Skip to content
Emdyca

IVD instrumentsHematology / histology / cytology instrumentsVarious hematology / histology /cytology instruments

Various hematology / histology / cytology instruments - IVD medical device software

EMDN code W02029092

12 manufacturers, 22 models including 22 on the market, 6 countries

Export to CSV
Manufacturers registered in Europe (EUDAMED) 12
  • 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.
ManufacturerCountryRegistered modelsClassContact
CellaVision FDA Sweden
2 others
 A, C IVDR Website EUDAMED record Report an error
VMscope Germany – 98/79 Website EUDAMED record Report an error
Deepbio EU representative : AR Experts B.V. (Netherlands) South Korea – 98/79 Website EUDAMED record Report an error
Techcyte EU representative : Medical Technology Promedt Consulting GmbH (Germany) United States – 98/79 Website EUDAMED record Report an error
CellSolutions FDA EU representative : CellSolutions GmbH (Germany) United States – 98/79 Website EUDAMED record Report an error
Curesponse EU representative : ProPharma Group The Netherlands BV (Netherlands) Israel – 98/79 Website support@curesponse.tech EUDAMED record Report an error
Hologic FDA EU representative : Hologic BV (Belgium) United States C IVDR EUDAMED record Report an error
Immucor FDA EU representative : IMMUCOR Medizinische Diagnostik GmbH (Germany) United States C IVDR EUDAMED record Report an error
Infinitt FDA EU representative : Obelis s.a. (Belgium) South Korea A IVDR Website EUDAMED record Report an error
Inify Sweden – 98/79 Website EUDAMED record Report an error
One Lambda FDA EU representative : MDSS GmbH (Germany) United States C IVDR Website EUDAMED record Report an error
Spotlight Medical France C IVDR Website 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) 8

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.

ManufacturerCountryBrandsFDA clearance
Scopio Labs , Ltd. Present in Europe in other categories Israel X100 Digital Scanner X100 Processing Unit (Complete Unit) X100HT System X100HT with Full Field Peripheral Blood Smear (PBS) Application X100HT Digital Scanner X100HT Processing Unit K243144 (2025)
Leica Biosystems Richmond, Inc. Present in Europe in other categories United States Leica Biosystems CytoVision Z-stack software license Leica Biosystems CytoVision GSL120 scanning system for Karyotyping Leica ADAPTOR C14 TO C7, POWER SUPPLY Leica Biosystems CytoVision DM5500 for FL-Ergo Head Leica Biosystems Slide Cassettes, SL200 Leica Biosystems CytoVision GSL120 scanning system - FISH registered
Applied Spectral Imaging , Ltd. Present in Europe in other categories Israel ASI IVD System K071398 (2007)
Sysmex America, Inc. Present in Europe in other categories United States Fully Automated Urine Particle Digital Imaging Device UD-10 K182062 (2018)
Bioview , Ltd. Present in Europe in other categories Israel – K061602 (2007)
Ikonisys, Inc. Present in Europe in other categories United States – K062755 (2007)
Kitron AB Sweden – registered
Sigtuple Technologies Pvt. , Ltd. Present in Europe in other categories India – K221309 (2023)

Didn't find it?

Tell us what you are looking for. Requests show us which categories to add first.

Related categories