IVD instrumentsHematology / histology / cytology instrumentsHistology / cytology
Various processing instruments for hystology / cytology
EMDN code W02020590
Manufacturers registered in Europe (EUDAMED) 82
- 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) 82
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 |
|---|---|---|---|
| SAKURA FINETEK U.S.A., INC. Present in Europe in other categories | United States | Tissue-Tek® TEC™ 6 Tissue-Tek AutoTEC® a120 Tissue-Tek Xpress® Tissue-Tek VIP® Tissue-Tek VIP® 6 Tissue-VIP® 6 AI | K881165 (1988) |
| RUSHABH INSTRUMENTS, LLC | United States | HistoPro® | registered |
| 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 |
| AccuTec, Inc. | United States | AccuThrive® | registered |
| Dakewe (Shenzhen) Medical Equipment Co., Ltd. | China | MT1 Rotary Microtome CT520 Cryostat Microtome CT620 Cryostat Microtome 6250 Cryostat Microtome HP300Plus Automatic Tissue Processor HP-HUGO Automatic Tissue Processor | 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 |
| FEATHER SAFETY RAZOR CO., LTD. Present in Europe in other categories | Japan | FEATHER MICROTOME BLADE | registered |
| Clarapath, Inc. | United States | ClaraBond™ Slide Coater Adhesive ClaraCut™ Blades ClaraTape™ Transfer Tape Clarapath™ SectionStar™ | 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 |
| BIOCYTECH CORPORATION SDN. BHD. Present in Europe in other categories | Malaysia | PathTezt® | registered |
| CUSTOM ASSEMBLIES, INC. | United States | Robbins Instruments | 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 |
| ANYBATTERY, INC | United States | Anybattery | 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 |
| Fisher Scientific Co., LLC | United States | Fisherbrand | 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 |
| AD Supply Group Limited | United Kingdom | – | registered |
| APRO SAFETY SUPPLIES INC. | Taiwan | – | 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 |
| Boekel Scientific | United States | – | registered |
| C. L. Sturkey, Inc. | United States | – | registered |
| CELLPATH LTD Present in Europe in other categories | United Kingdom | – | registered |
| CHEMEX INDUSTRIAL CO., LTD. | Taiwan | – | registered |
| CITOTEST LABWARE MANUFACTURING CO., LTD. Present in Europe in other categories | China | – | registered |
| CRESCENT MFG. CO. | United States | – | registered |
| CellSolutions LLC Present in Europe in other categories | United States | – | registered |
| Celnovte Biotechnology Co., Ltd | China | – | registered |
| Citotest Scientific Co.,Ltd. Present in Europe in other categories | China | – | registered |
| Core Biotech Co., Ltd. Present in Europe in other categories | South Korea | – | registered |
| Crown Surgical Corp. | Pakistan | – | 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 |
| Empire Surgical Instruments Company | Pakistan | – | registered |
| Epredia Holdings Ltd. | United States | – | registered |
| Falcon Surgical Co. (Pvt.) Ltd. Present in Europe in other categories | Pakistan | – | registered |
| Fuzhou Maixin Biotech Co., Ltd. | China | – | registered |
| General Data Company, Inc. | United States | – | registered |
| Guangzhou Four E's Scientific Co., Ltd. Present in Europe in other categories | China | – | registered |
| IGE Medical Devices, LLC | United States | – | registered |
| Jiangsu Medomics Medical Technology Co.,Ltd. Present in Europe in other categories | China | – | registered |
| Jinhua Craftek Instrument Co., Ltd | China | – | registered |
| KAI INDUSTRIES CO., LTD. | Japan | – | registered |
| Labpeak Co.,Ltd | China | – | registered |
| Leica Biosystems, division of Leica Microsystems, Inc. | United States | – | registered |
| MEDIMEAS INSTRUMENTS | India | – | registered |
| MIAN SHAHID CORP. | Pakistan | – | registered |
| Mark Enterprises | India | – | registered |
| MilliporeSigma | United States | – | registered |
| Muto Pure Chemicals Co.,Ltd | Japan | – | registered |
| NARANG MEDICAL, LTD. Present in Europe in other categories | India | – | registered |
| Newcomer Supply Inc | 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 |
| Q-Line Biotech Limited | India | – | registered |
| Roche Diagnostics Operations Inc. | United States | – | registered |
| SHANGHAI YOUDING INTERNATIONAL TRADE CO., LTD. | China | – | registered |
| SST International 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 |
| TED PELLA, INC. | United States | – | registered |
| TRAJAN SCIENTIFIC AUSTRALIA PTY LTD Present in Europe in other categories | Australia | – | 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 |
Didn't find it?
Tell us what you are looking for. Requests show us which categories to add first.