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Chemistry instrumentsChemistry analysersChemistry analysers - moderate to high routine (with ise mode test/h

Chemistry analysers - moderate to high routine (with ise mode test/h > 800 and <= 1.200)

EMDN code W0201010107

8 manufacturers, 13 models including 12 on the market, 3 countries

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Manufacturers registered in Europe (EUDAMED) 8
  • 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.
ManufacturerCountryRegistered modelsClassContact
Dirui FDA EU representative : Emergo Europe B.V. (Netherlands) China B IVDR, 98/79 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
Mindray FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) 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
Funotec EU representative : GRZAN GROUP SL (Spain) China A IVDR 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
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
Ailex EU representative : CMC Medical Devices & Drugs SL (Spain) No model still on the market China A IVDR 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.

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