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Emdyca

In vitro diagnostic medical devices

EMDN code W

1,558 manufacturers, 31,626 models including 31,133 on the market, 51 countries

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Manufacturers registered in Europe (EUDAMED) 1,558
  • 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
Bio SB FDA EU representative : QAdvis EAR AB (Sweden) United States
3,061 others
– 98/79 Website ra@biosb.com EUDAMED record Report an error
Vitrosens Türkiye
646 others
A, B, C IVDR, 98/79 Website info@vitrosens.com EUDAMED record Report an error
Hangzhou Alltest Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other China
595 others
A, B, C IVDR, 98/79 info@alltests.com.cn EUDAMED record Report an error
Intervactechnology Estonia
588 others
– 98/79 Website EUDAMED record Report an error
Cell Marque EU representative : Emergo Europe B.V. (Netherlands) United States
430 others
A, B, C IVDR, 98/79 Website EUDAMED record Report an error
Greiner Bio-One Austria
390 others
A IVDR, 98/79 Website regulatory-affairs.at@gbo.com EUDAMED record Report an error
Zytomed Systems Germany
334 others
– 98/79 Website info@zytomed-systems.de EUDAMED record Report an error
Acro Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other United States
325 others
A IVDR, 98/79 info@acrobiotech.com EUDAMED record Report an error
Euroimmun FDA Germany
320 others
A, B, C IVDR, 98/79 Website info@euroimmun.de EUDAMED record Report an error
Sarstedt FDA Germany
316 others
A IVDR, 98/79 Website EUDAMED record Report an error
Zeta FDA EU representative : Emergo Europe B.V. (Netherlands) United States
314 others
– 98/79 Website EUDAMED record Report an error
Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇ Türkiye
283 others
A, B, C IVDR Website info@visionbiotechnology.com EUDAMED record Report an error
TestLine Clinical Diagnostics s.r.o Czechia
275 others
B, C IVDR, 98/79 Website info@testlinecd.com EUDAMED record Report an error
Leicabiosystems FDA EU representative : AR Experts B.V. (Netherlands) and 1 other Australia, Germany, United Kingdom (ex Northern Ireland), United States
271 others
A, B, C IVDR, 98/79 Website support.de@LeicaBiosystems.com EUDAMED record Report an error
Gold Standard Diagnostics FDA EU representative : Emergo Europe B.V. (Netherlands) Germany, United States
269 others
A IVDR, 98/79 Website info.frankfurt@eu.goldstandarddiagnostics.com EUDAMED record Report an error
Dymind EU representative : Eunitor GmbH (Germany) China
249 others
A, B IVDR, 98/79 regulationdept@dymind.com EUDAMED record Report an error
Healgen FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other United States
246 others
– 98/79 quality@healgen.com EUDAMED record Report an error
Rapid Labs EU representative : Advena Limited (Malta) and 1 other United Kingdom (ex Northern Ireland)
231 others
A IVDR, 98/79 Website info@rapidlabs.co.uk EUDAMED record Report an error
Dartmon FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 2 others China
228 others
A IVDR, 98/79 Website EUDAMED record Report an error
Vircell Spain
220 others
A, B, C, D IVDR, 98/79 EUDAMED record Report an error
Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
212 others
A, B, C IVDR, 98/79 EUDAMED record Report an error
Abbott FDA EU representative : Abbott B.V. (Netherlands) and 5 others Germany, Ireland, Japan, South Korea, United Kingdom (ex Northern Ireland), United States
213 others
A, B, C, D IVDR, 98/79 Website ratransfusionmedicine@abbott.com EUDAMED record Report an error
ZytoVision FDA Germany
210 others
C IVDR, 98/79 Website info@zytovision.com EUDAMED record Report an error
Shanghai Zj Bio-Tech FDA EU representative : Lotus NL B.V. (Netherlands) and 1 other China
207 others
A IVDR, 98/79 Website EUDAMED record Report an error
Ttt Sağlik Hi̇zmetleri̇ Eği̇ti̇m İnşaat Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ Türkiye
202 others
– 98/79 EUDAMED record Report an error
Idilbiotech Türkiye
195 others
– 98/79 Website EUDAMED record Report an error
Sansure FDA EU representative : Lotus NL B.V. (Netherlands) and 3 others China
213 others
A, B, C IVDR, 98/79 Website info@sansure.com.cn EUDAMED record Report an error
Newlink Biotech EU representative : VidaQuick Biotech S.L. (Spain) China
184 others
A IVDR, 98/79 Website info@kylinew.com EUDAMED record Report an error
Agilent FDA EU representative : Agilent Technologies Denmark ApS (Denmark) Singapore, United States
199 others
A, C IVDR, 98/79 Website info.dk@agilent.com EUDAMED record Report an error
Biocyc Germany
170 others
A, C IVDR, 98/79 Website info@biocyc.de EUDAMED record Report an error
Vitro FDA Romania, Spain
168 others
A, B, C IVDR, 98/79 Website regulatory@vitro.bio EUDAMED record Report an error
Wuhan Life Origin Biotech Joint Stock EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) and 1 other China
154 others
– 98/79 EUDAMED record Report an error
SSI Diagnostica FDA Denmark
153 others
A IVDR, 98/79 Website info@ssidiagnostica.com EUDAMED record Report an error
Oacp Ireland
149 others
A IVDR, 98/79 Website EUDAMED record Report an error
Stago FDA France
141 others
A, B, C IVDR, 98/79 EUDAMED record Report an error
DiaSorin FDA EU representative : DiaSorin Italia S.p.A. (Italy) Italy, United States
139 others
A, B, C IVDR, 98/79 Website ivdr_dsu@diasorin.com EUDAMED record Report an error
Technoclone Austria
137 others
A, C IVDR, 98/79 Website regulatory@technoclone.com EUDAMED record Report an error
Shenzhen Zijian Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
134 others
A IVDR, 98/79 Website sales@szzijian.com EUDAMED record Report an error
Dirui FDA EU representative : Emergo Europe B.V. (Netherlands) and 1 other China
133 others
A, B, C IVDR, 98/79 EUDAMED record Report an error
LGC Clinical Diagnostics FDA EU representative : MediMark Europe Sarl. (France) United States
127 others
B IVDR, 98/79 EUDAMED record Report an error
Mindray FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
122 others
A, B, C, D IVDR, 98/79 Website EUDAMED record Report an error
Biobase FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
118 others
I, A IVDR, MDR, 98/79 EUDAMED record Report an error
Hangzhou Laihe Biotech FDA EU representative : Medunion S.L. (Spain) and 1 other China
117 others
B, C IVDR, 98/79 office@lyher.com EUDAMED record Report an error
AusDiagnostics EU representative : Advena Limited (Malta) and 1 other Australia
115 others
A IVDR, 98/79 Website regulatory@r-biopharm.com.au EUDAMED record Report an error
Ant Biyoteknoloji Sanayi Ve Ticaret Anonim Sirketi Türkiye
113 others
C IVDR, 98/79 Website EUDAMED record Report an error
Maccura EU representative : CMC Medical Devices & Drugs SL (Spain) and 2 others China
113 others
A, B IVDR, 98/79 Website EUDAMED record Report an error
Mikrogen Germany
113 others
A, B, C IVDR, 98/79 EUDAMED record Report an error
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş Türkiye
112 others
– 98/79 Website info@turklab.com.tr EUDAMED record Report an error
Beckman Coulter FDA EU representative : Beckman Coulter Ireland Inc. (Ireland) Germany, Ireland, Japan, United States
111 others
A, B, C IVDR, 98/79 Website ra.clare@beckman.com EUDAMED record Report an error
Disera Türkiye
110 others
A IVDR, 98/79 EUDAMED record Report an error
Siemens Healthcare Diagnostics Products FDA EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland) Germany, United Kingdom (ex Northern Ireland)
110 others
A, B, C, D IVDR, 98/79 Website contact@siemens-healthineers.com EUDAMED record Report an error
Siemens Healthcare Diagnostics FDA EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland) United States
109 others
A, B, C, D IVDR, 98/79 Website contact@siemens-healthineers.com EUDAMED record Report an error
Medcaptain FDA EU representative : R Sight B.V. (Netherlands) China
108 others
A, C IVDR, 98/79 Website info@medcaptain.com EUDAMED record Report an error
Rayto EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
106 others
A, B IVDR, 98/79 Website support@rayto.com EUDAMED record Report an error
Beijing Applied Biological Technologies EU representative : Luxus Lebenswelt GmbH (Germany) and 1 other China
104 others
A IVDR, 98/79 EUDAMED record Report an error
Lifotronic FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) and 1 other China
103 others
A, B, C IVDR, 98/79 Website EUDAMED record Report an error
Instrumentation Laboratory FDA EU representative : Instrumentation Laboratory SpA (Italy) United States
99 others
A, B, C IVDR Website Regulatory@werfen.com EUDAMED record Report an error
Talentbiomedical EU representative : SUNGO Europe B.V. (Netherlands) China
96 others
– 98/79 EUDAMED record Report an error
Vivachek FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
95 others
A IVDR, 98/79 info@vivachek.com EUDAMED record Report an error
Acesolab FDA EU representative : VidaQuick Biotech S.L. (Spain) United States
91 others
A IVDR, 98/79 info@acesolab.com EUDAMED record Report an error
Bioperfectus FDA EU representative : MedNet EC-REP GmbH (Germany) and 2 others China
89 others
A, C IVDR, 98/79 EUDAMED record Report an error
R&D Systems FDA EU representative : BIO-TECHNE SAS (France) United States
88 others
B IVDR, 98/79 regulatorydiagnosticsdivision@bio-techne.com EUDAMED record Report an error
Assure Tech. (Hangzhou) EU representative : CMC Medical Devices & Drugs SL (Spain) and 2 others China
82 others
A, B, C IVDR, 98/79 Website contact@diareagent.com EUDAMED record Report an error
Tongzhoubio FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
82 others
B IVDR, 98/79 EUDAMED record Report an error
bioMérieux FDA EU representative : bioMérieux SA (France) France, United States
81 others
A, B, C IVDR, 98/79 EUDAMED record Report an error
Zybio FDA EU representative : Lotus NL B.V. (Netherlands) and 2 others China
81 others
A, B, C IVDR, 98/79 PMS@zy-ivd.com EUDAMED record Report an error
Bioxol Hungary
80 others
A IVDR Website EUDAMED record Report an error
Vidia Czechia
79 others
– 98/79 Website EUDAMED record Report an error
AB Medical EU representative : KTR Europe GmbH (Germany) South Korea
78 others
A IVDR, 98/79 Website EUDAMED record Report an error
Human Germany
77 others
A, B IVDR, 98/79 Website EUDAMED record Report an error
Sanymed Italy
75 others
A IVDR, 98/79 Website info@sanymed.it EUDAMED record Report an error
Sysmex FDA EU representative : Sysmex Europe SE (Germany) Japan
77 others
A, C IVDR, 98/79 ra_archive@sysmex.co.jp EUDAMED record Report an error
Boditech FDA EU representative : Obelis s.a. (Belgium) South Korea
73 others
A, B, C IVDR, 98/79 Website marketing@boditech.co.kr EUDAMED record Report an error
Copan Italia FDA Italy
73 others
A IVDR, 98/79 Website regulatory.affairs@copangroup.com EUDAMED record Report an error
R-Biopharm FDA Germany
73 others
A, B, C IVDR, 98/79 Website EUDAMED record Report an error
Fortress Diagnostics Northern Ireland
72 others
– 98/79 Website info@fortressdiagnostics.com EUDAMED record Report an error
Pro-Lab Diagnostics EU representative : Advena Limited (Malta) Canada
72 others
– 98/79 Website support@pro-lab.com EUDAMED record Report an error
Clonit Italy
70 others
A, C IVDR, 98/79 Website info@clonit.it EUDAMED record Report an error
Diagnostic BioSystems FDA EU representative : MedEnvoy Global BV (Netherlands) United States
69 others
A IVDR, 98/79 EUDAMED record Report an error
Diapath FDA Italy
69 others
A IVDR Website info@diapath.com EUDAMED record Report an error
Kangsheng Information Technology (Hangzhou) EU representative : Crealkraft GmbH (Germany) China
69 others
– 98/79 EUDAMED record Report an error
Encode EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
68 others
– 98/79 Website EUDAMED record Report an error
Microbiologics FDA EU representative : MediMark Europe Sarl. (France) United States
67 others
A, B IVDR Website info@microbiologics.com EUDAMED record Report an error
Zenith Lab (Jiangsu) EU representative : Umedwings Netherlands B.V. (Netherlands) China
67 others
A IVDR Website service@labzj.com EUDAMED record Report an error
Atlas Medical FDA Germany
66 others
– 98/79 Website info@atlas-medical.com EUDAMED record Report an error
Bioer FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
66 others
A, B, C IVDR, 98/79 Website ra_oversea@bioer.com.cn EUDAMED record Report an error
Bitrumed EU representative : VidaQuick Biotech S.L. (Spain) China
65 others
– 98/79 info@bitrumed.com.cn EUDAMED record Report an error
Wuhan Easydiagnosis Biomedicine EU representative : CMC Medical Devices & Drugs SL (Spain) and 2 others China
149 others
– 98/79 EUDAMED record Report an error
Ecolidx Czechia
64 others
A IVDR, 98/79 Website EUDAMED record Report an error
HangZhou Biotest  Biotech FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) and 1 other China
64 others
B, C IVDR, 98/79 info@biotests.com.cn EUDAMED record Report an error
Weihai Sunway Medical Technology EU representative : CMC Medical Devices & Drugs SL (Spain) China
64 others
I, A IVDR, MDR EUDAMED record Report an error
Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇ Türkiye
63 others
– 98/79 info@kinetikkimya.com EUDAMED record Report an error
Safecare FDA EU representative : Medunion S.L. (Spain) and 4 others China
63 others
– 98/79 EUDAMED record Report an error
Anatolia Tani Ve Biyoteknoloji Urunleri Arastirma Gelistirme San Ve Tic Türkiye
62 others
A, C, D IVDR, 98/79 Website info@anatoliagenetik.com EUDAMED record Report an error
Hamilton FDA EU representative : Johner Medical GmbH (Germany) Switzerland
64 others
A IVDR Website Contact-PRRC.rob.ch@hamilton.ch EUDAMED record Report an error
gerbion Germany
61 others
A IVDR, 98/79 info@gerbion.com EUDAMED record Report an error
Merck Germany
61 others
A, B IVDR Website service@merckgroup.com EUDAMED record Report an error
Poly Diagnostics Luxembourg
61 others
B IVDR Website info@polydiagnostics.com EUDAMED record Report an error
Geneproof Czechia
60 others
A, B, C IVDR, 98/79 Website support@geneproof.com EUDAMED record Report an error
Immucor FDA EU representative : IMMUCOR Medizinische Diagnostik GmbH (Germany) Germany, United States
59 others
A, C, D IVDR Website regulatoryimmucor@werfen.com EUDAMED record Report an error
Immundiagnostik FDA Germany
59 others
A, B IVDR, 98/79 Website info@immundiagnostik.com EUDAMED record Report an error
Neomedica EU representative : Wellkang Ltd (Northern Ireland) Serbia
59 others
A IVDR, 98/79 Website EUDAMED record Report an error
Shenzhen Yhlo Biotech FDA EU representative : Lotus NL B.V. (Netherlands) and 1 other China
59 others
A, C IVDR, 98/79 Website info@szyhlo.com EUDAMED record Report an error
Wondfo FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
59 others
A, C, D IVDR, 98/79 Website sales@wondfo.com.cn EUDAMED record Report an error
altona Diagnostics FDA Germany
58 others
A, B, C IVDR, 98/79 info@altona-diagnostics.com EUDAMED record Report an error
Certest Spain
58 others
A, B, C IVDR, 98/79 Website quality@certest.es EUDAMED record Report an error
Actest EU representative : VidaQuick Biotech S.L. (Spain) China
57 others
A IVDR, 98/79 info@actest.com.cn EUDAMED record Report an error
Horiba FDA France
57 others
A, B, C IVDR, 98/79 EUDAMED record Report an error
Dezhou Guoke Medical Technology EU representative : MedPath GmbH (Germany) and 1 other China
56 others
– 98/79 office@guoke-medical.com EUDAMED record Report an error
Anhui Deepblue Medical Technology FDA EU representative : Luxus Lebenswelt GmbH (Germany) and 2 others China
55 others
C IVDR, 98/79 sales@dbluemedical.com EUDAMED record Report an error
Medotexbio EU representative : HUMISS TRADING S. L. (Spain) and 1 other China
55 others
B, C IVDR, 98/79 Website EUDAMED record Report an error
Urit FDA EU representative : Medunion S.L. (Spain) and 1 other China
