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Emdyca

IVD instruments

Chemistry / immunochemistry instruments

EMDN code W0201

337 manufacturers, 1,484 models including 1,456 on the market, 33 countries

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Manufacturers registered in Europe (EUDAMED) 337
  • 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
OSANG Healthcare FDA EU representative : Obelis s.a. (Belgium) South Korea
39 others
 A, C IVDR, 98/79 Website EUDAMED record Report an error
Dirui FDA EU representative : Emergo Europe B.V. (Netherlands) and 1 other China
32 others
 A, B IVDR, 98/79 EUDAMED record Report an error
Vivachek FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
31 others
 A IVDR, 98/79 info@vivachek.com EUDAMED record Report an error
Lifescan FDA EU representative : LifeScan Deutschland GmbH (Germany) Switzerland
29 others
 – 98/79 info@lifescan.ch EUDAMED record Report an error
Rayto EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
25 others
 A IVDR Website support@rayto.com EUDAMED record Report an error
Taidoc FDA EU representative : MedNet EC-REP GmbH (Germany) Taiwan
22 others
 – 98/79 Website sales@taidoc.com EUDAMED record Report an error
Arkray FDA EU representative : ARKRAY Europe, B.V. (Netherlands) Japan
25 others
 A IVDR, 98/79 support_arkrayeurope@arkray.co.jp EUDAMED record Report an error
YASEE BioMedical FDA EU representative : Prolinx GmbH (Germany) China
20 others
 – 98/79 EUDAMED record Report an error
Beckman Coulter FDA EU representative : Beckman Coulter Ireland Inc. (Ireland) Ireland, Japan, United States
16 others
 A IVDR, 98/79 Website ra.clare@beckman.com EUDAMED record Report an error
Biohermes FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China
15 others
 – 98/79 EUDAMED record Report an error
Zybio FDA EU representative : Lotus NL B.V. (Netherlands) China
15 others
 A IVDR, 98/79 PMS@zy-ivd.com EUDAMED record Report an error
77 Elektronika Műszeripari Kft Hungary
14 others
 A, C IVDR, 98/79 Website EUDAMED record Report an error
Boditech FDA EU representative : Obelis s.a. (Belgium) South Korea
14 others
 A IVDR Website marketing@boditech.co.kr EUDAMED record Report an error
Hangzhou Alltest Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other China
13 others
 A IVDR, 98/79 info@alltests.com.cn EUDAMED record Report an error
Human Germany
13 others
 A IVDR Website EUDAMED record Report an error
Biotecnica Italy
13 others
 A IVDR EUDAMED record Report an error
Increcare FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
11 others
 A IVDR EUDAMED record Report an error
Lifotronic FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) and 1 other China
11 others
 A IVDR, 98/79 Website EUDAMED record Report an error
Mindray FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
11 others
 A, B, C IVDR Website EUDAMED record Report an error
Seamaty EU representative : MedNet EC-REP GmbH (Germany) China
11 others
 A IVDR EUDAMED record Report an error
Siemens Healthcare Diagnostics FDA EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland) United States
11 others
 A, B IVDR Website contact@siemens-healthineers.com EUDAMED record Report an error
Aconbio EU representative : MedNet EC-REP GmbH (Germany) China
10 others
 A, C IVDR, 98/79 Website EUDAMED record Report an error
Epsbio FDA EU representative : Obelis s.a. (Belgium) Taiwan
9 others
 C IVDR, 98/79 Website info@epsbio.com.tw EUDAMED record Report an error
Hitachi High-Tech FDA EU representative : Roche Diagnostics GmbH (Germany) Japan
9 others
 A IVDR ra-contact.aj@hitachi-hightech.com EUDAMED record Report an error
Immundiagnostik FDA Germany
8 others
 A IVDR, 98/79 Website info@immundiagnostik.com EUDAMED record Report an error
Sejoy FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
8 others
 – 98/79 Website EUDAMED record Report an error
Cofoe FDA EU representative : SUNGO Europe B.V. (Netherlands) China
7 others
 C IVDR, 98/79 Website EUDAMED record Report an error
Illumaxbio EU representative : MedNet EC-REP GmbH (Germany) China
7 others
 A IVDR Website EUDAMED record Report an error
Infitek FDA EU representative : Kingsmead Service B.V. (Netherlands) and 1 other China
7 others
 A IVDR info@infitek.com EUDAMED record Report an error
Urit FDA EU representative : Medunion S.L. (Spain) and 1 other China
7 others
 A, B IVDR, 98/79 Website service@uritest.com EUDAMED record Report an error
Biochemical Systems International Italy
6 others
 – 98/79 Website EUDAMED record Report an error
Euroimmun FDA Germany
6 others
 A IVDR Website info@euroimmun.de EUDAMED record Report an error
Genrui Biotech FDA EU representative : Lotus NL B.V. (Netherlands) China
6 others
 A IVDR, 98/79 Website service@genrui-bio.com EUDAMED record Report an error
Sinocare FDA EU representative : SUNGO Europe B.V. (Netherlands) and 1 other China
6 others
 B, C IVDR, 98/79 RA@sinocare.com EUDAMED record Report an error
Erba Czechia
5 others
 A, B IVDR Website EUDAMED record Report an error
Maccura EU representative : Humiss International B.V. (Netherlands) China
5 others
 A, B IVDR, 98/79 Website EUDAMED record Report an error
Senlo EU representative : Umedwings Netherlands B.V. (Netherlands) China
5 others
 A IVDR Website sales@senlo.com.cn EUDAMED record Report an error
Tysonbio FDA EU representative : MDSS GmbH (Germany) Taiwan
5 others
 – 98/79 EUDAMED record Report an error
Ascensia FDA EU representative : Ascensia Diabetes Care Italy Srl (Italy) Switzerland
5 others
 C IVDR, 98/79 Website EUDAMED-info@ascensia.com EUDAMED record Report an error
Acro Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) United States
4 others
 A IVDR info@acrobiotech.com EUDAMED record Report an error
Biobase FDA EU representative : Luxus Lebenswelt GmbH (Germany) China
4 others
 A IVDR EUDAMED record Report an error
Eschweiler Germany
4 others
 – 98/79 Website info@eschweiler-kiel.de EUDAMED record Report an error
Furuno FDA EU representative : MedEnvoy Global BV (Netherlands) Japan
4 others
 A IVDR Website EUDAMED record Report an error
Keyubio EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
4 others
 A IVDR, 98/79 Website export@keyubio.com EUDAMED record Report an error
Linear FDA Spain
4 others
 A IVDR Website info@linear.es EUDAMED record Report an error
Abbott FDA EU representative : Abbott B.V. (Netherlands) and 2 others United Kingdom (ex Northern Ireland), United States
3 others
 A IVDR Website EUDAMED record Report an error
BioFynder EU representative : SUNGO Europe B.V. (Netherlands) United Kingdom (ex Northern Ireland)
3 others
 A IVDR EUDAMED record Report an error
Bioland FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
3 others
 C IVDR, 98/79 EUDAMED record Report an error
