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IVD generic use consumables

IVD general use consumables devices - other accessories

EMDN code W0580

70 manufacturers, 303 models including 298 on the market, 19 countries

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Manufacturers registered in Europe (EUDAMED) 70
  • 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
ZytoVision FDA Germany
47 others
A IVDR Website info@zytovision.com EUDAMED record Report an error
Diamond Diagnostics FDA EU representative : Diamond Diagnostics Inc. Magyarországi Fióktelepe (Hungary) United States
42 others
A IVDR Website EUDAMED record Report an error
Hamilton FDA EU representative : Johner Medical GmbH (Germany) Switzerland
32 others
A IVDR Website Contact-PRRC.rob.ch@hamilton.ch EUDAMED record Report an error
Optimedical FDA EU representative : Emergo Europe B.V. (Netherlands) United States
12 others
– 98/79 Website EUDAMED record Report an error
VitalScientific FDA France
8 others
A IVDR Website support@vitalscientific.com EUDAMED record Report an error
Euroimmun FDA Germany
6 others
A IVDR Website info@euroimmun.de EUDAMED record Report an error
Hlb Panagene EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea
6 others
A IVDR Website EUDAMED record Report an error
Junocare EU representative : Humiss International B.V. (Netherlands) China
3 others
A IVDR Website EUDAMED record Report an error
Diatrust FDA EU representative : Wellkang Ltd (Northern Ireland) China
1 other
I, A IVDR, MDR EUDAMED record Report an error
Devyser Sweden A IVDR info@deyvser.com EUDAMED record Report an error
Sentinel FDA Italy A IVDR Website EUDAMED record Report an error
Bindingsite FDA EU representative : The Binding Site Ireland Limited (Ireland) United Kingdom (ex Northern Ireland)
1 other
A IVDR Website info@bindingsite.com EUDAMED record Report an error
Abbott FDA EU representative : Abbott GmbH (Germany) Ireland, United States A IVDR Website ratransfusionmedicine@abbott.com EUDAMED record Report an error
Haemokinesis EU representative : Compliance Management Solutions Europe LTD (Bulgaria) Australia A IVDR EUDAMED record Report an error
Horiba FDA France A IVDR EUDAMED record Report an error
Macherey-Nagel FDA Germany A IVDR Website sales@mn-net.com EUDAMED record Report an error
Merck Millipore Ireland A IVDR Website PRRC_Cork@merckgroup.com EUDAMED record Report an error
Sichuan Orienter Biotechnology EU representative : Share info GmbH (Germany) China A IVDR Website info@orienterglobal.com EUDAMED record Report an error
"Bio-Ksel" Poland A IVDR Website EUDAMED record Report an error
Arcdia Finland A IVDR Website office@arcdia.com EUDAMED record Report an error
bioMérieux FDA EU representative : bioMérieux SA (France) United States A IVDR EUDAMED record Report an error
Bioway EU representative : Sungo Cert GmbH (Germany) China A IVDR EUDAMED record Report an error
C-Luminary Biotechnology EU representative : Share info GmbH (Germany) China A IVDR EUDAMED record Report an error
Fischer ANalysen Instrumente FDA Germany A IVDR Website EUDAMED record Report an error
Leicabiosystems FDA EU representative : AR Experts B.V. (Netherlands) United Kingdom (ex Northern Ireland) A IVDR Website EUDAMED record Report an error
Nanjing Norman Biological Technology EU representative : Sungo Cert GmbH (Germany) China A IVDR EUDAMED record Report an error
Oxoid FDA EU representative : Thermo Fisher Diagnostics B.V. (Netherlands) United Kingdom (ex Northern Ireland) A IVDR Website EUDAMED record Report an error
Precision System Science FDA EU representative : Emergo Europe B.V. (Netherlands) Japan A IVDR service@pss.co.jp EUDAMED record Report an error
Qiagen FDA Germany A IVDR Website info@qiagen.com EUDAMED record Report an error
R-Biopharm FDA Germany A IVDR Website EUDAMED record Report an error
Sarstedt FDA Germany A IVDR Website EUDAMED record Report an error
Stratec FDA Austria A IVDR 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
Alere San Diego FDA EU representative : Abbott Rapid Dx International Limited (Ireland) United States A IVDR Website EUDAMED record Report an error
Alfresa Pharma FDA EU representative : Emergo Europe B.V. (Netherlands) Japan A IVDR EUDAMED record Report an error
Alifax FDA Italy A IVDR Website regulatory@alifax.com EUDAMED record Report an error
Alivedx EU representative : Emergo Europe B.V. (Netherlands) Switzerland A IVDR Website EUDAMED record Report an error
Arraytech Spain A IVDR Website EUDAMED record Report an error
