IVD instrumentsHematology / histology / cytology instrumentsBlood grouping instruments
Blood grouping analysers
EMDN code W02020301
Manufacturers registered in Europe (EUDAMED) 13
- 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 |
|---|---|---|---|---|
| Aikang MedTech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | A IVDR | EUDAMED record Report an error | |
| Grifols FDA | Spain | A IVDR | regulatoryaffairs_dxbu@grifols.com EUDAMED record Report an error | |
| Immucor FDA EU representative : IMMUCOR Medizinische Diagnostik GmbH (Germany) | Germany, United States | A IVDR | Website regulatoryimmucor@werfen.com EUDAMED record Report an error | |
| Haemokinesis EU representative : Compliance Management Solutions Europe LTD (Bulgaria) | Australia | A IVDR, 98/79 | EUDAMED record Report an error | |
| Medcaptain FDA EU representative : R Sight B.V. (Netherlands) | China | A IVDR | Website info@medcaptain.com EUDAMED record Report an error | |
| Ortho-Clinical Diagnostics Raritan EU representative : Ortho-Clinical Diagnostics France (France) | United States | A IVDR | Website PRRC@quidelortho.com EUDAMED record Report an error | |
| Tianjin Dexiang Biotechnology EU representative : Medunion S.L. (Spain) | China | A IVDR | EUDAMED record Report an error | |
| Biosense EU representative : MD&D Alliance GmbH (Germany) | India | A IVDR | regulatory.affairs@biosense.in EUDAMED record Report an error | |
| BotuAImaging Technology EU representative : Kingsmead Service B.V. (Netherlands) | China | A IVDR | EUDAMED record Report an error | |
| Diagast FDA | France | A IVDR | Website contact@diagast.com EUDAMED record Report an error | |
| Di̇a Pro Tibbi̇ Ürünler San. Ve Ti̇c. A.Ş | Türkiye |
|
A IVDR | EUDAMED record Report an error |
| Ortho-Clinical Diagnostics FDA EU representative : Ortho-Clinical Diagnostics France (France) | United Kingdom (ex Northern Ireland) | A IVDR | Website PRRC@quidelortho.com EUDAMED record Report an error | |
| Suzhou Hokapi Biomedical Engineering EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | 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) 19
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 Medical Diagnostics GmbH Present in Europe in other categories | – | MLB 2 IH-Card Neutral Alsevers Solution Bromelin for Erytype TANGO infinity IH-1000 | registered |
| Eldon Biologicals A/S Present in Europe in other categories | Denmark | ELDON SCHOOL KIT SK 2511-30 ELDON SCHOOL KIT SKA 2521-25 ELDON SCHOOL KIT SKA 2511-30 ELDON HOME KIT HKA 2511-1 DOCTOR'S KIT DKS RhD-25 ELDON MILITARY KIT MKA 2521-25 | registered |
| BIOMEDICAL DATA SOLUTIONS LIMITED Present in Europe in other categories | United Kingdom | ORTHO CONNECT | registered |
| FUJIREBIO INC. Present in Europe in other categories | – | Beckman Coulter PK CMV-PA System Beckman Coulter PK TP System | registered |
| BOUND TREE MEDICAL, LLC | – | Curaplex | registered |
| MICRO TYPING SYSTEMS, INC | – | MTS | registered |
| Agilent Technologies, Inc. Present in Europe in other categories | United States | – | registered |
| BEMS Holdings, LLC | United States | – | registered |
| Bio-Rad Present in Europe in other categories | United States | – | registered |
| Bio-Rad Laboratories (Bio-Rad Services France) Present in Europe in other categories | France | – | registered |
| CBR Enterprise Limited | Hong Kong SAR China | – | registered |
| DiaMed GmbH (Bio-Rad Laboratories) Present in Europe in other categories | Switzerland | – | registered |
| Diamond Diagnostics Inc. Present in Europe in other categories | United States | – | registered |
| Fujirebio Diagnostics,Inc. Present in Europe in other categories | United States | – | registered |
| Ivy Technology | United States | – | registered |
| MACK MOLDING COMPANY | United States | – | registered |
| QuidelOrtho Corporation | United States | – | registered |
| STRATEC SE Present in Europe in other categories | Germany | – | registered |
| Tecan U.S., Ltd. Present in Europe in other categories | United States | – | registered |
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