Instrumentation Laboratory FDA Italy
3 others
 A IVDR Website EUDAMED record Report an error
Medconn FDA EU representative : JOYSUN GROUP S.L.U (Spain) and 1 other China
3 others
 A IVDR EUDAMED record Report an error
Rapid Labs EU representative : Advena Limited (Malta) and 1 other United Kingdom (ex Northern Ireland)
3 others
 A IVDR Website info@rapidlabs.co.uk EUDAMED record Report an error
Seleo Italy
3 others
 – 98/79 Website EUDAMED record Report an error
Shenzhen Yhlo Biotech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
3 others
 A IVDR Website info@szyhlo.com EUDAMED record Report an error
Sysmex FDA EU representative : Sysmex Europe SE (Germany) Japan
3 others
 A IVDR, 98/79 ra_archive@sysmex.co.jp EUDAMED record Report an error
Autobio FDA EU representative : Obelis s.a. (Belgium) China
2 others
 A IVDR Website EUDAMED record Report an error
Cormay Poland
2 others
 A IVDR regulatory_affairs@cormay.com EUDAMED record Report an error
Cornley EU representative : Caretechion GmbH (Germany) and 1 other China
2 others
 A IVDR, 98/79 Website sales@cornley.com EUDAMED record Report an error
DAS Italy
2 others
 A IVDR Website quality@dasitaly.com EUDAMED record Report an error
Jiangxi Aicare Medical Technology FDA EU representative : Caretechion GmbH (Germany) China
2 others
 – 98/79 Website EUDAMED record Report an error
Monobind FDA EU representative : AR Experts B.V. (Netherlands) United States
2 others
 A IVDR Website info@monobind.com EUDAMED record Report an error
sebia FDA France
2 others
 A IVDR Website EUDAMED record Report an error
General Life Biotechnology FDA EU representative : MDSS GmbH (Germany) Taiwan
3 others
 – 98/79 Website service@glbiotech.com.tw EUDAMED record Report an error
Acesolab FDA EU representative : VidaQuick Biotech S.L. (Spain) United States
1 other
 A IVDR info@acesolab.com EUDAMED record Report an error
Aichek FDA EU representative : SUNGO Europe B.V. (Netherlands) China
1 other
 A IVDR ra.rep@aichek.com EUDAMED record Report an error
Dynodx EU representative : HUMISS TRADING S. L. (Spain) China
1 other
 – 98/79 EUDAMED record Report an error
E-LAB Biological Science & Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China
1 other
 A IVDR EUDAMED record Report an error
Eaglenos FDA EU representative : MedPath GmbH (Germany) China
1 other
 A IVDR EUDAMED record Report an error
Ortho-Clinical Diagnostics Rochester EU representative : Ortho-Clinical Diagnostics France (France) United States
1 other
 A IVDR Website PRRC@quidelortho.com EUDAMED record Report an error
Ukinbio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China
1 other
 A IVDR, 98/79 sales@ukinbio.com EUDAMED record Report an error
Addcare FDA EU representative : Lepu Medical (Europe) Cooperatief U.A. (Netherlands) China A IVDR Website sales@addcare.cn 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
Beijing Lepu Medical Technology EU representative : Lepu Medical (Europe) Cooperatief U.A. (Netherlands) China A IVDR, 98/79 EUDAMED record Report an error
bioMérieux FDA France A IVDR, 98/79 EUDAMED record Report an error
DFI FDA EU representative : MDSS GmbH (Germany) South Korea A IVDR, 98/79 EUDAMED record Report an error
Foracare FDA EU representative : MedNet EC-REP GmbH (Germany) Switzerland – 98/79 Website EUDAMED record Report an error
GC Medical Science EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea A IVDR, 98/79 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
i-SENS FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea A, C IVDR Website regulatory@i-sens.com EUDAMED record Report an error
I.S.E. - Societa' A Responsabilita' Limitata - Sistemi Intelligenti Elettronici Italy A IVDR Website info@logotech-ise.com EUDAMED record Report an error
Inova Diagnostics FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) United States A IVDR Website EUDAMED record Report an error
Instrumentation Laboratory FDA EU representative : Instrumentation Laboratory SpA (Italy) United States A IVDR Website Regulatory@werfen.com EUDAMED record Report an error
Lordsmark EU representative : Obelis s.a. (Belgium) India 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
Newlink Biotech EU representative : VidaQuick Biotech S.L. (Spain) China A IVDR Website info@kylinew.com EUDAMED record Report an error
Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China A IVDR EUDAMED record Report an error
Pushkang EU representative : Sungo Cert GmbH (Germany) China A IVDR EUDAMED record Report an error
Ral Tecnica Para El Laboratorio Spain A IVDR Website EUDAMED record Report an error
Randox FDA Northern Ireland A IVDR Website 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
Sophonix EU representative : CMC Medical Devices & Drugs SL (Spain) China A IVDR EUDAMED record Report an error
Wesailbio EU representative : Lotus NL B.V. (Netherlands) and 1 other China A IVDR EUDAMED record Report an error
YD Diagnostics FDA EU representative : CARE diagnostica Laborreagenzien GmbH (Germany) and 1 other South Korea A IVDR, 98/79 Website admin@yd-diagnostics.com EUDAMED record Report an error
Assure Tech. (Hangzhou) EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China C IVDR, 98/79 Website contact@diareagent.com EUDAMED record Report an error
B&E Bio-Technology FDA EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR, 98/79 EUDAMED record Report an error
Biolabo France A IVDR support@biolabo.fr EUDAMED record Report an error
Biosystems FDA Spain A IVDR Website EUDAMED record Report an error
Contecmed FDA EU representative : Prolinx GmbH (Germany) China A, C IVDR Website pms.qms@contecmed.com EUDAMED record Report an error
Diamond Diagnostics FDA EU representative : Diamond Diagnostics Inc. Magyarországi Fióktelepe (Hungary) United States A IVDR Website EUDAMED record Report an error
DiaSorin FDA Italy A IVDR Website EUDAMED record Report an error
Edan FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China A IVDR, 98/79 EUDAMED record Report an error
Getein FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China A IVDR EUDAMED record Report an error
Goldsite EU representative : CMC Medical Devices & Drugs SL (Spain) China A IVDR Website export@goldsite.com.cn EUDAMED record Report an error
Helena Biosciences Europe FDA EU representative : Advena Limited (Malta) United Kingdom (ex Northern Ireland) A IVDR Website EUDAMED record Report an error
Meril Diagnostics FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other India A IVDR Website ram.kanoje@merillife.com EUDAMED record Report an error
opTricon Germany A IVDR Website info@optricon.de EUDAMED record Report an error
Orgentec Germany A IVDR Website EUDAMED record Report an error