55 others
A, B IVDR, 98/79 Website service@uritest.com EUDAMED record Report an error
Dbbiotech Slovakia
54 others
C IVDR Website EUDAMED record Report an error
Zhejiang Greylynx Biotech EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
54 others
C IVDR, 98/79 info@vivachek.com EUDAMED record Report an error
Baso Diagnostics Zhuhai EU representative : Eunitor GmbH (Germany) China
53 others
A IVDR EUDAMED record Report an error
Bioeksen Türkiye
52 others
A IVDR, 98/79 Website info@bioeksen.com.tr EUDAMED record Report an error
Egyptian For Biotechnology-Spectrum Diagnostics EU representative : MDSS GmbH (Germany) Egypt
51 others
– 98/79 Website info@spectrum-diagnostics.com EUDAMED record Report an error
Vitassay Spain
51 others
A IVDR, 98/79 Website info@vitassay.com EUDAMED record Report an error
ElitechGroup FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) Italy, United States
49 others
A, B, C, D IVDR, 98/79 Website info@elitechgroup.com EUDAMED record Report an error
Genes2Me EU representative : Obelis s.a. (Belgium) India
49 others
A IVDR, 98/79 Website EUDAMED record Report an error
Seegene FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea
49 others
A, B, C IVDR, 98/79 Website info@seegene.com EUDAMED record Report an error
Erba Czechia
48 others
A, B IVDR, 98/79 Website EUDAMED record Report an error
Gongdong FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
48 others
A IVDR EUDAMED record Report an error
Infitek FDA EU representative : Kingsmead Service B.V. (Netherlands) and 1 other China
48 others
I, A IVDR, MDR info@infitek.com EUDAMED record Report an error
Ustar Biotechnologies (Hangzhou) EU representative : Lotus NL B.V. (Netherlands) China
48 others
A, B, C IVDR, 98/79 Website service@bioustar.com EUDAMED record Report an error
Diesse FDA Italy
47 others
A, B, C IVDR Website EUDAMED record Report an error
Tcoag FDA Ireland
47 others
A, B IVDR, 98/79 Website EUDAMED record Report an error
Vela Operations Singapore Pte FDA EU representative : Vela Diagnostics Germany GmbH (Germany) Singapore
47 others
A IVDR, 98/79 Website infoAPAC@veladx.com EUDAMED record Report an error
Cybereagen EU representative : CMC Medical Devices & Drugs SL (Spain) China
46 others
– 98/79 info@cybereagen.com EUDAMED record Report an error
nal von minden Germany
46 others
A, B IVDR, 98/79 Website info@nal-vonminden.com EUDAMED record Report an error
Biosynex EU representative : BIOSYNEX (France) France, Switzerland
49 others
A, B, C IVDR, 98/79 Website reglementaire@biosynex.com EUDAMED record Report an error
Alba Bioscience FDA EU representative : Emergo Europe B.V. (Netherlands) United Kingdom (ex Northern Ireland)
45 others
– 98/79 Website regulatory.registrations@alivedx.com EUDAMED record Report an error
Ameritech Diagnostic Reagent (Jiaxing) EU representative : AR Experts B.V. (Netherlands) and 1 other China
45 others
– 98/79 EUDAMED record Report an error
Genegeo EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China
45 others
A IVDR, 98/79 sales@genegeo.com EUDAMED record Report an error
Jiangsu Macro & Micro-Test Med-Tech FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 2 others China
45 others
A, B, C IVDR, 98/79 marketing@hongweitest.com EUDAMED record Report an error
Lorne Laboratories EU representative : Advena Limited (Malta) United Kingdom (ex Northern Ireland)
45 others
– 98/79 Website info@lornelabs.com EUDAMED record Report an error
RAL Diagnostics FDA France
45 others
A IVDR Website info@ral-diagnostics.fr EUDAMED record Report an error
Ayset Türkiye
44 others
– 98/79 Website info@ayset.com EUDAMED record Report an error
Bdbiosciences FDA EU representative : Becton Dickinson Ireland Limited (Ireland) United States
44 others
A, B, C IVDR Website EUDAMEDenquiries@bd.com EUDAMED record Report an error
Linear FDA Spain
44 others
A IVDR, 98/79 Website info@linear.es EUDAMED record Report an error
Richard-Allan Scientific EU representative : Epredia Netherlands B.V. (Netherlands) United States
44 others
A IVDR EUDAMED record Report an error
Shenzhen Comen Medical Instruments FDA EU representative : Lotus NL B.V. (Netherlands) China
44 others
– 98/79 EUDAMED record Report an error
Shenzhen New Industries Biomedical Engineering 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
Ab Analitica Italy
43 others
A, C IVDR, 98/79 customersupport@abanalitica.it EUDAMED record Report an error
Aconbio EU representative : MedNet EC-REP GmbH (Germany) China
43 others
A, C, D IVDR, 98/79 Website EUDAMED record Report an error
Getein FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China
43 others
A, B, C IVDR, 98/79 EUDAMED record Report an error
KenDor Technology (Zhejiang) EU representative : CMC Medical Devices & Drugs SL (Spain) China
43 others
A IVDR, 98/79 EUDAMED record Report an error
Bosonbio FDA EU representative : Lotus NL B.V. (Netherlands) and 1 other China
42 others
A, C IVDR, 98/79 Website EUDAMED record Report an error
Denizbiyokimya Türkiye
42 others
– 98/79 EUDAMED record Report an error
Medikal Olusum Sanayi Ve Ticaret Sirketi Türkiye
40 others
I, A IVDR, MDR Website info@moslab.com EUDAMED record Report an error
Microprofit EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
40 others
A, C IVDR, 98/79 EUDAMED record Report an error
OSANG Healthcare FDA EU representative : Obelis s.a. (Belgium) South Korea
40 others
A, C IVDR, 98/79 Website EUDAMED record Report an error
Carloerbareagents France
39 others
A IVDR, 98/79 Website EUDAMED record Report an error
Vazyme EU representative : Caretechion GmbH (Germany) and 3 others China
39 others
A, B IVDR, 98/79 EUDAMED record Report an error
Qiagen FDA EU representative : QIAGEN GmbH (Germany) Germany, United States
40 others
A, C IVDR, 98/79 Website info@qiagen.com EUDAMED record Report an error
Diagnostics Belgium, Spain
38 others
A IVDR, 98/79 Website EUDAMED record Report an error
Hightopbio FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other China
38 others
– 98/79 Website EUDAMED record Report an error
Orgentec Germany
38 others
A IVDR, 98/79 Website EUDAMED record Report an error
Anhui Sinic Laboratory Medicine Technology EU representative : MedPath GmbH (Germany) China
37 others
A IVDR EUDAMED record Report an error
Biolytical FDA EU representative : Emergo Europe B.V. (Netherlands) Canada
37 others
– 98/79 EUDAMED record Report an error
Biotical Spain
37 others
– 98/79 Website EUDAMED record Report an error
Hybribio EU representative : Emergo Europe B.V. (Netherlands) and 3 others China
37 others
A IVDR, 98/79 EUDAMED record Report an error
HYPHEN BioMed FDA France
37 others
A, C IVDR Website info@hyphen-biomed.com EUDAMED record Report an error
Medicamed Romania
37 others
A IVDR Website office@medicamed.ro EUDAMED record Report an error
TIB MOLBIOL Syntheselabor Germany
37 others
– 98/79 Website EUDAMED record Report an error
Dialab Austria
36 others
A IVDR, 98/79 Website office@dialab.at EUDAMED record Report an error
Jiangsu Mole Bioscience EU representative : Lotus NL B.V. (Netherlands) and 2 others China
36 others
A IVDR, 98/79 EUDAMED record Report an error
Monobind FDA EU representative : AR Experts B.V. (Netherlands) United States
36 others
A IVDR, 98/79 Website info@monobind.com EUDAMED record Report an error
Spinreact Spain
36 others
A, D IVDR, 98/79 Website EUDAMED record Report an error
Technogenetics FDA Italy
36 others
A, B, C IVDR Website QA@TECHNOGENETICS.IT EUDAMED record Report an error
Viramed FDA Germany
36 others
A, B, C IVDR Website EUDAMED record Report an error
Aesku FDA Germany
35 others
– 98/79 Website EUDAMED record Report an error
Aichek FDA EU representative : Medunion S.L. (Spain) and 1 other China
35 others
A IVDR, 98/79 ra.rep@aichek.com EUDAMED record Report an error
Hain Lifescience Germany
35 others
A, C, D IVDR, 98/79 EUDAMED record Report an error
AccuBioTech EU representative : MDSS GmbH (Germany) China
34 others
– 98/79 sales@accubiotech.com EUDAMED record Report an error
Genrui Biotech FDA EU representative : Lotus NL B.V. (Netherlands) and 1 other China
34 others
A, B IVDR, 98/79 Website service@genrui-bio.com EUDAMED record Report an error
Grifols FDA EU representative : Diagnostic Grifols, S.A. (Spain) Spain, Switzerland, United States
34 others
A, C, D IVDR, 98/79 Website regulatoryaffairs_dxbu@grifols.com EUDAMED record Report an error
Suzhou TianLong Biotechnology FDA EU representative : Lotus NL B.V. (Netherlands) and 1 other China
34 others
– 98/79 EUDAMED record Report an error
Becton Dickinson FDA EU representative : Becton Dickinson Ireland Limited (Ireland) United States
33 others
A, B, C IVDR, 98/79 Website eudamedenquiries@bd.com EUDAMED record Report an error
Cowingene EU representative : MedPath GmbH (Germany) China
33 others
A IVDR, 98/79 Website EUDAMED record Report an error
Diagreat EU representative : MedNet EC-REP GmbH (Germany) and 1 other China
32 others
A, B, C IVDR Website info@diagreat.com EUDAMED record Report an error
Gensurebio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China
32 others
C IVDR, 98/79 Website info@gensurebio.com EUDAMED record Report an error
Sclavo Italy
32 others
A IVDR, 98/79 qa@sclavo.it EUDAMED record Report an error
Shenzhen Drawray Biotech EU representative : Lotus NL B.V. (Netherlands) and 1 other China
32 others
A, C IVDR, 98/79 Website info@szdrawray.com EUDAMED record Report an error
Antitoxin Germany
31 others
– 98/79 Website EUDAMED record Report an error
Spectrum For Diagnostic Industries Joint Stock EU representative : MDSS GmbH (Germany) Egypt
31 others
– 98/79 Website EUDAMED record Report an error
Aitbiotech EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) Singapore
30 others
A IVDR, 98/79 Website EUDAMED record Report an error
Beijing Jinwofu Bioengineering Technology EU representative : CMC Medical Devices & Drugs SL (Spain) China
30 others
– 98/79 EUDAMED record Report an error
Bio-Optica Milano FDA Italy
30 others
A IVDR Website info@bio-optica.it EUDAMED record Report an error
Bio-Rad FDA France
30 others
A, B, C IVDR, 98/79 Website contact@bio-rad.com EUDAMED record Report an error
Bioantibody Biotechnology EU representative : Medunion S.L. (Spain) China
30 others
A IVDR, 98/79 EUDAMED record Report an error
Chronolab Spain
30 others
– 98/79 Website info@chronolab.com EUDAMED record Report an error
HEALSTONE Biotech FDA EU representative : CMC Medical Devices & Drugs SL (Spain) Canada
30 others
– 98/79 sales@orientgene.com EUDAMED record Report an error
Mpbio FDA EU representative : MP Biomedicals Germany GmbH (Germany) Germany, Singapore
30 others
A IVDR, 98/79 Website EUDAMED record Report an error
Oxoid FDA EU representative : Thermo Fisher Diagnostics B.V. (Netherlands) United Kingdom (ex Northern Ireland)
30 others
A, B, C IVDR, 98/79 Website EUDAMED record Report an error
Progenie molecular S.L.U Spain
30 others
– 98/79 EUDAMED record Report an error
Titolchimica Italy
30 others
A IVDR Website info@titolchimica.it EUDAMED record Report an error
C-Luminary Biotechnology EU representative : Share info GmbH (Germany) and 1 other China
30 others
A IVDR, 98/79 EUDAMED record Report an error
3Bblackbio EU representative : Wellkang Ltd (Northern Ireland) India
29 others
A, B, C IVDR, 98/79 Website info@3bblackbio.com EUDAMED record Report an error
Hangzhou Immuno Biotech EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
29 others
– 98/79 info@jgbiotech.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
Molbio Diagnostics EU representative : QbD RepS BV (Belgium) India
29 others
A, C IVDR, 98/79 Website customersupport@molbiodiagnostics.com EUDAMED record Report an error
Sigma-Aldrich EU representative : MDSS GmbH (Germany) United States
29 others
A IVDR Website customer.caredesk@milliporesigma.com EUDAMED record Report an error
Trinitybiotech FDA EU representative : TrinityBiotech (Ireland) United States
29 others
– 98/79 Website EUDAMED record Report an error
Arkray FDA EU representative : ARKRAY Europe, B.V. (Netherlands) and 1 other India, Japan
32 others
A, B, C IVDR, 98/79 Website support_arkrayeurope@arkray.co.jp EUDAMED record Report an error
Autobio FDA EU representative : Obelis s.a. (Belgium) China
31 others
A, C IVDR Website 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
BeijingModern GaoDa Biotechnology EU representative : Medunion S.L. (Spain) China
28 others
– 98/79 EUDAMED record Report an error
Chengdu Legend-Tec Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China
28 others
– 98/79 Website EUDAMED record Report an error
Dispomed For Manufacturing Medical Laboratory Supplies EU representative : EUROMED Authorized Services Kft (Hungary) Egypt
28 others
A IVDR EUDAMED record Report an error
E-LAB Biological Science & Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China
28 others
A IVDR, 98/79 EUDAMED record Report an error
Hologic FDA EU representative : Hologic BV (Belgium) United States
28 others
A, B, C, D IVDR EUDAMED record Report an error
Kangjian FDA EU representative : Humiss Beratung GmbH (Germany) and 2 others China
28 others
A IVDR, 98/79 EUDAMED record Report an error
Nordic Biomarker Sweden
28 others
A, C IVDR, 98/79 Website info@nordicbiomarker.com EUDAMED record Report an error
Quimica Clinica Aplicada Spain
28 others
A IVDR, 98/79 Website EUDAMED record Report an error
Tellgencorp EU representative : MedNet EC-REP GmbH (Germany) and 1 other China
28 others
– 98/79 Website sales@tellgen.com EUDAMED record Report an error
InTec PRODUCTS EU representative : MedNet EC-REP GmbH (Germany) and 1 other China
31 others
– 98/79 Website 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
Biolabo France
27 others
A, B, C IVDR support@biolabo.fr EUDAMED record Report an error
Hangzhou Danwei Biotechnology FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China
27 others
– 98/79 ra.danwei@danwei-bio.com EUDAMED record Report an error
HLB Life Science FDA EU representative : CMC Medical Devices & Drugs SL (Spain) South Korea
27 others
A IVDR Website EUDAMED record Report an error
Isiabio EU representative : CMC Medical Devices & Drugs SL (Spain) China
27 others
– 98/79 Website EUDAMED record Report an error
Keyubio EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
27 others
A IVDR, 98/79 Website export@keyubio.com EUDAMED record Report an error
Sejoy FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
27 others
– 98/79 Website EUDAMED record Report an error
Seramun Germany
27 others
B IVDR, 98/79 info@seramun.com EUDAMED record Report an error
Bioneer FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea
26 others
A, D IVDR, 98/79 Website sales@bioneer.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
Edan FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
26 others
A, B IVDR, 98/79 EUDAMED record Report an error
Medlab-Products Poland
26 others
A IVDR, 98/79 Website EUDAMED record Report an error
Nanjing Norman Biological Technology EU representative : Sungo Cert GmbH (Germany) China
26 others
A IVDR, 98/79 EUDAMED record Report an error
Xiamen Zeesan Biotech FDA EU representative : JOYSUN GROUP S.L.U (Spain) and 1 other China
26 others
A IVDR, 98/79 info@zsandx.com EUDAMED record Report an error
Tosoh FDA EU representative : Tosoh Europe N.V. (Belgium) Belgium, Japan
32 others
A, B, C IVDR, 98/79 Website csc@tosoh.co.jp EUDAMED record Report an error
Anicrin Italy
24 others
A IVDR, 98/79 Website info@anicrin.com EUDAMED record Report an error
Cesna Türkiye
24 others
A, B IVDR Website info@cesna.com.tr EUDAMED record Report an error
Hysenbiotech EU representative : Medunion S.L. (Spain) South Korea
24 others
A IVDR, 98/79 EUDAMED record Report an error
Jiangsu Qitian Gene biotechnology EU representative : JOYSUN GROUP S.L.U (Spain) and 1 other China
23 others
A IVDR, 98/79 Website EUDAMED record Report an error
