IVD instrumentsChemistry / immunochemistry instrumentsImmunochemistry instruments
Limited panel immunochemistry analysers
EMDN code W02010202
Manufacturers registered in Europe (EUDAMED) 61
- 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.
| Manufacturer | Country | Registered models | Class | Contact |
|---|---|---|---|---|
| Boditech FDA EU representative : Obelis s.a. (Belgium) | South Korea | A IVDR | Website marketing@boditech.co.kr EUDAMED record Report an error | |
| Hangzhou Alltest Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other | China | A IVDR, 98/79 | info@alltests.com.cn EUDAMED record Report an error | |
| Dynodx EU representative : HUMISS TRADING S. L. (Spain) | China |
1 other
|
– 98/79 | EUDAMED record Report an error |
| Human | Germany | A IVDR | Website EUDAMED record Report an error | |
| Rayto EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | A IVDR | Website support@rayto.com EUDAMED record Report an error | |
| Acro Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) | United States | A IVDR | info@acrobiotech.com EUDAMED record Report an error | |
| Monobind FDA EU representative : AR Experts B.V. (Netherlands) | United States | A IVDR | Website info@monobind.com EUDAMED record Report an error | |
| opTricon | Germany |
|
A IVDR | Website info@optricon.de EUDAMED record Report an error |
| R-Biopharm FDA | Germany | A IVDR | Website EUDAMED record Report an error | |
| Abbott FDA EU representative : Abbott Rapid Dx International Limited (Ireland) | United States | A IVDR | Website EUDAMED record Report an error | |
| Acesolab FDA EU representative : VidaQuick Biotech S.L. (Spain) | United States | A IVDR | info@acesolab.com EUDAMED record Report an error | |
| Genrui Biotech FDA EU representative : Lotus NL B.V. (Netherlands) | China | A IVDR | Website service@genrui-bio.com EUDAMED record Report an error | |
| Rapid Labs EU representative : VidaQuick Biotech S.L. (Spain) | United Kingdom (ex Northern Ireland) | A IVDR | Website info@rapidlabs.co.uk EUDAMED record Report an error | |
| Aidian FDA | Finland | A IVDR | Website eudamed@aidian.eu EUDAMED record Report an error | |
| Aucheer EU representative : MedPath GmbH (Germany) | China | A IVDR | info_office@aucheer.net EUDAMED record Report an error | |
| Biobase FDA EU representative : Luxus Lebenswelt GmbH (Germany) | China | A IVDR | EUDAMED record Report an error | |
| Cesna | Türkiye | A IVDR | Website info@cesna.com.tr EUDAMED record Report an error | |
| Citest Diagnostics EU representative : VidaQuick Biotech S.L. (Spain) | Canada | A IVDR | ra02@citestdiagnostics.com EUDAMED record Report an error | |
| Icarbonx EU representative : Kingsmead Service B.V. (Netherlands) | China | A IVDR | EUDAMED record Report an error | |
| Infitek FDA EU representative : Kingsmead Service B.V. (Netherlands) and 1 other | China | A IVDR | info@infitek.com EUDAMED record Report an error | |
| Newlink Biotech EU representative : VidaQuick Biotech S.L. (Spain) | China | A IVDR | Website info@kylinew.com EUDAMED record Report an error | |
| Shinjin Medics EU representative : Obelis s.a. (Belgium) | South Korea | A IVDR | Website EUDAMED record Report an error | |
| Siemens Healthcare Diagnostics Products FDA | Germany | A IVDR | Website contact@siemens-healthineers.com EUDAMED record Report an error | |
| Ukinbio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) | China | A IVDR | sales@ukinbio.com EUDAMED record Report an error | |
| Abionic FDA EU representative : Veranex Germany GmbH (Germany) | Switzerland | A IVDR | Website info@abionic.com EUDAMED record Report an error | |
| Aconbio EU representative : MedNet EC-REP GmbH (Germany) | China | A IVDR | Website EUDAMED record Report an error | |
| Actest EU representative : VidaQuick Biotech S.L. (Spain) | China | A IVDR | info@actest.com.cn EUDAMED record Report an error | |
| Addcare FDA EU representative : Lepu Medical (Europe) Cooperatief U.A. (Netherlands) | China | A IVDR | Website sales@addcare.cn EUDAMED record Report an error | |
| Aichek FDA EU representative : SUNGO Europe B.V. (Netherlands) | China | A IVDR | ra.rep@aichek.com EUDAMED record Report an error | |
| Becton Dickinson FDA EU representative : Becton Dickinson Ireland Limited (Ireland) | United States | A IVDR | Website EUDAMED record Report an error | |
| Beijing North Institute of Biotechnology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) | China | A IVDR | EUDAMED record Report an error | |
| Bio-Novum | Poland | A IVDR | Website EUDAMED record Report an error | |
| Biobase Biogrand EU representative : Luxus Lebenswelt GmbH (Germany) | China | A IVDR | EUDAMED record Report an error | |
| BioChain (Beijing) Science & Technology EU representative : Medunion S.L. (Spain) | China | A IVDR | EUDAMED record Report an error | |
| biomed Dr. Wieser | Austria | A IVDR | Website office@biomed-technics.com EUDAMED record Report an error | |
| DAS | Italy | A IVDR | Website quality@dasitaly.com EUDAMED record Report an error | |
