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Emdyca

IVD instruments

EMDN code W02

773 manufacturers, 3,803 models including 3,740 on the market, 39 countries

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Manufacturers registered in Europe (EUDAMED) 773
  • 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
Zenith Lab (Jiangsu) EU representative : Umedwings Netherlands B.V. (Netherlands) China
67 others
 A IVDR Website service@labzj.com EUDAMED record Report an error
Rayto EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
62 others
 A, B IVDR, 98/79 Website support@rayto.com EUDAMED record Report an error
Dirui FDA EU representative : Emergo Europe B.V. (Netherlands) and 1 other China
47 others
 A, B IVDR, 98/79 EUDAMED record Report an error
Infitek FDA EU representative : Kingsmead Service B.V. (Netherlands) and 1 other China
47 others
 I, A IVDR, MDR info@infitek.com EUDAMED record Report an error
Dymind EU representative : Eunitor GmbH (Germany) China
44 others
 A, B IVDR, 98/79 regulationdept@dymind.com EUDAMED record Report an error
Mindray FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
44 others
 A, B, C IVDR, 98/79 Website EUDAMED record Report an error
OSANG Healthcare FDA EU representative : Obelis s.a. (Belgium) South Korea
39 others
 A, C IVDR, 98/79 Website EUDAMED record Report an error
Beckman Coulter FDA EU representative : Beckman Coulter Ireland Inc. (Ireland) Germany, Ireland, Japan, United States
38 others
 A IVDR, 98/79 Website ra.clare@beckman.com EUDAMED record Report an error
Zybio FDA EU representative : Lotus NL B.V. (Netherlands) and 2 others China
36 others
 A, B, C IVDR, 98/79 PMS@zy-ivd.com EUDAMED record Report an error
Sysmex FDA EU representative : Sysmex Europe SE (Germany) Japan
32 others
 A IVDR, 98/79 ra_archive@sysmex.co.jp 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
LifeGlobal Group FDA EU representative : CooperSurgical Distribution B.V. (Netherlands) United States
29 others
 I 93/42 Ra@coopersurgical.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
Accumaxlab EU representative : mdi Europa GmbH (Germany) India
29 others
 A IVDR, 98/79 Website compliance@accumaxlab.com EUDAMED record Report an error
Human Germany
28 others
 A IVDR, 98/79 Website EUDAMED record Report an error
Leicabiosystems FDA EU representative : AR Experts B.V. (Netherlands) and 1 other Australia, Germany, United States
28 others
 A IVDR Website support.de@LeicaBiosystems.com EUDAMED record Report an error
Amos Scientific Pty EU representative : Luxus Lebenswelt GmbH (Germany) Australia
27 others
 A IVDR info@amos-scientific.com EUDAMED record Report an error
Changsha Yingtai Instrument FDA EU representative : Kingsmead Service B.V. (Netherlands) China
26 others
 A IVDR EUDAMED record Report an error
Arkray FDA EU representative : ARKRAY Europe, B.V. (Netherlands) Japan
28 others
 A IVDR, 98/79 support_arkrayeurope@arkray.co.jp EUDAMED record Report an error
Urit FDA EU representative : Medunion S.L. (Spain) and 1 other China
24 others
 A, B IVDR, 98/79 Website service@uritest.com EUDAMED record Report an error
Autobio FDA EU representative : Obelis s.a. (Belgium) China
25 others
 A, C IVDR Website EUDAMED record Report an error
E-LAB Biological Science & Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China
22 others
 A IVDR, 98/79 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
bioMérieux FDA EU representative : bioMérieux SA (France) France, United States
21 others
 A, B IVDR, 98/79 EUDAMED record Report an error
Maccura EU representative : Humiss International B.V. (Netherlands) and 1 other China
21 others
 A, B IVDR, 98/79 Website EUDAMED record Report an error
Biobase FDA EU representative : Luxus Lebenswelt GmbH (Germany) China
20 others
 I, A IVDR, MDR EUDAMED record Report an error
Siemens Healthcare Diagnostics FDA EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland) United States
20 others
 A, B IVDR, 98/79 Website contact@siemens-healthineers.com EUDAMED record Report an error
YASEE BioMedical FDA EU representative : Prolinx GmbH (Germany) China
20 others
 – 98/79 EUDAMED record Report an error
Andreas Hettich FDA Germany
19 others
 IIa, A IVDR, MDR, 98/79 Website EUDAMED record Report an error
Linear FDA Spain
19 others
 A IVDR Website info@linear.es EUDAMED record Report an error
Horiba FDA France
19 others
 A, B IVDR, 98/79 EUDAMED record Report an error
Genegeo EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China
18 others
 A IVDR, 98/79 sales@genegeo.com EUDAMED record Report an error
Vitrosens Türkiye
18 others
 A IVDR Website info@vitrosens.com EUDAMED record Report an error
Shandon Diagnostics FDA EU representative : Epredia Netherlands B.V. (Netherlands) United Kingdom (ex Northern Ireland)
17 others
 A IVDR EUDAMED record Report an error
Boditech FDA EU representative : Obelis s.a. (Belgium) South Korea
16 others
 A IVDR Website marketing@boditech.co.kr EUDAMED record Report an error
Genrui Biotech FDA EU representative : Lotus NL B.V. (Netherlands) China
16 others
 A, B IVDR, 98/79 Website service@genrui-bio.com EUDAMED record Report an error
Instrumentation Laboratory FDA EU representative : Instrumentation Laboratory SpA (Italy) United States
16 others
 A IVDR Website Regulatory@werfen.com EUDAMED record Report an error
Seamaty EU representative : GRZAN GmbH (Germany) and 1 other China
16 others
 A IVDR 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
77 Elektronika Műszeripari Kft Hungary
14 others
 A, C IVDR, 98/79 Website EUDAMED record Report an error
Bioer FDA EU representative : MedNet EC-REP GmbH (Germany) China
14 others
 A IVDR Website ra_oversea@bioer.com.cn EUDAMED record Report an error
Erba Czechia
13 others
 A, B IVDR Website 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
Mpw Poland
13 others
 A IVDR Website EUDAMED record Report an error
Biotecnica Italy
13 others
 A IVDR EUDAMED record Report an error
Aconbio EU representative : MedNet EC-REP GmbH (Germany) China
12 others
 A, C IVDR, 98/79 Website EUDAMED record Report an error
Evident FDA EU representative : Evident Europe GmbH (Germany) Japan
12 others
 A IVDR EUDAMED record Report an error
Abbott FDA EU representative : Abbott B.V. (Netherlands) and 2 others United Kingdom (ex Northern Ireland), United States
11 others
 A, B IVDR Website ratransfusionmedicine@abbott.com EUDAMED record Report an error
Euroimmun FDA Germany
11 others
 A IVDR Website info@euroimmun.de EUDAMED record Report an error
Iline Microsystems FDA Spain
11 others
 A IVDR, 98/79 eudamed@ilinemicrosystems.com 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
Optika Microscopes Italy
11 others
 A IVDR EUDAMED record Report an error
Shenzhen Yhlo Biotech FDA EU representative : Lotus NL B.V. (Netherlands) and 1 other China
11 others
 A IVDR, 98/79 Website info@szyhlo.com EUDAMED record Report an error
Hitachi High-Tech FDA EU representative : Roche Diagnostics GmbH (Germany) Japan
10 others
 A IVDR ra-contact.aj@hitachi-hightech.com EUDAMED record Report an error
Hybribio EU representative : Kingsmead Service B.V. (Netherlands) China
10 others
 A IVDR EUDAMED record Report an error
AFI Centrifuge France
9 others
 A IVDR Website contact@afigroups.com EUDAMED record Report an error
Becton Dickinson FDA EU representative : Becton Dickinson Ireland Limited (Ireland) United States
9 others
 A IVDR 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
Especialidades Médicas Myr FDA Spain
9 others
 A IVDR Website EUDAMED record Report an error
Álvarez Redondo Spain
9 others
 A IVDR Website info@ortoalresa.com EUDAMED record Report an error
Challenbio EU representative : MedPath GmbH (Germany) China
8 others
 A IVDR sale@challenbio.com EUDAMED record Report an error
Eppendorf FDA Germany
8 others
 A IVDR RA.Corporate@eppendorf.de 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
Sunbiote EU representative : Lotus NL B.V. (Netherlands) China
8 others
 A IVDR Website EUDAMED record Report an error
Qiagen FDA EU representative : QIAGEN GmbH (Germany) Germany, United States
8 others
 A IVDR Website info@qiagen.com EUDAMED record Report an error
Aikang MedTech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
7 others
 A IVDR EUDAMED record Report an error
Bio-Optica Milano FDA Italy
7 others
 A IVDR Website info@bio-optica.it 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
Edan FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
7 others
 A, B IVDR, 98/79 EUDAMED record Report an error
Illumaxbio EU representative : MedNet EC-REP GmbH (Germany) China
7 others
 A IVDR Website EUDAMED record Report an error
Leica Microsystems CMS FDA Germany
7 others
 A IVDR EUDAMED record Report an error
Medconn FDA EU representative : JOYSUN GROUP S.L.U (Spain) and 1 other China
7 others
 A IVDR, 98/79 EUDAMED record Report an error
Medical Scientific Equipment France
7 others
 A IVDR Website info@mse-sas.fr EUDAMED record Report an error
Sakura Seiki EU representative : Sakura Finetek Europe B.V. (Netherlands) Japan
7 others
 A IVDR Website EUDAMED record Report an error
Ustar Biotechnologies (Hangzhou) EU representative : Lotus NL B.V. (Netherlands) China
7 others
 A IVDR Website service@bioustar.com EUDAMED record Report an error
Xi An Tianlong Science Technology FDA EU representative : SUNGO Europe B.V. (Netherlands) China
7 others
 A IVDR EUDAMED record Report an error
Biochemical Systems International Italy
6 others
 – 98/79 Website EUDAMED record Report an error
BioFynder EU representative : SUNGO Europe B.V. (Netherlands) United Kingdom (ex Northern Ireland)
6 others
 A IVDR EUDAMED record Report an error
Medite FDA Germany
6 others
 A IVDR Website 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
Slee FDA Germany
6 others
 A IVDR EUDAMED record Report an error
Ukinbio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China
6 others
 A IVDR, 98/79 sales@ukinbio.com EUDAMED record Report an error
Aitbiotech EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) Singapore
5 others
 A IVDR 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
Shenzhen Comen Medical Instruments FDA EU representative : Lotus NL B.V. (Netherlands) China
5 others
 – 98/79 EUDAMED record Report an error
Shimadzu FDA EU representative : Shimadzu Europa GmbH (Germany) Japan