Kogene EU representative : Obelis s.a. (Belgium) South Korea
23 others
A IVDR, 98/79 Website info@kogene.co.kr EUDAMED record Report an error
Nexlab EU representative : MedNet EC-REP GmbH (Germany) China
23 others
– 98/79 EUDAMED record Report an error
Ortho-Clinical Diagnostics Dba Quidel EU representative : MDSS GmbH (Germany) and 1 other United States
23 others
A IVDR, 98/79 Website PRRC@quidelortho.com EUDAMED record Report an error
Taiwan Advanced Nanotech FDA EU representative : mdi Europa GmbH (Germany) Taiwan
23 others
A IVDR Website EUDAMED record Report an error
Biologicals Quality Control Netherlands
22 others
B IVDR Website info@bioqcontrol.com EUDAMED record Report an error
Gmt Sarl France
22 others
A IVDR, 98/79 Website EUDAMED record Report an error
Microgenics FDA EU representative : B·R·A·H·M·S GmbH (Germany) United States
22 others
A IVDR, 98/79 Website EUDAMED record Report an error
Seamaty EU representative : GRZAN GmbH (Germany) and 1 other China
22 others
A IVDR 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
Dakewe FDA EU representative : Lotus NL B.V. (Netherlands) and 1 other China
21 others
A IVDR, 98/79 Website EUDAMED record Report an error
Norgen Biotek EU representative : Emergo Europe B.V. (Netherlands) Canada
21 others
A, B IVDR Website regulatory@norgenbiotek.com EUDAMED record Report an error
Operon FDA Spain
21 others
B IVDR, 98/79 Website infoeudamed@operon.es EUDAMED record Report an error
Phasescientific FDA EU representative : CMC Medical Devices & Drugs SL (Spain) Hong Kong SAR China
21 others
– 98/79 Website info@phasesci.com EUDAMED record Report an error
Qnostics EU representative : WMDE B.V. (Netherlands) United Kingdom (ex Northern Ireland)
21 others
– 98/79 quality@qnostics.com EUDAMED record Report an error
Realytech EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
21 others
– 98/79 Website info@realytech.com EUDAMED record Report an error
Wheisman Medical Technology EU representative : Umedwings Netherlands B.V. (Netherlands) China
21 others
A IVDR, 98/79 EUDAMED record Report an error
Wizbiotech EU representative : Lotus NL B.V. (Netherlands) and 1 other China
21 others
A IVDR, 98/79 EUDAMED record Report an error
Yanengbio EU representative : Obelis s.a. (Belgium) China
21 others
A IVDR, 98/79 Website EUDAMED record Report an error
YASEE BioMedical FDA EU representative : Lotus NL B.V. (Netherlands) and 1 other China
21 others
I MDR, 98/79 EUDAMED record Report an error
Diatron FDA Hungary
20 others
A IVDR, 98/79 Website EUDAMED record Report an error
Genobio Pharmaceutical FDA EU representative : Caretechion GmbH (Germany) and 2 others China
20 others
A IVDR, 98/79 Website marketing@era-bio.com EUDAMED record Report an error
Arcdia Finland
21 others
A IVDR, 98/79 Website office@arcdia.com EUDAMED record Report an error
SD Biosensor FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) India, South Korea
20 others
A, B, C, D IVDR, 98/79 Website EUDAMED record Report an error
3Klab Türkiye
19 others
A IVDR, 98/79 Website EUDAMED record Report an error
Ablsa Luxembourg
19 others
– 98/79 Website contact@ablsa.com EUDAMED record Report an error
Advanced Molecular Diagnostics EU representative : Advena Limited (Malta) United Kingdom (ex Northern Ireland)
19 others
– 98/79 Website info@am-diagnostics.co.uk EUDAMED record Report an error
Andreas Hettich FDA Germany
19 others
IIa, A IVDR, MDR, 98/79 Website EUDAMED record Report an error
Eurobio Scientific France
19 others
A IVDR, 98/79 reglementaire@eurobio-scientific.com EUDAMED record Report an error
Hebei Xinle Sci&Tech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
19 others
A IVDR EUDAMED record Report an error
Illumaxbio EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
19 others
A IVDR, 98/79 Website EUDAMED record Report an error
Shandon Diagnostics FDA EU representative : Epredia Netherlands B.V. (Netherlands) United Kingdom (ex Northern Ireland)
19 others
A IVDR EUDAMED record Report an error
Biohermes FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China
18 others
– 98/79 EUDAMED record Report an error
Clongene FDA EU representative : HUMISS TRADING S. L. (Spain) and 1 other China
18 others
– 98/79 Website marketing@clongene.com EUDAMED record Report an error
Meridian Bioscience FDA EU representative : Meridian Bioscience Europe S.r.l. (Italy) United States
18 others
A, C IVDR Website EUDAMED record Report an error
Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach Poland
18 others
A IVDR, 98/79 Website EUDAMED record Report an error
TECO Medical Instruments, Production + Trading Germany
18 others
A IVDR, 98/79 Website info@teco-medical.com EUDAMED record Report an error
Biocare Medical EU representative : Emergo Europe B.V. (Netherlands) United States
19 others
– 98/79 Website EUDAMED record Report an error
Iline Microsystems FDA Spain
17 others
A IVDR, 98/79 eudamed@ilinemicrosystems.com EUDAMED record Report an error
Sentinel FDA Italy
17 others
A, C IVDR Website EUDAMED record Report an error
Synthgene (Yixing) Health Technology EU representative : MedPath GmbH (Germany) China
17 others
– 98/79 sales@syngenebio.com EUDAMED record Report an error
Citest Diagnostics EU representative : VidaQuick Biotech S.L. (Spain) Canada
16 others
A IVDR, 98/79 ra02@citestdiagnostics.com EUDAMED record Report an error
Diagon Hungary
16 others
A IVDR, 98/79 Website EUDAMED record Report an error
Giesse Diagnostics Italy
16 others
– 98/79 Website info@giessediagnostics.com EUDAMED record Report an error
Hunan Ehome Health Technology EU representative : Medunion S.L. (Spain) and 1 other China
16 others
A IVDR, 98/79 EUDAMED record Report an error
Kaltek Italy
16 others
A IVDR info@kaltek.it EUDAMED record Report an error
Meril Diagnostics FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other India
16 others
A, D IVDR, 98/79 Website ram.kanoje@merillife.com EUDAMED record Report an error
Syscanbio EU representative : Obelis s.a. (Belgium) China
16 others
– 98/79 EUDAMED record Report an error
Xenta Biomedical Science FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China
16 others
– 98/79 Website EUDAMED record Report an error
ZOVEC diagnostics Germany
16 others
– 98/79 Website EUDAMED record Report an error
Orasure FDA EU representative : QbD RepS BV (Belgium) United States
19 others
– 98/79 Website customercare@orasure.com EUDAMED record Report an error
Cormay Poland
15 others
A IVDR, 98/79 regulatory_affairs@cormay.com EUDAMED record Report an error
DiaMex Germany
15 others
B IVDR Website EUDAMED record Report an error
Gama Czechia
15 others
A IVDR, 98/79 EUDAMED record Report an error
Goldsite EU representative : CMC Medical Devices & Drugs SL (Spain) China
15 others
A IVDR, 98/79 Website export@goldsite.com.cn EUDAMED record Report an error
Ingenetix Austria
15 others
– 98/79 Website office@ingenetix.com EUDAMED record Report an error
Lituo EU representative : CMC Medical Devices & Drugs SL (Spain) China
15 others
A IVDR, 98/79 Website EUDAMED record Report an error
Mpw Poland
15 others
A IVDR Website EUDAMED record Report an error
MTD Diagnostics Italy
15 others
– 98/79 Website EUDAMED record Report an error
NORMA Instruments Zártkörűen Működő Részvénytársaság Hungary
15 others
A IVDR EUDAMED record Report an error
Sichuan Orienter Biotechnology EU representative : Lotus NL B.V. (Netherlands) and 2 others China
15 others
A IVDR, 98/79 Website info@orienterglobal.com EUDAMED record Report an error
Biotecnica Italy
15 others
A IVDR, 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
Autobio Diagnostics FDA EU representative : QbD RepS BV (Belgium) China
14 others
C IVDR, 98/79 info@autobio-diagnostics.com EUDAMED record Report an error
Bio-Rad Medical Diagnostics Germany
14 others
A, C IVDR Website contact@bio-rad.com EUDAMED record Report an error
BioFynder EU representative : SUNGO Europe B.V. (Netherlands) United Kingdom (ex Northern Ireland)
14 others
A IVDR, 98/79 EUDAMED record Report an error
Genekam Germany
14 others
A IVDR, 98/79 Website office@genekam.de EUDAMED record Report an error
Haemokinesis EU representative : Compliance Management Solutions Europe LTD (Bulgaria) Australia
14 others
A IVDR, 98/79 EUDAMED record Report an error
Limingbio EU representative : Wellkang Ltd (Northern Ireland) China
14 others
– 98/79 Website sales@limingbio.com EUDAMED record Report an error
MedicalSystem Biotechnology FDA EU representative : Lotus NL B.V. (Netherlands) China
14 others
A IVDR, 98/79 EUDAMED record Report an error
Meus FDA Italy
14 others
A IVDR, 98/79 Website EUDAMED record Report an error
Orphée EU representative : PZ CORMAY Spółka Akcyjna (Poland) Switzerland
14 others
A IVDR, 98/79 ra@orphee-medical.com EUDAMED record Report an error
Randox FDA Northern Ireland
14 others
A, B IVDR Website EUDAMED record Report an error
ZeptoMetrix FDA EU representative : Emergo Europe B.V. (Netherlands) United States
14 others
B IVDR Website EUDAMED record Report an error
Ardentbiomed EU representative : MedPath GmbH (Germany) China
13 others
A IVDR Website EUDAMED record Report an error
Kalians EU representative : MDSS GmbH (Germany) Egypt
13 others
– 98/79 EUDAMED record Report an error
Nanjing Synthgene Medical Technology FDA EU representative : Lotus NL B.V. (Netherlands) and 1 other China
13 others
C IVDR, 98/79 Website sales@syngenebio.com EUDAMED record Report an error
Pilotgene EU representative : Medunion S.L. (Spain) China
13 others
A IVDR, 98/79 EUDAMED record Report an error
Reetoo EU representative : Umedwings Netherlands B.V. (Netherlands) China
13 others
A IVDR, 98/79 Website service@reetoo.com.cn EUDAMED record Report an error
Singuway EU representative : CMC Medical Devices & Drugs SL (Spain) China
13 others
A IVDR, 98/79 sales@singuway.com EUDAMED record Report an error
Thermofisher FDA EU representative : Life Technologies Europe B.V. (Netherlands) Finland, Lithuania, United States
13 others
A, C IVDR, 98/79 Website info.baltics@thermofisher.com EUDAMED record Report an error
AIDA Germany
12 others
– 98/79 EUDAMED record Report an error
Anhui Formaster Biosci EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China
12 others
– 98/79 Website EUDAMED record Report an error
Astra Biotech Germany
12 others
A IVDR, 98/79 Website info@astrabiotech.de EUDAMED record Report an error
Biosystems FDA Spain
12 others
A IVDR, 98/79 Website EUDAMED record Report an error
Cellomics (Shenzhen) EU representative : Lotus NL B.V. (Netherlands) China
12 others
A, C IVDR EUDAMED record Report an error
CellSolutions FDA EU representative : CellSolutions GmbH (Germany) United States
12 others
A IVDR Website EUDAMED record Report an error
Diapro Italy
12 others
A IVDR, 98/79 Website info@diapro.it EUDAMED record Report an error
Dynamiker EU representative : JOYSUN GROUP S.L.U (Spain) and 1 other China
12 others
– 98/79 Website marketing@dynamiker.com EUDAMED record Report an error
Evident FDA EU representative : Evident Europe GmbH (Germany) Japan
12 others
A IVDR EUDAMED record Report an error
Jiangsu Q-Array EU representative : Caretechion GmbH (Germany) China
12 others
A IVDR, 98/79 EUDAMED record Report an error
KH Medical EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea
12 others
A IVDR, 98/79 Website info@khmedical.co.kr EUDAMED record Report an error
Roche FDA Germany
12 others
B, C, D IVDR, 98/79 Website EUDAMED record Report an error
Shenzhen Superbio Technology FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
12 others
– 98/79 info@sup-bio.com EUDAMED record Report an error
Targetingone EU representative : Medunion S.L. (Spain) and 1 other China
12 others
A IVDR, 98/79 EUDAMED record Report an error
Wiener Laboratorios SAIC FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) Argentina
29 others
A IVDR, 98/79 Website marketing@wiener-lab.com EUDAMED record Report an error
Abon Biopharm(Hangzhou) EU representative : Medical Technology Promedt Consulting GmbH (Germany) China
11 others
– 98/79 EUDAMED record Report an error
Aidian FDA Finland
11 others
A IVDR, 98/79 Website eudamed@aidian.eu EUDAMED record Report an error
Biomaxima Poland
11 others
A, B, C IVDR, 98/79 Website info@biomaxima.com EUDAMED record Report an error
Daan Gene EU representative : Lotus NL B.V. (Netherlands) and 1 other China
11 others
A IVDR, 98/79 EUDAMED record Report an error
DNA-Technology, Research & Production EU representative : Obelis s.a. (Belgium) Russia
11 others
A IVDR Website EUDAMED record Report an error
Flmedical FDA Italy
11 others
A IVDR, 98/79 Website info@flmedical.com EUDAMED record Report an error
Hartbio FDA EU representative : Amstermed UK Ltd (Northern Ireland) United Kingdom (ex Northern Ireland)
11 others
– 98/79 EUDAMED record Report an error
Henan Tuoren Medical Technology EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
11 others
A IVDR EUDAMED record Report an error
Increcare FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
11 others
A IVDR EUDAMED record Report an error
Jiangsu CoWin Biotech EU representative : CMC Medical Devices & Drugs SL (Spain) China
11 others
A IVDR, 98/79 EUDAMED record Report an error
LTA Italy
11 others
– 98/79 Website office@ltaonline.it EUDAMED record Report an error
NanoEntek FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea
11 others
A IVDR, 98/79 Website eudamed@nanoentek.com EUDAMED record Report an error
Optika Microscopes Italy
11 others
A IVDR EUDAMED record Report an error
r2 Diagnostics FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) United States
11 others
– 98/79 Website qa@r2diagnostics.com EUDAMED record Report an error
Reagena Finland
11 others
A IVDR, 98/79 Website info@reagena.com EUDAMED record Report an error
Rrmechatronics FDA Netherlands
11 others
A IVDR Website support@rrmechatronics.com EUDAMED record Report an error
Seleo Italy
11 others
– 98/79 Website EUDAMED record Report an error
Suzhou Shengtian Biotechnology EU representative : Kingsmead Service B.V. (Netherlands) China
11 others
A IVDR EUDAMED record Report an error
Techlab FDA EU representative : Emergo Europe B.V. (Netherlands) United States
11 others
B IVDR, 98/79 Website EUDAMED record Report an error
Ortho-Clinical Diagnostics Rochester EU representative : Ortho-Clinical Diagnostics France (France) United States
11 others
A IVDR, 98/79 Website PRRC@quidelortho.com EUDAMED record Report an error
Anbio EU representative : Lotus NL B.V. (Netherlands) and 1 other China
10 others
A IVDR, 98/79 info@anbio.com EUDAMED record Report an error
AVE Science & Technology FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
10 others
A IVDR, 98/79 EUDAMED record Report an error
Bgi Denmark
10 others
A IVDR, 98/79 Website EUDAMED record Report an error
Celnovte EU representative : Umedwings Netherlands B.V. (Netherlands) China
10 others
A IVDR EUDAMED record Report an error
Credo Diagnostics Biomedical Pte Taiwan Branch EU representative : MedNet EC-REP GmbH (Germany) Taiwan
10 others
A IVDR, 98/79 service@credodxbiomed.com EUDAMED record Report an error
Ddk Italia Italy
10 others
A IVDR info@ddkitalia.com EUDAMED record Report an error
Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH Germany
10 others
A IVDR, 98/79 Website info@gfeblut.de 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
Iontek Türkiye
10 others
– 98/79 Website EUDAMED record Report an error
Labnovation EU representative : MedNet EC-REP GmbH (Germany) China
10 others
A IVDR, 98/79 Website info@labnovation.com EUDAMED record Report an error
Labsystems Diagnostics FDA Finland
10 others
A IVDR, 98/79 Website EUDAMED record Report an error
Lysunbio FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China
10 others
A IVDR, 98/79 EUDAMED record Report an error
Ningbo High-Tech Bluesky Manufactory & Trading FDA EU representative : Wellkang Ltd (Northern Ireland) China