| Dynex | Czechia | A IVDR | Website EUDAMED record Report an error | |
| Elitbiotech EU representative : CMC Medical Devices & Drugs SL (Spain) | China | A IVDR | EUDAMED record Report an error | |
| Eurolyser | Austria | A IVDR | Website EUDAMED record Report an error | |
| Hangzhou Zheda Dixun Biological Gene Engineering EU representative : CMC Medical Devices & Drugs SL (Spain) | China | A IVDR | EUDAMED record Report an error | |
| Hidex | Finland | A IVDR | Website EUDAMED record Report an error | |
| Jiangsu Macro & Micro-Test Med-Tech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | A IVDR | marketing@hongweitest.com EUDAMED record Report an error | |
| Joinstar EU representative : Lotus NL B.V. (Netherlands) | China | A IVDR | EUDAMED record Report an error | |
| Keyubio EU representative : CMC Medical Devices & Drugs SL (Spain) | China | A IVDR | Website export@keyubio.com EUDAMED record Report an error | |
| Labsystems Diagnostics FDA | Finland | A IVDR | Website EUDAMED record Report an error | |
| Meril Diagnostics FDA EU representative : CMC Medical Devices & Drugs SL (Spain) | India | A IVDR | Website ram.kanoje@merillife.com EUDAMED record Report an error | |
| Mindray FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | A IVDR | Website EUDAMED record Report an error | |
| Mpbio FDA | Germany | A IVDR | Website EUDAMED record Report an error | |
| nal von minden | Germany | A IVDR | Website info@nal-vonminden.com EUDAMED record Report an error | |
| Protia EU representative : Medical Technology Promedt Consulting GmbH (Germany) | South Korea | A IVDR | EUDAMED record Report an error | |
| Responsebio FDA EU representative : Emergo Europe B.V. (Netherlands) | Canada | A IVDR | Website EUDAMED record Report an error | |
| Revvity FDA EU representative : Wallac Oy (Finland) | United Kingdom (ex Northern Ireland) | A IVDR | Website EUDAMED record Report an error | |
| Shanghai Kehua Laboratory System FDA EU representative : Obelis s.a. (Belgium) | China | A IVDR | Website EUDAMED record Report an error | |
| Shenzhen Uni-medica Technology EU representative : CMC Medical Devices & Drugs SL (Spain) | China | A IVDR | Website marketing@uni-medica.com EUDAMED record Report an error | |
| Strumed FDA EU representative : Amstermed B.V. (Netherlands) | India |
|
– 98/79 | Website EUDAMED record Report an error |
| Suzhou Helmen Precision Insturments EU representative : Lotus NL B.V. (Netherlands) | China | A IVDR | Website EUDAMED record Report an error | |
| Tecan FDA | Austria | A IVDR | Website regulatory.affairs.at@tecan.com EUDAMED record Report an error | |
| Vigilant Biosciences FDA EU representative : Vigilant Biosciences GmbH (Germany) | United States |
|
A IVDR | EUDAMED record Report an error |
| Vitrosens | Türkiye | A IVDR | Website info@vitrosens.com EUDAMED record Report an error | |
| Zybio FDA EU representative : Lotus NL B.V. (Netherlands) | China | A IVDR | PMS@zy-ivd.com EUDAMED record Report an error | |
| Salofa FDA No model still on the market | Finland |
|
– 98/79 | Website info@salofa.com EUDAMED record Report an error |
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) 16
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 |
|---|---|---|---|
| Roche Diagnostics Corp. Present in Europe in other categories | United States | Tinaquant IgG Gen2 IGG Immunoglobulin G Turbidimetric) Tina-quant IgG Gen.2 | K050113 (2005) |
| Randox Laboratories, Ltd. Present in Europe in other categories | United Kingdom | IgG | K955798 (1996) |
| AGILENT TECHNOLOGIES SINGAPORE PTE LTD Present in Europe in other categories | – | Poly Rb a Hu Alpha-1-Antitrypsin Poly Rb A-Hu IgG Poly Rb A-Hu IgA, IgG, IgM | registered |
| Beckman Coulter, Inc. Present in Europe in other categories | United States | Synchron | registered |
| bioMerieux, Inc. Present in Europe in other categories | United States | VIDAS® VIDAS® PC SOFTWARE V4.9 | registered |
| HORIBA ABX SAS Present in Europe in other categories | France | Yumizen C1200 Immunoglobulin G | registered |
| Kamiya Biomedical Co. Present in Europe in other categories | United States | K-ASSAY® IgG Reagent | K993281 (1999) |
| Kent Laboratories, Inc. | United States | Antiserum to Human IgG (gamma chain specific) | K790702 (1979) |
| Agilent Technologies, Inc. Present in Europe in other categories | United States | – | registered |
| BIT Analytical Solutions GmbH | Germany | – | registered |
| Diamond Diagnostics Inc. Present in Europe in other categories | United States | – | registered |
| Nittobo Medical Co., Ltd. | Japan | – | registered |
| Roche Diagnostics Operations Inc. | United States | – | registered |
| Siemens Healthcare Diagnostics, Inc. Present in Europe in other categories | United States | – | registered |
| Thermo Fisher Scientific Present in Europe in other categories | United States | – | registered |
| Zeus Scientific, Inc. Present in Europe in other categories | United States | – | K924197 (1992) |
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