5 others
 A IVDR, 98/79 Website EUDAMED record Report an error
Tysonbio FDA EU representative : MDSS GmbH (Germany) Taiwan
5 others
 – 98/79 EUDAMED record Report an error
Vazyme EU representative : Caretechion GmbH (Germany) and 2 others China
5 others
 A IVDR 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
Agilent FDA EU representative : Agilent Technologies Denmark ApS (Denmark) Singapore
4 others
 A IVDR Website info.dk@agilent.com EUDAMED record Report an error
Anatolia Tani Ve Biyoteknoloji Urunleri Arastirma Gelistirme San Ve Tic Türkiye
4 others
 A IVDR Website info@anatoliagenetik.com EUDAMED record Report an error
Diagon Hungary
4 others
 A IVDR Website EUDAMED record Report an error
Diapath FDA Italy
4 others
 A IVDR Website info@diapath.com 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
Hunan Michael Laboratory Instrument EU representative : Humiss International B.V. (Netherlands) China
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
Milestone FDA Italy
4 others
 A IVDR Website marketing@milestonemedsrl.com EUDAMED record Report an error
pfm medical FDA Germany
4 others
 A IVDR Website info@pfmmedical.com EUDAMED record Report an error
Ral Tecnica Para El Laboratorio Spain
4 others
 A IVDR Website EUDAMED record Report an error
Seleo Italy
4 others
 – 98/79 Website EUDAMED record Report an error
Weinkauf Medizintechnik Germany
4 others
 A IVDR Website info@weinkauf-medizintechnik.de EUDAMED record Report an error
Beiantmed EU representative : Kingsmead Service B.V. (Netherlands) China
3 others
 A IVDR EUDAMED record Report an error
Beijing Lepu Medical Technology EU representative : Lepu Medical (Europe) Cooperatief U.A. (Netherlands) China
3 others
 A IVDR, 98/79 EUDAMED record Report an error
Biocomma EU representative : CMC Medical Devices & Drugs SL (Spain) China
3 others
 A IVDR Website sales@biocomma.cn 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
Drucker Diagnostics FDA EU representative : Emergo Europe B.V. (Netherlands) United States
3 others
 A IVDR, 98/79 Website regulatory@druckerdiagnostics.com EUDAMED record Report an error
Gmt Sarl France
3 others
 A IVDR, 98/79 Website EUDAMED record Report an error
Instrumentation Laboratory FDA Italy
3 others
 A IVDR Website EUDAMED record Report an error
Medcaptain FDA EU representative : R Sight B.V. (Netherlands) China
3 others
 A IVDR Website info@medcaptain.com 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
Reetoo EU representative : Umedwings Netherlands B.V. (Netherlands) China
3 others
 A IVDR, 98/79 Website service@reetoo.com.cn EUDAMED record Report an error
Sansure FDA EU representative : Obelis s.a. (Belgium) China
3 others
 A IVDR Website info@sansure.com.cn EUDAMED record Report an error
Shenzhen New Industries Biomedical Engineering FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
3 others
 A IVDR Website EUDAMED record Report an error
Wheisman Medical Technology EU representative : Umedwings Netherlands B.V. (Netherlands) China
3 others
 – 98/79 EUDAMED record Report an error
Zhuhai DL Biotech EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
7 others
 A IVDR Website EUDAMED record Report an error
3Dhistech Hungary
2 others
 A IVDR Website info@3dhistech.com EUDAMED record Report an error
Accriva Diagnostics FDA EU representative : MDSS GmbH (Germany) United States
2 others
 A IVDR, 98/79 Website EUDAMED record Report an error
Bioneer FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea
2 others
 A IVDR Website sales@bioneer.com 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
Dakewe FDA EU representative : Lotus NL B.V. (Netherlands) and 1 other China
2 others
 A IVDR Website EUDAMED record Report an error
Dartmon FDA EU representative : R Sight B.V. (Netherlands) and 1 other China
2 others
 A IVDR Website EUDAMED record Report an error
DAS Italy
2 others
 A IVDR Website quality@dasitaly.com EUDAMED record Report an error
Diatron FDA Hungary
2 others
 A IVDR Website EUDAMED record Report an error
Gold Standard Diagnostics FDA EU representative : Emergo Europe B.V. (Netherlands) United States
2 others
 A IVDR Website EUDAMED record Report an error
Grifols FDA EU representative : Diagnostic Grifols, S.A. (Spain) Spain, United States
2 others
 A IVDR Website regulatoryaffairs_dxbu@grifols.com EUDAMED record Report an error
Hunan Ehome Health Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China
2 others
 A IVDR, 98/79 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
Kaltek Italy
2 others
 A IVDR info@kaltek.it EUDAMED record Report an error
Life Technologies Holdings Pte EU representative : Life Technologies Europe B.V. (Netherlands) Singapore
2 others
 A IVDR EUDAMED record Report an error
Lordsmark EU representative : Obelis s.a. (Belgium) India
2 others
 A IVDR Website EUDAMED record Report an error
MagBio Genomics FDA EU representative : CEpartner4U (Netherlands) United States
2 others
 A IVDR Website info@magbiogenomics.com EUDAMED record Report an error
Meril Diagnostics FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other India
2 others
 A IVDR Website ram.kanoje@merillife.com 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
Opta-Tech Poland
2 others
 A IVDR Website EUDAMED record Report an error
PentaBase Denmark
2 others
 A IVDR Website info@pentabase.com EUDAMED record Report an error
sebia FDA France
2 others
 A IVDR Website EUDAMED record Report an error
Shandong Bohong Gene Technology EU representative : Luxus Lebenswelt GmbH (Germany) China
2 others
 A IVDR EUDAMED record Report an error
Shanghai LeChen Biotechnology EU representative : Everbiz GmbH (Austria) China
2 others
 A IVDR EUDAMED record Report an error
Siemens Healthcare Diagnostics Products FDA EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland) Germany, United Kingdom (ex Northern Ireland)
2 others
 A IVDR Website contact@siemens-healthineers.com EUDAMED record Report an error
Strumed FDA EU representative : Amstermed B.V. (Netherlands) India
2 others
 – 98/79 Website EUDAMED record Report an error
Taiwan Advanced Nanotech FDA EU representative : mdi Europa GmbH (Germany) Taiwan
2 others
 A IVDR Website EUDAMED record Report an error
Targetingone EU representative : SUNGO Europe B.V. (Netherlands) China
2 others
 A IVDR EUDAMED record Report an error
Wallac Finland
2 others
 A IVDR Website regulatoryaffairs.turku@revvity.com EUDAMED record Report an error
Wondfo FDA EU representative : QbD RepS BV (Belgium) China
2 others
 A IVDR Website sales@wondfo.com.cn EUDAMED record Report an error
Zhuhai Shineway Biotech EU representative : CMC Medical Devices & Drugs SL (Spain) China
2 others
 A IVDR Website EUDAMED record Report an error
ZOVEC diagnostics Germany
2 others
 – 98/79 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
Zeiss FDA EU representative : Carl Zeiss Microscopy GmbH (Germany) China, Germany
2 others
 A IVDR Website regulatoryaffairs.microscopy@zeiss.com 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
Adaltis Italy
1 other
 – 98/79 Website info@adaltis.net 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
Aperbio Technologies (Suzhou) EU representative : Medunion S.L. (Spain) China
1 other
 A IVDR EUDAMED record Report an error
Daan Gene EU representative : Lotus NL B.V. (Netherlands) China
1 other
 A IVDR EUDAMED record Report an error
DiaSorin FDA Italy
1 other
 A IVDR Website EUDAMED record Report an error
Dynex Czechia
1 other
 A IVDR Website EUDAMED record Report an error
Dynodx EU representative : HUMISS TRADING S. L. (Spain) China
1 other
 – 98/79 EUDAMED record Report an error
Eaglenos FDA EU representative : MedPath GmbH (Germany) China
1 other
 A IVDR EUDAMED record Report an error
Genemind EU representative : Umedwings Netherlands B.V. (Netherlands) China
1 other
 A IVDR regulatoryaffairs@genemind.com EUDAMED record Report an error
Gonotec Germany
1 other
 – 98/79 Website contact_gonotec@elitechgroup.com EUDAMED record Report an error
Intelsint Italy
1 other
 A IVDR Website info@intelsint.com EUDAMED record Report an error
Lituo EU representative : CMC Medical Devices & Drugs SL (Spain) China
1 other
 A IVDR, 98/79 Website 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
Pro-med (Beijing) Technology EU representative : Sungo Cert GmbH (Germany) China
1 other
 A IVDR, 98/79 EUDAMED record Report an error
Pushkang EU representative : Sungo Cert GmbH (Germany) China
1 other
 A IVDR EUDAMED record Report an error
Randox FDA Northern Ireland
1 other
 A IVDR Website EUDAMED record Report an error
Rrmechatronics FDA Netherlands
1 other
 A IVDR Website support@rrmechatronics.com EUDAMED record Report an error
Shanghai THAN Medical Technology EU representative : SUNGO Europe B.V. (Netherlands) China
1 other
 A IVDR EUDAMED record Report an error
Shenzhen Zijian Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
1 other
 A IVDR, 98/79 Website sales@szzijian.com EUDAMED record Report an error
Spinreact Spain
1 other
 A IVDR, 98/79 Website EUDAMED record Report an error
YD Diagnostics FDA EU representative : CARE diagnostica Laborreagenzien GmbH (Germany) and 1 other South Korea
1 other
 A IVDR, 98/79 Website admin@yd-diagnostics.com EUDAMED record Report an error
Micro Instrument EU representative : CMC Medical Devices & Drugs SL (Spain) India
1 other
 I, A IVDR, MDR Website info@mikoindia.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
Bio-Rad FDA France A IVDR Website contact@bio-rad.com 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
DFI FDA EU representative : MDSS GmbH (Germany) South Korea A IVDR, 98/79 EUDAMED record Report an error
Diagnostics Belgium, Spain A IVDR, 98/79 Website EUDAMED record Report an error
Diesse FDA Italy A, B IVDR Website EUDAMED record Report an error
Euromex Netherlands A IVDR Website info@euromex.com 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
Hamamatsu EU representative : Hamamatsu Photonics Deutschland GmbH (Germany) Japan A IVDR Website sales@sys.hpk.co.jp EUDAMED record Report an error
Hermle Labortechnik FDA Germany A IVDR Website info@hermleLT.de 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
Jinquanmedical EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR sales1@jinquanmedical.com 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
