IVD instruments
Microbiology instruments (cultures)
EMDN code W0203
Manufacturers registered in Europe (EUDAMED) 43
- 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) 195
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 |
|---|---|---|---|
| SCC SOFT COMPUTER | United States | SoftPathDx SoftBiochemistry SoftHLA SoftLab SoftCytogenetics SoftMolecular | registered |
| 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 |
| Bruker Daltonik GmbH | Germany | MBT Pilot System - US IVD MALDI Biotyper sirius CA System MALDI Biotyper-BD sirius CA System MALDI Biotyper CA System MALDI Biotyper-BD sirius one CA System MALDI Biotyper sirius one CA System | registered |
| Trek Diagnostic Systems, Inc. Present in Europe in other categories | United States | Sensititre Sensititre AIM™ Sensititre™ OptiRead™ Thermo Scientific™ Sensititre™ ARIS HiQ™ System STP8F | K110583 (2011) |
| 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 |
| Fisher Scientific Co., LLC | United States | Fisherbrand | registered |
| CliniSys, Inc | United States | Clinisys Atlas Clinisys Laboratory Solution Clinisys SQ Lab Sunquest Atlas Clinisys Laboratory Solutions | registered |
| Roche Diagnostics Corp. Present in Europe in other categories | United States | cobas pro i 601 BL cobas i 601 SBL cobas i 601 navify Quality Control B-Gate Interface navify POC Operations | registered |
| LW SCIENTIFIC, INC. | United States | LW Scientific, Inc LW Scientific, Inc. LW Scientific, Inc` | registered |
| Abbott Rapid Diagnostics Informatics, Inc. | – | RALS | 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) |
| Changsha Yingtai Instrument Co., Ltd Present in Europe in other categories | China | Yingtai | registered |
| Siemens Healthcare Diagnostics, Inc. Present in Europe in other categories | United States | POCcelerator™ Data Management System RAPIDComm® Data Management System Xprecia Stride™ Accessory Kit Atellica Connect SE POCcelerator™ SE Data Management System Atellica Connect | registered |
| 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) |
| Tecan U.S., Ltd. Present in Europe in other categories | United States | MAGELLAN PRO MAGELLAN USB-STICK MAGELLAN V 7.5 USB-STICK MAGELLAN PRO V7.5 USB-STICK MAGELLAN 7.3 SP2 USB-STICK MAGELLAN PRO V7.4 | registered |
| AGENA BIOSCIENCE, INC. | United States | SpectroChip Standalone Chip Only) SpectroChip CPM Kit (10x96) Calibrant CPM Dx MassARRAY Clean Resin 28g SpectroChip CPM Kit (2x96) | registered |
| 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 |
| BIOGENEX LABORATORIES | United States | i6000™ Infinity Xmatrx® Nano Xmatrx® MINI Xmatrx® Elite NanoVIP® i6000™ Diagnostics | registered |
| Hangzhou Genesis Biodetection & Biocontrol Co., LTD. Present in Europe in other categories | China | KaiBiLi Extended ViralTrans Saline KaiBiLi Extended ViralTrans PBS | registered |
| TECHNIDATA | France | TDWorkstation TDHisto/Cyto TDBactiLink TD-Web TDGenet TDMind | registered |
| Wallac Oy Present in Europe in other categories | Finland | Qsight 225 MD Screening System MSMS Workstation EVOYA Platform Specimen Gate Laboratory Screening Center PatientCare | registered |
| EDGE BIOLOGICALS, INC. | – | EDGE BIOLOGICALS INC | registered |
| STRYKER CORPORATION Present in Europe in other categories | United States | SURGICOUNT TRITON SpinePlex VertaPlex VertaPlex HV | registered |
| COPAN WASP SRL Present in Europe in other categories | Italy | WASPLab® Single Incubator WASPLab® Server WASPLab® WASPLab® Double Incubator WASPLab® Conveyor | registered |
| Sansure Biotech Inc. Present in Europe in other categories | China | Sample Storage Reagent | registered |
| Agilent Technologies, Inc. Present in Europe in other categories | United States | K6460 Triple Quadrupole MS – ESI K6460 Triple Quadrupole MS – AJS BIOSPA-SI BIOSPAG-SI | registered |
| BYG INFORMATIQUE | – | Lab Composer POC Controller nYna Ypoc | registered |
| DIAGNOSTICA STAGO Present in Europe in other categories | United States | Coag.One server license STA Coag Expert® | 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 |
| Q-Linea AB Present in Europe in other categories | Sweden | ASTar BC G- Kit software ASTar BC G- Consumable kit ASTar BC G- Frozen insert ASTar Instrument | registered |
| Synthes GmbH Present in Europe in other categories | United States | – | registered |
| Affinity Biosensors, LLC | United States | LSGN LifeScale Sensor LifeScale AST | registered |
| Labotect Labor-Technik Göttingen Gesellschaft mit beschränkter Haftung | – | CO2 Inkubator C60 CO2 Inkubator C200 CO2 Inkubator Labo C-Top | registered |
| Avalign Technologies, Inc. | United States | Millennium | registered |
