Immunochemistry instrumentsAutomated immunochemistry analysersAutomated immunochemistry analysers - moderate to high routine (throughput
Automated immunochemistry analysers - moderate to high routine (throughput > 250 and <= 700 test/h)
EMDN code W0201020103
Manufacturers registered in Europe (EUDAMED) 22
- 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 | |
| Wesailbio EU representative : Lotus NL B.V. (Netherlands) and 1 other | China | A IVDR | 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 | |
| Lifotronic FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) and 1 other | China | A IVDR | Website 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 | |
| Hitachi High-Tech FDA EU representative : Roche Diagnostics GmbH (Germany) | Japan | A IVDR | ra-contact.aj@hitachi-hightech.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 | |
| 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 | |
| Adaltis | Italy |
|
– 98/79 | Website info@adaltis.net EUDAMED record Report an error |
| Apollo FDA EU representative : Emergo Europe B.V. (Netherlands) | Taiwan | A IVDR | Website info@apollo.bio EUDAMED record Report an error | |
| Autobio FDA EU representative : Obelis s.a. (Belgium) | China | A IVDR | Website EUDAMED record Report an error | |
| Dirui FDA EU representative : SUNGO Europe B.V. (Netherlands) | China | A IVDR | EUDAMED record Report an error | |
| Immundiagnostik FDA | Germany |
|
A IVDR | Website info@immundiagnostik.com EUDAMED record Report an error |
| Kangrun EU representative : Sungo Cert GmbH (Germany) | China | A IVDR | EUDAMED record Report an error | |
| Maccura EU representative : Humiss International B.V. (Netherlands) | 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 | |
| Shanghai Kehua Laboratory System FDA EU representative : Obelis s.a. (Belgium) | China | A IVDR | Website 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 | |
| Wallac | Finland | A IVDR | Website regulatoryaffairs.turku@revvity.com EUDAMED record Report an error | |
| Zhejiang Gewuzhizhi Biotechnology EU representative : Llins Service & Consulting GmbH (Germany) | China | A IVDR | Website EUDAMED record Report an error |
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