered |
| CarboLink Corporate Consulting, LLC | United States | – | registered |
| Cliniqa Corporation | United States | – | registered |
| Currier Plastics | United States | – | registered |
| Diafarma Ecza Deposu ve Medikal Dis Ticaret Dis Tic Ltd Sti | Türkiye | – | registered |
| Diatron MI Plc | Hungary | – | registered |
| Diazyme Laboratories Present in Europe in other categories | United States | – | registered |
| ELHoda trade and supplies | Egypt | – | registered |
| ELITECHGROUP INC. Present in Europe in other categories | United States | – | registered |
| EPITOPE DIAGNOSTICS, INC. | United States | – | registered |
| FandF Co., Ltd. Medical Device Department | Japan | – | registered |
| Flextronics International USA, Inc. | United States | – | registered |
| Getein Biotech,Inc Present in Europe in other categories | China | – | registered |
| HEALTHCARE TECHNOLOGY INTERNATIONAL LTD. | Hong Kong SAR China | – | registered |
| Hamilton Co. Present in Europe in other categories | United States | – | K943493 (1995) |
| Harvard Bioscience Inc | United States | – | registered |
| Healgen Scientific,, LLC Present in Europe in other categories | United States | – | registered |
| High Technology, Inc. Present in Europe in other categories | United States | – | registered |
| IDEXX LABORATORIES INC. | United States | – | registered |
| Ids, Ltd. Present in Europe in other categories | South Korea | – | registered |
| Innovation Scientific Pty Ltd | Australia | – | registered |
| Inpeco SA Present in Europe in other categories | Italy | – | registered |
| Ixensor Co, Ltd. | Taiwan | – | registered |
| JEOL LTD. | Japan | – | registered |
| Jabil Inc. | United States | – | registered |
| LABSYSTEMS DIAGNOSTICS Present in Europe in other categories | Finland | – | registered |
| Lighthouse Lab Services | United States | – | registered |
| Lords Mark Global LLC | United States | – | registered |
| MGS Germantown, A Division of MGS Group NA Inc | United States | – | registered |
| Nova Biomedical Corp. | United States | – | registered |
| PRECISION SYSTEM SCIENCE COMPANY LIMITED Present in Europe in other categories | Japan | – | registered |
| QuidelOrtho Corporation | United States | – | registered |
| Roche Diagnostics Operations Inc. | United States | – | registered |
| SST International Inc. | United States | – | registered |
| STANBIO LABORATORY, L.P. | United States | – | K042169 (2005) |
| STRATEC Switzerland AG c/o STRATEC SE | Germany | – | registered |
| STS Corporation | United States | – | registered |
| Sanzay Corporation - Integrated Diagnostics Group | United States | – | registered |
| Sekisui Diagnostics, LLC Present in Europe in other categories | United States | – | registered |
| Sequitur Health Corp. | United States | – | registered |
| Shenzhen Increcare Biotech Co., Ltd Present in Europe in other categories | China | – | registered |
| Spiral SA Laboratories | France | – | registered |
| Sysmex America, Inc. Present in Europe in other categories | United States | – | registered |
| TESSY PLASTICS CORP. | United States | – | registered |
| TN Michigan, LLC | United States | – | registered |
| Tecan U.S., Ltd. Present in Europe in other categories | United States | – | registered |
| Technimark | United States | – | registered |
| Tosoh Bioscience, Inc. | United States | – | registered |
| Westfall-Technik | United States | – | registered |
| Wuhan Landing Intelligence Medical Co.,Ltd Present in Europe in other categories | China | – | registered |
| Wuxi Biohermes Bio & Medical Technology Co.,Ltd. Present in Europe in other categories | China | – | registered |
| YAMURA ELECTRIC INDUSTRY CO., LTD. | Japan | – | registered |
| tst Biomedical Electronics Co., Ltd. | Taiwan | – | registered |
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