Chemistry / immunochemistry instrumentsImmunochemistry instrumentsAutomated immunochemistry analysers
Automated immunochemistry analysers - low routine (throughput <= 100 test/h)
EMDN code W0201020101
Manufacturers registered in Europe (EUDAMED) 99
- 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 |
|---|---|---|---|---|
| Illumaxbio EU representative : MedNet EC-REP GmbH (Germany) | China | A IVDR | Website EUDAMED record Report an error | |
| Euroimmun FDA | Germany | A IVDR | Website info@euroimmun.de EUDAMED record Report an error | |
| Aikang MedTech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | A IVDR | EUDAMED record Report an error | |
| bioMérieux FDA | France | A IVDR, 98/79 | EUDAMED record Report an error | |
| Gold Standard Diagnostics FDA EU representative : Emergo Europe B.V. (Netherlands) | United States | A IVDR | Website EUDAMED record Report an error | |
| Medconn FDA EU representative : JOYSUN GROUP S.L.U (Spain) and 1 other | China | A IVDR | 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 | |
| Sophonix EU representative : CMC Medical Devices & Drugs SL (Spain) | China |
|
A IVDR | EUDAMED record Report an error |
| Linear FDA | Spain | A IVDR | Website info@linear.es EUDAMED record Report an error | |
| Orgentec | Germany | A IVDR | Website 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 | |
| Celnovte EU representative : Umedwings Netherlands B.V. (Netherlands) | China | A IVDR | EUDAMED record Report an error | |
| D-tek | Belgium | A IVDR | Website EUDAMED record Report an error | |
| Dynex Technologies FDA EU representative : Acorn Regulatory Consultancy Services Ltd (Ireland) | United States |
|
A IVDR | Website EUDAMED record Report an error |
| Genobio Pharmaceutical FDA EU representative : Lotus NL B.V. (Netherlands) | China | A IVDR | Website marketing@era-bio.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 | |
| Monobind FDA EU representative : AR Experts B.V. (Netherlands) | United States | A IVDR | Website info@monobind.com EUDAMED record Report an error | |
| Accucise EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | A IVDR | sales@accucise.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 | |
| Biobase FDA EU representative : Luxus Lebenswelt GmbH (Germany) | China | A IVDR | EUDAMED record Report an error | |
| BioFynder EU representative : SUNGO Europe B.V. (Netherlands) | United Kingdom (ex Northern Ireland) | A IVDR | EUDAMED record Report an error | |
| Hipro FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) | China | A IVDR | EUDAMED record Report an error | |
| Hitachi High-Tech FDA EU representative : Roche Diagnostics GmbH (Germany) | Japan | A IVDR | ra-contact.aj@hitachi-hightech.com EUDAMED record Report an error | |
| Human | Germany | A IVDR | Website EUDAMED record Report an error | |
| Lifotronic FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) and 1 other | China | A IVDR | Website EUDAMED record Report an error | |
| MacroArray Diagnostics | Austria | A IVDR | Website office@madx.com EUDAMED record Report an error | |
| Nanjing Norman Biological Technology EU representative : Sungo Cert GmbH (Germany) | China | A IVDR | EUDAMED record Report an error | |
| Ortho-Clinical Diagnostics Rochester EU representative : Ortho-Clinical Diagnostics France (France) | United States | A IVDR | Website PRRC@quidelortho.com EUDAMED record Report an error | |
| Shenzhen Yhlo Biotech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | A IVDR | Website info@szyhlo.com EUDAMED record Report an error | |
| SSI Diagnostica FDA | Denmark | A IVDR, 98/79 | Website info@ssidiagnostica.com EUDAMED record Report an error | |
| Sugentech FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) | South Korea | A IVDR | ra@sugentech.com EUDAMED record Report an error | |
| Vazyme EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | A IVDR | EUDAMED record Report an error | |
| Zhongshan Ruifu Medical Equipment Technology EU representative : Medunion S.L. (Spain) | China | A IVDR | ra@refmedical.net EUDAMED record Report an error | |
| Abbott FDA EU representative : Abbott GmbH (Germany) | United States |
|
A IVDR | Website EUDAMED record Report an error |