Ningbo HEALTH Gene Technologies EU representative : Lotus NL B.V. (Netherlands) and 1 other China A IVDR EUDAMED record Report an error
NORMA Instruments Zártkörűen Működő Részvénytársaság Hungary A IVDR EUDAMED record Report an error
Optolane FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea A IVDR info@optolane.com EUDAMED record Report an error
Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China A IVDR EUDAMED record Report an error
Poweam EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
R-Biopharm FDA Germany A IVDR Website EUDAMED record Report an error
Rocgene FDA EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR sale@rocgene.com EUDAMED record Report an error
Sanymed Italy A IVDR Website info@sanymed.it 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
Shenzhen Everbest Machinery lndustry EU representative : Kingsmead Service B.V. (Netherlands) and 1 other China A IVDR EUDAMED record Report an error
Shenzhen Shengqiang Technology EU representative : HUMISS TRADING S. L. (Spain) China A IVDR Website EUDAMED record Report an error
Sikun EU representative : Obelis s.a. (Belgium) China A IVDR EUDAMED record Report an error
Sophonix EU representative : CMC Medical Devices & Drugs SL (Spain) China A IVDR EUDAMED record Report an error
SysCan MedTech (Suzhou) EU representative : Obelis s.a. (Belgium) China A IVDR EUDAMED record Report an error
Tharmac Germany A IVDR Website info@tharmac.de EUDAMED record Report an error
Thermo Electron Led Zweigniederlassung Osterode Germany A IVDR Website EUDAMED record Report an error
Translite FDA EU representative : E C REP LIMITED (Ireland) United States I 93/42 Website info@veinlite.com EUDAMED record Report an error
Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇ Türkiye A IVDR Website info@visionbiotechnology.com EUDAMED record Report an error
Wesailbio EU representative : Lotus NL B.V. (Netherlands) and 1 other China A IVDR EUDAMED record Report an error
Grundium Finland A IVDR Website support@grundium.com EUDAMED record Report an error
"Bio-Ksel" Poland A IVDR Website EUDAMED record Report an error
3D Biomedicine Science & Technology FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China A IVDR 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
B.P.C. Biosed – Italy A IVDR Website info@bpcbiosed.it EUDAMED record Report an error
Behnk Germany A IVDR Website regulatory@behnk.de EUDAMED record Report an error
Beijing Applied Biological Technologies EU representative : Luxus Lebenswelt GmbH (Germany) China A IVDR EUDAMED record Report an error
Bioteke FDA EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR Website info@bioteke.cn EUDAMED record Report an error
Bruker FDA Germany A IVDR Website info.md@bruker.com EUDAMED record Report an error
Cellomics (Shenzhen) EU representative : Lotus NL 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
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
DNA-Technology, Research & Production EU representative : Obelis s.a. (Belgium) Russia A IVDR Website EUDAMED record Report an error
ElitechGroup FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) Italy, United States A IVDR, 98/79 Website info@elitechgroup.com EUDAMED record Report an error
Eurobio Scientific France A IVDR reglementaire@eurobio-scientific.com 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
Guangdong RunPon Bioscience EU representative : Share info GmbH (Germany) China A IVDR Service_RP@fapon.com EUDAMED record Report an error
Guangzhou Xiuwei Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) and 1 other China A IVDR Website EUDAMED record Report an error
Hangzhou HealthSky Biotechnology FDA EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR 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
High Technology FDA EU representative : MedEnvoy Global BV (Netherlands) United States A IVDR Website EUDAMED record Report an error
Hologic FDA EU representative : Hologic BV (Belgium) United States A, C IVDR EUDAMED record Report an error
Huron Technologies International EU representative : 4 Easy Prrc 2 Smart Mdr, Lda (Portugal) Canada A IVDR Website regulatory@hurondigitalpathology.com EUDAMED record Report an error
igenetech EU representative : CMC Medical Devices & Drugs SL (Spain) South Korea A IVDR Website EUDAMED record Report an error
Illumina FDA EU representative : Illumina Netherlands B.V. (Netherlands) United States A IVDR Website EUDAMED record Report an error
Jokoh EU representative : MDSS GmbH (Germany) Japan A IVDR, 98/79 Website EUDAMED record Report an error
Molarray EU representative : Caretechion GmbH (Germany) China A IVDR EUDAMED record Report an error
Motic FDA EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR 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
Objective Imaging EU representative : Acorn Regulatory Consultancy Services Ltd (Ireland) United Kingdom (ex Northern Ireland) A IVDR Website 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
Orphée EU representative : PZ CORMAY Spółka Akcyjna (Poland) Switzerland – 98/79 ra@orphee-medical.com EUDAMED record Report an error
Pilotgene EU representative : Medunion S.L. (Spain) China A IVDR 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
Renderbio EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Riele Germany A IVDR Website info@riele.de EUDAMED record Report an error
Shenzhen Channel Biotechnology EU representative : Luxus Lebenswelt GmbH (Germany) China – 98/79 Website service.channel@szchenna.com EUDAMED record Report an error
Sichuan Orienter Biotechnology EU representative : Lotus NL B.V. (Netherlands) and 2 others China A IVDR Website info@orienterglobal.com EUDAMED record Report an error
Sistat Türkiye A IVDR Website info@sistat.com.tr 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
Visia Lab FDA Italy A IVDR, 98/79 Website quality@visialab.com EUDAMED record Report an error
Xiaogan Kuohai Medical Technology EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR 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
Genesystem FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea A IVDR Website ra@genesystem.co.kr EUDAMED record Report an error
Hmdbio FDA EU representative : Luana Med. B.V. (Netherlands) Taiwan – 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
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
AVE Science & Technology FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China A IVDR, 98/79 EUDAMED record Report an error
Avecon Healthcare EU representative : Amstermed B.V. (Netherlands) India A IVDR Website EUDAMED record Report an error
BioFire Diagnostics FDA EU representative : bioMérieux SA (France) United States A IVDR EUDAMED record Report an error
Bi̇yofen Kurumsal Sağlik Hi̇zmetleri̇ Yazilim Turi̇zm Sanayi̇ Ti̇caret Şti̇ Türkiye A IVDR EUDAMED record Report an error
BotuAImaging Technology EU representative : Kingsmead Service B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Celnovte EU representative : Umedwings Netherlands B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Copan Wasp FDA Italy A IVDR Website regulatory.wasp@copangroup.com EUDAMED record Report an error
Coyotebio EU representative : QbD RepS BV (Belgium) China A IVDR sales@coyotebio.com EUDAMED record Report an error
Cube Dx Austria A IVDR Website info@cubedx.com 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
Guangzhou Naturn Medical Devices EU representative : MedPath GmbH (Germany) China A IVDR EUDAMED record Report an error
Guilin Royalyze Medical Instrument EU representative : Caretechion GmbH (Germany) China – 98/79 EUDAMED record Report an error
Haemokinesis EU representative : Compliance Management Solutions Europe LTD (Bulgaria) Australia A IVDR, 98/79 EUDAMED record Report an error
Hangzhou Bigfish Bio-tech EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Hangzhou Bio-gener Technology EU representative : MedPath GmbH (Germany) China A IVDR info@bio-gener.com EUDAMED record Report an error
Hangzhou Biobank Bio-technology EU representative : MedPath GmbH (Germany) China A IVDR EUDAMED record Report an error
Hospitex Italy A IVDR Website info@hospitex.com EUDAMED record Report an error
Icarbonx EU representative : Kingsmead Service B.V. (Netherlands) China A IVDR 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
Immunodiagnostic Systems FDA EU representative : Immunodiagnostic Systems SA (Belgium) United Kingdom (ex Northern Ireland) A IVDR Website EUDAMED record Report an error
Islandpolymer Germany A IVDR Website EUDAMED record Report an error
Jiangsu Xinkang Medical Instrument EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China A IVDR 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
KH Medical EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea A IVDR Website info@khmedical.co.kr EUDAMED record Report an error
Konsung FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China A IVDR, 98/79 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
Mast Group FDA EU representative : Mast Diagnostica GmbH (Germany) United Kingdom (ex Northern Ireland) A IVDR Website sales@mastgrp.com EUDAMED record Report an error
Meridian Bioscience FDA EU representative : Meridian Bioscience Europe S.r.l. (Italy) United States A IVDR Website EUDAMED record Report an error
Ningbo Chiwell Biotechnology FDA EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Ortho-Clinical Diagnostics Dba Quidel EU representative : MDSS GmbH (Germany) and 1 other United States A IVDR Website PRRC@quidelortho.com EUDAMED record Report an error
Pluslife EU representative : PureCE B.V. (Netherlands) and 1 other China A IVDR Website ra@pluslife.com EUDAMED record Report an error
Qingdao MGI Tech EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China A IVDR EUDAMED record Report an error
Qitan Taike Biotechnology Chengdu EU representative : MedPath GmbH (Germany) China A IVDR EUDAMED record Report an error
RAL Diagnostics FDA France A IVDR Website info@ral-diagnostics.fr EUDAMED record Report an error
RevoSketch EU representative : CMC Medical Devices & Drugs SL (Spain) South Korea A IVDR Website EUDAMED record Report an error
Roche FDA Germany C IVDR, 98/79 Website EUDAMED record Report an error
