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Glycosilated hemoglobin devices
EMDN code W0201060101
Manufacturers registered in Europe (EUDAMED) 25
- 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 |
|---|---|---|---|---|
| Biohermes FDA EU representative : CMC Medical Devices & Drugs SL (Spain) | China |
|
– 98/79 | EUDAMED record Report an error |
| GC Medical Science EU representative : Medical Technology Promedt Consulting GmbH (Germany) | South Korea | A IVDR, 98/79 | EUDAMED record Report an error | |
| OSANG Healthcare FDA EU representative : Obelis s.a. (Belgium) | South Korea | A IVDR, 98/79 | Website EUDAMED record Report an error | |
| B&E Bio-Technology FDA EU representative : SUNGO Europe B.V. (Netherlands) | China | A IVDR, 98/79 | EUDAMED record Report an error | |
| Goldsite EU representative : CMC Medical Devices & Drugs SL (Spain) | China | A IVDR | Website export@goldsite.com.cn 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 |
| Maccura EU representative : Humiss International B.V. (Netherlands) | China | – 98/79 | Website EUDAMED record Report an error | |
| Ailex EU representative : MedPath GmbH (Germany) | China | A IVDR | EUDAMED record Report an error | |
| Anbio EU representative : Lotus NL B.V. (Netherlands) | China |
|
– 98/79 | info@anbio.com EUDAMED record Report an error |
| Apexbio FDA EU representative : Obelis s.a. (Belgium) | Taiwan | A IVDR | info@apexbio.com EUDAMED record Report an error | |
| Assure Tech. (Hangzhou) EU representative : Lotus NL B.V. (Netherlands) | China | – 98/79 | Website contact@diareagent.com EUDAMED record Report an error | |
| Atlas Medical FDA | Germany | – 98/79 | Website info@atlas-medical.com EUDAMED record Report an error | |
| Beijing Lepu Medical Technology EU representative : Lepu Medical (Europe) Cooperatief U.A. (Netherlands) | China | – 98/79 | EUDAMED record Report an error | |
| BioFynder EU representative : SUNGO Europe B.V. (Netherlands) | United Kingdom (ex Northern Ireland) | A IVDR | EUDAMED record Report an error | |
| Empecs FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | South Korea | A IVDR | EUDAMED record Report an error | |
| Human | Germany | A IVDR | Website EUDAMED record Report an error | |
| Jiezibio EU representative : SUNGO Europe B.V. (Netherlands) | China |
|
– 98/79 | EUDAMED record Report an error |
| Mindray FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | C IVDR | Website EUDAMED record Report an error | |
| Shenzhen Dake Medical Technology EU representative : HyperCert Limited B.V. (Netherlands) | China | A IVDR | EUDAMED record Report an error | |
| Sinocare FDA EU representative : SUNGO Europe B.V. (Netherlands) | China |
|
B IVDR | RA@sinocare.com EUDAMED record Report an error |
| Urit FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China |
|
– 98/79 | Website service@uritest.com EUDAMED record Report an error |
| Vivachek FDA EU representative : Lotus NL B.V. (Netherlands) | China |
|
A IVDR | info@vivachek.com EUDAMED record Report an error |
| Gc Medis EU representative : Obelis s.a. (Belgium) No model still on the market | South Korea |
|
– 98/79 | Website EUDAMED record Report an error |
| Tosoh FDA EU representative : Tosoh Europe N.V. (Belgium) No model still on the market | Japan |
|
– 98/79 | csc@tosoh.co.jp EUDAMED record Report an error |
| Biotime EU representative : Sungo Cert GmbH (Germany) No model still on the market | China |
|
A IVDR | 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) 24
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) |
| 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) |
| 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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