| Absology EU representative : Medical Technology Promedt Consulting GmbH (Germany) | South Korea | A IVDR | 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 | |
| Agnitio Science &Technology EU representative : CMC Medical Devices & Drugs SL (Spain) | Taiwan | A IVDR | Website contact.us@agnitiost.com EUDAMED record Report an error | |
| Autobio FDA EU representative : Obelis s.a. (Belgium) | China | A IVDR | Website EUDAMED record Report an error | |
| Beckman Coulter FDA EU representative : Beckman Coulter Ireland Inc. (Ireland) | United States | A IVDR | Website EUDAMED record Report an error | |
| Bindingsite FDA EU representative : The Binding Site Ireland Limited (Ireland) | United Kingdom (ex Northern Ireland) | A IVDR | Website info@bindingsite.com EUDAMED record Report an error | |
| Biobase Diagnostic Technology (Shandong) EU representative : Luxus Lebenswelt GmbH (Germany) | China | A IVDR | EUDAMED record Report an error | |
| Blusense Diagnostics Aps | Denmark | A IVDR | Website info@blusense-diagnostics.com EUDAMED record Report an error | |
| Bosonbio FDA EU representative : MedPath GmbH (Germany) | China | A IVDR | Website EUDAMED record Report an error | |
| B·R·A·H·M·S FDA | Germany | A IVDR | EUDAMED record Report an error | |
| Cormay | Poland | A IVDR | regulatory_affairs@cormay.com EUDAMED record Report an error | |
| DiaSorin FDA | Italy | A IVDR | Website EUDAMED record Report an error | |
| Diesse FDA | Italy | A IVDR | Website EUDAMED record Report an error | |
| Draeger FDA | Germany | – 98/79 | Website EUDAMED@draeger.com EUDAMED record Report an error | |
| Dymind EU representative : Eunitor GmbH (Germany) | China | A IVDR | regulationdept@dymind.com EUDAMED record Report an error | |
| Getein FDA EU representative : CMC Medical Devices & Drugs SL (Spain) | China | A IVDR | EUDAMED record Report an error | |
| Guangzhou LBP Medicine Science & Technology EU representative : Kingsmead Service B.V. (Netherlands) | China | A IVDR | EUDAMED record Report an error | |
| Hangzhou Alltest Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) | China | A IVDR | info@alltests.com.cn EUDAMED record Report an error | |
| Hebei Sanxin Pharmaceutical Technology EU representative : SUNGO Europe B.V. (Netherlands) | China | A IVDR | EUDAMED record Report an error | |
| Hunan Drawray Biotech EU representative : Lotus NL B.V. (Netherlands) | China | A IVDR | info@szdrawray.com EUDAMED record Report an error | |
| Hycor Biomedical FDA EU representative : Advena Limited (Malta) | United States | A IVDR | Website info@hycorbiomedical.com EUDAMED record Report an error | |
| Inova Diagnostics FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) | United States | A IVDR | Website EUDAMED record Report an error | |
| Jiezibio EU representative : SUNGO Europe B.V. (Netherlands) | China | A IVDR | EUDAMED record Report an error | |
| Keylights EU representative : SUNGO Europe B.V. (Netherlands) | China | A IVDR | EUDAMED record Report an error | |
| Lituo EU representative : CMC Medical Devices & Drugs SL (Spain) | China | A IVDR | EUDAMED record Report an error | |
| Lordsmark EU representative : Obelis s.a. (Belgium) | India | A IVDR | Website EUDAMED record Report an error | |
| Maccura EU representative : Humiss International B.V. (Netherlands) | China | A IVDR | Website EUDAMED record Report an error | |
| Medcaptain FDA EU representative : R Sight B.V. (Netherlands) | China | A IVDR | Website info@medcaptain.com EUDAMED record Report an error | |
| Meril Diagnostics FDA EU representative : Obelis s.a. (Belgium) | India | A IVDR | Website ram.kanoje@merillife.com EUDAMED record Report an error | |
| NanoEntek FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) | South Korea |
|
A IVDR | Website eudamed@nanoentek.com EUDAMED record Report an error |
| Neomedica EU representative : Wellkang Ltd (Northern Ireland) | Serbia | A IVDR | Website 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 | |
| Paitzar EU representative : Metridium OÜ (Estonia) | Iran | A IVDR | Website info@paitzar.am EUDAMED record Report an error | |