Sakura Finetek USA EU representative : Sakura Finetek Europe B.V. (Netherlands) United States A IVDR PRRC@sakuraus.com EUDAMED record Report an error
Shanghai Chuangkun Biotech EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR 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
Shenyang Kingpel Biotech EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Shenzhen Tailaored Medical EU representative : Lotus NL B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Sichuan Shuke Instrument FDA EU representative : JOYSUN GROUP S.L.U (Spain) China A IVDR sales@shukelab.com EUDAMED record Report an error
Sidena France A IVDR info@sidena.com 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
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
Suzhou Hokapi Biomedical Engineering EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China A IVDR EUDAMED record Report an error
Swiscare Technology EU representative : MedNet EC-REP GmbH (Germany) Taiwan – 98/79 EUDAMED record Report an error
Thermofisher FDA Finland A IVDR Website EUDAMED record Report an error
Tridema Italy A IVDR Website EUDAMED record Report an error
Typenex FDA EU representative : Qualrep Services B.V. (Netherlands) United States A IVDR Website EUDAMED record Report an error
VitalScientific FDA Netherlands A IVDR Website EUDAMED record Report an error
Wizbiosolution EU representative : CMC Medical Devices & Drugs SL (Spain) South Korea A IVDR EUDAMED record Report an error
Wuhan Landing Intelligence Medical FDA EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Wuhan MGI Tech EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China A IVDR EUDAMED record Report an error
Yanengbio EU representative : Obelis s.a. (Belgium) China A IVDR Website EUDAMED record Report an error
ZKYH AImed Technology （Guangxi） EU representative : Sungo Cert GmbH (Germany) China A IVDR 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
Ailex EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China A IVDR 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
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
Aidian FDA Finland A IVDR Website eudamed@aidian.eu EUDAMED record Report an error
Alifax FDA Italy A IVDR Website regulatory@alifax.com EUDAMED record Report an error
Amazingbio EU representative : Kingsmead Service B.V. (Netherlands) China A IVDR EUDAMED record Report an error
ASTA EU representative : Emergo Europe B.V. (Netherlands) South Korea C IVDR, 98/79 Website EUDAMED record Report an error
AusDiagnostics EU representative : R-Biopharm AG (Germany) Australia A IVDR Website regulatory@r-biopharm.com.au EUDAMED record Report an error
Bdbiosciences FDA EU representative : Becton Dickinson Ireland Limited (Ireland) United States A IVDR Website EUDAMEDenquiries@bd.com 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
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
Bioanalyse Türkiye A IVDR Website info@bioanalyse.com EUDAMED record Report an error
Bioantibody Biotechnology EU representative : Medunion S.L. (Spain) 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
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
Biosense EU representative : MD&D Alliance GmbH (Germany) India A IVDR regulatory.affairs@biosense.in EUDAMED record Report an error
Bioway EU representative : Sungo Cert GmbH (Germany) China A IVDR EUDAMED record Report an error
Biyosistem Türkiye A IVDR Website info@biyosistem.com.tr EUDAMED record Report an error
Boule FDA Sweden B IVDR Website info@boule.com EUDAMED record Report an error
B·R·A·H·M·S FDA Germany A IVDR EUDAMED record Report an error
Callegari Italy 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
CoaguSense FDA EU representative : Emergo Europe B.V. (Netherlands) United States A, C IVDR Website EUDAMED record Report an error
Comfit Italy A IVDR Website EUDAMED record Report an error
Conlett EU representative : Lotus NL B.V. (Netherlands) China I MDR EUDAMED record Report an error
CooperSurgical FDA EU representative : CooperSurgical Distribution B.V. (Netherlands) United States I MDR RA-CSI@coopersurgical.com EUDAMED record Report an error
Credo Diagnostics Biomedical Pte Taiwan Branch EU representative : MedNet EC-REP GmbH (Germany) Taiwan A IVDR service@credodxbiomed.com EUDAMED record Report an error
Dagatron FDA EU representative : BZT-TCP Certification GmbH (Germany) South Korea A IVDR Website EUDAMED record Report an error
devemed FDA Germany I MDR Website info@devemed.de EUDAMED record Report an error
Dezhou Guoke Medical Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 office@guoke-medical.com EUDAMED record Report an error
Diagnostic BioSystems FDA EU representative : MedEnvoy Global BV (Netherlands) United States A IVDR EUDAMED record Report an error
Diagnostics For Real World Europe FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) United Kingdom (ex Northern Ireland) A IVDR Website qa@drw-ltd.com 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
Dlabsci FDA EU representative : Kingsmead Service B.V. (Netherlands) China A IVDR info@dlabsci.com EUDAMED record Report an error
e-LinkCare Meditech FDA EU representative : Wellkang Ltd (Northern Ireland) China – 98/79 EUDAMED record Report an error
EFA Engineering for All EU representative : MedNet EC-REP GmbH (Germany) Israel – 98/79 Website EUDAMED record Report an error
Elmontsrl Italy A IVDR Website EUDAMED record Report an error
Essenlix EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China A IVDR Website info@essenlix.com.cn EUDAMED record Report an error
Eurospital FDA Italy A IVDR regulatory@eurospital.it EUDAMED record Report an error
FlashDx Shenzhen EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China A IVDR info@flash-dx.com EUDAMED record Report an error
Futurlab Italy A IVDR Website EUDAMED record Report an error
Geneplus EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China A IVDR EUDAMED record Report an error
Genes2Me EU representative : Obelis s.a. (Belgium) India A IVDR Website EUDAMED record Report an error
GenMark Diagnostics FDA EU representative : Roche Diagnostics GmbH (Germany) United States A IVDR regulatory.rmd_international@roche.com EUDAMED record Report an error
Globescientific Netherlands A IVDR Website EUDAMED record Report an error
Guangzhou Deaou Gene Technology EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Guangzhou Four E’s Healthcare EU representative : Kingsmead Service B.V. (Netherlands) China A IVDR Website cs4@4e-s.com EUDAMED record Report an error
Guangzhou Hearty Expression Medical Technology EU representative : Everbiz GmbH (Germany) 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
Haierbiomedical FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China A IVDR EUDAMED record Report an error
Hain Lifescience Germany A IVDR 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
Healgen FDA EU representative : CMC Medical Devices & Drugs SL (Spain) United States – 98/79 quality@healgen.com EUDAMED record Report an error
Hettich FDA EU representative : Andreas Hettich GmbH (Germany) Switzerland A IVDR Website info@hettich.ch 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
Hlb Panagene EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea A IVDR Website EUDAMED record Report an error
HplanetBio (Shijiazhuang) EU representative : Lotus NL B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Hunan Xiang Yi Laboratory Instrument Development FDA EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Hysenbiotech EU representative : Medunion S.L. (Spain) South Korea A IVDR EUDAMED record Report an error
Imedikers EU representative : Veritas Eston OÜ (Estonia) South Korea A IVDR info@veritaseston.eu EUDAMED record Report an error
Inpeco FDA EU representative : QbD RepS BV (Belgium) Switzerland A IVDR Regulatory.Affairs@inpeco.com EUDAMED record Report an error
Jiangsu Q-Array EU representative : Caretechion GmbH (Germany) China A IVDR EUDAMED record Report an error
Joinstar EU representative : Lotus NL B.V. (Netherlands) and 1 other China A IVDR EUDAMED record Report an error
Katsura EU representative : Kingsmead Service B.V. (Netherlands) Taiwan A IVDR Website EUDAMED record Report an error
Labex Canada EU representative : Obelis s.a. (Belgium) Canada A IVDR Website info@labexcanada.com EUDAMED record Report an error
Labitec Germany 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
Lifereal EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Lumatas FDA EU representative : Emergo Europe B.V. (Netherlands) United States 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
Medical Devices EU representative : Obelis s.a. (Belgium) Pakistan I MDR Website EUDAMED record Report an error
Megarobo EU representative : MedPath GmbH (Germany) China A IVDR EUDAMED record Report an error
Microprofit EU representative : MedNet EC-REP GmbH (Germany) China A IVDR EUDAMED record Report an error
Mpbio FDA EU representative : MP Biomedicals Germany GmbH (Germany) Germany, Singapore A IVDR Website 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
Nantong Mevid Life Scientific EU representative : Sungo Cert GmbH (Germany) China A IVDR 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
Nev Yazilim Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ Türkiye A IVDR info@nevasoftai.com EUDAMED record Report an error
Ningbo MedicalSystem Biotechnology FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China A IVDR EUDAMED record Report an error
NTP Nano Tech Projects FDA Italy A IVDR info@ntpsrl.biz EUDAMED record Report an error
Optimedical FDA EU representative : Emergo Europe B.V. (Netherlands) United States A IVDR Website EUDAMED record Report an error
OptraSCAN FDA EU representative : AR Experts B.V. (Netherlands) United States A IVDR Website info@optrascan.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
Otsukael FDA EU representative : Emergo Europe B.V. (Netherlands) Japan A IVDR Website EUDAMED record Report an error
Philips FDA Netherlands A IVDR eudamed@philips.com 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
Radon Tibbi̇ Malzemeler İthalat İhracat Pazarlama Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ Türkiye I 93/42 Website info@radonfix.net EUDAMED record Report an error
