IVD instrumentsMicrobiology instruments (cultures)
Microbiology susceptibility / identification
EMDN code W020301
Manufacturers registered in Europe (EUDAMED) 19
- 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.
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) 67
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 | REMEL BACTICARD Remel™ RapID™ ERIC™ (ELECTRONIC RAPID IDENTIFICATION COMPENDIUM) PLATE DRY CLI GRAM+ ID AUTO SENSITITRE YEASTONE SUSCEPTIBILITY PLATES THE SENSITITRE AIM | K935124 (1994) |
| HARDY DIAGNOSTICS | United States | HardyFlask™ ParaCon | registered |
| Oxoid U.S.A., Inc. Present in Europe in other categories | United States | COLUMBIA BLOOD AGAR BASE NUTRIENT BROTH BLOOD FREE CAMPY SELECT AGAR DERMASEL AGAR BASE SIGNAL BLOOD CULTURE SYSTEM 1 X 20 SHEEP BLOOD AGAR NO 2 | K862946 (1986) |
| AnalytiChem USA, Inc. | United States | Redipor | registered |
| Chengdu Rich Science Industry Co., Ltd. Present in Europe in other categories | – | C.D.RICH | registered |
| Bioteke Corporation (Wuxi) Co., Ltd. Present in Europe in other categories | China | BioTeke | registered |
| Anaerobe Systems | United States | PRAS Brain Heart Infusion Broth (BHI BROTH) PRAS Tryptic Soy Agar with Tween® and Lecithin (TSA-TL) PRAS Brucella Agar Deep CLSI Formulation 19mL (BRU DEEP CLSI 19mL) PRAS Brain Heart Infusion Agar (BHI) PRAS Yeast Malt Extract Agar (YMEA) PRAS Brucella Agar Deep 18mL (BRU DEEP 18mL) | K841303 (1984) |
| Selux Diagnostics, Inc. | United States | Bulk Analyzer Reagent Pack Selux Seaparator Reagent Kit Selux AST System Selux AST Gram Negative Panel Selux AST Gram Positive Panels AST Analyzer | K211748 (2023) |
| BIO-MED DIAGNOSTICS, INC. Present in Europe in other categories | – | Saline Solution (0.85%) InTray® BHI InTray® Mueller Hinton Chocolate Agar InTray® PDA InTray® TSA InTray® SAB | registered |
| Hangzhou Genesis Biodetection & Biocontrol Co., LTD. Present in Europe in other categories | China | KaiBiLi Extended ViralTrans Saline KaiBiLi Extended ViralTrans PBS | registered |
| EDGE BIOLOGICALS, INC. | – | EDGE BIOLOGICALS INC | registered |
| Sansure Biotech Inc. Present in Europe in other categories | China | Sample Storage Reagent | registered |
| KEYSTONE MANUFACTURING, LLC | United States | Keystone Nasal / Respiratory Specimen Collection Kit – 100 pack | registered |
| Oxyrase, Inc. | United States | OxyPRAS Plus 3-pack, Brucella, PEA, and KVL OxyPRAS Plus Brucella Agar plate OxyPRAS Plus 3-pack: Brucella, PEA and BBE/KVL Bi-Plate OxyPRAS Plus 2-pack, Brucella and BBE/KVL Bi-Plate | registered |
| Affinity Biosensors, LLC | United States | LSGN LifeScale Sensor LifeScale AST | registered |
| Bruker Daltonik GmbH | Germany | MBT FAST Shuttle US IVD MBT Compass HT CA MBT HT Sepsityper CA Module | registered |
| STRYKER CORPORATION Present in Europe in other categories | United States | SpinePlex VertaPlex VertaPlex HV | registered |
| COPAN ITALIA SPA Present in Europe in other categories | Italy | LBM® Thiol Broth BHI BROTH | registered |
| DEROYAL INDUSTRIES, INC. Present in Europe in other categories | United States | DeRoyal | registered |
| Greiner Bio-One GmbH Present in Europe in other categories | – | Vacuette | registered |
| Kolplast C I | Brazil | KOLPLAST | registered |
| Puritan Medical Products | United States | Puritan® | registered |
| A. L. B. LUZ | Brazil | – | registered |
| Alpha Biosciences | United States | – | registered |
| Arx Sciences, Inc. | United States | – | registered |
| BOEN HEALTHCARE CO., LTD. Present in Europe in other categories | China | – | registered |
| Biolog Inc | United States | – | registered |
| Bruker Daltonics, Inc. Present in Europe in other categories | United States | – | K251495 (2025) |
| Bruker Scientific LLC Present in Europe in other categories | United States | – | registered |
| CITOTEST LABWARE MANUFACTURING CO., LTD. Present in Europe in other categories | China | – | registered |
| CREATIVE LIFE SCIENCE CO., LTD. | Taiwan | – | registered |
| Changsha Renji Medical Equipment Co., Ltd. | China | – | registered |
| Citotest Scientific Co.,Ltd. Present in Europe in other categories | China | – | registered |
| Clementine Bidco Limited | United Kingdom | – | registered |
| Diagnostic Consulting Network, LLC. Present in Europe in other categories | United States | – | registered |
| Diamond Diagnostics Inc. Present in Europe in other categories | United States | – | registered |
| GREINER BIO-ONE NA | United States | – | registered |
| GUANGDONG HUANKAI BIOLOGY SCI.&TECH.CO.,LTD | China | – | registered |
| HAIMEN SHENGBANG LABORATORY EQUIPMENT CO., LTD Present in Europe in other categories | China | – | registered |
| Hach Company | United States | – | registered |
| Hangzhou Bioer Technology Co., Ltd. Present in Europe in other categories | China | – | registered |
| Hardwood Products Co., LP | United States | – | registered |
| Himedia Laboratories Private Limited | India | – | registered |
| Huachenyang (Shenzhen) Technology Co., Ltd | China | – | registered |
| Jiangsu Rongye Technology Co., Ltd. Present in Europe in other categories | China | – | registered |
| Jinan Babio Biotechnology Co., Ltd. | China | – | registered |
| KEY SCIENTIFIC PRODUCTS | United States | – | registered |
| Kolplast CI Ltda Present in Europe in other categories | Brazil | – | registered |
| LABONE, LLC., d/b/a Quest Diagnostics | United States | – | registered |
| Laboratorios PiSA S.A. de C.V. | Mexico | – | registered |
| Legacy Biologicals | United States | – | registered |
| MEDICO TECHNOLOGY CO., LTD | China | – | registered |
| Medical Wire & Equipment Co. | United States | – | K900112 (1990) |
| Ningbo Guangbo medical Technology co.,ltd | China | – | registered |
| Precision Medical Devices Present in Europe in other categories | United States | – | registered |
| S2 Media | United States | – | registered |
| Shenzhen Dakewe Bio-engineering Co., Ltd Present in Europe in other categories | China | – | registered |
| Thermo Fisher Scientific Present in Europe in other categories | United States | – | K191914 (2019) |
| Trademark Plastics Inc. | United States | – | registered |
| Trinity Biotech USA Present in Europe in other categories | United States | – | K033064 (2003) |
| Vorzeigen | United States | – | registered |
| Wuxi Nest Biotechnology Co., Ltd. Present in Europe in other categories | China | – | registered |
| XCaliber Sciences, Inc. | United States | – | registered |
| YENI BIYOTEKNOLOJI ANONIM SIRKETI | Türkiye | – | registered |
| YONG CHANG Co., Ltd. | South Korea | – | registered |
| ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD. Present in Europe in other categories | China | – | registered |
| Zhejiang GENE SCIENCE Co., Ltd | China | – | registered |
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