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Emdyca

IVD instrumentsHematology / histology / cytology instruments

Haematology / cell counting

EMDN code W020201

74 manufacturers, 377 models including 366 on the market, 17 countries

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Manufacturers registered in Europe (EUDAMED) 74
  • 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
Dymind EU representative : Eunitor GmbH (Germany) China
36 others
 A, B IVDR, 98/79 regulationdept@dymind.com EUDAMED record Report an error
Rayto EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
19 others
 B IVDR, 98/79 Website support@rayto.com EUDAMED record Report an error
Genegeo EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China
17 others
 A IVDR, 98/79 sales@genegeo.com EUDAMED record Report an error
E-LAB Biological Science & Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China
14 others
 – 98/79 EUDAMED record Report an error
Horiba FDA France
10 others
 B IVDR, 98/79 EUDAMED record Report an error
Mindray FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
10 others
 B IVDR, 98/79 Website EUDAMED record Report an error
Sysmex FDA EU representative : Sysmex Europe SE (Germany) Japan
9 others
 – 98/79 ra_archive@sysmex.co.jp EUDAMED record Report an error
Urit FDA EU representative : Medunion S.L. (Spain) and 1 other China
9 others
 B IVDR, 98/79 Website service@uritest.com EUDAMED record Report an error
Dirui FDA EU representative : Emergo Europe B.V. (Netherlands) and 1 other China
7 others
 – 98/79 EUDAMED record Report an error
Shenzhen Comen Medical Instruments FDA EU representative : Lotus NL B.V. (Netherlands) China
5 others
 – 98/79 EUDAMED record Report an error
Beckman Coulter FDA EU representative : Beckman Coulter Ireland Inc. (Ireland) Ireland, United States
4 others
 – 98/79 Website ra.clare@beckman.com EUDAMED record Report an error
Genrui Biotech FDA EU representative : Lotus NL B.V. (Netherlands) China
4 others
 B IVDR, 98/79 Website service@genrui-bio.com EUDAMED record Report an error
Maccura EU representative : Humiss International B.V. (Netherlands) and 1 other China
4 others
 B IVDR, 98/79 Website EUDAMED record Report an error
Edan FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
3 others
 B IVDR, 98/79 EUDAMED record Report an error
Wheisman Medical Technology EU representative : Umedwings Netherlands B.V. (Netherlands) China
3 others
 – 98/79 EUDAMED record Report an error
Hunan Ehome Health Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China
2 others
 A IVDR, 98/79 EUDAMED record Report an error
Zybio FDA EU representative : QbD RepS BV (Belgium) China
2 others
 B IVDR PMS@zy-ivd.com EUDAMED record Report an error
Diatron FDA Hungary A IVDR Website EUDAMED record Report an error
Drucker Diagnostics FDA EU representative : Emergo Europe B.V. (Netherlands) United States – 98/79 Website regulatory@druckerdiagnostics.com EUDAMED record Report an error
Gmt Sarl France – 98/79 Website EUDAMED record Report an error
Human Germany – 98/79 Website EUDAMED record Report an error
Ukinbio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 sales@ukinbio.com EUDAMED record Report an error
Abbott FDA EU representative : Abbott GmbH (Germany) United States B IVDR Website EUDAMED record Report an error
Erba Czechia B IVDR Website EUDAMED record Report an error
NORMA Instruments Zártkörűen Működő Részvénytársaság Hungary A IVDR EUDAMED record Report an error
Orphée EU representative : PZ CORMAY Spółka Akcyjna (Poland) Switzerland – 98/79 ra@orphee-medical.com EUDAMED record Report an error
Seamaty EU representative : MedNet EC-REP GmbH (Germany) China A IVDR EUDAMED record Report an error
Shenzhen Channel Biotechnology EU representative : Luxus Lebenswelt GmbH (Germany) China – 98/79 Website service.channel@szchenna.com EUDAMED record Report an error
Siemens Healthcare Diagnostics FDA EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland) United States B IVDR, 98/79 Website contact@siemens-healthineers.com EUDAMED record Report an error
Spinreact Spain – 98/79 Website EUDAMED record Report an error
Accriva Diagnostics FDA EU representative : MDSS GmbH (Germany) United States A IVDR Website EUDAMED record Report an error
Medconn FDA EU representative : JOYSUN GROUP S.L.U (Spain) China – 98/79 EUDAMED record Report an error
NanoEntek FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea A IVDR Website eudamed@nanoentek.com EUDAMED record Report an error
ZOVEC diagnostics Germany – 98/79 Website EUDAMED record Report an error
Aconbio EU representative : MedNet EC-REP GmbH (Germany) China – 98/79 Website EUDAMED record Report an error
