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IVD instrumentsChemistry / immunochemistry instrumentsIntegrated / modular chemistry / immunochemistry instruments

Integrated / modular chemistry / immunochemistry instruments - other

EMDN code W02010399

8 manufacturers, 28 models including 28 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
Hitachi High-Tech FDA EU representative : Roche Diagnostics GmbH (Germany) Japan
12 others
 A IVDR ra-contact.aj@hitachi-hightech.com EUDAMED record Report an error
Getein FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China A IVDR EUDAMED record Report an error
ReLIA Biotechnologies (Jiangsu) EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China A IVDR EUDAMED record Report an error
Talentbiomedical EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR, 98/79 EUDAMED record Report an error
Beijing Applied Biological Technologies EU representative : Luxus Lebenswelt GmbH (Germany) China A IVDR EUDAMED record Report an error
Biobase FDA EU representative : Luxus Lebenswelt GmbH (Germany) China A IVDR EUDAMED record Report an error
Dymind EU representative : Eunitor GmbH (Germany) China – 98/79 regulationdept@dymind.com EUDAMED record Report an error
Luminexcorp FDA EU representative : DiaSorin Italia S.p.A. (Italy) United States A IVDR Website regulatoryaffairs@luminexcorp.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.

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