R-Biopharm FDA Germany A IVDR Website EUDAMED record Report an error
Riele Germany A IVDR Website info@riele.de EUDAMED record Report an error
SD Biosensor FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea A IVDR, 98/79 Website EUDAMED record Report an error
Vazyme EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) and 1 other China A IVDR EUDAMED record Report an error
Wallac Finland A IVDR Website regulatoryaffairs.turku@revvity.com 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
ZOVEC diagnostics Germany – 98/79 Website EUDAMED record Report an error
Gc Medis EU representative : Obelis s.a. (Belgium) South Korea
1 other
 – 98/79 Website EUDAMED record Report an error
Hmdbio FDA EU representative : Luana Med. B.V. (Netherlands) Taiwan – 98/79 Website EUDAMED record Report an error
Anbio EU representative : Lotus NL B.V. (Netherlands) and 1 other China A IVDR, 98/79 info@anbio.com EUDAMED record Report an error
Aucheer EU representative : MedPath GmbH (Germany) China A IVDR info_office@aucheer.net EUDAMED record Report an error
B.P.C. Biosed – Italy A IVDR Website info@bpcbiosed.it EUDAMED record Report an error
Celnovte EU representative : Umedwings Netherlands B.V. (Netherlands) China A IVDR EUDAMED record Report an error
D-tek Belgium A IVDR Website EUDAMED record Report an error
Drophil EU representative : MedNet EC-REP GmbH (Germany) China A IVDR info@drophil.com EUDAMED record Report an error
Dynex Technologies FDA EU representative : Acorn Regulatory Consultancy Services Ltd (Ireland) United States A IVDR Website EUDAMED record Report an error
Empecs FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China, South Korea A IVDR, 98/79 EUDAMED record Report an error
Fujifilm FDA EU representative : FUJIFILM Healthcare Europe GmbH (Germany) Japan A IVDR EUDAMED record Report an error
GB Lifecare EU representative : Obelis s.a. (Belgium) South Korea C IVDR Website EUDAMED record Report an error
Genobio Pharmaceutical FDA EU representative : Lotus NL B.V. (Netherlands) China A IVDR Website marketing@era-bio.com EUDAMED record Report an error
Guilin Royalyze Medical Instrument EU representative : Caretechion GmbH (Germany) China – 98/79 EUDAMED record Report an error
Immunodiagnostic Systems FDA EU representative : Immunodiagnostic Systems SA (Belgium) United Kingdom (ex Northern Ireland) A IVDR Website EUDAMED record Report an error
Jiezibio EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR, 98/79 EUDAMED record Report an error
Kangrun EU representative : Sungo Cert GmbH (Germany) China A IVDR EUDAMED record Report an error
Labnovation EU representative : MedNet EC-REP GmbH (Germany) China A IVDR Website info@labnovation.com EUDAMED record Report an error
Macherey-Nagel FDA Germany A IVDR Website sales@mn-net.com EUDAMED record Report an error
Sanymed Italy A IVDR Website info@sanymed.it EUDAMED record Report an error
Shanghai Kehua Laboratory System FDA EU representative : Obelis s.a. (Belgium) China A IVDR Website EUDAMED record Report an error
Shenzhen Tailaored Medical EU representative : Lotus NL B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Shimadzu FDA EU representative : Shimadzu Europa GmbH (Germany) Japan A IVDR, 98/79 Website EUDAMED record Report an error
Sichuan Orienter Biotechnology EU representative : Lotus NL B.V. (Netherlands) and 1 other China A IVDR Website info@orienterglobal.com EUDAMED record Report an error
Siemens Healthcare Diagnostics Products FDA EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland) Germany, United Kingdom (ex Northern Ireland) A IVDR Website contact@siemens-healthineers.com EUDAMED record Report an error
Sinseng EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) and 1 other China A IVDR service@sinseng.com.cn EUDAMED record Report an error
Sugentech FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea A, B IVDR ra@sugentech.com EUDAMED record Report an error
Swiscare Technology EU representative : MedNet EC-REP GmbH (Germany) Taiwan – 98/79 EUDAMED record Report an error
VitalScientific FDA Netherlands A IVDR Website EUDAMED record Report an error
Ailex EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China A IVDR EUDAMED record Report an error
Abaxis FDA EU representative : ABAXIS Europe GmbH (Germany) United States A IVDR Website EUDAMED record Report an error
Accucise EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China A IVDR sales@accucise.cn EUDAMED record Report an error
Adaltis Italy – 98/79 Website info@adaltis.net EUDAMED record Report an error
Agilent FDA EU representative : Agilent Technologies Denmark ApS (Denmark) Singapore A IVDR Website info.dk@agilent.com EUDAMED record Report an error
Aidian FDA Finland A IVDR Website eudamed@aidian.eu EUDAMED record Report an error
AVE Science & Technology FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China – 98/79 EUDAMED record Report an error
Bindingsite FDA EU representative : The Binding Site Ireland Limited (Ireland) United Kingdom (ex Northern Ireland) A IVDR Website info@bindingsite.com EUDAMED record Report an error
Bioendo EU representative : JOYSUN GROUP S.L.U (Spain) China A IVDR sale@bioendo.com EUDAMED record Report an error
Biomaxima Poland A IVDR Website info@biomaxima.com EUDAMED record Report an error
Bioway EU representative : Sungo Cert GmbH (Germany) China A IVDR EUDAMED record Report an error
B·R·A·H·M·S FDA Germany A IVDR EUDAMED record Report an error
Cesna Türkiye A IVDR Website info@cesna.com.tr EUDAMED record Report an error
Citest Diagnostics EU representative : VidaQuick Biotech S.L. (Spain) Canada A IVDR ra02@citestdiagnostics.com EUDAMED record Report an error
Diagnostics Belgium A IVDR Website EUDAMED record Report an error
Diapro Italy A IVDR Website info@diapro.it EUDAMED record Report an error
Diasia FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China A IVDR Website EUDAMED record Report an error
Diatron FDA Hungary A IVDR Website EUDAMED record Report an error
e-LinkCare Meditech FDA EU representative : Wellkang Ltd (Northern Ireland) China – 98/79 EUDAMED record Report an error
Futurlab Italy A IVDR Website EUDAMED record Report an error
Gmt Sarl France A IVDR Website EUDAMED record Report an error
Hangzhou Aokai Biotech EU representative : JOYSUN GROUP S.L.U (Spain) China A IVDR info@aokais.com.cn EUDAMED record Report an error
High Technology FDA EU representative : MedEnvoy Global BV (Netherlands) United States A IVDR Website EUDAMED record Report an error
Hipro FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China A IVDR EUDAMED record Report an error
Hivis Medical Technology EU representative : Sungo Cert GmbH (Germany) China A IVDR, 98/79 EUDAMED record Report an error
