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Emdyca

Hematology / histology / cytology instrumentsHemostasisCoagulometers

Automated coagulometers

EMDN code W0202020102

33 manufacturers, 106 models including 106 on the market, 13 countries

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Manufacturers registered in Europe (EUDAMED) 33
  • 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
Iline Microsystems FDA Spain
11 others
A IVDR, 98/79 eudamed@ilinemicrosystems.com EUDAMED record Report an error
Instrumentation Laboratory FDA EU representative : Instrumentation Laboratory SpA (Italy) United States
11 others
A IVDR Website Regulatory@werfen.com EUDAMED record Report an error
Sunbiote EU representative : Lotus NL B.V. (Netherlands) China
7 others
A IVDR Website EUDAMED record Report an error
Sysmex FDA EU representative : Sysmex Europe SE (Germany) Japan
5 others
A IVDR ra_archive@sysmex.co.jp EUDAMED record Report an error
Rayto EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
1 other
A IVDR Website support@rayto.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
SysCan MedTech (Suzhou) EU representative : Obelis s.a. (Belgium) China A IVDR EUDAMED record Report an error
"Bio-Ksel" Poland A IVDR Website EUDAMED record Report an error
Diagon Hungary A IVDR Website EUDAMED record Report an error
Zybio FDA EU representative : QbD RepS BV (Belgium) China A IVDR PMS@zy-ivd.com EUDAMED record Report an error
Dymind EU representative : Eunitor GmbH (Germany) China A IVDR regulationdept@dymind.com EUDAMED record Report an error
Erba Czechia A IVDR Website EUDAMED record Report an error
Horiba FDA France A IVDR EUDAMED record Report an error
Linear FDA Spain A IVDR Website info@linear.es EUDAMED record Report an error
Maccura EU representative : Humiss International B.V. (Netherlands) China A IVDR Website EUDAMED record Report an error
Seekxbio EU representative : GRZAN GROUP SL (Spain) China A IVDR EUDAMED record Report an error
Behnk Germany A IVDR Website regulatory@behnk.de 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
BotuAImaging Technology EU representative : Kingsmead Service B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Changchun Chenyu Taikang Medical Laboratory EU representative : MedPath GmbH (Germany) China A IVDR EUDAMED record Report an error
Dirui FDA EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
E-LAB Biological Science & Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China A IVDR EUDAMED record Report an error
Human Germany A IVDR Website EUDAMED record Report an error
Labitec Germany A IVDR EUDAMED record Report an error
Medcaptain FDA EU representative : R Sight B.V. (Netherlands) China A IVDR Website info@medcaptain.com EUDAMED record Report an error
Medconn FDA EU representative : JOYSUN GROUP S.L.U (Spain) China A IVDR EUDAMED record Report an error
Meril Diagnostics FDA EU representative : Obelis s.a. (Belgium) India A IVDR Website ram.kanoje@merillife.com EUDAMED record Report an error
Shenzhen New Industries Biomedical Engineering FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China A IVDR Website EUDAMED record Report an error
Siemens Healthcare Diagnostics Products FDA Germany A IVDR Website contact@siemens-healthineers.com EUDAMED record Report an error
Sistat Türkiye A IVDR Website info@sistat.com.tr EUDAMED record Report an error
Technoclone Austria A IVDR Website regulatory@technoclone.com EUDAMED record Report an error
TECO Medical Instruments, Production + Trading Germany A IVDR Website info@teco-medical.com EUDAMED record Report an error
Zonci EU representative : MedNet EC-REP GmbH (Germany) 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) 6

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
DIAGNOSTICA STAGO Present in Europe in other categories United States ST art® registered
Helena Laboratories United States Cascade M-4 (110V/220V) K931956 (1993)
BEMOTEC GmbH Germany – registered
Diamond Diagnostics Inc. Present in Europe in other categories United States – registered
Siemens Healthcare Diagnostics, Inc. Present in Europe in other categories United States – registered
Thermo Fisher Scientific Present in Europe in other categories United States – registered

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