Hematology / histology / cytology instrumentsHistology / cytologyLaboratory instruments for microscopic investigations
Digital laboratory microscopes
EMDN code W0202050304
Manufacturers registered in Europe (EUDAMED) 26
- 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 |
|---|---|---|---|---|
| 3Dhistech | Hungary | A IVDR | Website info@3dhistech.com EUDAMED record Report an error | |
| Leicabiosystems FDA EU representative : AR Experts B.V. (Netherlands) | United States | A IVDR | Website EUDAMED record Report an error | |
| Hamamatsu EU representative : Hamamatsu Photonics Deutschland GmbH (Germany) | Japan | A IVDR | Website sales@sys.hpk.co.jp EUDAMED record Report an error | |
| Grundium | Finland | A IVDR | Website support@grundium.com EUDAMED record Report an error | |
| Huron Technologies International EU representative : 4 Easy Prrc 2 Smart Mdr, Lda (Portugal) | Canada | A IVDR | Website regulatory@hurondigitalpathology.com EUDAMED record Report an error | |
| Objective Imaging EU representative : Acorn Regulatory Consultancy Services Ltd (Ireland) | United Kingdom (ex Northern Ireland) | A IVDR | Website EUDAMED record Report an error | |
| Euroimmun FDA | Germany | A IVDR | Website info@euroimmun.de EUDAMED record Report an error | |
| NTP Nano Tech Projects FDA | Italy | A IVDR | info@ntpsrl.biz EUDAMED record Report an error | |
| OptraSCAN FDA EU representative : AR Experts B.V. (Netherlands) | United States | A IVDR | Website info@optrascan.com EUDAMED record Report an error | |
| Philips FDA | Netherlands | A IVDR | eudamed@philips.com EUDAMED record Report an error | |
| Suzhou Ruiqian Technologies EU representative : Medunion S.L. (Spain) | China | A IVDR | EUDAMED record Report an error | |
| Sysmex FDA EU representative : Sysmex Europe SE (Germany) | Japan | A IVDR | ra_archive@sysmex.co.jp EUDAMED record Report an error | |
| BioView FDA EU representative : MedNet EC-REP GmbH (Germany) | Israel | A IVDR | Website info@bioview.co.il EUDAMED record Report an error | |
| Diagon | Hungary | A IVDR | Website EUDAMED record Report an error | |
| Evident FDA EU representative : Evident Europe GmbH (Germany) | Japan |
|
A IVDR | EUDAMED record Report an error |
| Evident Technology Center Europe | Germany | A IVDR | Website EUDAMED record Report an error | |
| Evidentscientific EU representative : Evident Europe GmbH (Germany) | United States |
|
A IVDR | Website EUDAMED record Report an error |
| Excilone | France | A IVDR | Website EUDAMED record Report an error | |
| FFEI EU representative : Eurolink Europe Compliance Limited (Ireland) | United Kingdom (ex Northern Ireland) | A IVDR | Website regulatory@ffei.co.uk EUDAMED record Report an error | |
| Human | Germany | A IVDR | Website EUDAMED record Report an error | |
| Konan FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) | Japan | A IVDR | Website EUDAMED record Report an error | |
| PreciPoint | Germany |
|
A IVDR | Website info@precipoint.de EUDAMED record Report an error |
| Shandon Diagnostics FDA EU representative : Epredia Netherlands B.V. (Netherlands) | United Kingdom (ex Northern Ireland) | A IVDR | EUDAMED record Report an error | |
| Zeiss FDA | Germany |
|
A IVDR | Website regulatoryaffairs.microscopy@zeiss.com EUDAMED record Report an error |
| ZKYH AImed Technology （Guangxi） EU representative : Sungo Cert GmbH (Germany) | China | A IVDR | EUDAMED record Report an error | |
| Micro Instrument EU representative : CMC Medical Devices & Drugs SL (Spain) No model still on the market | India |
|
I MDR | Website info@mikoindia.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) 14
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) |
| 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 |
| Carl Zeiss CMP GmbH | Germany | – | registered |
| Epredia Holdings Ltd. | United States | – | registered |
| Indica Labs, Inc. Present in Europe in other categories | United States | – | K232833 (2024) |
| Leica Biosystems, division of Leica Microsystems, Inc. | 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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