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Chemistry / immunochemistry instrumentsChemistry / immunochemistry rapid tests + POC testsVarious rapid test chemistry / immunochemistry instruments ("point of care" and/or emergency)

Various rapid test chemistry / immunochemistry instruments - hardware accessories

EMDN code W0201069080

9 manufacturers, 13 models including 13 on the market, 9 countries

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Manufacturers registered in Europe (EUDAMED) 9
  • 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
Association Of Medicine Analytics EU representative : CMC Medical Devices & Drugs SL (Spain) Russia A IVDR, 98/79 Website EUDAMED record Report an error
BioSciTec Germany A IVDR Website info@bioscitec.de EUDAMED record Report an error
Apexbio FDA EU representative : Obelis s.a. (Belgium) Taiwan A IVDR, 98/79 info@apexbio.com EUDAMED record Report an error
Arkray FDA EU representative : ARKRAY Europe, B.V. (Netherlands) Japan – 98/79 support_arkrayeurope@arkray.co.jp EUDAMED record Report an error
Biohit FDA Finland A IVDR Website info@biohit.fi EUDAMED record Report an error
MicroBioSensor EU representative : QNET B.V. (Netherlands) United Kingdom (ex Northern Ireland) – 98/79 Website enquiries@microbiosensor.com EUDAMED record Report an error
NIOX Sweden B IVDR qa@niox.com EUDAMED record Report an error
ProciseDx FDA EU representative : QbD RepS BV (Belgium) United States 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

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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