10 others
I MDR Website EUDAMED record Report an error
Shenzhen Chenghui Medical Technology EU representative : HUMISS TRADING S. L. (Spain) China
10 others
B IVDR, 98/79 EUDAMED record Report an error
Verbiese France
10 others
A IVDR Website contact@verbiese.fr EUDAMED record Report an error
Zhejiang QL Biotech EU representative : CMC Medical Devices & Drugs SL (Spain) China
10 others
C IVDR, 98/79 EUDAMED record Report an error
Hangzhou Genesis Biodetection Biocontrol FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
14 others
– 98/79 Website EUDAMED record Report an error
Sinocare FDA EU representative : Lotus NL B.V. (Netherlands) and 2 others China
10 others
A, B, C IVDR, 98/79 RA@sinocare.com EUDAMED record Report an error
AFI Centrifuge France
9 others
A IVDR Website contact@afigroups.com EUDAMED record Report an error
ALS Life Sciences Portugal Portugal
9 others
A IVDR Website EUDAMED record Report an error
Beijing Wantai Biological Pharmacy Enterprise EU representative : QbD RepS BV (Belgium) China
9 others
– 98/79 EUDAMED record Report an error
Challenbio EU representative : MedPath GmbH (Germany) China
9 others
A IVDR sale@challenbio.com 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
Guangzhou KOFA Biotechnology EU representative : Medunion S.L. (Spain) China
9 others
A IVDR, 98/79 EUDAMED record Report an error
Institut de Biotechnologies Jacques Boy France
9 others
– 98/79 Website contact@ibjb.fr EUDAMED record Report an error
Jiangsu Confidence Medical Technology EU representative : JOYSUN GROUP S.L.U (Spain) China
9 others
– 98/79 EUDAMED record Report an error
Medconn FDA EU representative : JOYSUN GROUP S.L.U (Spain) and 2 others China
9 others
A IVDR, 98/79 EUDAMED record Report an error
Nano Diagnosis for Health Biotech (Guangzhou) EU representative : MedPath GmbH (Germany) and 1 other China
9 others
A IVDR, 98/79 EUDAMED record Report an error
Nihon Kohden FDA EU representative : NIHON KOHDEN EUROPE GmbH (Germany) India, Japan
9 others
A, B, C IVDR Website information@db.nkc.co.jp EUDAMED record Report an error
Ortho-Clinical Diagnostics Raritan EU representative : Ortho-Clinical Diagnostics France (France) United States
9 others
A IVDR, 98/79 Website PRRC@quidelortho.com EUDAMED record Report an error
Pluslife EU representative : Kingsmead Service B.V. (Netherlands) and 3 others China
9 others
A, C IVDR, 98/79 Website ra@pluslife.com EUDAMED record Report an error
Remel Europe FDA EU representative : Thermo Fisher Diagnostics B.V. (Netherlands) United Kingdom (ex Northern Ireland)
9 others
C IVDR, 98/79 Website EUDAMED record Report an error
Sunbiote EU representative : Lotus NL B.V. (Netherlands) China
9 others
A IVDR Website EUDAMED record Report an error
Ukinbio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China
9 others
A IVDR, 98/79 sales@ukinbio.com EUDAMED record Report an error
Álvarez Redondo Spain
9 others
A IVDR Website info@ortoalresa.com EUDAMED record Report an error
3D Biomedicine Science & Technology FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China
8 others
A IVDR, 98/79 EUDAMED record Report an error
Aptaca FDA Italy
8 others
A IVDR Website EUDAMED record Report an error
CareDx FDA EU representative : QbD RepS BV (Belgium) Australia, Sweden
8 others
A, C IVDR, 98/79 Website regulatory-au@gendx.com EUDAMED record Report an error
CellPath FDA EU representative : Emergo Europe B.V. (Netherlands) United Kingdom (ex Northern Ireland)
8 others
A IVDR Website info@cellpath.com EUDAMED record Report an error
Cube Dx Austria
8 others
A IVDR, 98/79 Website info@cubedx.com EUDAMED record Report an error
Diaglobal Germany
8 others
– 98/79 Website info@diaglobal.de EUDAMED record Report an error
Eppendorf FDA Germany
8 others
A IVDR RA.Corporate@eppendorf.de EUDAMED record Report an error
Hotgen FDA EU representative : MedNet EC-REP GmbH (Germany) China
8 others
B, C IVDR, 98/79 service@hotgen.com.cn EUDAMED record Report an error
Ing. Petr Švec - PENTA s.r.o Czechia
8 others
A IVDR Website info@pentachemicals.eu EUDAMED record Report an error
Labex Canada EU representative : Obelis s.a. (Belgium) Canada
8 others
A IVDR, 98/79 Website info@labexcanada.com EUDAMED record Report an error
Ortho-Clinical Diagnostics Summers Ridge San Diego EU representative : MDSS GmbH (Germany) United States
8 others
– 98/79 Website PRRC@quidelortho.com EUDAMED record Report an error
Redcell Türkiye
8 others
A IVDR, 98/79 Website info@redcell.com.tr EUDAMED record Report an error
Steellex EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China
8 others
– 98/79 info@steellex.com EUDAMED record Report an error
Yvsolab Belgium
8 others
A IVDR Website info@yvsolab.be EUDAMED record Report an error
Ailex EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
9 others
A IVDR, 98/79 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
Artronlab FDA EU representative : MedNet EC-REP GmbH (Germany) Canada
7 others
C, D IVDR, 98/79 Website info@artronlab.com 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
Drucker Diagnostics FDA EU representative : Emergo Europe B.V. (Netherlands) United States
7 others
A IVDR, 98/79 Website regulatory@druckerdiagnostics.com EUDAMED record Report an error
Eurotrol FDA Netherlands
7 others
– 98/79 Website office@eurotrol.com EUDAMED record Report an error
FlashDx Shenzhen EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China
7 others
A IVDR, 98/79 info@flash-dx.com EUDAMED record Report an error
Genesignbio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) and 1 other China
7 others
– 98/79 info@genesignbio.com EUDAMED record Report an error
Hamiltoncompany FDA EU representative : Johner Medical GmbH (Germany) United States
7 others
A IVDR, 98/79 EUDAMED record Report an error
IBL International Germany
7 others
A, B IVDR, 98/79 Website EUDAMED record Report an error
Irvine Scientific FDA EU representative : Emergo Europe B.V. (Netherlands) United States
7 others
– 98/79 EUDAMED record Report an error
Leica Microsystems CMS FDA Germany
7 others
A IVDR EUDAMED record Report an error
Lingen Precision Medical Products (Shanghai) EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
7 others
A IVDR info@labtub.com EUDAMED record Report an error
Medical Scientific Equipment France
7 others
A IVDR Website info@mse-sas.fr EUDAMED record Report an error
Microbio EU representative : Qualrep Services B.V. (Netherlands) Australia
7 others
– 98/79 Website info@microbio.com.au EUDAMED record Report an error
Nasmeddiagnostic EU representative : AF Pharma Service Europe SL (Spain) India
7 others
A IVDR EUDAMED record Report an error
One Lambda FDA EU representative : MDSS GmbH (Germany) United States
7 others
C IVDR Website EUDAMED record Report an error
Reagen EU representative : CMC Medical Devices & Drugs SL (Spain) China
7 others
– 98/79 Website info@reagenus.com EUDAMED record Report an error
RTA Laboratuvarları Biyolojik Ürünler İlaç ve Makine Sanayi Ticaret Anonim Şirketi Türkiye
7 others
A IVDR, 98/79 Website 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
Shanghai BioGerm Medical Technology EU representative : MedNet EC-REP GmbH (Germany) and 2 others China
7 others
A IVDR, 98/79 EUDAMED record Report an error
Widufit Germany
7 others
– 98/79 Website info@widufit.de 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
Adaltis Italy
6 others
– 98/79 Website info@adaltis.net EUDAMED record Report an error
Beijing Lepu Medical Technology EU representative : Lepu Medical (Europe) Cooperatief U.A. (Netherlands) China
6 others
A IVDR, 98/79 EUDAMED record Report an error
Biochemical Systems International Italy
6 others
– 98/79 Website EUDAMED record Report an error
Biocomma EU representative : CMC Medical Devices & Drugs SL (Spain) China
6 others
A IVDR Website sales@biocomma.cn EUDAMED record Report an error
BioFire Diagnostics FDA EU representative : bioMérieux SA (France) United States
6 others
A, B, C, D IVDR EUDAMED record Report an error
Guangzhou Improve Medical Instruments FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
6 others
A IVDR, 98/79 ra@improve-medical.com EUDAMED record Report an error
Hangzhou Zhunxin Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
6 others
A IVDR, 98/79 EUDAMED record Report an error
Jiangsu Rongye Technology FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China
6 others
A IVDR EUDAMED record Report an error
Ldbio Diagnostics France
6 others
C IVDR, 98/79 Website EUDAMED record Report an error
Lordsmark EU representative : Obelis s.a. (Belgium) India
6 others
A IVDR Website EUDAMED record Report an error
MagBio Genomics FDA EU representative : CEpartner4U (Netherlands) United States
6 others
A IVDR Website info@magbiogenomics.com EUDAMED record Report an error
Medite FDA Germany
6 others
A IVDR Website EUDAMED record Report an error
Milestone FDA Italy
6 others
A IVDR Website marketing@milestonemedsrl.com EUDAMED record Report an error
Nhs FDA EU representative : Quality First International OÜ (Estonia) United Kingdom (ex Northern Ireland)
6 others
– 98/79 EUDAMED record Report an error
PRIMA Lab EU representative : QbD RepS BV (Belgium) Switzerland
6 others
– 98/79 quality@primahometest.com EUDAMED record Report an error
Sanquin Reagents FDA Netherlands
6 others
A IVDR, 98/79 Website info@essange-reagents.nl EUDAMED record Report an error
Shenzhen YOUYI Bioscience EU representative : Medunion S.L. (Spain) and 1 other China
6 others
A IVDR, 98/79 EUDAMED record Report an error
Slee FDA Germany
6 others
A IVDR EUDAMED record Report an error
Vellap Germany
6 others
C IVDR, 98/79 info@vellap.de EUDAMED record Report an error
Vitromed FDA Germany
6 others
A IVDR, 98/79 Website info@vitromed.com EUDAMED record Report an error
Wwhsbio EU representative : CMC Medical Devices & Drugs SL (Spain) China
6 others
A IVDR, 98/79 Website info@wwhsbio.com EUDAMED record Report an error
Zetmedikal Türkiye
6 others
– 98/79 Website info@zetmedikal.com EUDAMED record Report an error
General Life Biotechnology FDA EU representative : MDSS GmbH (Germany) Taiwan
7 others
– 98/79 Website service@glbiotech.com.tw EUDAMED record Report an error
Aaz Productions Le Materiel Biomedical France
5 others
D IVDR, 98/79 EUDAMED record Report an error
Abacus Diagnostica Finland
5 others
– 98/79 info@abacusdiagnostica.com EUDAMED record Report an error
Abiores Technology (Beijing) EU representative : Medunion S.L. (Spain) and 2 others China
5 others
– 98/79 EUDAMED record Report an error
Biobase Diagnostic Technology (Shandong) EU representative : Luxus Lebenswelt GmbH (Germany) China
5 others
A IVDR, 98/79 EUDAMED record Report an error
BioChain (Beijing) Science & Technology EU representative : Medunion S.L. (Spain) China
5 others
A IVDR, 98/79 EUDAMED record Report an error
Chengdu Puth Medical Technology EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
5 others
A IVDR EUDAMED record Report an error
Engelbrecht Germany
5 others
A IVDR Website EUDAMED record Report an error
Eschweiler Germany
5 others
– 98/79 Website info@eschweiler-kiel.de EUDAMED record Report an error
Eurospital FDA Italy
5 others
A, B IVDR, 98/79 regulatory@eurospital.it EUDAMED record Report an error
Genmark Türkiye
5 others
A IVDR, 98/79 Website info@genmark.com.tr EUDAMED record Report an error
Genotropy France
5 others
– 98/79 Website EUDAMED record Report an error
Medicon Hellas FDA Greece
5 others
A, C IVDR, 98/79 Website EUDAMED record Report an error
Micropointbio EU representative : Obelis s.a. (Belgium) China
5 others
– 98/79 Website EUDAMED record Report an error
Precision System Science FDA EU representative : Emergo Europe B.V. (Netherlands) Japan
5 others
A IVDR service@pss.co.jp EUDAMED record Report an error
Pushkang EU representative : MedPath GmbH (Germany) and 1 other China
5 others
A IVDR, 98/79 EUDAMED record Report an error
Realmindbio EU representative : Lotus NL B.V. (Netherlands) and 1 other China
5 others
A IVDR, 98/79 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
Shandong Aosaite Medical Devices EU representative : SUNGO Europe B.V. (Netherlands) China
5 others
A IVDR 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
Singclean EU representative : SUNGO Europe B.V. (Netherlands) China
5 others
– 98/79 Website EUDAMED record Report an error
Suzhou Cyrunfeh Medical Devices Technology EU representative : SUNGO Europe B.V. (Netherlands) China
5 others
A IVDR EUDAMED record Report an error
Tisenc EU representative : QbD RepS BV (Belgium) and 1 other China
5 others
– 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
VMRD FDA EU representative : MediMark Europe Sarl. (France) United States
5 others
– 98/79 Website 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
Daltonbio EU representative : MedPath GmbH (Germany) and 2 others China
5 others
C IVDR, 98/79 Website EUDAMED record Report an error
Avioq Bio-tech EU representative : Lotus NL B.V. (Netherlands) and 1 other China
4 others
– 98/79 EUDAMED record Report an error
Biyosistem Türkiye
4 others
A IVDR Website info@biyosistem.com.tr EUDAMED record Report an error
Centre Europeen De Biotechnologie France
4 others
A IVDR, 98/79 contact@ceb-angers.fr EUDAMED record Report an error
Concepta Diagnostics United Kingdom (ex Northern Ireland)
4 others
I, IIa MDR Website info@conceptaivd.com EUDAMED record Report an error
Deltalab Spain
4 others
A IVDR, 98/79 Website info@deltalabgroup.com EUDAMED record Report an error
DiagCor Life Science EU representative : Medunion S.L. (Spain) and 1 other Hong Kong SAR China
4 others
A IVDR, 98/79 QARA@diagcorlifescience.com EUDAMED record Report an error
Diasia FDA EU representative : CMC Medical Devices & Drugs SL (Spain) China
4 others
A IVDR, 98/79 Website EUDAMED record Report an error
Furuno FDA EU representative : MedEnvoy Global BV (Netherlands) Japan
4 others
A IVDR Website EUDAMED record Report an error
GC Medical Science EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea
4 others
A IVDR, 98/79 EUDAMED record Report an error
GenDx FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China, United States
4 others
– 98/79 Website orders@genbio.com EUDAMED record Report an error
Genemind EU representative : Medunion S.L. (Spain) and 1 other China
4 others
A IVDR, 98/79 regulatoryaffairs@genemind.com EUDAMED record Report an error
Haimen Shengbang Laboratory Equipment FDA EU representative : SUNGO Europe B.V. (Netherlands) China
4 others
A IVDR, 98/79 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
Kingcreate EU representative : Kingsmead Service B.V. (Netherlands) and 1 other China
4 others
A, C IVDR, 98/79 EUDAMED record Report an error
Konsung FDA EU representative : Lotus NL B.V. (Netherlands) and 1 other China
4 others
A IVDR, 98/79 info@konsung.com EUDAMED record Report an error
Lumatas FDA EU representative : Emergo Europe B.V. (Netherlands) and 1 other United States
4 others
A IVDR EUDAMED record Report an error
Nanjing Leading Medical Technology EU representative : Medunion S.L. (Spain) China
4 others
– 98/79 EUDAMED record Report an error
Ningbo Dasky Life Science FDA EU representative : Kingsmead Service B.V. (Netherlands) China
4 others
A IVDR Website sale@daskymed.com EUDAMED record Report an error
Ortho-Clinical Diagnostics FDA EU representative : Ortho-Clinical Diagnostics France (France) United Kingdom (ex Northern Ireland)
4 others
A, C IVDR Website PRRC@quidelortho.com EUDAMED record Report an error
PentaBase Denmark
4 others
A IVDR, 98/79 Website info@pentabase.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
Seekxbio EU representative : GRZAN GROUP SL (Spain) China
4 others
A IVDR, 98/79 EUDAMED record Report an error
Shandong Bohong Gene Technology EU representative : Luxus Lebenswelt GmbH (Germany) China
4 others
A IVDR EUDAMED record Report an error