Horiba FDA France A IVDR EUDAMED record Report an error
Icarbonx EU representative : Kingsmead Service B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Labsystems Diagnostics FDA Finland A IVDR Website EUDAMED record Report an error
Leadmanbio EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China A IVDR EUDAMED record Report an error
Lysunbio FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 EUDAMED record Report an error
MacroArray Diagnostics Austria A IVDR Website office@madx.com 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
Mr International Healthcare Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China A IVDR EUDAMED record Report an error
Nano Diagnosis for Health Biotech (Guangzhou) EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China A IVDR EUDAMED record Report an error
Optimedical FDA EU representative : Emergo Europe B.V. (Netherlands) United States A IVDR Website EUDAMED record Report an error
Otsukael FDA EU representative : Emergo Europe B.V. (Netherlands) Japan A IVDR Website EUDAMED record Report an error
Poweam EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Protia EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea A IVDR EUDAMED record Report an error
Radiometer FDA Denmark A IVDR Website radiometerra_eu@radiometer.dk EUDAMED record Report an error
Reetoo EU representative : Umedwings Netherlands B.V. (Netherlands) China A IVDR, 98/79 Website service@reetoo.com.cn EUDAMED record Report an error
Scienco Technology EU representative : CMC Medical Devices & Drugs SL (Spain) Taiwan – 98/79 Website EUDAMED record Report an error
Shandong Bohong Gene Technology EU representative : Luxus Lebenswelt GmbH (Germany) China A IVDR EUDAMED record Report an error
Shenzhen Dake Medical Technology EU representative : HyperCert Limited B.V. (Netherlands) and 1 other China A IVDR EUDAMED record Report an error
Shenzhen Drawray Biotech EU representative : Lotus NL B.V. (Netherlands) China A IVDR Website info@szdrawray.com EUDAMED record Report an error
Shenzhen Zijian Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain) China A IVDR Website sales@szzijian.com EUDAMED record Report an error
Shinjin Medics EU representative : Obelis s.a. (Belgium) South Korea A IVDR Website EUDAMED record Report an error
Skyla EU representative : Medical Technology Promedt Consulting GmbH (Germany) Taiwan A IVDR Website EUDAMED record Report an error
Spinreact Spain A IVDR Website EUDAMED record Report an error
SSI Diagnostica FDA Denmark A IVDR, 98/79 Website info@ssidiagnostica.com EUDAMED record Report an error
Stratec FDA Germany A IVDR Website info@stratec.com EUDAMED record Report an error
Strumed FDA EU representative : Amstermed B.V. (Netherlands) India – 98/79 Website EUDAMED record Report an error
Sunlant EU representative : MedPath GmbH (Germany) China 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
Taizhou Zecen Biotech EU representative : MedPath GmbH (Germany) China A IVDR EUDAMED record Report an error
Terumo FDA EU representative : TERUMO EUROPE N.V. (Belgium) Japan – 98/79 Eudamed_LAA@terumo.co.jp EUDAMED record Report an error
TestCard EU representative : CS Life Sciences Europe Ltd (Ireland) United Kingdom (ex Northern Ireland) A IVDR Website info@testcard.com EUDAMED record Report an error
Thermofisher FDA Finland A IVDR Website EUDAMED record Report an error
Wuhan BGI Biomedical Engineering EU representative : MedPath GmbH (Germany) China A IVDR EUDAMED record Report an error
Zhongshan Ruifu Medical Equipment Technology EU representative : Medunion S.L. (Spain) China A IVDR ra@refmedical.net EUDAMED record Report an error
Tosoh FDA EU representative : Tosoh Europe N.V. (Belgium) Japan A IVDR, 98/79 csc@tosoh.co.jp 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
77 Elektronika Műszeripari Korlátolt Felelősségű Társaság Hungary IIa MDR Website EUDAMED record Report an error
Abionic FDA EU representative : Veranex Germany GmbH (Germany) Switzerland A IVDR Website info@abionic.com EUDAMED record Report an error
Abiores Technology (Beijing) EU representative : Wellkang Ltd (Northern Ireland) China – 98/79 EUDAMED record Report an error
Absology EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea A IVDR EUDAMED record Report an error
Accriva Diagnostics FDA EU representative : MDSS GmbH (Germany) United States – 98/79 Website EUDAMED record Report an error
Actest EU representative : VidaQuick Biotech S.L. (Spain) China A IVDR info@actest.com.cn EUDAMED record Report an error
Aehealth EU representative : MedNet EC-REP GmbH (Germany) China – 98/79 sales@aehealth.com.cn EUDAMED record Report an error
Agnitio Science &Technology EU representative : CMC Medical Devices & Drugs SL (Spain) Taiwan A IVDR Website contact.us@agnitiost.com EUDAMED record Report an error
Aikang Diagnostics EU representative : MedNet EC-REP GmbH (Germany) China A IVDR marketing@aikang-medical.com EUDAMED record Report an error
Apel EU representative : Medical Technology Promedt Consulting GmbH (Germany) Japan A IVDR Website sales@apel.co.jp EUDAMED record Report an error
Apexbio FDA EU representative : Obelis s.a. (Belgium) Taiwan A IVDR info@apexbio.com EUDAMED record Report an error
Apollo FDA EU representative : Emergo Europe B.V. (Netherlands) Taiwan A IVDR Website info@apollo.bio EUDAMED record Report an error
Athenesedx EU representative : Obelis s.a. (Belgium) India A IVDR Website EUDAMED record Report an error
Atlas Medical FDA Germany – 98/79 Website info@atlas-medical.com EUDAMED record Report an error
Avecon Healthcare EU representative : Amstermed B.V. (Netherlands) India A IVDR Website EUDAMED record Report an error
Becton Dickinson FDA EU representative : Becton Dickinson Ireland Limited (Ireland) United States A IVDR Website EUDAMED record Report an error
Beijing North Institute of Biotechnology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China A IVDR EUDAMED record Report an error
Bgi Denmark A IVDR Website EUDAMED record Report an error
Bio-Novum Poland A IVDR Website EUDAMED record Report an error
Bioantibody Biotechnology EU representative : Medunion S.L. (Spain) China A IVDR EUDAMED record Report an error
Biobase Biogrand EU representative : Luxus Lebenswelt GmbH (Germany) China A IVDR EUDAMED record Report an error
Biobase Diagnostic Technology (Shandong) EU representative : Luxus Lebenswelt GmbH (Germany) China A IVDR EUDAMED record Report an error
BioChain (Beijing) Science & Technology EU representative : Medunion S.L. (Spain) China A IVDR EUDAMED record Report an error
Biolis Medical FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) Japan A IVDR Website EUDAMED record Report an error
biomed Dr. Wieser Austria A IVDR Website office@biomed-technics.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
