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Chemistry / immunochemistry rapid tests + POC testsDiabetes monitoringVarious diabetes monitoring instruments

Various diabetes monitoring instruments - hardware accessories

EMDN code W020106019080

1 manufacturer, 1 model including 1 on the market, 1 country

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Manufacturers registered in Europe (EUDAMED) 1
  • 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
Tosoh FDA EU representative : Tosoh Europe N.V. (Belgium) Japan A IVDR csc@tosoh.co.jp 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) 25

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
Bio-Rad Present in Europe in other categories United States D-100 D-10 VARIANT II TURBO K161687 (2016)
ARKRAY USA, INC. Present in Europe in other categories United States HEMOLYSIS WASHING SOLUTION 80H ELUENT 80A ELUENT 80B ELUENT 80CV ADAMS™ A1c HA-8180V (UL) Analyzer DILUENT 80 registered
Abbott Laboratories Present in Europe in other categories United States ARCHITECT Alinity K140654 (2015)
Siemens Healthcare Diagnostics, Inc. Present in Europe in other categories United States ADVIA Chemistry Enzymatic Hemoglobin A1c Dimension Clinical Chemistry System A1C Kit ADVIA Chemistry Enzymatic hemoglobin A1c Pretreatment Dimension Vista System Flex reagent cartridge A1C KIT Atellica CH A1c_E K200256 (2021)
Roche Diagnostics Corp. Present in Europe in other categories United States Tina-quant Hemoglobin A1cDx Gen.3 Tina-quant Hemoglobin A1cDx Gen.2 Whole blood Application registered
Abbott Diagnostics Technologies AS Present in Europe in other categories Norway Afinion HbA1c Dx registered
Beckman Coulter, Inc. Present in Europe in other categories United States AU K182651 (2019)
Ortho-Clinical Diagnostics, Inc. Present in Europe in other categories United States VITROS K142595 (2015)
Sebia Present in Europe in other categories United States CAPI 3 Hb A1c K171861 (2018)
Wuxi Biohermes Bio & Medical Technology Co.,Ltd. Present in Europe in other categories China BioHermes Automated Glycohemoglobin Analyzer registered
Alere Technologies AS Norway – K182988 (2018)
Arkray Factory USA, Inc. Present in Europe in other categories United States – K162822 (2017)
HITACHI HIGH-TECH CORP. Present in Europe in other categories Japan – registered
OEM SYSTEMS CO. LTD. Japan – registered
QuidelOrtho Corporation United States – registered
Roche Diagnostics Operations (Rdo) United States – K193053 (2020)
Roche Diagnostics Operations Inc. United States – K121610 (2013)
SEKISUI MEDICAL CO., LTD. Japan – registered
Sekisui Diagnostics P.E.I., Inc. Canada – K173206 (2018)
Sekisui Diagnostics, LLC Present in Europe in other categories United States – registered
Shanghai Medconn Biotechnology Co., Ltd. Present in Europe in other categories China – registered
Shanghai Medconn Medical Technology Co., Ltd. Present in Europe in other categories China – K252749 (2026)
Shenzhen Lifotronic Technology Co., Ltd. Present in Europe in other categories China – K260468 (2026)
Shijiazhuang Hipro Biotechnology Co., Ltd. Present in Europe in other categories China – K220999 (2024)
Tosoh Bioscience, Inc. United States – K250073 (2025)

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