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Emdyca

IVD instrumentsHematology / histology / cytology instruments

Various hematology / histology /cytology instruments

EMDN code W020290

32 manufacturers, 60 models including 58 on the market, 12 countries

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Manufacturers registered in Europe (EUDAMED) 32
  • 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
Linear FDA Spain
1 other
 A IVDR Website info@linear.es EUDAMED record Report an error
Shenzhen Yhlo Biotech FDA EU representative : Lotus NL B.V. (Netherlands) China
1 other
 – 98/79 Website info@szyhlo.com EUDAMED record Report an error
Rrmechatronics FDA Netherlands A IVDR Website support@rrmechatronics.com EUDAMED record Report an error
Strumed FDA EU representative : Amstermed B.V. (Netherlands) India – 98/79 Website EUDAMED record Report an error
Alcor Scientific FDA EU representative : Emergo Europe B.V. (Netherlands) United States A IVDR EUDAMED record Report an error
Cellomics (Shenzhen) EU representative : Lotus NL B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Diesse FDA Italy A, B IVDR Website EUDAMED record Report an error
Jokoh EU representative : MDSS GmbH (Germany) Japan – 98/79 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
Greiner Bio-One Austria A IVDR Website regulatory-affairs.at@gbo.com EUDAMED record Report an error
Alifax FDA Italy A IVDR Website regulatory@alifax.com EUDAMED record Report an error
Aquisel FDA Spain A IVDR EUDAMED record Report an error
Biobase FDA EU representative : Luxus Lebenswelt GmbH (Germany) China A IVDR EUDAMED record Report an error
Bndhematech EU representative : Umedwings Netherlands B.V. (Netherlands) China I MDR marketing@bndhematech.com EUDAMED record Report an error
Chongqing NanFang Numerical ControlEquipment EU representative : Medunion S.L. (Spain) China – 98/79 EUDAMED record Report an error
Chubio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China I MDR EUDAMED record Report an error
Disera Türkiye A IVDR EUDAMED record Report an error
Guangzhou Improve Medical Instruments FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China A IVDR ra@improve-medical.com EUDAMED record Report an error
Human Germany – 98/79 Website EUDAMED record Report an error
Möller Medical FDA Germany I MDR Website info@moeller-medical.com EUDAMED record Report an error
Ral Tecnica Para El Laboratorio Spain A IVDR Website EUDAMED record Report an error
Sarstedt FDA Germany A IVDR Website EUDAMED record Report an error
Sclavo Italy – 98/79 qa@sclavo.it EUDAMED record Report an error
Shinwha Medi EU representative : Advena Limited (Malta) South Korea A IVDR Website 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
Singlecellbiotech EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China A IVDR EUDAMED record Report an error
Sinobiocan EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China I MDR EUDAMED record Report an error
Sistat Türkiye A IVDR Website info@sistat.com.tr EUDAMED record Report an error
Sterile Safequip Chemicals FDA EU representative : CMC Medical Devices & Drugs SL (Spain) India A IVDR Website EUDAMED record Report an error
Thermogenesis FDA EU representative : MDSS GmbH (Germany) United States IIa MDR Website regulatoryaffairs@thermogenesis.com EUDAMED record Report an error
Weihai Sunway Medical Technology EU representative : CMC Medical Devices & Drugs SL (Spain) China I MDR EUDAMED record Report an error
Wiener Laboratorios SAIC FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) Argentina A IVDR Website marketing@wiener-lab.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) 19

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
ELITECHGROUP INC. Present in Europe in other categories United States Excyte 20 Excyte® ESR Vacuum Tube, Carton Monosed® ESR Vacuum Tubes, Carton Excyte® ESR Vacuum Tube Excyte Excyte® ESR Vacuum Tubes registered
Mechatronics USA LLC – Starrsed registered
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
Streck Laboratories, Inc. Present in Europe in other categories United States ESR-Auto Plus ESR-10 Manual Rack registered
Applied Spectral Imaging , Ltd. Present in Europe in other categories Israel ASI IVD System K071398 (2007)
Sarstedt Aktiengesellschaft & Co.KG – Sediplus® S 200, 12 V DC Sediplus® S 2000 NX registered
Airscan, Inc. United States ESR STAT 6 registered
Biobase Biodustry(Shandong)Co., Ltd. China BIOBASE registered
DRUCKER DIAGNOSTICS Present in Europe in other categories United States QBC Diagnostics registered
STERILE SAFEQUIP & CHEMICALS LLP – ZBT-ESR registered
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
Labpeak Co.,Ltd China – registered
Polymedco, Inc. United States – registered
Scitek Global Co.,Ltd China – registered
Sigtuple Technologies Pvt. , Ltd. Present in Europe in other categories India – K221309 (2023)

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