IVD instrumentsMicrobiology instruments (cultures)Blood cultures and mycobacteria
Automated blood culture analysers
EMDN code W02030201
Manufacturers registered in Europe (EUDAMED) 11
- 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 |
|---|---|---|---|---|
| bioMérieux FDA EU representative : bioMérieux SA (France) | United States | A IVDR, 98/79 | EUDAMED record Report an error | |
| Zhuhai DL Biotech EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | A IVDR | Website EUDAMED record Report an error | |
| Autobio FDA EU representative : Obelis s.a. (Belgium) | China |
2 others
|
A IVDR | Website EUDAMED record Report an error |
| Becton Dickinson FDA EU representative : Becton Dickinson Ireland Limited (Ireland) | United States | A IVDR | Website EUDAMED record Report an error | |
| Bi̇yofen Kurumsal Sağlik Hi̇zmetleri̇ Yazilim Turi̇zm Sanayi̇ Ti̇caret Şti̇ | Türkiye | A IVDR | EUDAMED record Report an error | |
| Mindray FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | A IVDR | Website EUDAMED record Report an error | |
| Biobase FDA EU representative : Luxus Lebenswelt GmbH (Germany) | China | A IVDR | EUDAMED record Report an error | |
| Grant Technology (HK) EU representative : Share info GmbH (Germany) | Hong Kong SAR China | A IVDR | info@gtech.hk EUDAMED record Report an error | |
| Hosmed Grup Medi̇kal Sağlik Hi̇zmetleri̇ Şi̇rketi̇ | Türkiye | A IVDR | EUDAMED record Report an error | |
| Taho Future ( Tianjin ) Biotechnology EU representative : MedPath GmbH (Germany) | China | A IVDR | info@tahobiology.com EUDAMED record Report an error | |
| Zybio FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | A IVDR | PMS@zy-ivd.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.
Other manufacturers known in the United States (FDA) 9
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 |
|---|---|---|---|
| Remel Co. Present in Europe in other categories | United States | VERSATREK 240 W/10 DR/CTRL MOD 220V VERSATREK 528 W/18 DRAWERS/CTRL MOD VERSATREK 240 W/4 DRAWERS/CTRL MOD VERSATREK 240 W/4 DR/CTRL MOD, 220V VersaTREK | registered |
| Bd Diagnostic Systems | United States | – | K260213 (2026) |
| CBR Enterprise Limited | Hong Kong SAR China | – | registered |
| DON EVANS, INC. | United States | – | registered |
| Diamond Diagnostics Inc. Present in Europe in other categories | United States | – | registered |
| Jabil Inc. | United States | – | registered |
| Mainline Medical Dental Supply | Canada | – | registered |
| Medical Wholsale Suplies, Inc, | Canada | – | registered |
| ORTA MEDICAL LTD | Israel | – | registered |
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