Biodatacorp EU representative : mdi Europa GmbH (Germany) United States A IVDR Website customer.service@biodatacorp.com EUDAMED record Report an error
Biotype Germany A IVDR Website info@biotype.de EUDAMED record Report an error
CellPath FDA EU representative : Emergo Europe B.V. (Netherlands) United Kingdom (ex Northern Ireland) A IVDR Website info@cellpath.com EUDAMED record Report an error
Celltivity FDA EU representative : AR Experts B.V. (Netherlands) United States A IVDR Website info@celltivity.com EUDAMED record Report an error
Citotest FDA EU representative : Wellkang Ltd (Northern Ireland) China A IVDR Website info@citotest.com EUDAMED record Report an error
Fluxergy FDA EU representative : CMC Medical Devices & Drugs SL (Spain) United States A IVDR Website info@fluxergy.com EUDAMED record Report an error
Gold Standard Diagnostics FDA EU representative : Emergo Europe B.V. (Netherlands) United States A IVDR Website EUDAMED record Report an error
Hunan Ehome Health Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China A IVDR EUDAMED record Report an error
inno-train Diagnostik Germany A IVDR Website info@inno-train.de EUDAMED record Report an error
Jadesci EU representative : Obelis s.a. (Belgium) United States A IVDR Website customerservice@jadesci.com EUDAMED record Report an error
Jiangsu Comeon Medical Apparatus EU representative : Sungo Cert GmbH (Germany) China A IVDR EUDAMED record Report an error
Jiangsu CoWin Biotech EU representative : CMC Medical Devices & Drugs SL (Spain) China A IVDR EUDAMED record Report an error
Jiangsu Kangjie Medical Devices EU representative : SUNGO Europe B.V. (Netherlands) China I MDR EUDAMED record Report an error
Jokoh EU representative : MDSS GmbH (Germany) Japan A IVDR Website EUDAMED record Report an error
Life Technologies EU representative : Life Technologies Europe B.V. (Netherlands) United States A IVDR EUDAMED record Report an error
MA-COM d.o.o.Stolac EU representative : Advena Limited (Malta) Bosnia & Herzegovina A IVDR Website info@ma-com.net EUDAMED record Report an error
magtivio Netherlands A IVDR info@magtivio.com EUDAMED record Report an error
Marfour Poland A IVDR Website info@marfour.com.pl EUDAMED record Report an error
Medconn FDA EU representative : Kingsmead Service B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Medtronic FDA EU representative : Medtronic B.V. (Netherlands) United States A IVDR EUDAMED record Report an error
Micropointbio EU representative : Obelis s.a. (Belgium) China A IVDR Website EUDAMED record Report an error
Oxford Immunotec FDA EU representative : Wallac Oy (Finland) United Kingdom (ex Northern Ireland) A IVDR regulatory.oxford@revvity.com EUDAMED record Report an error
QuinTron Instrument FDA EU representative : Emergo Europe B.V. (Netherlands) United States A IVDR Website regulatory@quintron-usa.com EUDAMED record Report an error
Randox FDA Northern Ireland A IVDR Website EUDAMED record Report an error
Remel FDA EU representative : Thermo Fisher Diagnostics B.V. (Netherlands) United States A IVDR Website EUDAMED record Report an error
Remel Europe FDA EU representative : Thermo Fisher Diagnostics B.V. (Netherlands) United Kingdom (ex Northern Ireland) A IVDR Website EUDAMED record Report an error
Richard-Allan Scientific EU representative : Epredia Netherlands B.V. (Netherlands) United States A IVDR EUDAMED record Report an error
SD Biosensor FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea A IVDR Website EUDAMED record Report an error
Streck FDA EU representative : MediMark Europe Sarl. (France) United States A IVDR Website EUDAMED record Report an error
Viramed FDA Germany A IVDR Website EUDAMED record Report an error
Vircell Spain A IVDR 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

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) 12

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
Bedfont Scientific, Ltd. Present in Europe in other categories United Kingdom Gastrolyzer registered
HOME AIDE DIAGNOSTICS, INC. – Pure Comfort Breath Exerciser registered
ALACER INDUSTRIA ELETRONICA LTDA Brazil – registered
FoodMarble Digestive Health Limited Ireland – registered
HUWANT Corp. South Korea – registered
MD Diagnostics Limited Present in Europe in other categories United Kingdom – registered
Mainline Medical Dental Supply Canada – registered
Owlstone Medical Ltd United Kingdom – registered
Qi Diagnostics Limited China – registered
Rayco Electronic Ltd. Hong Kong SAR China – registered
Sentech Korea Corp South Korea – registered
ZHEJIANG MEDIUNION HEALTHCARE GROUP CO.,LTD China – registered

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