Immunochemistry instrumentsAutomated immunochemistry analysersAutomated immunochemistry analysers - moderate routine (throughput
Automated immunochemistry analysers - moderate routine (throughput > 100 and <= 250 test/h)
EMDN code W0201020102
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 |
|---|---|---|---|---|
| Increcare FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | A IVDR | EUDAMED record Report an error | |
| DAS | Italy |
1 other
|
A IVDR | Website quality@dasitaly.com EUDAMED record Report an error |
| Vivachek FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other | China | A IVDR | info@vivachek.com 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 | |
| Autobio FDA EU representative : Obelis s.a. (Belgium) | China | A IVDR | Website EUDAMED record Report an error | |
| DiaSorin FDA | Italy | A IVDR | Website 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 | |
| Maccura EU representative : Humiss International B.V. (Netherlands) | China | A IVDR | Website EUDAMED record Report an error | |
| SD Biosensor FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) | South Korea | A IVDR | Website 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 | |
| Aichek FDA EU representative : SUNGO Europe B.V. (Netherlands) | China | A IVDR | ra.rep@aichek.com 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 | |
| Diapro | Italy | A IVDR | Website info@diapro.it EUDAMED record Report an error | |
| Erba | Czechia | A IVDR | Website EUDAMED record Report an error | |
| Euroimmun FDA | Germany | A IVDR | Website info@euroimmun.de 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 | |
| Getein FDA EU representative : CMC Medical Devices & Drugs SL (Spain) | China | A IVDR | 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 | |
| Nanjing Norman Biological Technology EU representative : Sungo Cert GmbH (Germany) | China | A IVDR | EUDAMED record Report an error | |
| Shenzhen New Industries Biomedical Engineering FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | A IVDR | Website 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 | |
| Suzhou Hokapi Biomedical Engineering EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | A IVDR | EUDAMED record Report an error | |
| Vazyme EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) and 1 other | China | A IVDR | EUDAMED record Report an error | |
| Wuhan BGI Biomedical Engineering EU representative : MedPath GmbH (Germany) | China | A IVDR | EUDAMED record Report an error | |
| Abbott FDA EU representative : Abbott GmbH (Germany) | United States |
|
A IVDR | Website EUDAMED record Report an error |
| Adaltis | Italy |
|
– 98/79 | Website info@adaltis.net EUDAMED record Report an error |
| Anbio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) | China | A IVDR | info@anbio.com EUDAMED record Report an error | |
| Aucheer EU representative : MedPath GmbH (Germany) | China | A IVDR | info_office@aucheer.net EUDAMED record Report an error | |
| Beijing Lepu Medical Technology EU representative : Lepu Medical (Europe) Cooperatief U.A. (Netherlands) | China | A IVDR | 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 | |
| B·R·A·H·M·S FDA | Germany | A IVDR | EUDAMED record Report an error | |
| Cavanbio EU representative : HyperCert Limited B.V. (Netherlands) | China | A IVDR | EUDAMED record Report an error | |
| Diagreat EU representative : Medunion S.L. (Spain) | China | A IVDR | Website info@diagreat.com EUDAMED record Report an error | |
| Dirui FDA EU representative : SUNGO Europe B.V. (Netherlands) | China | A IVDR | EUDAMED record Report an error | |
| E-LAB Biological Science & Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) | China | A IVDR | EUDAMED record Report an error | |
| Eiken FDA EU representative : Advena Limited (Malta) | Japan | A IVDR | regulatoryaffairs@eiken.co.jp EUDAMED record Report an error | |
| Eurospital FDA | Italy |
|
A IVDR | regulatory@eurospital.it EUDAMED record Report an error |
| General Biologicals EU representative : Medical Technology Promedt Consulting GmbH (Germany) | Taiwan | A IVDR | sales.group@gbc.com.tw EUDAMED record Report an error | |
| Guangzhou KOFA Biotechnology EU representative : Medunion S.L. (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 | |
| ImmunoDiagnostic Systems France FDA | France | A IVDR | Website EUDAMED record Report an error | |
| Kangrun EU representative : Sungo Cert GmbH (Germany) | China |
|
A IVDR | EUDAMED record Report an error |
| Lifotronic FDA EU representative : Umedwings Netherlands 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 | |
| Medical FDA EU representative : Obelis s.a. (Belgium) | Japan | A IVDR | Website EUDAMED record Report an error | |
| Next Level | Italy |
|
A IVDR | EUDAMED record Report an error |
| Realmindbio EU representative : Sungo Cert GmbH (Germany) | China | A IVDR | EUDAMED record Report an error | |
| Shenzhen AmTech Bioengineering 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 | |
| Sichuan Orienter Biotechnology EU representative : Lotus NL B.V. (Netherlands) | China | A IVDR | Website info@orienterglobal.com EUDAMED record Report an error | |
| Siemens Healthcare Diagnostics FDA EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland) | United States | A IVDR | Website contact@siemens-healthineers.com EUDAMED record Report an error | |
| Siemens Healthcare Diagnostics Products FDA EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland) | United Kingdom (ex Northern Ireland) | A IVDR | Website contact@siemens-healthineers.com EUDAMED record Report an error | |
| Stratec FDA | Germany | A IVDR | Website info@stratec.com EUDAMED record Report an error | |
| Sunlant EU representative : MedPath GmbH (Germany) | China | A IVDR | 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 | |
| Technogenetics FDA | Italy | A IVDR | Website QA@TECHNOGENETICS.IT EUDAMED record Report an error | |
| Urit FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | A IVDR | Website service@uritest.com EUDAMED record Report an error | |
| Virtue Diagnostics (Suzhou) EU representative : Kingsmead Service B.V. (Netherlands) | China | A IVDR | EUDAMED record Report an error | |
| Wallac | Finland | A IVDR | Website regulatoryaffairs.turku@revvity.com EUDAMED record Report an error | |
| Wizbiotech EU representative : QbD RepS BV (Belgium) | 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 |
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