Shijiazhuang Yuanding Medical Device FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
4 others
A IVDR EUDAMED record Report an error
Solveco Sweden
4 others
A IVDR Website EUDAMED record Report an error
Tigsun EU representative : CMC Medical Devices & Drugs SL (Spain) China
4 others
– 98/79 EUDAMED record Report an error
Vwr FDA Belgium, France
4 others
A IVDR, 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
General Biologicals EU representative : Medical Technology Promedt Consulting GmbH (Germany) Taiwan
4 others
A IVDR, 98/79 sales.group@gbc.com.tw EUDAMED record Report an error
Pharmasave Romania
4 others
A IVDR, 98/79 OFFICE@PHARMASAVE.RO EUDAMED record Report an error
Anchor Diagnostics Germany
3 others
C IVDR, 98/79 info@anchor-diagnostics.com EUDAMED record Report an error
Association Of Medicine Analytics EU representative : CMC Medical Devices & Drugs SL (Spain) Russia
3 others
– 98/79 Website EUDAMED record Report an error
B&E Bio-Technology FDA EU representative : SUNGO Europe B.V. (Netherlands) China
3 others
A IVDR, 98/79 EUDAMED record Report an error
Beaverbio EU representative : Kingsmead Service B.V. (Netherlands) China
3 others
A IVDR sales@beaverbio.com EUDAMED record Report an error
Beiantmed EU representative : Kingsmead Service B.V. (Netherlands) China
3 others
A IVDR EUDAMED record Report an error
BioGnost Croatia
3 others
A IVDR Website 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
Bordier FDA EU representative : Leman Diagnostics SARL (France) Switzerland
3 others
B IVDR, 98/79 Website EUDAMED record Report an error
Caltag FDA EU representative : Advena Limited (Malta) United Kingdom (ex Northern Ireland)
3 others
A IVDR, 98/79 Website EUDAMED record Report an error
Diagnostic Systems Germany
3 others
– 98/79 Website info@ab-ds.de EUDAMED record Report an error
Dutch Diagnostics Netherlands
3 others
– 98/79 Website info@dutch-diagnostics.com EUDAMED record Report an error
Dyonmed Greece
3 others
– 98/79 Website customerservice@dyonmedical.com EUDAMED record Report an error
Eiken FDA EU representative : Advena Limited (Malta) and 1 other Japan
3 others
A, C IVDR regulatoryaffairs@eiken.co.jp EUDAMED record Report an error
FRIZ Biochem Germany
3 others
B IVDR Website info@frizbiochem.de EUDAMED record Report an error
Genetree EU representative : Obelis s.a. (Belgium) South Korea
3 others
B, C IVDR, 98/79 Website ra@genetree.co.kr EUDAMED record Report an error
Hospitex Italy
3 others
A IVDR Website info@hospitex.com EUDAMED record Report an error
Hunan Kangxin Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain) China
3 others
– 98/79 EUDAMED record Report an error
inno-train Diagnostik Germany
3 others
A IVDR, 98/79 Website info@inno-train.de EUDAMED record Report an error
Instrumentation Laboratory FDA Italy
3 others
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Laboveritas Latvia
3 others
A IVDR Website EUDAMED record Report an error
Opta-Tech Poland
3 others
A IVDR Website EUDAMED record Report an error
Pentapharm FDA EU representative : Emergo Europe B.V. (Netherlands) Switzerland
3 others
B IVDR, 98/79 Website RA@pentapharm.com EUDAMED record Report an error
Rocgene FDA EU representative : Medunion S.L. (Spain) and 1 other China
3 others
A IVDR, 98/79 sale@rocgene.com EUDAMED record Report an error
Roll Italy
3 others
A IVDR, 98/79 Website EUDAMED record Report an error
sebia FDA France
3 others
A IVDR Website EUDAMED record Report an error
Shanghai THAN Medical Technology EU representative : SUNGO Europe B.V. (Netherlands) China
3 others
A IVDR EUDAMED record Report an error
Shenzhen Kang Sheng Bao Bio-Technology EU representative : QbD RepS BV (Belgium) China
3 others
– 98/79 Website info@ksbbiotech.com EUDAMED record Report an error
SpeeDx FDA EU representative : MedEnvoy Global BV (Netherlands) Australia
3 others
A, B, C IVDR Website regulatory@speedx.com.au EUDAMED record Report an error
Streck FDA EU representative : MediMark Europe Sarl. (France) United States
3 others
A, B IVDR Website EUDAMED record Report an error
Vitrex Medical A S FDA Denmark
3 others
A IVDR Website info@vitrexmg.com EUDAMED record Report an error
Wallac Finland
3 others
A IVDR, 98/79 Website regulatoryaffairs.turku@revvity.com EUDAMED record Report an error
Wuhan MGI Tech EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
3 others
A IVDR EUDAMED record Report an error
Youpubiotech EU representative : MedPath GmbH (Germany) China
3 others
A IVDR ra@youpubiotech.com EUDAMED record Report an error
Zhuhai Shineway Biotech EU representative : CMC Medical Devices & Drugs SL (Spain) China
3 others
A IVDR, 98/79 Website 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
Gc Medis EU representative : Obelis s.a. (Belgium) South Korea
5 others
– 98/79 Website EUDAMED record Report an error
Innodx EU representative : QbD RepS BV (Belgium) China
3 others
C IVDR, 98/79 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
Avantor Performance Materials Poland FDA Poland
2 others
A IVDR Website regulatory.pl@avantorsciences.com EUDAMED record Report an error
Biokit FDA Spain
2 others
B, C IVDR EUDAMED record Report an error
Capitalbiotech EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
2 others
– 98/79 EUDAMED record Report an error
Cepheid FDA EU representative : Cepheid AB (Sweden) Sweden, United States
2 others
A, B, C IVDR, 98/79 Website EUDAMED record Report an error
Chemtronbio EU representative : CMC Medical Devices & Drugs SL (Spain) and 2 others China
2 others
B, C IVDR, 98/79 Website EUDAMED record Report an error
Chengwumedical EU representative : MedPath GmbH (Germany) and 1 other China
2 others
A IVDR EUDAMED record Report an error
CorDx FDA EU representative : Medunion S.L. (Spain) United States
2 others
C IVDR 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
Coyotebio EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China
2 others
A IVDR, 98/79 sales@coyotebio.com EUDAMED record Report an error
DAS Italy
2 others
A IVDR Website quality@dasitaly.com EUDAMED record Report an error
Diatrust FDA EU representative : Wellkang Ltd (Northern Ireland) China
2 others
A IVDR EUDAMED record Report an error
Dynodx EU representative : HUMISS TRADING S. L. (Spain) China
2 others
– 98/79 EUDAMED record Report an error
Eurolyser Austria
2 others
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Guangzhou LBP Medicine Science & Technology EU representative : Kingsmead Service B.V. (Netherlands) China
2 others
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Hecin EU representative : Share info GmbH (Germany) China
2 others
B IVDR EUDAMED record Report an error
I.S.E. - Societa' A Responsabilita' Limitata - Sistemi Intelligenti Elettronici Italy
2 others
A IVDR Website info@logotech-ise.com EUDAMED record Report an error
Inbios FDA EU representative : AR Experts B.V. (Netherlands) United States
2 others
– 98/79 Website EUDAMED record Report an error
Jiangsu Xinkang Medical Instrument EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China
2 others
A IVDR 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
Kamiya Biomedical FDA EU representative : Advena Limited (Malta) United States
2 others
B IVDR, 98/79 Website info@k-assay.com EUDAMED record Report an error
Katsura EU representative : Kingsmead Service B.V. (Netherlands) Taiwan
2 others
A IVDR Website EUDAMED record Report an error
Kurin FDA EU representative : MDSS GmbH (Germany) United States
2 others
IIa 93/42 Website 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
Margomed Poland
2 others
A IVDR, 98/79 Website EUDAMED record Report an error
Micras Italy
2 others
A IVDR info@micras.it EUDAMED record Report an error
Ningbo HEALTH Gene Technologies EU representative : Lotus NL B.V. (Netherlands) and 1 other China
2 others
A IVDR, 98/79 EUDAMED record Report an error
PaxGenBio EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea
2 others
A IVDR, 98/79 Website EUDAMED record Report an error
Plasticerveira - Transformação de Plástico, Lda Portugal
2 others
A IVDR Website EUDAMED record Report an error
Pro-med (Beijing) Technology EU representative : Sungo Cert GmbH (Germany) China
2 others
A IVDR, 98/79 EUDAMED record Report an error
Sanowa PlastoTec Germany
2 others
A IVDR Website EUDAMED record Report an error
Scytek FDA EU representative : Emergo Europe B.V. (Netherlands) United States
2 others
A, C IVDR Website EUDAMED record Report an error
Serosep FDA Ireland
2 others
A IVDR, 98/79 Website info@serosep.com EUDAMED record Report an error
Shanghai LeChen Biotechnology EU representative : Everbiz GmbH (Austria) China
2 others
A IVDR EUDAMED record Report an error
Shenzhen Dake Medical Technology EU representative : HyperCert Limited B.V. (Netherlands) and 1 other China
2 others
A, B, C IVDR EUDAMED record Report an error
Sterilin EU representative : NUNC A/S (Denmark) United Kingdom (ex Northern Ireland)
2 others
– 98/79 EUDAMED record Report an error
Strumed FDA EU representative : Amstermed B.V. (Netherlands) India
2 others
– 98/79 Website EUDAMED record Report an error
Wesailbio EU representative : Lotus NL B.V. (Netherlands) and 1 other China
2 others
A IVDR, 98/79 EUDAMED record Report an error
XEMA EU representative : Polmed.de Beata Rozwadowska (Germany) Russia
2 others
– 98/79 Website EUDAMED record Report an error
Xi'An Huawei Technology EU representative : SUNGO Europe B.V. (Netherlands) China
2 others
A IVDR EUDAMED record Report an error
YD Diagnostics FDA EU representative : CARE diagnostica Laborreagenzien GmbH (Germany) and 1 other South Korea
2 others
A IVDR, 98/79 Website admin@yd-diagnostics.com EUDAMED record Report an error
Yzymedical EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China
2 others
– 98/79 EUDAMED record Report an error
Genetic Signatures FDA EU representative : mdi Europa GmbH (Germany) Australia
3 others
A IVDR, 98/79 Website RAQA@geneticsignatures.com EUDAMED record Report an error
Suzhou Sym-Bio Lifescience EU representative : Emergo Europe B.V. (Netherlands) China
3 others
A, C IVDR, 98/79 quality.taicang@revvity.com EUDAMED record Report an error
Zymo Research FDA EU representative : DAVID Catherine Elisabeth Marie (France) United States
3 others
A IVDR info@zymoresearch.com EUDAMED record Report an error
Atomo Diagnostics EU representative : QbD RepS BV (Belgium) Australia
2 others
– 98/79 Website info@atomodiagnostics.com 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
"Bio-Ksel" Poland
1 other
A IVDR, 98/79 Website EUDAMED record Report an error
Amsino FDA EU representative : Emergo Europe B.V. (Netherlands) United States
1 other
I MDR, 93/42 EUDAMED record Report an error
Aperbio Technologies (Suzhou) EU representative : Medunion S.L. (Spain) China
1 other
A IVDR EUDAMED record Report an error
Bioendo EU representative : JOYSUN GROUP S.L.U (Spain) China
1 other
A IVDR sale@bioendo.com EUDAMED record Report an error
Biohit FDA Finland
1 other
A IVDR, 98/79 Website info@biohit.fi EUDAMED record Report an error
Boen Healthcare FDA EU representative : Everbiz GmbH (Austria) China
1 other
I, A IVDR, MDR Website EUDAMED record Report an error
Bruker FDA Germany
1 other
A IVDR, 98/79 Website info.md@bruker.com EUDAMED record Report an error
Citotest FDA EU representative : Obelis s.a. (Belgium) and 1 other China
1 other
I, A IVDR, MDR Website info@citotest.com EUDAMED record Report an error
Codisan Italy
1 other
A IVDR EUDAMED record Report an error
CTK Biotech FDA EU representative : MDSS GmbH (Germany) United States
1 other
B, C IVDR Website info@ctkbiotech.com EUDAMED record Report an error
Dynex Czechia
1 other
A IVDR Website EUDAMED record Report an error
Eaglenos FDA EU representative : MedPath GmbH (Germany) China
1 other
A IVDR EUDAMED record Report an error
Fanttest EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China
1 other
– 98/79 info@fanttest.com EUDAMED record Report an error
Fujifilm FDA EU representative : FUJIFILM Healthcare Europe GmbH (Germany) and 1 other Japan
1 other
A, C IVDR EUDAMED record Report an error
Gonotec Germany
1 other
– 98/79 Website contact_gonotec@elitechgroup.com EUDAMED record Report an error
Guangdong Kindly Medical Device Group FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
1 other
A IVDR EUDAMED record Report an error
Hangzhou HealthSky Biotechnology FDA EU representative : SUNGO Europe B.V. (Netherlands) China
1 other
A IVDR EUDAMED record Report an error
Helena Biosciences Europe FDA EU representative : Advena Limited (Malta) and 1 other United Kingdom (ex Northern Ireland)
1 other
A, C IVDR, 98/79 Website EUDAMED record Report an error
Inova Diagnostics FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) United States
1 other
A IVDR, 98/79 Website EUDAMED record Report an error
Intelsint Italy
1 other
A IVDR Website info@intelsint.com EUDAMED record Report an error
Jiangxi Medicalsystem Biological Technology EU representative : Medunion S.L. (Spain) China
1 other
– 98/79 EUDAMED record Report an error
Langenbrinck Germany
1 other
A IVDR EUDAMED record Report an error
Maine Molecular Quality Controls FDA EU representative : QbD RepS BV (Belgium) United States
1 other
B IVDR, 98/79 Website info@mmqci.com EUDAMED record Report an error
Marfour Poland
1 other
A IVDR Website info@marfour.com.pl EUDAMED record Report an error
Milenia Biotec Germany
1 other
– 98/79 Website info@milenia-biotec.de EUDAMED record Report an error
Ndimopoulos Greece
1 other
– 98/79 Website info@ndimopoulos.gr EUDAMED record Report an error
PathoNostics Netherlands
1 other
A, B IVDR, 98/79 Website info@pathonostics.com EUDAMED record Report an error
Roboscreen Germany
1 other
A IVDR, 98/79 Website info@roboscreen.com EUDAMED record Report an error
Sakura Netherlands
1 other
A IVDR Website quality@sakura.eu EUDAMED record Report an error
Sakura Finetek USA EU representative : Sakura Finetek Europe B.V. (Netherlands) United States
1 other
A IVDR PRRC@sakuraus.com EUDAMED record Report an error
Shenzhen Channel Biotechnology EU representative : Luxus Lebenswelt GmbH (Germany) China
1 other
– 98/79 Website service.channel@szchenna.com EUDAMED record Report an error
Shenzhen CoooSeee Biomedical EU representative : MedNet EC-REP GmbH (Germany) China
1 other
A, B IVDR service@comenbio.com EUDAMED record Report an error
Suzhou Hokapi Biomedical Engineering EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China
1 other
A, C IVDR EUDAMED record Report an error
Tauns EU representative : Emergo Europe B.V. (Netherlands) Japan
1 other
A IVDR, 98/79 Website EUDAMED record Report an error
Tharmac Germany
1 other
A IVDR Website info@tharmac.de EUDAMED record Report an error
Triplex International Biosciences (China) EU representative : Lotus NL B.V. (Netherlands) China
1 other
– 98/79 Website info@tibchina.com EUDAMED record Report an error
Vacure EU representative : CMC Medical Devices & Drugs SL (Spain) China
1 other
– 98/79 EUDAMED record Report an error
Wells Bio EU representative : MDSS GmbH (Germany) South Korea
1 other
– 98/79 Website info@wellsbio.net EUDAMED record Report an error
Genesystem FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea
1 other
A IVDR Website ra@genesystem.co.kr 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
AD Nucleis France A IVDR, 98/79 Website 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
Ademtech France B IVDR Website EUDAMED record Report an error
Agendia FDA Netherlands A IVDR Website EUDAMED record Report an error
Alwsci EU representative : Kingsmead Service B.V. (Netherlands) China A IVDR Website marketing@alwsci.com EUDAMED record Report an error
Ant Medi̇kal İthalat İhracat Pazarlama Sanayi̇ Ve Ti̇caret Şi̇rketi̇ Türkiye A IVDR Website info@antmedical.com EUDAMED record Report an error
Appolon Bioteck France A, B, C IVDR, 98/79 Website contact@appolonbioteck.com EUDAMED record Report an error