| PCL EU representative : Medical Technology Promedt Consulting GmbH (Germany) | South Korea | A IVDR | Website EUDAMED record Report an error | |
| Phadia FDA | Sweden |
|
A IVDR | Website RegulatoryAffairs.Uppsala.IDD@thermofisher.com EUDAMED record Report an error |
| Protia EU representative : Medical Technology Promedt Consulting GmbH (Germany) | South Korea | A IVDR | EUDAMED record Report an error | |
| Pushkang EU representative : Sungo Cert GmbH (Germany) | China | A IVDR | EUDAMED record Report an error | |
| Quidel Cardiovascular FDA EU representative : MDSS GmbH (Germany) | United States |
|
– 98/79 | Website PRRC@quidelortho.com EUDAMED record Report an error |
| Radiometer FDA | Denmark | A IVDR | Website radiometerra_eu@radiometer.dk EUDAMED record Report an error | |
| Randox FDA | Northern Ireland | A IVDR | Website EUDAMED record Report an error | |
| Rapid Labs EU representative : Advena Limited (Malta) | United Kingdom (ex Northern Ireland) | A IVDR | Website info@rapidlabs.co.uk EUDAMED record Report an error | |
| Renderbio EU representative : SUNGO Europe B.V. (Netherlands) | China | A IVDR | EUDAMED record Report an error | |
| Sansure FDA EU representative : Obelis s.a. (Belgium) | China |
|
A IVDR | Website info@sansure.com.cn EUDAMED record Report an error |
| Seamaty EU representative : MedNet EC-REP GmbH (Germany) | China | A IVDR | EUDAMED record Report an error | |
| Shenzhen Dake Medical Technology EU representative : SUNGO Europe B.V. (Netherlands) | China | A IVDR | EUDAMED record Report an error | |
| Shenzhen Drawray Biotech EU representative : Lotus NL B.V. (Netherlands) | China | A IVDR | Website info@szdrawray.com EUDAMED record Report an error | |
| Shenzhen Tailaored Medical EU representative : Lotus NL B.V. (Netherlands) | China | A IVDR | EUDAMED record Report an error | |
| Shenzhen Zijian Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain) | China | A IVDR | Website sales@szzijian.com EUDAMED record Report an error | |
| Singuway EU representative : CMC Medical Devices & Drugs SL (Spain) | China | A IVDR | sales@singuway.com EUDAMED record Report an error | |
| Sinseng EU representative : Sungo Cert GmbH (Germany) | China | A IVDR | service@sinseng.com.cn EUDAMED record Report an error | |
| Skyla EU representative : Medical Technology Promedt Consulting GmbH (Germany) | Taiwan | A IVDR | Website EUDAMED record Report an error | |
| Stratec FDA | Germany | A IVDR | Website info@stratec.com EUDAMED record Report an error | |
| Suzhou Astrabio Technology EU representative : MedPath GmbH (Germany) | China | A IVDR | marketing@astra-biotech.com EUDAMED record Report an error | |
| Suzhou Sym-Bio Lifescience EU representative : Emergo Europe B.V. (Netherlands) | China |
|
A IVDR | quality.taicang@revvity.com EUDAMED record Report an error |
| Sysmex FDA EU representative : Sysmex Europe SE (Germany) | Japan | A IVDR | ra_archive@sysmex.co.jp EUDAMED record Report an error | |
| Taizhou Zecen Biotech EU representative : MedPath GmbH (Germany) | China | A IVDR | EUDAMED record Report an error | |
| tascom EU representative : Medical Technology Promedt Consulting GmbH (Germany) | South Korea | A IVDR | EUDAMED record Report an error | |
| Tosoh FDA EU representative : Tosoh Europe N.V. (Belgium) | Japan | A IVDR | csc@tosoh.co.jp EUDAMED record Report an error | |
| Vivachek FDA EU representative : Lotus NL B.V. (Netherlands) | China | A IVDR | info@vivachek.com EUDAMED record Report an error | |
| Wallac | Finland | A IVDR | Website regulatoryaffairs.turku@revvity.com EUDAMED record Report an error | |
| Wondfo FDA EU representative : QbD RepS BV (Belgium) | China | A IVDR | Website sales@wondfo.com.cn EUDAMED record Report an error | |
| Zhongshan Chuangyi Biochemical Engineering EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | A IVDR | EUDAMED record Report an error | |
| Chemclin EU representative : MedNet EC-REP GmbH (Germany) No model still on the market | China |
|
A IVDR | Website EUDAMED record Report an error |
| QuantaMatrix EU representative : KTR Europe GmbH (Germany) No model still on the market | South Korea |
|
– 98/79 | EUDAMED record Report an error |
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