| Awareness Technology, Inc. | United States | StatFax | registered |
| BIONIME CORPORATION Present in Europe in other categories | United States | GE Rightest | K113007 (2012) |
| COPAN ITALIA SPA Present in Europe in other categories | Italy | LBM® Thiol Broth BHI BROTH | registered |
| Inpeco SA Present in Europe in other categories | Italy | ProTube | registered |
| Nidek, Inc. Present in Europe in other categories | United States | IOL-Station | registered |
| ACON Laboratories, Inc. | United States | On Call Diabetes Management Software | registered |
| ARKRAY USA, INC. Present in Europe in other categories | United States | ARK Care® | registered |
| ASSOCIATES OF CAPE COD, INC. | United States | BG Analytics Software | registered |
| Aclarion, Inc. | United States | NociCalc | registered |
| Aesku.Diagnostics GmbH & Co. KG Present in Europe in other categories | Germany | HERA | registered |
| Ascensia Diabetes Care Holdings AG Present in Europe in other categories | United States | GLUCOFACTS® DELUXE | registered |
| DEROYAL INDUSTRIES, INC. Present in Europe in other categories | United States | DeRoyal | registered |
| Ekf-Diagnostic GmbH Present in Europe in other categories | Germany | EKF Link | registered |
| Greiner Bio-One GmbH Present in Europe in other categories | – | Vacuette | registered |
| HAGER WORLDWIDE, INC. Present in Europe in other categories | United States | CATALINA WATER BATH 2000 110V Serial Number: | registered |
| HORIBA ABX SAS Present in Europe in other categories | France | Yumizen P8000 | registered |
| HU-FRIEDY MFG. CO., LLC | United States | HuFriedyGroup | registered |
| Kolplast C I | Brazil | KOLPLAST | registered |
| MEDICAL INFORMATION TECHNOLOGY, INC. | United States | Expanse Laboratory/Genetics/Microbiology/Anatomical Pathology | registered |
| Omnitech Labs Inc. | Canada | OMNI-Lab | registered |
| Perkinelmer Health Sciences Canada, Inc | – | QSight(tm) 210 Screening System | registered |
| Pfizer, Inc. | United States | wtATTR-CM AcceleraTTR™ | registered |
| Puritan Medical Products | United States | Puritan® | registered |
| Roche Diabetes Care GmbH Present in Europe in other categories | Germany | Accu-Chek Care | registered |
| SERCON LIMITED | United Kingdom | Sercon | registered |
| Sysmex America, Inc. Present in Europe in other categories | United States | Caresphere Workflow Solution | registered |
| TELCARE, LLC | – | Telserve® Data Management System | registered |
| TRIVIDIA HEALTH, INC. | United States | TRUEmanager | registered |
| VALUE PROVIDERS LLC | – | Smart Diabetes | registered |
| A. L. B. LUZ | Brazil | – | registered |
| ASCENTRY FRANCE | France | – | registered |
| ASPEN SURGICAL PRODUCTS, INC. Present in Europe in other categories | United States | – | registered |
| Advanced Sterilization Products Present in Europe in other categories | United States | – | registered |
| Alpha Biosciences | United States | – | registered |
| Arx Sciences, Inc. | United States | – | registered |
| Auxein Medical Pvt Ltd | India | – | registered |
| BENCHMARK ELECTRONICS, INC. | United States | – | registered |
| BOEN HEALTHCARE CO., LTD. Present in Europe in other categories | China | – | registered |
| Bd Diagnostic Systems | United States | – | K260213 (2026) |
| Bio-Rad Present in Europe in other categories | United States | – | K923316 (1993) |
| Bio-Rad Laboratories (Bio-Rad Services France) Present in Europe in other categories | France | – | registered |
| Biobase Biodustry(Shandong)Co., Ltd. | China | – | registered |
| Biolog Inc | United States | – | registered |
| Bionostics, Inc. | United States | – | registered |
| CBR Enterprise Limited | Hong Kong SAR China | – | registered |
| CITOTEST LABWARE MANUFACTURING CO., LTD. Present in Europe in other categories | China | – | registered |
| COMPASS BIOINFORMATICS INC. | Taiwan | – | 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 |
| DATA INNOVATIONS LLC Present in Europe in other categories | United States | – | registered |
| DE NOVO SOFTWARE | United States | – | registered |
| DIGISYSTEM LABORATORY INSTRUMENTS INC. | Taiwan | – | registered |
| DON EVANS, INC. | United States | – | 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 |
| Domel, d.o.o., (Business Unit LABS) Present in Europe in other categories | Slovenia | – | registered |
| ESPECIALIDADES MEDICAS MYR SL Present in Europe in other categories | Spain | – | registered |
| Echosens Present in Europe in other categories | France | – | registered |
| Emsere, Inc | Netherlands | – | registered |
The 100 most active manufacturers are shown, out of 195.
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