Blusense Diagnostics Aps Denmark A IVDR Website info@blusense-diagnostics.com EUDAMED record Report an error
Bosonbio FDA EU representative : MedPath GmbH (Germany) China A IVDR Website EUDAMED record Report an error
Bosurebio EU representative : Lotus NL B.V. (Netherlands) China – 98/79 Website info@bosurebio.com.cn EUDAMED record Report an error
Callegari Italy A IVDR EUDAMED record Report an error
Careforu EU representative : Meridius Medical Europe Limited (Ireland) South Korea – 98/79 Website sales@careforu.co.kr EUDAMED record Report an error
Cavanbio EU representative : HyperCert Limited B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Changsha Contec Yixin Biotechnology EU representative : Lotus NL B.V. (Netherlands) China C IVDR EUDAMED record Report an error
Diagreat EU representative : Medunion S.L. (Spain) China A IVDR Website info@diagreat.com EUDAMED record Report an error
Dialab Austria A IVDR Website office@dialab.at EUDAMED record Report an error
Diesse FDA Italy A IVDR Website EUDAMED record Report an error
Doasense Germany A IVDR Website info@doasense.de EUDAMED record Report an error
Draeger FDA Germany – 98/79 Website EUDAMED@draeger.com EUDAMED record Report an error
Dymind EU representative : Eunitor GmbH (Germany) China A IVDR regulationdept@dymind.com EUDAMED record Report an error
Dynex Czechia A IVDR Website EUDAMED record Report an error
Eiken FDA EU representative : Advena Limited (Malta) Japan A IVDR regulatoryaffairs@eiken.co.jp EUDAMED record Report an error
Elitbiotech EU representative : CMC Medical Devices & Drugs SL (Spain) China A IVDR EUDAMED record Report an error
ElitechGroup FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) United States – 98/79 Website info@elitechgroup.com EUDAMED record Report an error
Epocal FDA EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland) Canada A IVDR Website contact@siemens-healthineers.com EUDAMED record Report an error
Eurolyser Austria A IVDR Website EUDAMED record Report an error
Eurospital FDA Italy A IVDR regulatory@eurospital.it EUDAMED record Report an error
EXIAS Medical Austria A IVDR Website office@exias-medical.com EUDAMED record Report an error
Funotec EU representative : GRZAN GROUP SL (Spain) China A IVDR EUDAMED record Report an error
GenBody FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea C IVDR EUDAMED record Report an error
General Biologicals EU representative : Medical Technology Promedt Consulting GmbH (Germany) Taiwan A IVDR sales.group@gbc.com.tw EUDAMED record Report an error
Ginevri Italy A IVDR Website mail@ginevri.com EUDAMED record Report an error
Guangzhou KOFA Biotechnology EU representative : Medunion S.L. (Spain) China A IVDR EUDAMED record Report an error
Guangzhou LBP Medicine Science & Technology EU representative : Kingsmead Service B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Guangzhou Yunrui Medical Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China I MDR EUDAMED record Report an error
Hangzhou Zheda Dixun Biological Gene Engineering EU representative : CMC Medical Devices & Drugs SL (Spain) China A IVDR EUDAMED record Report an error
Healthy FDA EU representative : AR Experts B.V. (Netherlands) Israel – 98/79 Website EUDAMED record Report an error
Hebei Sanxin Pharmaceutical Technology EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Hidex Finland A IVDR Website EUDAMED record Report an error
Humadx EU representative : Human Gesellschaft für Biochemica und Diagnostica mbH (Germany) China A IVDR service@humadx.com.cn EUDAMED record Report an error
Hunan Drawray Biotech EU representative : Lotus NL B.V. (Netherlands) China A IVDR info@szdrawray.com EUDAMED record Report an error
Hycor Biomedical FDA EU representative : Advena Limited (Malta) United States A IVDR Website info@hycorbiomedical.com EUDAMED record Report an error
Iki France A IVDR contact@iki-diag.com EUDAMED record Report an error
ImmunoDiagnostic Systems France FDA France A IVDR Website EUDAMED record Report an error
Interlab Italy A IVDR Website EUDAMED record Report an error
Jeol Mf EU representative : JEOL(Europe)BV AR (Netherlands) Japan A IVDR EUDAMED record Report an error
Jiangsu Jinzhun Biotech EU representative : MedNet EC-REP GmbH (Germany) China A IVDR EUDAMED record Report an error
Jiangsu Macro & Micro-Test Med-Tech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China A IVDR marketing@hongweitest.com EUDAMED record Report an error
Joinstar EU representative : Lotus NL B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Jokoh EU representative : MDSS GmbH (Germany) Japan A IVDR Website EUDAMED record Report an error
JS Medicina Electrónica EU representative : CMC Medical Devices & Drugs SL (Spain) Argentina A IVDR Website info@diestroweb.com EUDAMED record Report an error
Keylights EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Konsung FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China A IVDR EUDAMED record Report an error
Leisonbio EU representative : MedNet EC-REP GmbH (Germany) Taiwan – 98/79 Website service@leisonbio.com EUDAMED record Report an error
Lituo EU representative : CMC Medical Devices & Drugs SL (Spain) China A IVDR EUDAMED record Report an error
Locmedt EU representative : Lotus NL B.V. (Netherlands) China A IVDR EUDAMED record Report an error
MDX Netherlands Diagnostics EU representative : SUNGO Europe B.V. (Netherlands) Philippines A IVDR EUDAMED record Report an error
Medicacorp EU representative : Emergo Europe B.V. (Netherlands) United States B IVDR Website EUDAMED record Report an error
Medical FDA EU representative : Obelis s.a. (Belgium) Japan A IVDR Website EUDAMED record Report an error
Mpbio FDA Germany A IVDR Website EUDAMED record Report an error
MTD Diagnostics Italy – 98/79 Website EUDAMED record Report an error
nal von minden Germany A IVDR Website info@nal-vonminden.com EUDAMED record Report an error
NanoEntek FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea A IVDR Website eudamed@nanoentek.com EUDAMED record Report an error
Neomedica EU representative : Wellkang Ltd (Northern Ireland) Serbia A IVDR Website EUDAMED record Report an error
Next Level Italy A IVDR EUDAMED record Report an error
Ningbo MedicalSystem Biotechnology FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China A IVDR EUDAMED record Report an error
Novatech Tibbi̇ Ci̇haz Ürünleri̇ Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ Türkiye – 98/79 Website info@novadiag.com EUDAMED record Report an error
numares FDA Germany A IVDR info@numares.com EUDAMED record Report an error
OK biotech FDA EU representative : MDSS GmbH (Germany) Taiwan – 98/79 Website service@okbiotech.com EUDAMED record Report an error