Regengeek EU representative : MedPath GmbH (Germany) China A IVDR EUDAMED record Report an error
RWD Life Science FDA EU representative : WISELINK MEDICAL, S.L.U. (Spain) China A IVDR Website EUDAMED record Report an error
Samantree FDA EU representative : SamanTree Medical France SASU (France) Belgium, Switzerland I, A IVDR, MDR Website info@samantree.com EUDAMED record Report an error
Scienco Technology EU representative : CMC Medical Devices & Drugs SL (Spain) Taiwan – 98/79 Website EUDAMED record Report an error
Sciex FDA EU representative : Leica Microsystems CMS GmbH (Germany) Singapore A IVDR EUDAMED record Report an error
Sclavo Italy A IVDR, 98/79 qa@sclavo.it EUDAMED record Report an error
Seekxbio EU representative : GRZAN GROUP SL (Spain) China A IVDR EUDAMED record Report an error
Shanghai Howsome Biotechnology EU representative : SUNGO Europe B.V. (Netherlands) 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 Landwind Biomedical Technology EU representative : Lotus NL B.V. (Netherlands) China A IVDR, 98/79 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
Shenzhen YC Biotechnology EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR, 98/79 EUDAMED record Report an error
Shenzhen YOUYI Bioscience EU representative : Umedwings Netherlands B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Shinjin Medics EU representative : Obelis s.a. (Belgium) South Korea A IVDR Website EUDAMED record Report an error
Sigma Laborzentrifugen FDA Germany IIa, A IVDR, MDR Website info@sigma-zentrifugen.de EUDAMED record Report an error
Singlecellbiotech EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China A IVDR EUDAMED record Report an error
Singleragenomics EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) and 1 other China A IVDR RA@singleragenomics.com EUDAMED record Report an error
Skyla EU representative : Medical Technology Promedt Consulting GmbH (Germany) Taiwan 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
Sunlant EU representative : MedPath GmbH (Germany) China A IVDR EUDAMED record Report an error
Suzhou Ruiqian Technologies EU representative : Medunion S.L. (Spain) China A IVDR EUDAMED record Report an error
Taizhou Zecen Biotech EU representative : MedPath GmbH (Germany) China A IVDR 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
Tem Innovations FDA Germany 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
Tiangen EU representative : Humiss International B.V. (Netherlands) China A IVDR Website ran.zhang@tiangen.com EUDAMED record Report an error
Tianjin Dexiang Biotechnology EU representative : Medunion S.L. (Spain) China A IVDR EUDAMED record Report an error
Triolab Sweden A IVDR Website info@triolab.se EUDAMED record Report an error
Wuhan BGI Biomedical Engineering EU representative : MedPath GmbH (Germany) China A IVDR EUDAMED record Report an error
Wuxi Opulen Technology EU representative : SUNGO Europe B.V. (Netherlands) and 1 other China A IVDR EUDAMED record Report an error
Wuxi Qitian Biological Science Instrument EU representative : SUNGO Europe B.V. (Netherlands) 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
Xiamen Zeesan Biotech FDA EU representative : Lotus NL B.V. (Netherlands) China A IVDR info@zsandx.com 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
Zhongshan Ruifu Medical Equipment Technology EU representative : Medunion S.L. (Spain) China A IVDR ra@refmedical.net EUDAMED record Report an error
Zonci EU representative : MedNet EC-REP GmbH (Germany) China A IVDR Website EUDAMED record Report an error
Greiner Bio-One Austria A IVDR Website regulatory-affairs.at@gbo.com EUDAMED record Report an error
77 Elektronika Műszeripari Korlátolt Felelősségű Társaság Hungary IIa MDR Website EUDAMED record Report an error
Ab Analitica Italy A IVDR customersupport@abanalitica.it EUDAMED record Report an error
ABI Enterprises EU representative : CMC Medical Devices & Drugs SL (Spain) Pakistan I MDR 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
ABW Medizin und Technik Germany A IVDR Website info@abw-medizintechnik.de 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
AD Nucleis France A IVDR Website 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
Affymetrix EU representative : Life Technologies Europe B.V. (Netherlands) United States A IVDR 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
Aigene EU representative : SUNGO Europe B.V. (Netherlands) South Korea A IVDR 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
Anhui Wanyi Science Technology EU representative : Eunitor GmbH (Germany) China A IVDR Website 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
Appolon Bioteck France A IVDR Website contact@appolonbioteck.com EUDAMED record Report an error
Aquisel FDA Spain A IVDR EUDAMED record Report an error
AR Instrumed EU representative : AR Instrumed Deutschland GmbH (Germany) Pakistan I MDR Website info@ar-instrumed.com EUDAMED record Report an error
Arteion France B IVDR contact@arteion.com EUDAMED record Report an error
Ascend Diagnostics EU representative : Advena Limited (Malta) United Kingdom (ex Northern Ireland) – 98/79 Website 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
Attomol Germany A IVDR Website info@attomol.de EUDAMED record Report an error
BaSO Biotech EU representative : CMC Medical Devices & Drugs SL (Spain) Taiwan A IVDR Website services@basobiotech.com EUDAMED record Report an error
Baso Diagnostics Zhuhai EU representative : Eunitor GmbH (Germany) China A IVDR EUDAMED record Report an error
Baybio EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Bd FDA Netherlands A IVDR Website EUDAMED record Report an error
Beijing High-Grade Biotechnology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China A IVDR admin@biohighgrade.com EUDAMED record Report an error
Bensrl Italy A IVDR Website EUDAMED record Report an error
BGI Hangzhou CycloneSEQ Technology EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China A IVDR EUDAMED record Report an error
Bio-Novum Poland A IVDR Website EUDAMED record Report an error
BioArray Solutions FDA EU representative : IMMUCOR Medizinische Diagnostik GmbH (Germany) United States A IVDR Website 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
Biocartis FDA Belgium A IVDR Website regulatory@biocartis.com EUDAMED record Report an error
Bioda Diagnostics (Wuhan) EU representative : CMC Medical Devices & Drugs SL (Spain) China A IVDR 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
Bioeksen Türkiye A IVDR Website info@bioeksen.com.tr EUDAMED record Report an error
Biogenvet Romania I MDR contact@biogenvet.ro 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
BioView FDA EU representative : MedNet EC-REP GmbH (Germany) Israel A IVDR Website info@bioview.co.il EUDAMED record Report an error
Blusense Diagnostics Aps Denmark A IVDR Website info@blusense-diagnostics.com EUDAMED record Report an error
Bndhematech EU representative : Umedwings Netherlands B.V. (Netherlands) China I MDR marketing@bndhematech.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
Brightbiomed EU representative : MedPath GmbH (Germany) China A IVDR info@brightbiomed.com EUDAMED record Report an error
BSL FDA EU representative : CMC Medical Devices & Drugs SL (Spain) South Korea I MDR 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
Cepheid FDA EU representative : Cepheid AB (Sweden) United States A IVDR Website EUDAMED record Report an error
Changchun Medicside Medical Technology EU representative : Umedwings Netherlands B.V. (Netherlands) China A IVDR info@mcside.com EUDAMED record Report an error
Changsha CenLee Technology EU representative : SUNGO Europe 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
Changsha Han Biotechnology EU representative : Medunion S.L. (Spain) China A IVDR EUDAMED record Report an error
Changsha Xiangzhi Centrifuge Instrument EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Changzhou Richgenius Medlab EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR info@rich-gen.com EUDAMED record Report an error
Chengdu One-Chip Biotechnology EU representative : Share info GmbH (Germany) China A IVDR EUDAMED record Report an error
Chongqing ME Instruments Technology EU representative : MedPath GmbH (Germany) China A IVDR EUDAMED record Report an error
Chongqing NanFang Numerical ControlEquipment EU representative : Medunion S.L. (Spain) China – 98/79 EUDAMED record Report an error
Chroma Ate FDA EU representative : MedNet EC-REP GmbH (Germany) Taiwan A IVDR Website info@chromaate.com EUDAMED record Report an error
Chubio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China I MDR EUDAMED record Report an error
Cision Vision FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) United States A IVDR EUDAMED record Report an error
CompAI MedTech (Dalian) EU representative : Debao International GmbH (Germany) China A IVDR ra@comp-ai.com EUDAMED record Report an error
Cosmosol Italy IIa MDR Website info@cosmosol-it.com EUDAMED record Report an error
Cowingene EU representative : MedPath GmbH (Germany) China A IVDR Website EUDAMED record Report an error
Ctcells FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea A IVDR Website EUDAMED record Report an error
Cytekbio EU representative : Emergo Europe B.V. (Netherlands) United States A IVDR Website EUDAMED record Report an error
Cytochipinc FDA EU representative : Medunion S.L. (Spain) United States A IVDR quality@cytochipinc.com EUDAMED record Report an error
Dainippon Seiki FDA EU representative : MedNet EC-REP GmbH (Germany) Japan A IVDR Website EUDAMED record Report an error
Danaus Italy A IVDR Website info@danaus.it EUDAMED record Report an error
Datexim France – 98/79 Website contact@datexim.com EUDAMED record Report an error
Delbio EU representative : Emergo Europe B.V. (Netherlands) Taiwan A IVDR Website EUDAMED record Report an error
Dermagnostix Germany – 98/79 Website info@dermagnostix.com EUDAMED record Report an error
Diagast FDA France A IVDR Website contact@diagast.com EUDAMED record Report an error
DiagCor Life Science EU representative : SUNGO Europe B.V. (Netherlands) Hong Kong SAR China A IVDR QARA@diagcorlifescience.com 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
Disera Türkiye A IVDR EUDAMED record Report an error
Di̇a Pro Tibbi̇ Ürünler San. Ve Ti̇c. A.Ş Türkiye A IVDR EUDAMED record Report an error
