IVD instrumentsHematology / histology / cytology instrumentsHistology / cytology
Laboratory instruments for microscopic investigations
EMDN code W02020503
Manufacturers registered in Europe (EUDAMED) 52
- 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) 30
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 |
|---|---|---|---|
| Barco N.V. Present in Europe in other categories | Belgium | Barco | K203364 (2021) |
| Genea Biomedx Pty, Ltd. | Australia | Geri Connect Server (including software) Geri Embryo Incubator Geri Software Connect and Assess 2.0 Geri Software Connect and Assess 1.3 | registered |
| Inova Diagnostics, Inc. Present in Europe in other categories | United States | NOVA Lite® DAPI ANA Kit NOVA View® AUTOLoader NOVA View® Automated Fluorescence Microscope NOVA Lite® DAPI dsDNA Crithidia Luciliae Kit | K153150 (2015) |
| Hua Yue Medical Technology Co., Ltd. | China | Harioculture TL-16 Time-lapse Incubator Time-lapse Incubator Capacity Expansion Module | registered |
| LW SCIENTIFIC, INC. | United States | LW Scientific, Inc. | registered |
| Zeus Scientific, Inc. Present in Europe in other categories | United States | Anti-Neutrophil Cytoplasmic Antibodies (Formalin-fixed) Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed) | registered |
| Aesku.Diagnostics GmbH & Co. KG Present in Europe in other categories | Germany | HELIOS® Automated IFA System | registered |
| Aesku.Systems GmbH & Co. KG Present in Europe in other categories | – | HELIOS | registered |
| FUJIFILM Healthcare Americas Corporation Present in Europe in other categories | United States | Synapse Pathology | registered |
| Hamamatsu Photonics K.K. | Japan | NanoZoomer S360MD Slide scanner system | K260964 (2026) |
| Proscia, Inc. Present in Europe in other categories | United States | Concentriq AP-Dx | K230839 (2024) |
| Roche Diagnostics Corp. Present in Europe in other categories | United States | VENTANA DP 600 slide scanner | registered |
| Vitrolife A/S Present in Europe in other categories | Denmark | EmbryoScope+ | registered |
| Wuhan Huchuang Union Technology Co., Ltd. Present in Europe in other categories | China | Metiec | registered |
| Appasamy Associates Private Limited (MN Kuppam) Present in Europe in other categories | India | – | registered |
| Appasamy Associates Private Limited (Thiruvandar Koil) Present in Europe in other categories | India | – | registered |
| COHEN INDUSTRY CO., LTD. | Japan | – | registered |
| Carl Zeiss CMP GmbH | Germany | – | registered |
| Carl Zeiss, Inc. | United States | – | registered |
| Epredia Holdings Ltd. | United States | – | registered |
| Indica Labs, Inc. Present in Europe in other categories | United States | – | K232833 (2024) |
| Instrumentation Laboratory CO Present in Europe in other categories | United States | – | registered |
| Leica Biosystems, division of Leica Microsystems, Inc. | United States | – | registered |
| Ningbo Haishu District Proway Imp. & Exp. Co., Ltd. | China | – | registered |
| PLEXUS CORP. | United States | – | registered |
| Paige.Ai, Inc. Present in Europe in other categories | United States | – | registered |
| Roche Diagnostics Operations Inc. | United States | – | registered |
| Sectra AB Present in Europe in other categories | United States | – | K232208 (2024) |
| Ventana Medical Systems, Inc. Present in Europe in other categories | United States | – | K242783 (2024) |
| Virasoft Corporation Present in Europe in other categories | United States | – | K251952 (2026) |
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