Ortho Clinical Diagnostics Biotechnology Development (Shanghai) EU representative : Ortho-Clinical Diagnostics France (France) China A IVDR Website EUDAMED record Report an error
Paitzar EU representative : Metridium OÜ (Estonia) Iran A IVDR Website info@paitzar.am EUDAMED record Report an error
PAL Finland Finland – 98/79 Website EUDAMED record Report an error
PCL EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea A IVDR Website EUDAMED record Report an error
Phadia FDA Sweden A IVDR Website RegulatoryAffairs.Uppsala.IDD@thermofisher.com EUDAMED record Report an error
Pinnacles (Suzhou) Medical Technology EU representative : Lotus NL B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Qualigeninc FDA EU representative : MDSS GmbH (Germany) United States A IVDR Website EUDAMED record Report an error
Quidel Cardiovascular FDA EU representative : MDSS GmbH (Germany) United States – 98/79 Website PRRC@quidelortho.com EUDAMED record Report an error
Quimica Clinica Aplicada Spain A IVDR Website EUDAMED record Report an error
Realmindbio EU representative : Sungo Cert GmbH (Germany) China A IVDR EUDAMED record Report an error
Renderbio EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Responsebio FDA EU representative : Emergo Europe B.V. (Netherlands) Canada A IVDR Website EUDAMED record Report an error
Revvity FDA EU representative : Wallac Oy (Finland) United Kingdom (ex Northern Ireland) A IVDR Website EUDAMED record Report an error
Roche FDA Germany C IVDR Website EUDAMED record Report an error
Sansure FDA EU representative : Obelis s.a. (Belgium) China A IVDR Website info@sansure.com.cn EUDAMED record Report an error
Sensacore EU representative : Obelis s.a. (Belgium) India A IVDR Website EUDAMED record Report an error
Shenzhen AmTech Bioengineering EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Shenzhen Landwind Biomedical Technology EU representative : Lotus NL B.V. (Netherlands) China A IVDR sales@landwindmedical.com EUDAMED record Report an error
Shenzhen Uni-medica Technology EU representative : CMC Medical Devices & Drugs SL (Spain) China A IVDR Website marketing@uni-medica.com EUDAMED record Report an error
Shinva FDA EU representative : Eunitor GmbH (Germany) China A IVDR EUDAMED record Report an error
Singuway EU representative : CMC Medical Devices & Drugs SL (Spain) China A IVDR sales@singuway.com EUDAMED record Report an error
Suzhou Astrabio Technology EU representative : MedPath GmbH (Germany) China A IVDR marketing@astra-biotech.com EUDAMED record Report an error
Suzhou Helmen Precision Insturments EU representative : Lotus NL B.V. (Netherlands) China A IVDR Website EUDAMED record Report an error
Suzhou Sym-Bio Lifescience EU representative : Emergo Europe B.V. (Netherlands) China A IVDR quality.taicang@revvity.com EUDAMED record Report an error
tascom EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea A IVDR EUDAMED record Report an error
Tecan FDA Austria A IVDR Website regulatory.affairs.at@tecan.com EUDAMED record Report an error
Technogenetics FDA Italy A IVDR Website QA@TECHNOGENETICS.IT EUDAMED record Report an error
Tecom Science EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Todylaboratories Romania A IVDR Website contact@todylaboratories.com EUDAMED record Report an error
Utsat Türkiye A IVDR Website info@utsat.com.tr EUDAMED record Report an error
Vigilant Biosciences FDA EU representative : Vigilant Biosciences GmbH (Germany) United States A IVDR EUDAMED record Report an error
Virtue Diagnostics (Suzhou) EU representative : Kingsmead Service B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Vitrosens Türkiye A IVDR Website info@vitrosens.com EUDAMED record Report an error
Vodenmedical Italy A IVDR Website EUDAMED record Report an error
Wholecare Biomedical FDA EU representative : MDSS GmbH (Germany) Taiwan – 98/79 info.wholecare@microlife.com.tw EUDAMED record Report an error
Wizbiotech EU representative : QbD RepS BV (Belgium) China A IVDR EUDAMED record Report an error
Yercon Diagnostic EU representative : CMC Medical Devices & Drugs SL (Spain) China A IVDR Website EUDAMED record Report an error
Zhejiang Gewuzhizhi Biotechnology EU representative : Llins Service & Consulting GmbH (Germany) China A IVDR Website EUDAMED record Report an error
Zhongshan Chuangyi Biochemical Engineering EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China A IVDR EUDAMED record Report an error
Chemclin EU representative : MedNet EC-REP GmbH (Germany) No model still on the market China A IVDR Website EUDAMED record Report an error
Ns Biotec EU representative : CMC Medical Devices & Drugs SL (Spain) No model still on the market Egypt – 98/79 Website info@nsbiotec.com EUDAMED record Report an error
Beijingyicheng EU representative : Caretechion GmbH (Germany) No model still on the market China – 98/79 Website mail@beijingyicheng.com.cn EUDAMED record Report an error
Biotime EU representative : Sungo Cert GmbH (Germany) No model still on the market China A IVDR EUDAMED record Report an error
Chongqing Aolun Technology EU representative : CMC Medical Devices & Drugs SL (Spain) No model still on the market China A IVDR EUDAMED record Report an error
QuantaMatrix EU representative : KTR Europe GmbH (Germany) No model still on the market South Korea – 98/79 EUDAMED record Report an error
Salofa FDA No model still on the market Finland – 98/79 Website info@salofa.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) 324

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
Nova Biomedical Corp. United States STAT PROFILE NOVA NOVA/STAT PROFILE StatSensor/StatStrip STATSTRIP Nova Max K221326 (2024)
ACON Laboratories, Inc. United States Mission Urinalysis Reagent Strips Mission U120 Smart Urine Analyzer Mission U120 Touch Urine Analyzer HealthyMe UTI Urinary Tract Infection Test Strips Mission Urinary Tract Infection (UTI) Test strips On Call Vivid Blood Glucose Test Strips K170587 (2017)
TECO DIAGNOSTICS United States TECO DIAGNOSTICS Teco Diagnostics Uritek TC-201 Urine Chemistry Test System Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer System Teco Diagnostics Uritek TC-720+ Urine Chemistry Test System Teco Diagnostics TC Matrix Clinical Chemistry Analyzer Teco Diagnostics Glucose (Oxidase) Liquid Reagent Set K170118 (2017)
Medica Corp. United States ISE Reagent Pack pH/pCO2/pO2/Na/K/Ca Analyzer Na/K Solution Pack Na/K/Cl Analyzer Na/K/Cl Solution Pack Na/K/Ca/pH Solution Pack K220328 (2024)
Bio-Rad Present in Europe in other categories United States EVOLIS BioPlex 2200 VARIANT II TURBO D-10 VARIANT II Hemoglobin A1c D-100 K161687 (2016)
GERMAINE LABORATORIES, INC United States AIMSTRIP 10-SG AIMSTRIP US-9 AIMSTRIP US-11 AIMSTRIP US-5 AIMSTRIP US-4OB AIMSTRIP US-5B K051727 (2005)
