Chemistry / immunochemistry instrumentsChemistry / immunochemistry rapid tests + POC testsDiabetes monitoring
Various diabetes monitoring instruments
EMDN code W0201060190
Manufacturers registered in Europe (EUDAMED) 17
- 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.
| Manufacturer | Country | Registered models | Class | Contact |
|---|---|---|---|---|
| Hangzhou Aokai Biotech EU representative : JOYSUN GROUP S.L.U (Spain) and 1 other | China | A IVDR | info@aokais.com.cn EUDAMED record Report an error | |
| Ascensia FDA EU representative : Ascensia Diabetes Care Italy Srl (Italy) | Switzerland |
2 others |
C IVDR, 98/79 | Website EUDAMED-info@ascensia.com EUDAMED record Report an error |
| Medtronic FDA EU representative : Medtronic B.V. (Netherlands) | United States |
|
I, IIa MDR | EUDAMED record Report an error |
| Biohermes FDA EU representative : CMC Medical Devices & Drugs SL (Spain) | China |
|
– 98/79 | EUDAMED record Report an error |
| General Life Biotechnology FDA EU representative : MDSS GmbH (Germany) | Taiwan | – 98/79 | Website service@glbiotech.com.tw EUDAMED record Report an error | |
| Apexbio FDA EU representative : Obelis s.a. (Belgium) | Taiwan | A IVDR | info@apexbio.com EUDAMED record Report an error | |
| Arkray FDA EU representative : ARKRAY Europe, B.V. (Netherlands) | Japan | A IVDR | support_arkrayeurope@arkray.co.jp EUDAMED record Report an error | |
| Bionime FDA EU representative : Emergo Europe B.V. (Netherlands) | Taiwan |
|
– 98/79 | EUDAMED record Report an error |
| e-LinkCare Meditech FDA EU representative : Wellkang Ltd (Northern Ireland) | China |
|
– 98/79 | EUDAMED record Report an error |
| i-SENS FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) | South Korea | A IVDR | Website regulatory@i-sens.com EUDAMED record Report an error | |
| Line Systems | Denmark |
|
I MDR | Website EUDAMED record Report an error |
| OSANG Healthcare FDA EU representative : Obelis s.a. (Belgium) | South Korea |
|
A IVDR | Website EUDAMED record Report an error |
| Sinocare FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | – 98/79 | RA@sinocare.com EUDAMED record Report an error | |
| Tosoh FDA EU representative : Tosoh Europe N.V. (Belgium) | Japan | A IVDR | csc@tosoh.co.jp EUDAMED record Report an error | |
| Vivachek FDA EU representative : CMC Medical Devices & Drugs SL (Spain) | China | A IVDR | info@vivachek.com EUDAMED record Report an error | |
| Beijingyicheng EU representative : Caretechion GmbH (Germany) No model still on the market | China |
|
– 98/79 | Website mail@beijingyicheng.com.cn EUDAMED record Report an error |
| Lifescan FDA EU representative : LifeScan Deutschland GmbH (Germany) No model still on the market | Switzerland |
|
– 98/79 | info@lifescan.ch 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) 22
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.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| Bio-Rad Present in Europe in other categories | United States | D-100 D-10 VARIANT II TURBO | K161687 (2016) |
| 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) |
| Alere Technologies AS | Norway | – | K182988 (2018) |
| 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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