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Emdyca

IVD instrumentsHematology / histology / cytology instruments

Blood grouping instruments

EMDN code W020203

19 manufacturers, 39 models including 39 on the market, 10 countries

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Manufacturers registered in Europe (EUDAMED) 19
  • 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
Translite FDA EU representative : E C REP LIMITED (Ireland) United States I 93/42 Website info@veinlite.com EUDAMED record Report an error
Grifols FDA Spain A IVDR regulatoryaffairs_dxbu@grifols.com EUDAMED record Report an error
Aikang MedTech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China A IVDR EUDAMED record Report an error
Haemokinesis EU representative : Compliance Management Solutions Europe LTD (Bulgaria) Australia A IVDR, 98/79 EUDAMED record Report an error
Immucor FDA EU representative : IMMUCOR Medizinische Diagnostik GmbH (Germany) Germany, United States A IVDR Website regulatoryimmucor@werfen.com EUDAMED record Report an error
Conlett EU representative : Lotus NL B.V. (Netherlands) China I MDR 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
Medical Devices EU representative : Obelis s.a. (Belgium) Pakistan I MDR Website EUDAMED record Report an error
Neotech Products FDA EU representative : Emergo Europe B.V. (Netherlands) United States I MDR Website ra@neotechproducts.com EUDAMED record Report an error
Ortho-Clinical Diagnostics Raritan EU representative : Ortho-Clinical Diagnostics France (France) United States A IVDR Website PRRC@quidelortho.com EUDAMED record Report an error
Tianjin Dexiang Biotechnology EU representative : Medunion S.L. (Spain) China A IVDR EUDAMED record Report an error
Wwhsbio EU representative : CMC Medical Devices & Drugs SL (Spain) China A IVDR Website info@wwhsbio.com EUDAMED record Report an error
Biosense EU representative : MD&D Alliance GmbH (Germany) India A IVDR regulatory.affairs@biosense.in EUDAMED record Report an error
BotuAImaging Technology EU representative : Kingsmead Service B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Diagast FDA France A IVDR Website contact@diagast.com EUDAMED record Report an error
Di̇a Pro Tibbi̇ Ürünler San. Ve Ti̇c. A.Ş Türkiye A IVDR EUDAMED record Report an error
International Biomedical FDA EU representative : Emergo Europe B.V. (Netherlands) United States I MDR Website regulatory@int-bio.com EUDAMED record Report an error
Ortho-Clinical Diagnostics FDA EU representative : Ortho-Clinical Diagnostics France (France) United Kingdom (ex Northern Ireland) A IVDR Website PRRC@quidelortho.com EUDAMED record Report an error
Suzhou Hokapi Biomedical Engineering EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China A IVDR 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
Bio-Rad Medical Diagnostics GmbH Present in Europe in other categories – MLB 2 IH-Card Neutral Alsevers Solution Bromelin for Erytype TANGO infinity IH-1000 registered
Eldon Biologicals A/S Present in Europe in other categories Denmark ELDON SCHOOL KIT SK 2511-30 ELDON SCHOOL KIT SKA 2521-25 ELDON SCHOOL KIT SKA 2511-30 ELDON HOME KIT HKA 2511-1 DOCTOR'S KIT DKS RhD-25 ELDON MILITARY KIT MKA 2521-25 registered
Welch Allyn, Inc. Present in Europe in other categories United States Welch Allyn, Inc. registered
Heine Optotechnik GmbH & Co. KG Present in Europe in other categories Germany FINOFF TRANSILLUMINATOR OPHTHALMIC EXAMINATION LAMP registered
Zumax Medical Co., LTD Present in Europe in other categories China zumax registered
Bernell – Bernell registered
DENTMATE TECHNOLOGY CO., LTD. Present in Europe in other categories Taiwan LUMINDEX registered
Amico Diagnostic Incorporated Present in Europe in other categories United States Amico Diagnostic Illuminator registered
BIOMEDICAL DATA SOLUTIONS LIMITED Present in Europe in other categories United Kingdom ORTHO CONNECT registered
FUJIREBIO INC. Present in Europe in other categories – Beckman Coulter PK CMV-PA System Beckman Coulter PK TP System registered
PRACTICON, INC. United States Lumindex 3 LED Transilluminator Standard 3mm Light Guide Lumindex 3 LED Transilluminator registered
VENOSCOPE, LLC United States Venoscope registered
BOUND TREE MEDICAL, LLC – Curaplex registered
FABINJECT INDUSTRIA E COMERCIO IMPORTACAO E EXPORTACAO LTDA Brazil VF1000LED Vein locator registered
FABINJECT LLC United States VF1000LED Vein locator registered
MICRO TYPING SYSTEMS, INC – MTS registered
Stihler Electronic GmbH Present in Europe in other categories Germany ASTODIA registered
U.S. OPHTHALMIC, L.L.C. United States EZ-TRI-3600 registered
Addent, Inc. United States – registered
Agilent Technologies, Inc. Present in Europe in other categories United States – registered
Apothecaries Sundries Mfg Pvt Ltd India – registered
BEMS Holdings, LLC United States – registered
Baxter Healthcare Corp Present in Europe in other categories United States – registered
Bio-Rad Present in Europe in other categories United States – registered
Bio-Rad Laboratories (Bio-Rad Services France) Present in Europe in other categories France – registered
CBR Enterprise Limited Hong Kong SAR China – registered
DiaMed GmbH (Bio-Rad Laboratories) Present in Europe in other categories Switzerland – registered
Diamond Diagnostics Inc. Present in Europe in other categories United States – registered
Fujirebio Diagnostics,Inc. Present in Europe in other categories United States – registered
I.C.LERCHER-Solutions GmbH Present in Europe in other categories Germany – registered
Ivy Technology United States – registered
MACK MOLDING COMPANY United States – registered
MEDIMAGING INTEGRATED SOLUTION INC. Present in Europe in other categories China – registered
NORTH EOS INDUSTRIES INC. Present in Europe in other categories Taiwan – registered
Neitz Instruments Company, Ltd. Present in Europe in other categories Japan – registered
Peak Medical Ltd. Israel – registered
QuidelOrtho Corporation United States – registered
STRATEC SE Present in Europe in other categories Germany – registered
Sanicure BV Netherlands – registered
Sylvan Corp. United States – K901309 (1990)
TEN COMFORT CORP. Taiwan – registered
Tecan U.S., Ltd. Present in Europe in other categories United States – registered
VINCENT MEDICAL MANUFACTURING CO., LTD. Hong Kong SAR China – registered
Vincent Medical(Dongguan)Technology Company Limited China – registered
Walsh Medical Devices, Inc. Canada – registered
Worldwide Supplies Limited Hong Kong SAR China – registered
XENOSYS CO., LTD. Present in Europe in other categories South Korea – registered

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