BTNX Inc – Rapid Response registered
HENRY SCHEIN, INC. Present in Europe in other categories United States Henry Schein CardioChek registered
MCKESSON MEDICAL-SURGICAL INC. – McKesson registered
Chromsystems Instruments + Chemicals GmbH Germany Plasma Calibrator Set Plasma Calibration Standard Serum Calibrator Set Serum Calibration Standard Urine Calibration Standard Whole Blood Calibration Standard registered
Phoenix Diagnostics, Inc. United States PHOENIX DIAGNOSTICS, INC. Phoenix Diagnostics K020364 (2002)
MOORE MEDICAL LLC – Moore Medical registered
STANBIO LABORATORY, L.P. United States Uri-Trak 120 M Urine Analyzer Uri-Chek 10SG Strips STAT-Site WB B-Ketone Test Strips STAT-Site B-HB Controls STAT-Site M B-HB Strips STAT-Site M B-HB Analyzer Pack K090093 (2009)
Cardinal Health 200, LLC Present in Europe in other categories United States CARDINAL HEALTH registered
CAROLINA LIQUID CHEMISTRIES CORPORATION United States ISE ELECTROLYTE BUFFEER REAGENT KIT 88810 CLC6410 Chemistry Analyzer with or without ISE ISE ELECTROLYTE REFERENCE 88811 CLC1600 Chemistry Analyzer with ISE Module CLC800 Chemistry Analyzer with ISE Module Carolina Liquid Chemistries Corp. ISE Reference Solution DT88811 K133519 (2014)
Immunostics Company, Inc United States Detector UA 2GP Detector UA 10SG Detector UA 10 Detector UA 5 Detector UA 2 hemochroma PLUS Starter Kit K182298 (2018)
HORIBA INSTRUMENTS INCORPORATED United States Pointe Scientific, Inc. Pointe Scientific, Inc Pointe Scientific Pointe Scientific, Inc. ISE Internal Reference Pointe Scientific, Inc. Glucose Ox Pointe Scientific, Inc. Glucose Hex K853356 (1985)
MEDLINE INDUSTRIES, INC. Present in Europe in other categories United States Medline MEDLINE INDUSTRIES registered
JANT PHARMACAL CORPORATION – Accustrip 10-Parameter Urine Reagent Strip Accutest Accustrip URS Strips + Reader LipidPlus® Meter LipidPlus® Glucose Test Strips registered
Shenzhen Yuwen E-Commerce Co., Ltd. China AUVON registered
Primus Corp. United States Trinity Biotech K062658 (2007)
YSI INCORPORATED United States YSI Incorporated K210933 (2024)
INFRARED LABORATORY SYSTEMS LLC United States Synermed® registered
POLYMER TECHNOLOGY SYSTEMS, INC. United States CardioChek® Plus Professional Analyzer CardioChek Plus Home Self-Test Analyzer CardioChek Plus Lipid + eGLU Test Strips Smart Bundle™ (2-pk) CardioChek® PA analyzer PTS Panels® CHOL+Glu Test Strips PTS Panels® CHOL+HDL+GLU Test Strips (10-ct) K151530 (2015)
DREW SCIENTIFIC, INC. United Kingdom JAS Diagnostics Drew Scientific Drew K070704 (2007)
Hemocue AB Present in Europe in other categories United States HemoCue® Glucose 201 Microcuvettes HemoCue® Glucose 201 Analyzer HemoCue® Hb 301 Microcuvettes HemoCue® Hb 201 Microcuvettes HemoCue® Hb 201+ Analyzer HemoCue® Hb 201 DM Analyzer K201217 (2020)
Ortho-Clinical Diagnostics, Inc. Present in Europe in other categories United States VITROS K190520 (2019)
PHILOSYS Co., Ltd United States Gmate® STEP Blood Glucose Monitoring System Gmate® VOICE Blood Glucose Monitoring System Gmate® Origin Blood Glucose Monitoring System Gmate® mini Blood Glucose Monitoring System GlucoTrack SMART Blood Glucose Monitoring System Gmate® SMART Blood Glucose Monitoring System K113636 (2013)
Circassia AB United States NIOX K170983 (2017)
PEPTONIC MEDICAL ISRAEL LTD Present in Europe in other categories – Equate VS-SENSE OTC Nuvetest VagiVital VS Screening Kit for Vaginal Health Florisense Preconception Vaginal Health Test registered
BIONIME CORPORATION Present in Europe in other categories United States GE Rightest ODM registered
Lifehealth – CC Cartridge GL Cartridge H4 Cartridge H3 Cartridge BG Cartridge LA Cartridge registered
Safecare Biotech (Hangzhou) Co., Ltd. Present in Europe in other categories China Exploro Urinary Tract Infection (UTI) Test T Testahead URINARY TRACT INFECTION TEST Welcheck URINARY TRACT INFECTION TEST URINARY TRACT INFECTION TEST K242767 (2025)
WATERS TECHNOLOGIES CORPORATION Present in Europe in other categories – MassTrak Acquity registered
EASY HEALTHCARE CORPORATION – Easy@Home Urinary Tract Infection Test Strips (10 Pack) Easy@Home Urinary Tract Infection Test Strips (20 Pack) Areta Ketone Urinalysis Reagent Strips (100 tests kit） Areta 10 Parameters Urinalysis Reagent Strips (100 tests kit） Areta 10 Parameters Urinalysis Reagent Strips （50 tests kit） Areta pH Urinalysis Reagent Strips (100 tests kit） registered
LW SCIENTIFIC, INC. United States Urine Reagent Strips, 10-parameter Urine Reagent Strips, 5-parameter Urine Reagent Strips, 1-parameter, ketone Urine Reagent Strips, 2-parameter; glucose, protein registered
Prodigy Diabetes Care, LLC – Prodigy No Coding Blood Glucose Test Strips Prodigy AutoCode Blood Glucose Monitoring System Prodigy Pocket Blood Glucose Monitoring System Prodigy Voice Blood Glucose Monitoring System Prodigy iConnect Blood Glucose Monitoring System PRODIGY ASTRO PRO No Coding Blood Glucose Test Strips registered
Biobase Biodustry(Shandong)Co., Ltd. China BIOBASE BIOBASEBK200mini registered
Verichem Laboratories, Inc. United States Total Protein / Albumin Standard Kit Serum ISE Standard Kit Carbon Dioxide Standard Kit Iron Standard Kit Urine Chemistry Standard Kit Carbon Dioxide Standard K112834 (2012)
Diagnostic Automation, Inc. – QMedix™ InstaTest registered
WAL-MART STORES, INC. – ReliOn™ Premier Blood Glucose Test Strips Members Mark ReliOn® Prime Blood Glucose Test Strips ReliOn® Confirm/micro Blood Glucose Test Strips ReliOn™ Premier Voice Basic Meter ReliOn™ Premier Classic Meter registered
BIOTEST MEDICAL CORPORATION – Oracle Perfect 3 Smartest PersonaII B T M registered
Minaris Medical America, Inc. – CLA® Allergen-Specific IgE Assay - Southeastern Inhalant Panel CLA® Positive Control Serum CLA-1™ Luminometer AP 720S™ Semi-Automated Processor OPTIGEN® AP 3600™ Automated Instrument OPTIGEN® Allergen-Specific IgE Assay - US Inhalant 36 Panel registered
TOKYO BOEKI MEDISYS INC. United States K (Potassium) Electrode Na (Sodium) Electrode Cl (Chloride) Electrode Calibrator 2 Urine Calibrator Set Calibrator 1 K110520 (2012)
MERCEDES MEDICAL, LLC – Tanner Scientific® registered
Cardinal Health 110, Inc. – LEADER registered
KPI HEALTHCARE, INC. – CURO A1c Curo L5 Curo A1c Analyzer CURO L5 Total Cholesterol Strips registered
LABSTYLE INNOVATION LTD – Dario® USB-C Blood Glucose Monitoring System - Starter Kit 50 Dario Blood Glucose Test Strip Dario LC Blood Glucose Monitoring System & Dario Membership 100 Blood Glucose Test Strip 25 Blood Glucose Test Strip Dario 300 Test Strips Bundle registered
TRIVIDIA HEALTH, INC. United States TRUEtrack TRUEbalance TRUEplus registered
