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Emdyca

Chemistry / immunochemistry instrumentsElectrophoresis / chromatography instrumentsChromatography instruments (hplc)

High performance liquid chromatography systems

EMDN code W0201050201

14 manufacturers, 42 models including 42 on the market, 4 countries

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Manufacturers registered in Europe (EUDAMED) 14
  • 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
Immundiagnostik FDA Germany
7 others
 – 98/79 Website info@immundiagnostik.com EUDAMED record Report an error
Lifotronic FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) and 1 other China
5 others
 A IVDR, 98/79 Website EUDAMED record Report an error
Arkray FDA EU representative : ARKRAY Europe, B.V. (Netherlands) Japan
1 other
 A IVDR, 98/79 support_arkrayeurope@arkray.co.jp EUDAMED record Report an error
Shimadzu FDA EU representative : Shimadzu Europa GmbH (Germany) Japan A IVDR, 98/79 Website EUDAMED record Report an error
Ukinbio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 sales@ukinbio.com EUDAMED record Report an error
Aehealth EU representative : MedNet EC-REP GmbH (Germany) China – 98/79 sales@aehealth.com.cn EUDAMED record Report an error
Ailex EU representative : CMC Medical Devices & Drugs SL (Spain) China A IVDR EUDAMED record Report an error
Human Germany A IVDR Website EUDAMED record Report an error
Labnovation EU representative : MedNet EC-REP GmbH (Germany) China A IVDR Website info@labnovation.com EUDAMED record Report an error
MDX Netherlands Diagnostics EU representative : SUNGO Europe B.V. (Netherlands) Philippines 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
Shinva FDA EU representative : Eunitor GmbH (Germany) China A IVDR 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
ZOVEC diagnostics Germany – 98/79 Website 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.

Other manufacturers known in the United States (FDA) 9

Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.

ManufacturerCountryBrandsFDA clearance
WATERS TECHNOLOGIES CORPORATION Present in Europe in other categories – Acquity registered
Bio-Rad Present in Europe in other categories United States D-10 Hemoglobin Variants System VARIANT II TURBO D-100 VARIANT II K960392 (1996)
CEI Pte Ltd Singapore – registered
GES Singapore Pte Ltd Singapore – registered
Infitek Co., Ltd. Present in Europe in other categories China – registered
Labpeak Co.,Ltd China – registered
SEKISUI MEDICAL CO., LTD. Japan – registered
Scitek Global Co.,Ltd China – registered
WATERS CORPORATION Present in Europe in other categories United States – K961557 (1996)

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