Doasense Germany A IVDR Website info@doasense.de EUDAMED record Report an error
Domel FDA Slovenia A IVDR Website EUDAMED record Report an error
Draeger FDA Germany – 98/79 Website EUDAMED@draeger.com EUDAMED record Report an error
Ecolidx 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
EKF-diagnostic FDA Germany B IVDR info@ekf-diagnostic.de EUDAMED record Report an error
Element Biosciences EU representative : QbD RepS BV (Belgium) United States A IVDR support@elembio.com EUDAMED record Report an error
Elitbiotech EU representative : CMC Medical Devices & Drugs SL (Spain) China A IVDR EUDAMED record Report an error
EntroGen FDA EU representative : TANJA TOPOVSEK S.P. (Slovenia) United States A IVDR Website contact@entrogen.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
Evident Technology Center Europe Germany A IVDR Website EUDAMED record Report an error
Evidentscientific EU representative : Evident Europe GmbH (Germany) United States A IVDR Website EUDAMED record Report an error
Excilone France A IVDR Website EUDAMED record Report an error
EXIAS Medical Austria A IVDR Website office@exias-medical.com EUDAMED record Report an error
FFEI EU representative : Eurolink Europe Compliance Limited (Ireland) United Kingdom (ex Northern Ireland) A IVDR Website regulatory@ffei.co.uk EUDAMED record Report an error
Flash Pathology Netherlands A IVDR Website info@flashpathology.com EUDAMED record Report an error
Funotec EU representative : GRZAN GROUP SL (Spain) China A IVDR EUDAMED record Report an error
GBUK Group FDA EU representative : Qualrep Services B.V. (Netherlands) United Kingdom (ex Northern Ireland) A IVDR Website customerservices@gbukgroup.com EUDAMED record Report an error
GenBody FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea C IVDR EUDAMED record Report an error
Genedrive EU representative : Advena Limited (Malta) United Kingdom (ex Northern Ireland) A IVDR Website EUDAMED record Report an error
Geneproof Czechia A IVDR Website support@geneproof.com 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
Geneus Technologies (Chengdu) EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Genomictree EU representative : KTR Europe GmbH (Germany) South Korea A IVDR Website EUDAMED record Report an error
Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH Germany A IVDR Website info@gfeblut.de EUDAMED record Report an error
Ginevri Italy A IVDR Website mail@ginevri.com EUDAMED record Report an error
Grant Technology (HK) EU representative : Share info GmbH (Germany) Hong Kong SAR China A IVDR info@gtech.hk EUDAMED record Report an error
Guangzhou Four E’s Scientific FDA EU representative : Humiss Beratung GmbH (Germany) China 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
Guangzhou KOFA Biotechnology EU representative : Medunion S.L. (Spain) China A IVDR EUDAMED record Report an error
Guangzhou Topms Technology EU representative : Share info GmbH (Germany) 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
Gyrozen EU representative : AR Experts B.V. (Netherlands) South Korea A IVDR EUDAMED record Report an error
Haemonetics FDA EU representative : Haemonetics Italia s.r.l (Italy) Switzerland A IVDR regulatoryeurope@haemonetics.com EUDAMED record Report an error
Haimen Rotest Labware Manufacturing EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR export@hmrotest.com EUDAMED record Report an error
Haimen Shengbang Laboratory Equipment FDA EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Hangzhou MiYin Biotechnology EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Hangzhou PathoAl Technology EU representative : BioDomi GmbH (Germany) China A IVDR EUDAMED record Report an error
Hangzhou Yipai Intelligent Technology EU representative : Lotus NL B.V. (Netherlands) China A IVDR 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
Hangzhou Zhunxin Biotechnology EU representative : Lotus NL B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Hanwooltpc FDA EU representative : Javitech Consulting GmbH (Germany) South Korea A IVDR Website EUDAMED record Report an error
Healthy FDA EU representative : AR Experts B.V. (Netherlands) Israel – 98/79 Website EUDAMED record Report an error
Hebei Boxin Recovery Equipment EU representative : SUNGO Europe B.V. (Netherlands) China I MDR info@boxinhomecare.com EUDAMED record Report an error
Hebei Sanxin Pharmaceutical Technology EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Helixgen (GUANGZHOU) EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China – 98/79 EUDAMED record Report an error
HemoCue FDA Sweden A IVDR Website info@hemocue.se EUDAMED record Report an error
Hemonart Türkiye – 98/79 Website info@hemonart.com EUDAMED record Report an error
Hidex Finland A IVDR Website EUDAMED record Report an error
Hosmed Grup Medi̇kal Sağlik Hi̇zmetleri̇ Şi̇rketi̇ Türkiye A IVDR EUDAMED record Report an error
Hrjbio EU representative : CMC Medical Devices & Drugs SL (Spain) China A IVDR Website info@hrjbio.com EUDAMED record Report an error
Huchuang FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China I MDR 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 Biojoint Instrument EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR info@bio-joint.com 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
Hunan Labwe Scientific Instruments EU representative : Humiss Beratung GmbH (Germany) China A IVDR sales@lab-we.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
Hyris Italy A IVDR Website support@hyris.net EUDAMED record Report an error
Igenesis Shanghai EU representative : CMC Medical Devices & Drugs SL (Spain) China A IVDR support@igenesisbio.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
Intelligence Artificielle Applications France A IVDR Website EUDAMED record Report an error
Interlab Italy A IVDR Website 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
Intron EU representative : Obelis s.a. (Belgium) South Korea A IVDR EUDAMED record Report an error
Invenio Imaging FDA EU representative : QbD RepS BV (Belgium) United States A IVDR Website contact@invenio-imaging.com EUDAMED record Report an error
Jazbar International EU representative : KHANG BAO INTERNATIONAL KFT (Hungary) Pakistan I MDR EUDAMED record Report an error
Jeol Mf EU representative : JEOL(Europe)BV AR (Netherlands) Japan A IVDR EUDAMED record Report an error
Jiangsu Bojia Biomedical Technology EU representative : MedPath 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 Jinzhun Biotech EU representative : MedNet EC-REP GmbH (Germany) China A IVDR EUDAMED record Report an error
Jiangsu Kahotest Citotest Labware Manufacturing EU representative : SUNGO Europe B.V. (Netherlands) 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
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
Jiangsu ME Instruments EU representative : MedPath GmbH (Germany) China A IVDR EUDAMED record Report an error
Jiangsu Yuli Medical Instrument EU representative : Sungo Cert GmbH (Germany) China A IVDR EUDAMED record Report an error
Joanlab EU representative : Everbiz GmbH (Germany) China A IVDR 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
Kangjian FDA EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
KenDor Technology (Zhejiang) EU representative : CMC Medical Devices & Drugs SL (Spain) China A IVDR EUDAMED record Report an error
Keylights EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Kogene EU representative : Obelis s.a. (Belgium) South Korea A IVDR Website info@kogene.co.kr EUDAMED record Report an error
Konan FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) Japan A IVDR Website EUDAMED record Report an error
Kotsteel EU representative : CMC Medical Devices & Drugs SL (Spain) Pakistan I MDR Website EUDAMED record Report an error
Labpathexperts Poland I MDR Website office@labpathexperts.com EUDAMED record Report an error
Langenbrinck Germany 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
Locmedt EU representative : Lotus NL B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Longgene EU representative : MedPath GmbH (Germany) China A IVDR info@longgene.com EUDAMED record Report an error
Longlight Technology EU representative : GRZAN GROUP SL (Spain) China A IVDR marketing@longlightech.com EUDAMED record Report an error
Luminexcorp FDA EU representative : DiaSorin Italia S.p.A. (Italy) United States A IVDR Website regulatoryaffairs@luminexcorp.com EUDAMED record Report an error
Mark One Surgical EU representative : KHANG BAO INTERNATIONAL KFT (Hungary) Pakistan I MDR Website sales@markonesurgical.com EUDAMED record Report an error
Masmec FDA Italy A IVDR Website 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
Medical Wire & Equipment Bath EU representative : Advena Limited (Malta) United Kingdom (ex Northern Ireland) – 98/79 Website info@mwe.co.uk EUDAMED record Report an error
Medspo EU representative : ANTEX MEDI SOLUTION (Germany) Pakistan I MDR Website EUDAMED record Report an error
Mehrish EU representative : ANTEX MEDI SOLUTION (Germany) Pakistan I MDR Website EUDAMED record Report an error
Meyosis Türkiye I MDR Website info@meyosis.com EUDAMED record Report an error
Mgitech Latvia A IVDR Website EUDAMED record Report an error
Miracell FDA EU representative : CMC Medical Devices & Drugs SL (Spain) South Korea A IVDR Website EUDAMED record Report an error
Morphlelabs FDA EU representative : Amstermed B.V. (Netherlands) India A IVDR sales@morphlelabs.com EUDAMED record Report an error
MTD Diagnostics Italy – 98/79 Website EUDAMED record Report an error
Möller Medical FDA Germany I MDR Website info@moeller-medical.com EUDAMED record Report an error
nal von minden Germany A IVDR Website info@nal-vonminden.com EUDAMED record Report an error
Nanjing Superfit I & E EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Nantong Huayun Medical Equipment Technology EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Neomedica EU representative : Wellkang Ltd (Northern Ireland) Serbia A IVDR Website EUDAMED record Report an error
Newmars Technologies Kft Hungary IIa 93/42 EUDAMED record Report an error
Next Level Italy A IVDR EUDAMED record Report an error
Nikon FDA EU representative : Nikon Europe B.V. (Netherlands) Japan A IVDR Regulatory.Affairs@nikon.com EUDAMED record Report an error