ALFA WASSERMANN, INC. United States Alfa Wassermann ACE Axcel® ACE Alera® ACE K063306 (2007)
BIOCHROM LIMITED Present in Europe in other categories – Bio30+ Physiological HR Bio30+ Physio W/O A/S HR Bio30+ Physio High Performance Bio30+ System Physio HR Bio30+ System Physio HP Bio30+ Physio Accelerated registered
NATIONAL DISTRIBUTION & CONTRACTING, INC. – Pro Advantage registered
U. S. Diagnostics, Inc. United States INFINITY™ Starter Kit EasyGluco™G2 Test Strips Easygluco® Plus Test Strips INFINITY™ Meter Kit EasyGluco™G2 Starter Kit Control™ Meter Kit K061431 (2007)
Kamiya Biomedical Co. Present in Europe in other categories United States K-ASSAY® IgG Reagent K-ASSAY® Multi-Analyte Calibrator K-ASSAY® Apo AI/B Calibrator K-ASSAY® Hemoglobin A1c Reagent K-ASSAY® Hemoglobin A1c Reagent (L) K-ASSAY® Hemoglobin A1c Control K993281 (1999)
REESE PHARMACEUTICAL COMPANY – TopCare DG Health registered
VIVOSENS INC. United States Vivoo At-Home Urinary Tract Infection Test Vivoo At-Home UTI Test Strips registered
Alere San Diego, Inc. Present in Europe in other categories United States Cholestech LDX™ Alere Cholestech LDX® K223179 (2023)
Ekf-Diagnostic GmbH Present in Europe in other categories Germany DiaSpect Tm Hemo Control DiaSpect Tm Cuvettes Cleaner Hemo Control Hemoglobin Microcuvette Add Pack Hemo Control DM K200909 (2020)
LIVONGO HEALTH, INC – Livongo Refill Kit Livongo Health, Inc. by Teladoc Health, Inc. Livongo Welcome Kit Livongo Test Strips Livongo Test Strips - Mexico registered
Lacar MDX Technologies Present in Europe in other categories Belgium SEEKER® registered
Medtronic Minimed Present in Europe in other categories United States Enlite™ Serter CGMS® iPro™ GUARDIAN® MiniLink® REAL-Time Enlite® Serter Medtronic Guardian™ Link registered
PHARMA TECH SOLUTIONS, INC. – GenUltimate Zephyr! Alltara Zephyr! GenUltimate! GenUltimate registered
AMVENTUREX, INC. – KETOCOACH BLOOD KETONE METER BIOCOACH Blood Glucose and Ketone Monitoring System BIOCOACH Blood Ketone Test Strips 50 Pack (Foil) KETOCOACH METER ONLY KETOCOACH CONTROL SOLUTION Level 2 KETOCOACH 50 BLOOD KETONE TEST STRIPS registered
APOTHECARY PRODUCTS, LLC United States Ezy Dose Diabetic Specialty Solutions registered
Caire Diagnostics Inc. Present in Europe in other categories United States CAIRE Diagnostics K213611 (2023)
Care Living Diagnostics Inc. United States CareLiving MM1100 Blood Glucose Test Strips 50ct CareLiving BGM101 Blood Glucose Meter CareLiving MM1100 Blood Glucose Test Strips 100ct CareLiving MM1100 Blood Glucose Monitoring System CareLiving Blood Glucose Test Strips 50ct CareLiving Blood Glucose Test Strips 100ct registered
Fisher Scientific Co., LLC United States Fisherbrand registered
Hearts Bio, Inc. – HeartsCare C1 Plus Multi-Functional Monitoring System heartscare B-Ketone Test Strips (10pcs/Box) HeartsCare LACTATE TEST STRIPS (25PCS/BOX) HeartsCare LACTATE TEST STRIPS (10PCS/BOX) HeartsCare C1 LACTATE TEST STRIPS (10PCS/BOX) registered
JEOL LTD. Japan Potassium Electrode Sodium Electrode Chloride Electrode ISE Serum Standard Set NA Internal Standard ISE Urine Standard Set registered
Teladoc Health, Inc. United States Teladoc Health, Inc. registered
UAN HEALTHCARE LIMITED – AUVON registered
Weihai Kangzheng Medical Equipment Technology Co., Ltd – urinalysis strips registered
Bosch Healthcare Solutions GmbH Present in Europe in other categories Germany Vivatmo pro Oxycap Vivatmo pro Level 0 Spare part: Vivatmo pro handheld US Vivatmo pro Spare part: Vivatmo pro base station US K243926 (2025)
FUJIREBIO INC. Present in Europe in other categories – LUMIPULSE G1200 Lumipulse G Substrate Solution Lumipulse G Wash Solution TENDIGO Disposable Trays TENDIGO registered
HOME AIDE DIAGNOSTICS, INC. – Easy Plus II Blood Glucose Testing Strips 25ct Easy Talk/Plus II Glucose Test Strips Easy Trak Blood Glucose Test Strips 25ct Easy Step Blood Glucose Test Strips 50ct Easy Talk Blood Glucose Testing Strips 25ct registered
KETOBM USA LLC – KetoBM registered
METENE LIMITED United States metene Blood Glucose Test Strips (50pcs*2) ANKOVO TD-4267 Blood Glucose Test Strips 100PCS metene Blood Glucose Test Strips (50pcs*6) ANKOVO TD-4267 BLOOD GLUCOSE MONITORING SYSTEM registered
OMNIS HEALTH, LLC – EmbraceWAVE Blood Glucose Test Strips 25 ct. EmbraceWAVE+ Blood Glucose Monitoring System Value Pack EmbraceWAVE Blood Glucose Test Strips 100 ct. EmbraceWAVE+ Blood Glucose Monitoring System Starter Kit EmbraceWAVE Blood Glucose Test Strips 50 ct. registered
ASAHI KASEI PHARMA CORPORATION Japan Lucica® Glycated Albumin-L GA R-2 Lucica® Glycated Albumin-L ALB R-1 Lucica® Glycated Albumin-L GA R-1 Lucica® Glycated Albumin-L ALB R-2 K170147 (2017)
Awareness Technology, Inc. United States SelectaLyte (Potassium Electrode) SelectaLyte (Sodium Electrode) SelectaLyte (Chloride Electrode) SelectaLyte K171476 (2018)
CLINICAL DIAGNOSTIC SOLUTIONS, INC. Present in Europe in other categories United States Chemistry Calibrator Set HbA1c Reagent Set HbA1c Calibrator Set HbA1c Control Set registered
Diazyme Laboratories Present in Europe in other categories United States Diazyme K160762 (2016)
FUTURE DIAGNOSTICS LLC – Care Touch registered
GEISS, DESTIN & DUNN, INC – GOODSENSE registered
Genabio Diagnostics Inc. – GenaCheck Rapid Self-Test Kit For Urinary Tract Infections registered
Inpeco SA Present in Europe in other categories Italy Aptio Automation Accelerator a3600 FlexLab FlexLab X K121012 (2012)
Quidel Corp. United States Sofia registered
REICHERT, INC. Present in Europe in other categories United States Clinical Refractometers Reichert® Digital Clinic-Chek Reichert® Digital USG-Chek registered
RICCA CHEMICAL COMPANY LLC United States Ricca Chemical Company® registered
Roche Molecular Systems, Inc. United States COBAS®TaqMan® 48 Analyzer COBAS® TaqMan® cobas® 6800 system cobas® 8800 system K012966 (2002)
S-CONNECT CO.,LTD – My Yodoc registered
SCI Medic, Inc. – NEW CHOICE registered
SENTINEL CH. SPA Present in Europe in other categories Italy Plasmaproteins Cal 3x Lipase NG Cal Clin Chem Cal K081533 (2008)
Solomon Park Research Laboratories, Inc. United States Solomon Commutable Quality Materials registered
VALUE PROVIDERS LLC – Eocene Smart Diabetes registered
VISGENEER, INC. Present in Europe in other categories Taiwan eBcarryon eBsensor registered
WALGREEN CO. – Walgreens Well at Walgreens registered
ABOUND Diagnostics, Inc. – VivaGuard Ino Smart Blood Glucose Meter VivaGuard Ino Blood Glucose Test Strips VivaGuard Ino Blood Glucose Meter registered
Bedfont Scientific, Ltd. Present in Europe in other categories United Kingdom NObreath® FeNOBreath NOBreath K203695 (2021)
Biorex Labs LLC United States K-CHECK DIAZO-CHEK registered

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