Biobase FDA EU representative : Luxus Lebenswelt GmbH (Germany) China A IVDR EUDAMED record Report an error
BioFynder EU representative : SUNGO Europe B.V. (Netherlands) United Kingdom (ex Northern Ireland) A IVDR EUDAMED record Report an error
Boule FDA Sweden B IVDR Website info@boule.com EUDAMED record Report an error
Changchun Chenyu Taikang Medical Laboratory EU representative : MedPath GmbH (Germany) China A IVDR EUDAMED record Report an error
Dezhou Guoke Medical Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 office@guoke-medical.com EUDAMED record Report an error
Diagon Hungary A IVDR Website EUDAMED record Report an error
EFA Engineering for All EU representative : MedNet EC-REP GmbH (Germany) Israel – 98/79 Website EUDAMED record Report an error
Essenlix EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China A IVDR Website info@essenlix.com.cn EUDAMED record Report an error
High Technology FDA EU representative : MedEnvoy Global BV (Netherlands) United States A IVDR Website EUDAMED record Report an error
Infitek FDA EU representative : Kingsmead Service B.V. (Netherlands) and 1 other China A IVDR info@infitek.com EUDAMED record Report an error
Konsung FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China – 98/79 EUDAMED record Report an error
Lordsmark EU representative : Obelis s.a. (Belgium) India A IVDR Website EUDAMED record Report an error
Meril Diagnostics FDA EU representative : CMC Medical Devices & Drugs SL (Spain) India A IVDR Website ram.kanoje@merillife.com EUDAMED record Report an error
Reetoo EU representative : Umedwings Netherlands B.V. (Netherlands) China – 98/79 Website service@reetoo.com.cn EUDAMED record Report an error
Shandong Bohong Gene Technology EU representative : Luxus Lebenswelt GmbH (Germany) China A IVDR EUDAMED record Report an error
Shenzhen YC Biotechnology EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR, 98/79 EUDAMED record Report an error
Arteion France B IVDR contact@arteion.com EUDAMED record Report an error
Avecon Healthcare EU representative : Amstermed B.V. (Netherlands) India A IVDR Website EUDAMED record Report an error
Bioantibody Biotechnology EU representative : Medunion S.L. (Spain) China A IVDR EUDAMED record Report an error
Boditech FDA EU representative : Obelis s.a. (Belgium) South Korea A IVDR Website marketing@boditech.co.kr EUDAMED record Report an error
Changsha Han Biotechnology EU representative : Medunion S.L. (Spain) China A IVDR EUDAMED record Report an error
Cytochipinc FDA EU representative : Medunion S.L. (Spain) United States A IVDR quality@cytochipinc.com EUDAMED record Report an error
Diagnostics Belgium – 98/79 Website EUDAMED record Report an error
EKF-diagnostic FDA Germany B IVDR info@ekf-diagnostic.de EUDAMED record Report an error
HemoCue FDA Sweden A IVDR Website info@hemocue.se EUDAMED record Report an error
Hrjbio EU representative : CMC Medical Devices & Drugs SL (Spain) China A IVDR Website info@hrjbio.com EUDAMED record Report an error
Ningbo MedicalSystem Biotechnology FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China A IVDR EUDAMED record Report an error
Pixcell Medical FDA EU representative : AR Experts B.V. (Netherlands) Israel B IVDR Website info@picxell-medical.com EUDAMED record Report an error
Poweam EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Pushkang EU representative : Sungo Cert GmbH (Germany) China A IVDR EUDAMED record Report an error
Shenzhen Cinnaray Life Technology EU representative : HUMISS TRADING S. L. (Spain) China A IVDR EUDAMED record Report an error
Shenzhen CoooSeee Biomedical EU representative : MedNet EC-REP GmbH (Germany) China B IVDR service@comenbio.com EUDAMED record Report an error
Shenzhen Landwind Biomedical Technology EU representative : Lotus NL B.V. (Netherlands) China – 98/79 sales@landwindmedical.com EUDAMED record Report an error
Shenzhen Zijian Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain) China A IVDR Website sales@szzijian.com EUDAMED record Report an error
Tcoag FDA Ireland – 98/79 Website EUDAMED record Report an error
Zhongshan Chuangyi Biochemical Engineering EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China A IVDR EUDAMED record Report an error
Xpenarray EU representative : CMC Medical Devices & Drugs SL (Spain) No model still on the market China
3 others
 – 98/79 EUDAMED record Report an error
Ns Biotec EU representative : CMC Medical Devices & Drugs SL (Spain) No model still on the market Egypt – 98/79 Website info@nsbiotec.com EUDAMED record Report an error
S.D. Sight Diagnostics FDA EU representative : CEpartner4U (Netherlands) No model still on the market Israel – 98/79 Website info@sightdx.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) 29