Ningbo Greetmed Medical Instruments FDA EU representative : MedPath GmbH (Germany) China I MDR EUDAMED record Report an error
Noul FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea – 98/79 Website cs@noul.com EUDAMED record Report an error
Novabone FDA EU representative : Emergo Europe B.V. (Netherlands) United States I 93/42 Website EUDAMED record Report an error
Novapro FDA EU representative : Javitech Consulting GmbH (Germany) South Korea 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
Nüve Sanayi̇ Malzemeleri̇ İmalat Ve Ti̇caret Anoni̇m Şi̇rketi̇ Türkiye IIa 93/42 Website 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
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
Paitzar EU representative : Metridium OÜ (Estonia) Iran A IVDR Website info@paitzar.am EUDAMED record Report an error
Pakkts EU representative : CS Active (Latvia) Pakistan I MDR Website info@pakkts.com EUDAMED record Report an error
PAL Finland Finland – 98/79 Website EUDAMED record Report an error
Pathcom Systems FDA EU representative : Hab Gov Strategics Applied Technologies Limited (Malta) United States A IVDR Website info@pathcomx.com EUDAMED record Report an error
PCL EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea A IVDR Website EUDAMED record Report an error
Personalgenome FDA EU representative : Emergo Europe B.V. (Netherlands) United States C IVDR Website EUDAMED record Report an error
Phadia FDA Sweden A IVDR Website RegulatoryAffairs.Uppsala.IDD@thermofisher.com EUDAMED record Report an error
PHC FDA EU representative : PHC Europe B.V. (Netherlands) Japan I MDR EUDAMED record Report an error
Pinnacles (Suzhou) Medical Technology EU representative : Lotus NL B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Pixcell Medical FDA EU representative : AR Experts B.V. (Netherlands) Israel B IVDR Website info@picxell-medical.com EUDAMED record Report an error
PreciPoint Germany A IVDR Website info@precipoint.de EUDAMED record Report an error
Qualigeninc FDA EU representative : MDSS GmbH (Germany) United States A IVDR Website EUDAMED record Report an error
Quantidx Hong Kong EU representative : MedPath GmbH (Germany) Hong Kong SAR China A IVDR 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
Rajimp EU representative : CS Active (Latvia) Pakistan I MDR info@rajimp.com EUDAMED record Report an error
Raydentinst EU representative : ANTEX MEDI SOLUTION (Germany) Pakistan I MDR Website info@raydentinst.com EUDAMED record Report an error
Realmindbio EU representative : Sungo Cert GmbH (Germany) 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
Rgbio EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Rheonova France – 98/79 Website EUDAMED record Report an error
Sacace Italy A IVDR Website info@sacace.com EUDAMED record Report an error
Sarstedt FDA Germany A IVDR Website EUDAMED record Report an error
Seegene FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea A IVDR Website info@seegene.com EUDAMED record Report an error
Sensacore EU representative : Obelis s.a. (Belgium) India A IVDR Website EUDAMED record Report an error
Sense Biodetection EU representative : Emergo Europe B.V. (Netherlands) United Kingdom (ex Northern Ireland) – 98/79 Website info@sense-bio.com EUDAMED record Report an error
Shandong Baiou Medical Technology EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Shanghai Lu Xiangyi Centrifuge Instrument FDA EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Shanghai Nokayun Medical Technology EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Shanghai Rendu Biotechnology EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China A IVDR EUDAMED record Report an error
Shanghai Zj Bio-Tech FDA EU representative : Lotus NL B.V. (Netherlands) China 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 Cinnaray Life Technology EU representative : HUMISS TRADING S. L. (Spain) China A IVDR EUDAMED record Report an error
Shenzhen CoooSeee Biomedical EU representative : MedNet EC-REP GmbH (Germany) China B IVDR service@comenbio.com EUDAMED record Report an error
Shenzhen Huisong Technology Development EU representative : Lotus NL B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Shenzhen MGI Biological Electronic Technology EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China A IVDR EUDAMED record Report an error
Shenzhen Tiantong Diagnostic Technology EU representative : GRZAN GmbH (Germany) China A IVDR EUDAMED record Report an error
ShijiYiKang (Tianjin) Medical Technology Development EU representative : HUMISS TRADING S. L. (Spain) China A IVDR EUDAMED record Report an error
Shinva FDA EU representative : Eunitor GmbH (Germany) China A IVDR EUDAMED record Report an error
Shinwha Medi EU representative : Advena Limited (Malta) South Korea A IVDR Website EUDAMED record Report an error
Sinobiocan EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China I MDR EUDAMED record Report an error
Stago FDA France A IVDR 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
Stratipath Sweden – 98/79 Website info@stratipath.com EUDAMED record Report an error
Surgnova FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIb MDR qara@surgnova.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 Changhe Biotech EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR 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 Sniper Medical Technologies FDA EU representative : MedPath GmbH (Germany) China A IVDR Website EUDAMED record Report an error
Swissmeca EU representative : Axon Lab AG (Austria) Switzerland A IVDR Website Info@swissmeca.ch EUDAMED record Report an error
Taho Future ( Tianjin ) Biotechnology EU representative : MedPath GmbH (Germany) China A IVDR info@tahobiology.com EUDAMED record Report an error
tanit evolution France I MDR Website EUDAMED record Report an error
tascom EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea A IVDR EUDAMED record Report an error
Tcoag FDA Ireland – 98/79 Website 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
Theradial France – 98/79 Website reglementaire@theradial.com 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
Todylaboratories Romania A IVDR Website contact@todylaboratories.com EUDAMED record Report an error
Toroivd Technology EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Tribo Poland I MDR Website EUDAMED record Report an error
Utsat Türkiye A IVDR Website info@utsat.com.tr EUDAMED record Report an error
Vela Operations Singapore Pte FDA EU representative : Vela Diagnostics Germany GmbH (Germany) Singapore A IVDR Website infoAPAC@veladx.com EUDAMED record Report an error
Vigilant Biosciences FDA EU representative : Vigilant Biosciences GmbH (Germany) United States A IVDR 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
Virtue Diagnostics (Suzhou) EU representative : Kingsmead Service B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Vitro FDA Spain A IVDR Website regulatory@vitro.bio EUDAMED record Report an error
Vodenmedical Italy A IVDR Website EUDAMED record Report an error
Waters FDA EU representative : Emergo Europe B.V. (Netherlands) United States A IVDR 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
Wholecare Biomedical FDA EU representative : MDSS GmbH (Germany) Taiwan – 98/79 info.wholecare@microlife.com.tw EUDAMED record Report an error
Winnoz EU representative : MedNet EC-REP GmbH (Germany) Taiwan A IVDR Website service@winnoz.com EUDAMED record Report an error
Wizbiotech EU representative : QbD RepS BV (Belgium) China A IVDR EUDAMED record Report an error
Wuhan Heer Medical Technology Development EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Wuxi Yanzhong Biotechnology EU representative : AION CIRCUITS, LDA (Portugal) China A IVDR EUDAMED record Report an error
Wuzhou Aokace Technology EU representative : SUNGO Europe B.V. (Netherlands) China I MDR EUDAMED record Report an error
Yancheng Huida Biotechnology EU representative : SUNGO Europe B.V. (Netherlands) 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
Youpubiotech EU representative : MedPath GmbH (Germany) China A IVDR ra@youpubiotech.com EUDAMED record Report an error
Zhejiang Gewuzhizhi Biotechnology EU representative : Llins Service & Consulting GmbH (Germany) China A IVDR Website EUDAMED record Report an error
Zhongke Meiling Cryogenics FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China A IVDR EUDAMED record Report an error
Zinexts EU representative : Obelis s.a. (Belgium) Taiwan A IVDR Website EUDAMED record Report an error
Žikplast Žitnik Anja Slovenia A IVDR EUDAMED record Report an error
Ns Biotec EU representative : CMC Medical Devices & Drugs SL (Spain) No model still on the market Egypt
3 others
 – 98/79 Website info@nsbiotec.com EUDAMED record Report an error
Xpenarray EU representative : CMC Medical Devices & Drugs SL (Spain) No model still on the market China
3 others
 – 98/79 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
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
Mobidiag No model still on the market Finland A IVDR Website sales.mob@hologic.com EUDAMED record Report an error
Primadiag No model still on the market France A IVDR Website 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
S.D. Sight Diagnostics FDA EU representative : CEpartner4U (Netherlands) No model still on the market Israel – 98/79 Website info@sightdx.com 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
Uniogen No model still on the market Finland A IVDR info@uniogen.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) 944

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)
SCC SOFT COMPUTER United States SoftPathDx SoftBiochemistry SoftHLA SoftLab SoftCytogenetics SoftMolecular registered
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)
Remel Co. Present in Europe in other categories United States REMEL BACTICARD Remel™ RapID™ ERIC™ (ELECTRONIC RAPID IDENTIFICATION COMPENDIUM) PLATE DRY CLI GRAM+ ID AUTO SENSITITRE YEASTONE SUSCEPTIBILITY PLATES THE SENSITITRE AIM K935124 (1994)
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)
Thermo Electron LED GmbH – Thermo Scientific Fisher Scientific Cardinal Fisherbrand registered
