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Emdyca

Hematology / histology / cytology instrumentsHistology / cytologyVarious processing instruments for hystology / cytology

Automated slide stainers

EMDN code W0202059002

49 manufacturers, 79 models including 74 on the market, 13 countries

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Manufacturers registered in Europe (EUDAMED) 49
  • 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
Dartmon FDA EU representative : R Sight B.V. (Netherlands) and 1 other China
1 other
 A IVDR Website EUDAMED record Report an error
Leicabiosystems FDA EU representative : CEpartner4U (Netherlands) Australia, Germany A IVDR Website support.de@LeicaBiosystems.com EUDAMED record Report an error
Agilent FDA EU representative : Agilent Technologies Denmark ApS (Denmark) Singapore A IVDR Website info.dk@agilent.com 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
RAL Diagnostics FDA France A IVDR Website info@ral-diagnostics.fr EUDAMED record Report an error
Sakura Seiki EU representative : Sakura Finetek Europe B.V. (Netherlands) Japan A IVDR Website EUDAMED record Report an error
Amos Scientific Pty EU representative : Luxus Lebenswelt GmbH (Germany) Australia A IVDR info@amos-scientific.com EUDAMED record Report an error
Dagatron FDA EU representative : BZT-TCP Certification GmbH (Germany) South Korea A IVDR Website EUDAMED record Report an error
Diapath FDA Italy A IVDR Website info@diapath.com EUDAMED record Report an error
Especialidades Médicas Myr FDA Spain A IVDR Website EUDAMED record Report an error
Lumatas FDA EU representative : Emergo Europe B.V. (Netherlands) United States A IVDR EUDAMED record Report an error
Nev Yazilim Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ Türkiye A IVDR info@nevasoftai.com EUDAMED record Report an error
Sidena France A IVDR info@sidena.com EUDAMED record Report an error
Abbott FDA EU representative : Abbott GmbH (Germany) United States A IVDR Website EUDAMED record Report an error
AVE Science & Technology FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China A IVDR EUDAMED record Report an error
BaSO Biotech EU representative : CMC Medical Devices & Drugs SL (Spain) Taiwan A IVDR Website services@basobiotech.com EUDAMED record Report an error
Baso Diagnostics Zhuhai EU representative : Eunitor GmbH (Germany) China A IVDR EUDAMED record Report an error
Becton Dickinson FDA EU representative : Becton Dickinson Ireland Limited (Ireland) United States A IVDR Website EUDAMED record Report an error
Beijing High-Grade Biotechnology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China A IVDR admin@biohighgrade.com EUDAMED record Report an error
Bio-Optica Milano FDA Italy A IVDR Website info@bio-optica.it EUDAMED record Report an error
BotuAImaging Technology EU representative : Kingsmead Service B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Dakewe FDA EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR Website EUDAMED record Report an error
Diagnostic BioSystems FDA EU representative : MedEnvoy Global BV (Netherlands) United States A IVDR EUDAMED record Report an error
Dirui FDA EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Dymind EU representative : Eunitor GmbH (Germany) China A IVDR regulationdept@dymind.com EUDAMED record Report an error
Guangzhou Naturn Medical Devices EU representative : MedPath GmbH (Germany) China A IVDR EUDAMED record Report an error
Guangzhou Xiuwei Technology EU representative : Sungo Cert GmbH (Germany) China A IVDR Website EUDAMED record Report an error
Hologic FDA EU representative : Hologic BV (Belgium) United States A IVDR EUDAMED record Report an error
Horiba FDA France A IVDR EUDAMED record Report an error
Hospitex Italy A IVDR Website info@hospitex.com EUDAMED record Report an error
Imedikers EU representative : Veritas Eston OÜ (Estonia) South Korea A IVDR info@veritaseston.eu EUDAMED record Report an error
Infitek FDA EU representative : Kingsmead Service B.V. (Netherlands) China A IVDR info@infitek.com EUDAMED record Report an error
Intelsint Italy A IVDR Website info@intelsint.com EUDAMED record Report an error
Maccura EU representative : Humiss International B.V. (Netherlands) China A IVDR Website EUDAMED record Report an error
Medite FDA Germany A IVDR Website EUDAMED record Report an error
Milestone FDA Italy A IVDR Website marketing@milestonemedsrl.com EUDAMED record Report an error
Mindray FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China A IVDR Website EUDAMED record Report an error
Ningbo Chiwell Biotechnology FDA EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Reetoo EU representative : Umedwings Netherlands B.V. (Netherlands) China A IVDR Website service@reetoo.com.cn EUDAMED record Report an error
Sakura Finetek USA EU representative : Sakura Finetek Europe B.V. (Netherlands) United States A IVDR PRRC@sakuraus.com EUDAMED record Report an error
Shanghai LeChen Biotechnology EU representative : Everbiz GmbH (Austria) China A IVDR EUDAMED record Report an error
Siemens Healthcare Diagnostics FDA EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland) United States A IVDR Website contact@siemens-healthineers.com EUDAMED record Report an error
Siemens Healthcare Diagnostics Products FDA Germany A IVDR Website contact@siemens-healthineers.com EUDAMED record Report an error
Tharmac Germany A IVDR Website info@tharmac.de EUDAMED record Report an error
Urit FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China A IVDR Website service@uritest.com EUDAMED record Report an error
Weinkauf Medizintechnik Germany A IVDR Website info@weinkauf-medizintechnik.de EUDAMED record Report an error
Wondfo FDA EU representative : QbD RepS BV (Belgium) China A IVDR Website sales@wondfo.com.cn EUDAMED record Report an error
Xiaogan Kuohai Medical Technology EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Zhuhai DL Biotech EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) No model still on the market China A 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) 47