Atom Scientific EU representative : Advena Limited (Malta) United Kingdom (ex Northern Ireland) A IVDR Website EUDAMED record Report an error
Avecon Healthcare EU representative : Amstermed B.V. (Netherlands) India A IVDR Website EUDAMED record Report an error
Azubio Diagnostics EU representative : CMC Medical Devices & Drugs SL (Spain) China C IVDR EUDAMED record Report an error
B.P.C. Biosed – Italy A IVDR Website info@bpcbiosed.it EUDAMED record Report an error
Becton Dickinson UK FDA EU representative : Becton Dickinson Ireland Limited (Ireland) United Kingdom (ex Northern Ireland) – 98/79 Website eudamedenquiries@bd.com EUDAMED record Report an error
Beijing Biosynthesis Biotechnology EU representative : Medunion S.L. (Spain) 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
Boule FDA Sweden A, B IVDR Website info@boule.com EUDAMED record Report an error
B·R·A·H·M·S FDA Germany A, C IVDR EUDAMED record Report an error
Centralsurgical FDA EU representative : KHANG BAO INTERNATIONAL KFT (Hungary) Pakistan I MDR Website EUDAMED record Report an error
Cerascreen Germany A IVDR Website EUDAMED record Report an error
CoaguSense FDA EU representative : Emergo Europe B.V. (Netherlands) United States A, C IVDR, 98/79 Website EUDAMED record Report an error
Cytecs Germany – 98/79 Website info@cytecs.com EUDAMED record Report an error
Cytogen FDA Germany – 98/79 info@cytogen.net EUDAMED record Report an error
DFI FDA EU representative : MDSS GmbH (Germany) South Korea A IVDR, 98/79 EUDAMED record Report an error
Elektromed Poland A IVDR Website EUDAMED record Report an error
Euromex Netherlands A IVDR Website info@euromex.com EUDAMED record Report an error
Exbio FDA Czechia C IVDR Website info@exbio.cz EUDAMED record Report an error
FertiPro FDA Belgium A, B IVDR Website info@fertipro.com EUDAMED record Report an error
Foracare FDA EU representative : MedNet EC-REP GmbH (Germany) Switzerland – 98/79 Website EUDAMED record Report an error
Globescientific Netherlands A IVDR Website EUDAMED record Report an error
Golias Slovenia A IVDR Website info@golias.si EUDAMED record Report an error
Guangzhou Biotron Technology EU representative : CMC Medical Devices & Drugs SL (Spain) China – 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
Igenesis Shanghai EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China A, C IVDR, 98/79 support@igenesisbio.com EUDAMED record Report an error
Innovacon EU representative : MDSS GmbH (Germany) United States – 98/79 EUDAMED record Report an error
Jiangsu Kangjie Medical Devices EU representative : SUNGO Europe B.V. (Netherlands) China I MDR EUDAMED record Report an error
Jinquanmedical EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR sales1@jinquanmedical.com EUDAMED record Report an error
Jokoh EU representative : MDSS GmbH (Germany) Japan A IVDR, 98/79 Website EUDAMED record Report an error
Junocare EU representative : Humiss International B.V. (Netherlands) China A IVDR Website EUDAMED record Report an error
Koroglu Medikal Tibbi Malzemeleri Kozmetik Ithalat Ihracat Sanayi Ve Ticaret Sti Türkiye B IVDR, 98/79 Website info@koroglugroup.com EUDAMED record Report an error
Laborkrone Germany I, IIa MDR Website EUDAMED record Report an error
Lansionbio EU representative : JOYSUN GROUP S.L.U (Spain) and 1 other China – 98/79 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
Microbix FDA EU representative : Obelis s.a. (Belgium) Canada B IVDR Website customer.service@microbix.com EUDAMED record Report an error
Microtrace Italy A IVDR Website office@microtrace.it 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 Mevid Life Scientific EU representative : Sungo Cert GmbH (Germany) China A IVDR EUDAMED record Report an error
Natera FDA EU representative : QbD RepS BV (Belgium) United States A IVDR Website support@natera.com EUDAMED record Report an error
Ningbo BESTest Bio-technology EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China B, C IVDR, 98/79 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
Panreac Química, S.L.U Spain A IVDR EUDAMED record Report an error
Paul Marienfeld FDA Germany A IVDR Website info@marienfeld-superior.com EUDAMED record Report an error
Poweam EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
PreAnalytiX FDA EU representative : QIAGEN GmbH (Germany) Switzerland A IVDR Website EUDAMED record Report an error
Precision Biosensor FDA EU representative : mdi Europa GmbH (Germany) South Korea – 98/79 Website info@precision-bio.com EUDAMED record Report an error
Ravo Germany – 98/79 Website info@ravo.de EUDAMED record Report an error
Remel FDA EU representative : Thermo Fisher Diagnostics B.V. (Netherlands) United States B IVDR, 98/79 Website EUDAMED record Report an error
Shanghai Rendu Biotechnology EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China A, C IVDR EUDAMED record Report an error
Shenzhen AmTech Bioengineering EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR, 98/79 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 Everbest Machinery lndustry EU representative : Kingsmead Service B.V. (Netherlands) and 1 other China A IVDR EUDAMED record Report an error
Shenzhen Huian Biosci Technology EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China – 98/79 info@huiantech.com EUDAMED record Report an error
Shenzhen Sciarray Biotech EU representative : SUNGO Europe B.V. (Netherlands) China – 98/79 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
Sugentech FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea A, B IVDR ra@sugentech.com EUDAMED record Report an error
SysCan MedTech (Suzhou) EU representative : Obelis s.a. (Belgium) China A IVDR EUDAMED record Report an error
TECOmedical EU representative : EUROBIO SCIENTIFIC (France) Switzerland – 98/79 Website info@tecomedical.com 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
Ventana Medical Systems FDA EU representative : Roche Diagnostics GmbH (Germany) United States A, C IVDR EUDAMED record Report an error
Viuick EU representative : SUNGO Europe B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Zhejiang Wantaifu Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China – 98/79 Website EUDAMED record Report an error
Etablissement Francais Du Sang France B IVDR, 98/79 EUDAMED record Report an error
Grundium Finland A IVDR Website support@grundium.com EUDAMED record Report an error
PathoFinder Netherlands B IVDR, 98/79 Website info@pathofinder.com EUDAMED record Report an error
Actim FDA Finland – 98/79 Website support@actimtest.com EUDAMED record Report an error
Alifax FDA Italy A IVDR Website regulatory@alifax.com EUDAMED record Report an error
Aquisel FDA Spain A IVDR EUDAMED record Report an error
Archem Türkiye A IVDR, 98/79 Website EUDAMED record Report an error
Behnk Germany A IVDR Website regulatory@behnk.de EUDAMED record Report an error
Beijing North Institute of Biotechnology EU representative : Lotus NL B.V. (Netherlands) and 1 other China A IVDR, 98/79 info@eugenebio.com EUDAMED record Report an error
Beijing OriginPoly Bio-Tec EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR, 98/79 EUDAMED record Report an error
Benoylab EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR Sale02@benoylab.com EUDAMED record Report an error
Bio-Novum Poland A IVDR, 98/79 Website EUDAMED record Report an error
Boettger Germany A IVDR Website sales@boettger.com 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
C.S.A. Service Italy A IVDR Website EUDAMED record Report an error
Calth EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea C IVDR, 98/79 Website info@thecalth.com EUDAMED record Report an error
Cellabs EU representative : WMDE B.V. (Netherlands) Australia – 98/79 Website enquiries@cellabs.com.au 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
Diagast FDA France A IVDR Website contact@diagast.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
Diazyme FDA EU representative : MDSS GmbH (Germany) United States – 98/79 Website EUDAMED record Report an error
EKF-diagnostic FDA Germany B IVDR info@ekf-diagnostic.de EUDAMED record Report an error
El-Comp Cezary Kostuch Poland A IVDR Website EUDAMED record Report an error
Elisabeth Czechia – 98/79 Website info@elisabeth.cz EUDAMED record Report an error
Fisher Diagnostics A division of Fisher Scientific EU representative : B·R·A·H·M·S GmbH (Germany) United States – 98/79 Website EUDAMED record Report an error
for you eHealth Germany I, IIa MDR Website info@foryouehealth.de EUDAMED record Report an error
GaDia EU representative : ER Egészségügyi, Kereskedelmi és Szolgáltató Kft. (Hungary) Switzerland – 98/79 Website info@gadia.net EUDAMED record Report an error
Genfine EU representative : MedPath GmbH (Germany) China A IVDR EUDAMED record Report an error
Guangdong Hao Jiang Laboratories EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR 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 Deaou Gene Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) and 1 other China A IVDR, 98/79 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 Aokai Biotech EU representative : JOYSUN GROUP S.L.U (Spain) and 1 other China A IVDR, 98/79 info@aokais.com.cn EUDAMED record Report an error
Hangzhou New Horizon Health Technology EU representative : MedPath GmbH (Germany) and 1 other China A, C IVDR, 98/79 Website compliance@nhbio.com.cn EUDAMED record Report an error
Hebei Sanxin Pharmaceutical Technology EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR, 98/79 EUDAMED record Report an error
HemoCue FDA Sweden A IVDR, 98/79 Website info@hemocue.se EUDAMED record Report an error
Hemonart Türkiye – 98/79 Website info@hemonart.com EUDAMED record Report an error
High Technology FDA EU representative : MedEnvoy Global BV (Netherlands) United States A IVDR Website 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
Huzhou Jierunxin Biotechnology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 EUDAMED record Report an error
Id Solutions France – 98/79 Website info@id-solutions.fr 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
Immunotech FDA France C IVDR EUDAMED record Report an error
Islandpolymer Germany A IVDR Website EUDAMED record Report an error
Jiezibio EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR, 98/79 EUDAMED record Report an error
Kangmei Tianhong Biotech (Beijing) EU representative : Lotus NL B.V. (Netherlands) China – 98/79 Website info@kindmay.com EUDAMED record Report an error
Kolasa Spółka Jawna Poland A IVDR EUDAMED record Report an error
Labpathexperts Poland I, A IVDR, MDR Website office@labpathexperts.com EUDAMED record Report an error
LaCAR MDx Technologies FDA Belgium – 98/79 Website EUDAMED record Report an error
Life Technologies Grand Island EU representative : Life Technologies Europe B.V. (Netherlands) United States A IVDR EUDAMED record Report an error
Lockcon EU representative : Emergo Europe B.V. (Netherlands) Switzerland IIa, A IVDR, MDR Website info@lockcon.ch EUDAMED record Report an error
Macherey-Nagel FDA Germany A IVDR Website sales@mn-net.com EUDAMED record Report an error
Macrunbio EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR, 98/79 EUDAMED record Report an error
Mascia Brunelli Italy A IVDR Website EUDAMED record Report an error
Matsunami Glass Ind FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) Japan A IVDR EUDAMED record Report an error
Medipak EU representative : AF Pharma Service Europe SL (Spain) United States I MDR info@medipak.com 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
Newmarket Biomedical FDA EU representative : MDSS GmbH (Germany) United Kingdom (ex Northern Ireland) C IVDR, 98/79 Website regulatory@new-bio.com EUDAMED record Report an error
Nihon Kohden Firenze Italy A IVDR Website info@nkf.it EUDAMED record Report an error
NovaGray France – 98/79 contact@nova-gray.com EUDAMED record Report an error
Nuclear Laser Medicine Italy A, C IVDR Website quality@nlm.it 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
Radiometer FDA Denmark A IVDR Website radiometerra_eu@radiometer.dk EUDAMED record Report an error
Remi Health Germany I, IIa MDR Website 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
Sakura Finetek Japan EU representative : Sakura Finetek Europe B.V. (Netherlands) Japan A IVDR Website EUDAMED record Report an error
SC - Sanguis Counting Kontrollblutherstellungs- und Vertriebs Germany A IVDR Website info@sanguis-counting.de EUDAMED record Report an error
Schebo FDA Germany A IVDR Website EUDAMED record Report an error
Shenzhen Lvshiyuan Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China B IVDR Website 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
Sinopharm EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR 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
Sistat Türkiye A IVDR Website info@sistat.com.tr EUDAMED record Report an error
Suntrine EU representative : Kingsmead Service B.V. (Netherlands) China A IVDR service@suntrine.com EUDAMED record Report an error
Tem Innovations FDA Germany A IVDR, 98/79 EUDAMED record Report an error
Tianjin Bai Lixin Bio-tech EU representative : Kingsmead Service B.V. (Netherlands) China A IVDR Website EUDAMED record Report an error
Trustmomed EU representative : Sungo Cert GmbH (Germany) China A IVDR sales@trustmomed.com EUDAMED record Report an error
Visia Lab FDA Italy A IVDR, 98/79 Website quality@visialab.com 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
Wizbiosolution EU representative : CMC Medical Devices & Drugs SL (Spain) South Korea A IVDR EUDAMED record Report an error
Xiamen Sciendox Biological Technology EU representative : MedPath GmbH (Germany) China A IVDR EUDAMED record Report an error
Xiaogan Kuohai Medical Technology EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Zentech FDA Belgium – 98/79 EUDAMED record Report an error
Hmdbio FDA EU representative : Luana Med. B.V. (Netherlands) Taiwan – 98/79 Website EUDAMED record Report an error
Ae Ireland IIa MDR Website regulatory@ae.expert 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
Alcor Scientific FDA EU representative : Emergo Europe B.V. (Netherlands) United States A IVDR EUDAMED record Report an error
AmplexDiagnostics Germany C IVDR info@amplexdiagnostics.de EUDAMED record Report an error
Anga Anioła Tomasz Anioła Poland A IVDR Website EUDAMED record Report an error
Aucheer EU representative : MedPath GmbH (Germany) China A IVDR info_office@aucheer.net EUDAMED record Report an error
Bamed Czechia A IVDR info@bamed.cz 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
Bio-Gram Diagnostics FDA Germany A IVDR Website contact@bio-gram.de EUDAMED record Report an error
Bioclarma Italy – 98/79 Website EUDAMED record Report an error
Biodatacorp EU representative : mdi Europa GmbH (Germany) United States A IVDR Website customer.service@biodatacorp.com EUDAMED record Report an error
Biogenvet Romania I MDR contact@biogenvet.ro EUDAMED record Report an error
BioLegend FDA EU representative : MedEnvoy Global BV (Netherlands) United States – 98/79 EUDAMED record Report an error
Biomed FDA Germany A IVDR Website info@biomed.de EUDAMED record Report an error
Biopanda Northern Ireland – 98/79 Website info@biopanda.co.uk 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
Biosigma FDA Italy A IVDR Website info@biosigmaeu.com EUDAMED record Report an error
Bi̇yofen Kurumsal Sağlik Hi̇zmetleri̇ Yazilim Turi̇zm Sanayi̇ Ti̇caret Şti̇ Türkiye A IVDR EUDAMED record Report an error
Bonraybio FDA EU representative : MDSS GmbH (Germany) Taiwan A IVDR service@bonraybio.com EUDAMED record Report an error
BotuAImaging Technology EU representative : Kingsmead Service B.V. (Netherlands) China A IVDR EUDAMED record Report an error
C.P.M. Compagnia Per La Medicina Italy A IVDR, 98/79 Website EUDAMED record Report an error