Sarstedt Aktiengesellschaft & Co.KG – Sediplus® S 200, 12 V DC Sediplus® S 2000 NX De-/Recapper 900 Flex ID, 115V De-/Recapper 900 Flex ID,115 V DCRC 900 Flex ID - Flow Health Aliquoter PVS 2125, 115 V registered
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)
Life Technologies Corporation United States SAE Admin Console Dx Software V1.0 Kit Diomni™ Software, V3.1.0 QuantStudio Dx Software V1.0.3, Kit SAE Admin Console Dx Software V1.2.0 Kit appliedbiosystems QuantStudioTM 7 Pro Dx Software DIOMNI SW V2.0.0 USB KIT K191030 (2020)
HENRY SCHEIN, INC. Present in Europe in other categories United States Henry Schein CardioChek 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 LW Scientific, Inc. E8 Combination Centrifuge, digital registered
BTNX Inc – Rapid Response registered
MCKESSON MEDICAL-SURGICAL INC. – McKesson registered
CAPlugs Present in Europe in other categories United States Caplugs/Evergreen registered
PLASMABIOTICS Present in Europe in other categories – Silicone connection set for colonoscopes, gastroscopes and duodenoscopes FUJIFIL Silicone connection set for colonoscopes, gastroscopes and duodenoscopes OLYMPUS Silicone connection set for colonoscopes, gastroscopes and duodenoscopes PENTAX Autoclavable version of Fg5W C-G-D Autoclavable version of OP B-Bp Autoclavable version of OW C-G-D 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
Cardinal Health 200, LLC Present in Europe in other categories United States CARDINAL HEALTH registered
Helena Laboratories United States Cascade M-4 (110V/220V) Helena Ristocetin Plateletworks Collagen Kit Plateletworks Combo-10 Kit Plateletworks Combo-25 Kit Plateletworks ADP Kit K061014 (2006)
Phoenix Diagnostics, Inc. United States PHOENIX DIAGNOSTICS, INC. Phoenix Diagnostics K020364 (2002)
Scientific Device Laboratory, Inc. United States – registered
HARDY DIAGNOSTICS United States HardyFlask™ ParaCon QuickSlide™ registered
Roche Molecular Systems, Inc. United States COBAS®TaqMan® 48 Analyzer COBAS® TaqMan® cobas&#x00AE prime Pre-analytical System AVENIO Edge System cobas&#x00AE prime Secondary Tube Tray AcfS Library Robot P100020 (2026)
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)
MOORE MEDICAL LLC – Moore Medical registered
MEDLINE INDUSTRIES, INC. Present in Europe in other categories United States Medline MEDLINE INDUSTRIES 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)
Biobase Biodustry(Shandong)Co., Ltd. China BIOBASE BIOBASEBK200mini registered
JANT PHARMACAL CORPORATION – Accustrip 10-Parameter Urine Reagent Strip Accutest Accustrip URS Strips + Reader LipidPlus® Meter LipidPlus® Glucose Test Strips registered
Caliper Life Sciences, Inc. – JANUS G3 Fontus JANUS G3 Blood iQ Janus G3 Automated Workstation JANUS G3 NGS Express registered
Precision Systems, Inc. United States Multi-OSMETTE OSMETTE Sample Tubes, 30 ul OSMETTE XL Micro-OSMETTE OSMETTE III OSMETTE A registered
Fisher Scientific Co., LLC United States Fisherbrand registered
Arteriocyte Medical Systems, Inc. Present in Europe in other categories United States Magellan Autologous Platelet Separator System Magellan Aspiration kit Magellan Complete One Source Kit Magellan Complete Disposable Kit Magellan Surgical tools for erythrocyte & marrow preparation kit 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)
Bruker Daltonik GmbH Germany MBT Pilot System - US IVD MALDI Biotyper sirius CA System MALDI Biotyper-BD sirius CA System MALDI Biotyper CA System MALDI Biotyper-BD sirius one CA System MALDI Biotyper sirius one CA System registered
INFRARED LABORATORY SYSTEMS LLC United States Synermed® registered
BIO SB, INC. Present in Europe in other categories United States TintoStainer Plus Automated System Mini TintoStainer Plus Automated System TintoStainer Plus Automated System LX TintoReagent Container used with tube 6mL TintoDetector Incubator TintoSlide Tray registered
EMCYTE CORP. United States Accelerate Platelet Concentrating System PRP-S 30mL Accelerate II Platelet Concentrating System PRP-S 30mL Accelerate II Platelet Concentrating System PRP-S 60mL AbsolutePRP 60mL GenesisCS Component Concentrating System PurePRP II 60mL GenesisCS Component Concentrating System PureBMC-120mL GenesisCS Component Concentrating System K183205 (2019)
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)
Lifehealth – CC Cartridge GL Cartridge H4 Cartridge H3 Cartridge BG Cartridge LA Cartridge registered
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)
SAKURA FINETEK U.S.A., INC. Present in Europe in other categories United States Tissue-Tek® TEC™ 6 Tissue-Tek AutoTEC® a120 Tissue-Tek Xpress® Tissue-Tek VIP® Tissue-Tek VIP® 6 Tissue-VIP® 6 AI K881165 (1988)
Trek Diagnostic Systems, Inc. Present in Europe in other categories United States Sensititre Sensititre AIM™ Sensititre™ OptiRead™ Thermo Scientific™ Sensititre™ ARIS HiQ™ System STP8F K110583 (2011)
Andwin Scientific United States Andwin Scientific Papette Andwin Rovers Safetex K983599 (1998)
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
EQUASHIELD MEDICAL LTD Israel CellSHILED EQUASHIELD registered
ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD. Present in Europe in other categories China Gongdong registered
BIONIME CORPORATION Present in Europe in other categories United States GE Rightest ODM K113007 (2012)
Rovers Medical Devices B.V. United States Rovers® Cervex-Brush® Rovers® Cervex-Brush® Combi Rovers® EndoCervex-Brush® Rovers® Viba-Brush® Rovers® Cervex-Brush® RT Rovers® EndoCervex-Brush®-S RT K043369 (2005)
Zhejiang CuraWay Medical Technology Co., Ltd. Present in Europe in other categories China Curaway K222001 (2023)
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
Oxoid U.S.A., Inc. Present in Europe in other categories United States COLUMBIA BLOOD AGAR BASE NUTRIENT BROTH BLOOD FREE CAMPY SELECT AGAR DERMASEL AGAR BASE SIGNAL BLOOD CULTURE SYSTEM 1 X 20 SHEEP BLOOD AGAR NO 2 K862946 (1986)
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)
AnalytiChem USA, Inc. United States Redipor registered
Chengdu Rich Science Industry Co., Ltd. Present in Europe in other categories – C.D.RICH registered
Diagnostic Automation, Inc. – QMedix™ InstaTest Diagnostic Automation, Inc. Diagnostic Automation registered
CliniSys, Inc United States Clinisys Atlas Clinisys Laboratory Solution Clinisys SQ Lab Sunquest Atlas Clinisys Laboratory Solutions Clinisys SQ Blood Bank 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
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
Dynarex Corporation United States LabChoice Centrifuge Tubes, Polypropylene, 50 ML, Sterile LabChoice Centrifuge Tubes, Polypropylene, 50ML LabChoice Microcentrifuge Tubes, Polypropylene, 2mL, Sterile LabChoice Centrifuge Tubes, Polypropylene LabChoice Centrifuge Tubes, Polypropylene, 50 ML LabChoice Microcentrifuge Tubes, Polypropylene, 1.5mL, Sterile registered
Awareness Technology, Inc. United States SelectaLyte (Potassium Electrode) SelectaLyte (Sodium Electrode) SelectaLyte (Chloride Electrode) SelectaLyte StatFax ChemWell® FUSION K171476 (2018)
Celling Biosciences – ART BMC System Centrifuge Celling ART BMC System Celling ART BMC Plus Celling ART BMC registered
POREX CORPORATION United States POREX SQ-EASY POREX SQ-EASY Prefilter 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)
Mechatronics USA LLC – Starrsed RPI registered
RESEARCH AND DIAGNOSTIC SYSTEMS, INC. – Research and Diagnostic Systems registered
RICHARD-ALLAN SCIENTIFIC COMPANY Present in Europe in other categories – Epredia registered
CRYO BIO SYSTEM United States STERILE 0.3 ML CBS STRAW WITH WHITE JACKET AND WHITE FLEXIBLE ROD / BLISTER 5X15 STERILE 0.3 ML CBS STRAW WITH WHITE JACKET AND GREEN FLEXIBLE ROD / BLISTER 5X15 CBS STERILE HIGH SECURITY TUBE BY 50 UNITS STERILE CBS 0.5 ML STRAW FOR SPERM WITH YELLOW COTTON PLUG / 5 X 20 STERILE CBS 0.5 ML STRAW FOR SPERM WITH COTTON PLUG / 5 x 20 STERILE 0.3 ML CBS STRAW WITH WHITE JACKET AND RED FLEXIBLE ROD / BLISTER 5X15 K002595 (2000)
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
AIM LAB AUTOMATION TECHNOLOGIES PTY LTD Australia PATHFINDER registered
BIOTEST MEDICAL CORPORATION – Oracle Perfect 3 Smartest PersonaII B T M 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
HELMER, INC. United States Helmer Scientific QuickThaw® registered
WELLSKY CORPORATION United States WellSky Transfusion WellSky Blood Centers WellSky Blood - Emergency Issue HCLL LifeTrak registered
Abbott Rapid Diagnostics Informatics, Inc. – RALS registered
AngioDynamics, Inc. United States NanoKnife K253198 (2026)
COPAN ITALIA SPA Present in Europe in other categories Italy LBM® Thiol Broth BHI BROTH Inoculation Loops Inoculation Needles Sputum Dipper registered
RUSHABH INSTRUMENTS, LLC United States HistoPro® registered
BIOCARE MEDICAL LLC Present in Europe in other categories – intelliPATH MAX intelliPATH Plus Decloaking Chamber™ NxGen Decloaking Chamber™ NxGen Reconditioned intelliPATH FLX Automated Slide Staining System registered
Corning Incorporated United States Corning 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)
ANITOA BIOTECHNOLOGY(HANGZHOU)CO.,LTD. – Fluorescence Quantitative PCR Detection System registered
AccuTec, Inc. United States AccuThrive® registered
Alere Scarborough, Inc. United States COVID-19 Swab Transport Accessory Pack Alere™ i Instrument ID NOW™ Instrument ID NOW Strep A 2 Control Swab Kit ID NOW RSV ID NOW RSV Control Swab Kit K151690 (2015)
MERCEDES MEDICAL, LLC – Tanner Scientific® registered
TRIVIDIA HEALTH, INC. United States TRUEtrack TRUEbalance TRUEplus TRUEmanager registered
BIOTECHNOLOGY INSTITUTE SL – ENDORET SYSTEM V CENTRIFUGE HEATING OVEN H-PLUS ENDORET® TEST-TUBE RACK FOR 9 ML TUBES 30MM BOROSILICATE VESSEL SAMPLE PREPARATION KIT ENDORET® TEST-TUBE RACK WITH COVER FOR TRANSPORT registered
Cardinal Health 110, Inc. – LEADER registered
Dakewe (Shenzhen) Medical Equipment Co., Ltd. China MT1 Rotary Microtome CT520 Cryostat Microtome CT620 Cryostat Microtome 6250 Cryostat Microtome HP300Plus Automatic Tissue Processor HP-HUGO Automatic Tissue Processor registered
KB Medical (group), Inc. – KBMED 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
Medtronic, Inc. Present in Europe in other categories United States CLOTtrac™ RACT CLOTtrac® HEPtrac® HEPline® registered

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