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
Becton, Dickinson & CO Present in Europe in other categories United States FACSCanto Simultest BD Tritest BD Multitest FACSCount K102064 (2011)
RESEARCH AND DIAGNOSTIC SYSTEMS, INC. – Research and Diagnostic Systems registered
AGILENT TECHNOLOGIES SINGAPORE PTE LTD Present in Europe in other categories – Mono Mo A-Hu CD8/RPE, Cl DK25 Mono Mo A-Hu CD19/RPE-Cy5, Cl HD37 MultiMix Dual-Colour Reagent A-Hu CD3/FITC A-Hu CD19/RPE Negative Control Mo IgG1/RPE, Cl DAK-GO1 Negative Control Mo IgG1/RPE-Cy5, Cl DAK-GO1 Mono Mo A-Hu CD3/RPE-Cy5, Cl UCHT1 registered
Athelas, Inc. United States Athelas Home Athelas One WBC Test Strip K243348 (2026)
CellaVision AB Present in Europe in other categories United States CellaVision® Body Fluid Application DM96 CellaVision® DM9600 CellaVision® DM1200 Automated Digital Morphology Analyzer DI-60 registered
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD. Present in Europe in other categories – QwikCheck Test Strips SQA-Vision Sperm Quality Analyzer registered
DREW SCIENTIFIC, INC. United Kingdom JAS Diagnostics K071562 (2007)
Immudex ApS Denmark Dextramer CMV Kit K153538 (2017)
Ad Astra Diagnostics, Inc. United States – K230878 (2023)
Agilent Technologies, Inc. Present in Europe in other categories United States – registered
Antibodies, Inc. United States – registered
BIT Analytical Solutions GmbH Germany – registered
BIT Group France France – registered
BONRAYBIO CO., LTD. Present in Europe in other categories Taiwan – registered
Diamond Diagnostics Inc. Present in Europe in other categories United States – registered
Diatron MI Plc Hungary – registered
Flextronics International USA, Inc. United States – registered
JAS Diagnostics/Drew Scientific United States – registered
Kitron AB Sweden – registered
Mindray Bio-Medical Electronics Co., Ltd. China – K160429 (2016)
R&D Systems, Inc. Present in Europe in other categories United States – K982231 (1998)
Roche Diagnostics Hematology, Inc. United States – K171655 (2018)
SST International Inc. United States – registered
Sanmina Corporation United States – registered
Sight Diagnostics , Ltd. Israel – K190898 (2019)
Streck Laboratories, Inc. Present in Europe in other categories United States – registered
Thermo Fisher Scientific Present in Europe in other categories United States – registered
Truvian Sciences, Inc. United States – K251249 (2026)
VTech Communications Ltd China – registered

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