Cariad EU representative : PureCE B.V. (Netherlands) China A IVDR Website support@cariad.com.cn EUDAMED record Report an error
CLARO-PROM društvo s ograničenom odgovornošću za proizvodnju, trgovinu i usluge Croatia A IVDR EUDAMED record Report an error
CleanNA Netherlands A IVDR Website info@cleanna.com EUDAMED record Report an error
Coei Biotech EU representative : Medunion S.L. (Spain) China – 98/79 EUDAMED record Report an error
Copan Wasp FDA Italy A IVDR Website regulatory.wasp@copangroup.com EUDAMED record Report an error
Cytochipinc FDA EU representative : Medunion S.L. (Spain) United States A IVDR, 98/79 quality@cytochipinc.com EUDAMED record Report an error
D-tek Belgium A IVDR Website EUDAMED record Report an error
Dagatron FDA EU representative : BZT-TCP Certification GmbH (Germany) South Korea A IVDR Website EUDAMED record Report an error
Diagenode FDA Belgium B, C IVDR info@diagenode.com EUDAMED record Report an error
DiaMed FDA EU representative : Bio-Rad (France) Switzerland A, D IVDR, 98/79 Website contact@bio-rad.com EUDAMED record Report an error
Dianabiotech Czechia – 98/79 Website info@dianabiotech.com EUDAMED record Report an error
Di̇a Pro Tibbi̇ Ürünler San. Ve Ti̇c. A.Ş Türkiye A, D IVDR EUDAMED record Report an error
DNA Genotek FDA EU representative : QbD RepS BV (Belgium) Canada A IVDR Website regulatory@dnagenotek.com 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
Fujirebio FDA Belgium C IVDR Website EUDAMED record Report an error
GB Lifecare EU representative : Obelis s.a. (Belgium) South Korea C IVDR Website EUDAMED record Report an error
GenBody FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea A, B, C IVDR EUDAMED record Report an error
GeneFirst EU representative : Advena Limited (Malta) United Kingdom (ex Northern Ireland) – 98/79 Website EUDAMED record Report an error
GeneMatrix EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea – 98/79 Website support@genematrix.net EUDAMED record Report an error
GenMark Diagnostics FDA EU representative : Roche Diagnostics GmbH (Germany) United States A, B IVDR regulatory.rmd_international@roche.com EUDAMED record Report an error
Genomictree EU representative : KTR Europe GmbH (Germany) South Korea A IVDR Website EUDAMED record Report an error
Gp Medical Devices A S FDA Denmark A IVDR Website EUDAMED record Report an error
Guangzhou Hearty Expression Medical Technology EU representative : Everbiz GmbH (Germany) China A IVDR 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
Hangzhou Agen Biotechnology EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR 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
Hunan AccuBio Biotech EU representative : SUNGO Europe B.V. (Netherlands) and 1 other China A IVDR, 98/79 info@hn-accubio.com EUDAMED record Report an error
Hyris Italy A IVDR Website support@hyris.net EUDAMED record Report an error
Icarbonx EU representative : Kingsmead Service B.V. (Netherlands) China 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
Immunodiagnostic Systems FDA EU representative : Immunodiagnostic Systems SA (Belgium) United Kingdom (ex Northern Ireland) A IVDR Website EUDAMED record Report an error
Invitrosco EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea A IVDR, 98/79 Website 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 Medomics Medical Technology FDA EU representative : R Sight B.V. (Netherlands) and 1 other China C IVDR, 98/79 Website info@medomics-dx.com EUDAMED record Report an error
Jiangsu Rongsheng Jiamei Biological Reagent EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China A IVDR EUDAMED record Report an error
Kangrun EU representative : Sungo Cert GmbH (Germany) China A IVDR EUDAMED record Report an error
Kreatech Biotechnology Netherlands – 98/79 Website QA.Amsterdam@leicabiosystems.com EUDAMED record Report an error
Labitec Germany A IVDR EUDAMED record Report an error
Ldn Germany – 98/79 Website regulatory@ldn.de EUDAMED record Report an error
Leadmanbio EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China A IVDR, 98/79 EUDAMED record Report an error
Luminexcorp FDA EU representative : DiaSorin Italia S.p.A. (Italy) United States A, C IVDR Website regulatoryaffairs@luminexcorp.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
Medical & Biological Laboratories EU representative : QbD RepS BV (Belgium) Japan B IVDR EUDAMED record Report an error
Meteromega EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR Website EUDAMED record Report an error
Neo-nostics (Suzhou) Bioengineering EU representative : Medunion S.L. (Spain) and 1 other China – 98/79 EUDAMED record Report an error
Ningbo Chiwell Biotechnology FDA EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Ningbo Trustlab Instruments EU representative : Lotus NL B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Noul FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea A IVDR, 98/79 Website cs@noul.com EUDAMED record Report an error
Poclight EU representative : HUMISS TRADING S. L. (Spain) China – 98/79 info@poclight.com EUDAMED record Report an error
Precision BioLogic FDA EU representative : Emergo Europe B.V. (Netherlands) Canada C IVDR EUDAMED record Report an error
Predicine EU representative : MDSS GmbH (Germany) United States A IVDR Website support.us@predicine.com EUDAMED record Report an error
Premier Medical EU representative : Obelis s.a. (Belgium) India – 98/79 Website info@premiermedcorp.com EUDAMED record Report an error
Probatix Germany IIa, A IVDR, MDR Website EUDAMED record Report an error
Proekosrl Italy A IVDR Website info@proekosrl.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
Reagens Fejlesztő Gyártó És Kereskedelmi Kft Hungary A IVDR Website EUDAMED record Report an error
RevoSketch EU representative : CMC Medical Devices & Drugs SL (Spain) South Korea A IVDR Website 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
Sekisui Diagnostics FDA EU representative : MDSS GmbH (Germany) United States – 98/79 Website 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 Bio-engineering EU representative : QbD RepS BV (Belgium) China A IVDR, 98/79 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
Swiscare Technology EU representative : MedNet EC-REP GmbH (Germany) Taiwan – 98/79 EUDAMED record Report an error
Syntesys Italy A IVDR, 98/79 Website EUDAMED record Report an error
Tianjin Jianbo Biological EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 EUDAMED record Report an error
Tianjin Mingao Biotechnology EU representative : SUNGO Europe B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Tmsmedikal Türkiye A IVDR Website info@tmsmedikal.com EUDAMED record Report an error
Toda Pharma France – 98/79 Website qualite@todapharma.com EUDAMED record Report an error
Todylaboratories Romania A IVDR Website contact@todylaboratories.com EUDAMED record Report an error
Transgen EU representative : Kingsmead Service B.V. (Netherlands) China A IVDR 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
Wuhan Landing Intelligence Medical FDA EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
X-ZELL Biotech Pte EU representative : X-ZELL Biotech GmbH (Germany) Singapore A IVDR Website support@x-zell.com EUDAMED record Report an error
Yancheng Huida Biotechnology EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Yancheng Jufan Lab Instrument EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Yhlo Biotech (Nanjing) EU representative : Medunion S.L. (Spain) China – 98/79 EUDAMED record Report an error
Zhejiang Kangshi Medical Devices EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Zhongshan Bio-Tech EU representative : Lotus NL B.V. (Netherlands) China – 98/79 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
ZKYH AImed Technology (Guangxi) EU representative : Sungo Cert GmbH (Germany) China A IVDR EUDAMED record Report an error
Lykon Germany
3 others
I, IIa MDR quality@lykon.com EUDAMED record Report an error
Responsebio FDA EU representative : Emergo Europe B.V. (Netherlands) Canada A IVDR, 98/79 Website EUDAMED record Report an error
-Diagnostics EU representative : mdi Europa GmbH (Germany) United States – 98/79 Website EUDAMED record Report an error
1drop EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea – 98/79 Website sales@1drop.co.kr 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
Acmed FDA EU representative : MedPath GmbH (Germany) China A IVDR EUDAMED record Report an error
Advanced Cell Diagnostics FDA EU representative : QbD RepS BV (Belgium) United States – 98/79 EUDAMED record Report an error
Aikang Diagnostics EU representative : MedNet EC-REP GmbH (Germany) China A IVDR, 98/79 marketing@aikang-medical.com EUDAMED record Report an error
Akmedical Italy A IVDR commerciale@akmedical.it EUDAMED record Report an error
Amazingbio EU representative : Kingsmead Service B.V. (Netherlands) China A IVDR EUDAMED record Report an error
AO Vector-Best EU representative : BIORON GmbH (Germany) Russia A IVDR Website EUDAMED record Report an error
Apiro Hungary C IVDR Website info@apiro.eu 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
Beckman EU representative : Beckman Coulter Ireland Inc. (Ireland) India C IVDR Website EUDAMED record Report an error
Beijing Healthgene Laboratory EU representative : Lotus NL B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Bensrl Italy A IVDR Website EUDAMED record Report an error
Bioanalyse Türkiye A IVDR Website info@bioanalyse.com EUDAMED record Report an error
Biocytech Sdn Bhd FDA EU representative : SUNGO Europe B.V. (Netherlands) Malaysia A IVDR EUDAMED record Report an error
Biodetect EU representative : Lotus NL B.V. (Netherlands) China – 98/79 Website 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
Biomerica FDA EU representative : MDSS GmbH (Germany) United States – 98/79 Website info@biomerica.com EUDAMED record Report an error
Bioway EU representative : Sungo Cert GmbH (Germany) China A IVDR EUDAMED record Report an error
Calibrescientific FDA EU representative : MDSS GmbH (Germany) United States A IVDR Website regulatory@calibrescientific.com EUDAMED record Report an error
Callegari Italy A IVDR EUDAMED record Report an error
Campmedica Romania B IVDR, 98/79 Website EUDAMED record Report an error
Cangzhou Fukang Medical Supplies EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Canterbury Scientific FDA EU representative : Emergo Europe B.V. (Netherlands) New Zealand – 98/79 Website cseymour@canterburyscientific.com EUDAMED record Report an error
Cavanbio EU representative : HyperCert Limited B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Cell Projects FDA EU representative : Advena Limited (Malta) United Kingdom (ex Northern Ireland) A IVDR Website EUDAMED record Report an error
Centroiidmeditech EU representative : AF Pharma Service Europe SL (Spain) India A IVDR Website EUDAMED record Report an error
Changsha Han Biotechnology EU representative : Medunion S.L. (Spain) China A IVDR EUDAMED record Report an error
Chengdu Find Medical Devices EU representative : MedPath GmbH (Germany) China A IVDR EUDAMED record Report an error
Chengdu One-Chip Biotechnology EU representative : Share info GmbH (Germany) China A IVDR, 98/79 EUDAMED record Report an error
Chengdu Rich Science Industry EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR, 98/79 Qa@cdrich.com EUDAMED record Report an error
Comedical Italy A IVDR Website info@comedical.biz 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
Cupidlimited FDA EU representative : Amstermed B.V. (Netherlands) India C, D IVDR Website qa@cupidlimited.com EUDAMED record Report an error
Darui Biotechnology EU representative : Lotus NL B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Delbio EU representative : Emergo Europe B.V. (Netherlands) Taiwan A IVDR Website EUDAMED record Report an error
devemed FDA Germany I MDR Website info@devemed.de EUDAMED record Report an error
Diagnostics For Real World FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) United States B, C IVDR Website ra@drw-ltd.com 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
Diagre EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR, 98/79 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
Durviz Spain A IVDR Website EUDAMED record Report an error
Dusons EU representative : AF Pharma Service Europe SL (Spain) India A IVDR regulatory@dusons.in EUDAMED record Report an error
Dxterity FDA EU representative : MedEnvoy Global BV (Netherlands) United States – 98/79 Website 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
Elitech Microbio France B, C IVDR Website EUDAMED record Report an error
Elmontsrl Italy A IVDR Website EUDAMED record Report an error
Enlightening Pallet Industry EU representative : SUNGO Europe B.V. (Netherlands) China – 98/79 sales02@icnplast.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
Essenlix EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China A IVDR Website info@essenlix.com.cn EUDAMED record Report an error
Esteriplas Portugal A IVDR Website EUDAMED record Report an error
Eurosirel FDA Italy – 98/79 EUDAMED record Report an error
Futurlab Italy A IVDR Website EUDAMED record Report an error
Gangdong Group FDA EU representative : MDSS GmbH (Germany) South Korea A IVDR Website EUDAMED record Report an error
Gcmedica EU representative : Kingsmead Service B.V. (Netherlands) China IIa 93/42 EUDAMED record Report an error
Geneplus EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China A IVDR EUDAMED record Report an error
Genfollower EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Gold Probe Diagnostic Biotechnology Mf EU representative : Lotus NL B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Guangdong Zijian Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain) China A IVDR sales@szzijian.com EUDAMED record Report an error
Guangzhou Decheng Biotechnology FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other China – 98/79 Website service@dochekbio.com 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
Haierbiomedical FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China A IVDR EUDAMED record Report an error
Hailife EU representative : Medunion S.L. (Spain) China A IVDR EUDAMED record Report an error
Haimen Henghui Lab Equipment Manufacturing Factory EU representative : Prolinx GmbH (Germany) China A IVDR Website EUDAMED record Report an error
Hangzhou MiYin Biotechnology EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Hanhengmed FDA EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR quality@hanhengmed.com EUDAMED record Report an error
Helixgen (GUANGZHOU) EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China – 98/79 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
Hisztopatológia Kft Hungary A IVDR Website info@histopat.hu 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
Hosmed Grup Medi̇kal Sağlik Hi̇zmetleri̇ Şi̇rketi̇ Türkiye A IVDR EUDAMED record Report an error
Hoyotek EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 Website inquiry@hoyotek.cn EUDAMED record Report an error
HplanetBio (Shijiazhuang) EU representative : Lotus NL B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Hubei V-Medical Products FDA EU representative : RAFFIN MEDICAL (France) China I MDR Website quality-liutao@v-medicalchina.com EUDAMED record Report an error
Humadx EU representative : Human Gesellschaft für Biochemica und Diagnostica mbH (Germany) China A IVDR, 98/79 service@humadx.com.cn EUDAMED record Report an error
Hunan Hehao Medical Technology EU representative : Lotus NL B.V. (Netherlands) China B IVDR, 98/79 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
Inpeco FDA EU representative : QbD RepS BV (Belgium) Switzerland A IVDR Regulatory.Affairs@inpeco.com EUDAMED record Report an error