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
BIOCARE MEDICAL LLC Present in Europe in other categories – intelliPATH MAX intelliPATH Plus Decloaking Chamber™ NxGen Decloaking Chamber™ NxGen Reconditioned intelliPATH FLX Automated Slide Staining System registered
ELITECHGROUP INC. Present in Europe in other categories United States Aerospray Hematology Stat Slide Stainer/Cytocentrifuge Aerospray TB Slide Stainer/Cytocentrifuge Aerospray® Gram Slide Stainer/Cytocentrifuge Aerospray® Cytology 12-Slide Carousel Aerospray Cytology Slide Stainer/Cytocentrifuge Aerospray® Cytology 30-Slide Carousel registered
bioMerieux, Inc. Present in Europe in other categories United States PREVI® COLOR SINGLE SAMPLE CHAMBERS FAST (WHITE) PREVI® COLOR GRAM V2 PREVI® COLOR POLY-L-LYSINE SLIDES SINGLE PREVI® COLOR POLY-L-LYSINE SLIDES DUAL PREVI® COLOR SINGLE SAMPLE CHAMBERS SLOW (TAN) PREVI® COLOR DUAL SAMPLE CHAMBERS SLOW (TAN) registered
Pathcom Systems Corporation Present in Europe in other categories United States MD Stainer Quantum HDx Nova Aura Oncore Pro Histostainer AT Delta. 36 registered
RUSHABH INSTRUMENTS, LLC United States HistoPro® registered
Ventana Medical Systems, Inc. Present in Europe in other categories United States BenchMark GX BenchMark Special Stains Stainer Module BenchMark ULTRA PLUS Instrument VENTANA HE 600 System BenchMark ULTRA registered
ASP Health Inc. United States ASP POD ASP HOOD ASP VIAL ASP Device; ASP System; ROSE Prep pro registered
BIO SB, INC. Present in Europe in other categories United States TintoStainer Plus Automated System Mini TintoStainer Plus Automated System TintoStainer Plus Automated System LX registered
Dakewe (Shenzhen) Medical Equipment Co., Ltd. China DP260 slide stainer DP360 slide stainer Fully Automated IHC Stainer registered
Tecan U.S., Ltd. Present in Europe in other categories United States PROFI BLOT 48 PROFI BLOT T48 K933996 (1994)
VITRO SA Present in Europe in other categories Spain VitroStainer 42 NeoPATH Pro registered
Beckman Coulter, Inc. Present in Europe in other categories United States UniCel DxH registered
Cytogen, Inc. Present in Europe in other categories South Korea Smart Biopsy™ IF Stainer registered
HARDY DIAGNOSTICS United States QuickSlide™ registered
NOVODIAX, INC. Present in Europe in other categories United States Q-STAIN® X Autostainer registered
Sigma-Aldrich, Inc. Present in Europe in other categories – MIDAS® III-Plus Automated Stainer registered
Amphenol Critical Medical Technologies, LLC United States – registered
Auer Precision United States – registered
BIOGENEX LABORATORIES United States – registered
BIT Analytical Solutions GmbH Germany – registered
Bio-Gram Diagnostics GmbH Present in Europe in other categories Germany – registered
Biocare Corp. Present in Europe in other categories United States – registered
Celnovte Biotechnology Co., Ltd China – registered
DiaTrust Medical Co., Ltd. Present in Europe in other categories China – registered
Diamond Diagnostics Inc. Present in Europe in other categories United States – registered
Epredia Holdings Ltd. United States – registered
Fuzhou Maixin Biotech Co., Ltd. China – registered
Hangzhou HealthSky Biotechnology Co., Ltd. Present in Europe in other categories China – registered
Jiangsu Medomics Medical Technology Co.,Ltd. Present in Europe in other categories China – registered
Labpeak Co.,Ltd China – registered
Leica Biosystems, division of Leica Microsystems, Inc. United States – registered
MEDIMEAS INSTRUMENTS India – registered
MilliporeSigma United States – registered
Noul Co., Ltd. Present in Europe in other categories South Korea – registered
PT PHC Indonesia Indonesia – registered
PathnSitu Biotechnologies Pvt Ltd India – registered
Planet Innovation Australia – registered
Roche Diagnostics Operations Inc. United States – registered
Sakura Global Holding Company United States – registered
Sanmina Corporation United States – registered
Scitek Global Co.,Ltd China – registered
Sipcon Technologies Private Limited India – registered
Sysmex America, Inc. Present in Europe in other categories United States – registered
UNI MEDITREK PRIVATE LIMITED India – registered
VOLUSOL United States – registered
Wuhan Landing Intelligence Medical Co.,Ltd Present in Europe in other categories China – registered
Zhejiang GENE SCIENCE Co., Ltd China – registered

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