IQ Products FDA Netherlands – 98/79 Website orders@iqproducts.nl EUDAMED record Report an error
Jiangsu OUKLAB Medical Devices EU representative : SUNGO Europe B.V. (Netherlands) 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
Jiangxi Exquisite Technology EU representative : SUNGO Europe B.V. (Netherlands) 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
Lifereal EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Liuyang Sanli Medical Technology Development EU representative : CMC Medical Devices & Drugs SL (Spain) China A IVDR EUDAMED record Report an error
Luminex Molecular Diagnostics FDA EU representative : DiaSorin Italia S.p.A. (Italy) Canada B IVDR, 98/79 Website regulatoryaffairs@luminexcorp.com EUDAMED record Report an error
Lybe Scientific Norway A IVDR Website contact@lybescientific.com EUDAMED record Report an error
MacroArray Diagnostics Austria A IVDR Website office@madx.com EUDAMED record Report an error
Meddo Romania A IVDR Website office@meddo.ro EUDAMED record Report an error
Medical FDA EU representative : Obelis s.a. (Belgium) Japan A IVDR Website EUDAMED record Report an error
Medical Devices EU representative : Obelis s.a. (Belgium) Pakistan I MDR Website EUDAMED record Report an error
Medical Electronic Systems Europe FDA Belgium A IVDR, 98/79 EUDAMED record Report an error
Medico Technology EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR info@medicoswab.com EUDAMED record Report an error
Medilab Czechia A IVDR Website EUDAMED record Report an error
Megarobo EU representative : MedPath GmbH (Germany) China A IVDR EUDAMED record Report an error
MES Medical Electronic Systems EU representative : Arazy Group GmbH (Germany) Israel A IVDR, 98/79 EUDAMED record Report an error
Miraclean Technology FDA EU representative : Share info GmbH (Germany) China A IVDR EUDAMED record Report an error
Moelab Germany – 98/79 Website info@moelab.de EUDAMED record Report an error
Monlab Spain – 98/79 Website EUDAMED record Report an error
Mr International Healthcare Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China A IVDR EUDAMED record Report an error
Nadeemsurgical EU representative : KHANG BAO INTERNATIONAL KFT (Hungary) Pakistan I MDR Website info@nadeemsurgical.com 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
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
New Erie Scientific EU representative : Epredia Netherlands B.V. (Netherlands) United States A IVDR EUDAMED record Report an error
Nichirei Biosciences EU representative : MedEnvoy Global BV (Netherlands) Japan A IVDR Website 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
Otsukael FDA EU representative : Emergo Europe B.V. (Netherlands) Japan A IVDR Website EUDAMED record Report an error
Oxford Immunotec FDA EU representative : Wallac Oy (Finland) United Kingdom (ex Northern Ireland) A, C IVDR regulatory.oxford@revvity.com EUDAMED record Report an error
PHC FDA EU representative : PHC Europe B.V. (Netherlands) Japan I, C IVDR, MDR EUDAMED record Report an error
Philips FDA Netherlands A IVDR eudamed@philips.com EUDAMED record Report an error
Physikit Germany IIa MDR Website EUDAMED record Report an error
Pro-Lab Diagnostics UK EU representative : Advena Limited (Malta) United Kingdom (ex Northern Ireland) A IVDR, 98/79 Website EUDAMED record Report an error
Pro.Lab FDA Italy I, A IVDR, MDR EUDAMED record Report an error
Promega FDA EU representative : Abbott GmbH (Germany) United States A IVDR EUDAMED record Report an error
Protia EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea A IVDR EUDAMED record Report an error
Quidel Cardiovascular FDA EU representative : MDSS GmbH (Germany) United States – 98/79 Website PRRC@quidelortho.com 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
Rastin EU representative : Source of Commerce GmbH (Germany) Iran C IVDR Website EUDAMED record Report an error
Regengeek EU representative : MedPath GmbH (Germany) China A IVDR EUDAMED record Report an error
ReLIA Biotechnologies (Jiangsu) EU representative : Luxus Lebenswelt GmbH (Germany) China – 98/79 EUDAMED record Report an error
Sacace Italy A IVDR Website info@sacace.com EUDAMED record Report an error
Sanqi Biomedical Shandong EU representative : Lotus NL B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Sc Spd Star Romania A IVDR Website OFFICE@SPDGROUP.RO 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
SD Innovation France A IVDR contact@sd-innovation.fr EUDAMED record Report an error
Self-screen Netherlands – 98/79 Website EUDAMED record Report an error
Shanghai Howsome Biotechnology EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Shanghai Sunshore Medical Instruments EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR 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 Landwind Biomedical Technology EU representative : Lotus NL B.V. (Netherlands) China A IVDR, 98/79 sales@landwindmedical.com EUDAMED record Report an error
ShenZhen PRS EU representative : Kingsmead Service B.V. (Netherlands) China A IVDR 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
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
Siliconbiosystems FDA EU representative : Menarini Silicon Biosystems S.p.A. (Italy) United States – 98/79 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
Specchiasol Italy IIa MDR 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
Suny (Xiamen) Biotechnology EU representative : Lotus NL B.V. (Netherlands) and 1 other China – 98/79 EUDAMED record Report an error
Sussex Biologicals EU representative : Eurolink Europe Compliance Limited (Ireland) United Kingdom (ex Northern Ireland) A IVDR Website info@sussexbiologicals.co.uk EUDAMED record Report an error
Suzhou Ruiqian Technologies EU representative : Medunion S.L. (Spain) China A IVDR 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
Taizhou Kangwei Medical Instrument EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Taizhou Zecen Biotech EU representative : MedPath GmbH (Germany) China A IVDR EUDAMED record Report an error
tascom EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea A IVDR, 98/79 EUDAMED record Report an error
Tassoinc FDA EU representative : Emergo Europe B.V. (Netherlands) United States IIa MDR, 93/42 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 Bioscience Diagnostic Technology EU representative : SUNGO Europe B.V. (Netherlands) China – 98/79 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
Vecmedical FDA Spain – 98/79 Website eudamed@vecmedical.com EUDAMED record Report an error
vivatura Germany I, IIa MDR Website EUDAMED record Report an error
Waldemar Knittel Glasbearbeitungs Germany A IVDR Website quality@knittel-glaeser.de EUDAMED record Report an error
WellMed FDA Netherlands A IVDR Website info@wellmed.nl EUDAMED record Report an error
Whpm FDA EU representative : Lotus NL B.V. (Netherlands) and 1 other China – 98/79 customerservice@whpm.com.cn 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
Yali Biotech EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR info@yalibiotech.com EUDAMED record Report an error
Yingmed FDA EU representative : Lotus NL B.V. (Netherlands) China I MDR Website info@yingmed.com EUDAMED record Report an error
ZEUS Scientific FDA EU representative : Emergo Europe B.V. (Netherlands) United States – 98/79 Website regulatory@zeusscientific.com EUDAMED record Report an error
Zhejiang Aicor Medical Technology FDA EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Zhejiang Gewuzhizhi Biotechnology EU representative : Llins Service & Consulting GmbH (Germany) and 1 other China A IVDR, 98/79 Website EUDAMED record Report an error
Zhejiang Rongda Bio Technology EU representative : Sungo Cert GmbH (Germany) China A IVDR EUDAMED record Report an error
Zhongshan Ruifu Medical Equipment Technology EU representative : Medunion S.L. (Spain) China A IVDR ra@refmedical.net EUDAMED record Report an error
Zonci EU representative : MedNet EC-REP GmbH (Germany) China A IVDR Website EUDAMED record Report an error
Žikplast Žitnik Anja Slovenia A IVDR EUDAMED record Report an error
Zhejiang Anji Saianfu Biotechnology EU representative : Lotus NL B.V. (Netherlands) China
41 others
– 98/79 EUDAMED record Report an error
YourBio Health FDA EU representative : Emergo Europe B.V. (Netherlands) United States IIa 93/42 Website info@yourbiohealth.com EUDAMED record Report an error
Lionex Germany C IVDR, 98/79 Website info@lionex.de EUDAMED record Report an error
Salofa FDA Finland – 98/79 Website info@salofa.com EUDAMED record Report an error
2cureX Denmark A IVDR Website support@2curex.com EUDAMED record Report an error
77 Elektronika Műszeripari Korlátolt Felelősségű Társaság Hungary IIa MDR Website EUDAMED record Report an error
Abbexa EU representative : Abbexa BV (Netherlands) United Kingdom (ex Northern Ireland) A IVDR Website info@abbexa.com 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
Absology EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea A IVDR EUDAMED record Report an error
Abviris Germany – 98/79 Website info@abviris.de EUDAMED record Report an error
ABW Medizin und Technik Germany A IVDR Website info@abw-medizintechnik.de EUDAMED record Report an error
Acmexbio EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 info@acmexbio.com EUDAMED record Report an error
Addaxbio FDA Italy A IVDR Website administration@addaxbio.com 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
Aiesi Italy A IVDR COMMERCIALE@AIESI.IT EUDAMED record Report an error
Aigene EU representative : SUNGO Europe B.V. (Netherlands) South Korea A IVDR EUDAMED record Report an error
Alere San Diego FDA EU representative : Abbott Rapid Dx International Limited (Ireland) United States A IVDR Website EUDAMED record Report an error
Alfresa Pharma FDA EU representative : Emergo Europe B.V. (Netherlands) Japan A IVDR EUDAMED record Report an error
Allsheng FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China A IVDR EUDAMED record Report an error
Andehealthcare FDA EU representative : MedNet EC-REP GmbH (Germany) China I MDR Website EUDAMED record Report an error
Anhui Wanyi Science Technology EU representative : Eunitor GmbH (Germany) China A IVDR Website EUDAMED record Report an error
Anhui Weizhen Bioengineering Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China A IVDR 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
Apexpulp EU representative : Advena Limited (Malta) Malaysia I MDR sales@apexpulp.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
AR Instrumed EU representative : AR Instrumed Deutschland GmbH (Germany) Pakistan I MDR Website info@ar-instrumed.com EUDAMED record Report an error
Arghavan Teb Kavian EU representative : Medisol Technologies S.L. (Spain) Iran C IVDR Website info@atkdiagnostic.com EUDAMED record Report an error
Arrow Diagnostics Italy C IVDR Website info@arrowdiagnostics.it 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
Asel Tibbi Aletler Türkiye I MDR Website info@aseltech.com.tr EUDAMED record Report an error
Athenesedx EU representative : Obelis s.a. (Belgium) India A IVDR Website EUDAMED record Report an error
Atlas Link Technology FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) China C IVDR Website EUDAMED record Report an error
Atlascerrahialetler Türkiye I MDR Website EUDAMED record Report an error
Attomol Germany A IVDR Website info@attomol.de EUDAMED record Report an error
Ayala Sample Kits Spain A IVDR eudamed.ayalasamplekits@gmail.com 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
Batrik Medical Manufacturing FDA EU representative : Advena Limited (Malta) Canada I MDR Website info@surgmed.com 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
Bedfont FDA EU representative : Emergo Europe B.V. (Netherlands) United Kingdom (ex Northern Ireland) I MDR 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
Beijing Kewei Clinical Diagnostic Reagent EU representative : Lotus NL B.V. (Netherlands) China – 98/79 Website EUDAMED record Report an error
Beijing Microfuture Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 EUDAMED record Report an error
Beijing Zhongjian Antai Diagnostic Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China B IVDR EUDAMED record Report an error
Berpu FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China A IVDR EUDAMED record Report an error
Better2Know EU representative : Patient Guard Europe UG (Germany) United Kingdom (ex Northern Ireland) A IVDR Website info@better2know.com EUDAMED record Report an error
Beyotime EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR 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
BGl Biotechnology (Wuhan) EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China A IVDR Website EUDAMED record Report an error
Bio-Rad Laboratories FDA EU representative : Bio-Rad (France) United States C IVDR Website contact@bio-rad.com 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
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
Bioeuropegmbh Germany – 98/79 Website info@bioeuropegmbh.com EUDAMED record Report an error
BioGX FDA Netherlands – 98/79 Website EUDAMED record Report an error
Biolab Hungary A IVDR Website EUDAMED record Report an error
Biolifeit Italy A IVDR Website EUDAMED record Report an error
Biome Diagnostics Austria A IVDR Website service@biome-dx.com EUDAMED record Report an error
biomed Dr. Wieser Austria A IVDR Website office@biomed-technics.com EUDAMED record Report an error
Biomes Germany A IVDR Website info@biomes.world EUDAMED record Report an error
BiopSafe FDA Denmark A IVDR Website info@biopsafe.com EUDAMED record Report an error
biosurfit Portugal – 98/79 info@biosurfit.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
Biovis Germany A IVDR ivdr@biovis.de EUDAMED record Report an error
Bioyuan EU representative : Obelis s.a. (Belgium) China – 98/79 ra@bioyuan.cn EUDAMED record Report an error
Blisscare Spain IIa MDR Website 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
Bournas Medicals Greece A IVDR Website EUDAMED record Report an error
Bredlifesci EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China A IVDR info@bredlifesci.com 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
Calpro Norway A IVDR Website EUDAMED record Report an error
Candore EU representative : CMC Medical Devices & Drugs SL (Spain) India A IVDR Website EUDAMED record Report an error
Cangzhou Shengfeng Plastic Product EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Careforu EU representative : Meridius Medical Europe Limited (Ireland) South Korea – 98/79 Website sales@careforu.co.kr EUDAMED record Report an error
CelltraZone FDA EU representative : Javitech Consulting GmbH (Germany) South Korea A IVDR Website info@celltrazone.com EUDAMED record Report an error
Cerca Biotech Germany A IVDR EUDAMED record Report an error
Cespu Portugal A IVDR EUDAMED record Report an error
Cetro Medical FDA Sweden I MDR Website info@cetromedical.se 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 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 Polytech Biological Technology EU representative : MedNet EC-REP GmbH (Germany) China – 98/79 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
Chongqing Sanfeng Medical Device EU representative : Kingsmead Service B.V. (Netherlands) China A IVDR 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
Clinical EU representative : MedEnvoy Global BV (Netherlands) United Kingdom (ex Northern Ireland) A IVDR Website info@clinical.design EUDAMED record Report an error
Clonallon Northern Ireland I MDR Website 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
Core Technology FDA EU representative : Medunion S.L. (Spain) China – 98/79 EUDAMED record Report an error
Cosmosol Italy IIa MDR Website info@cosmosol-it.com EUDAMED record Report an error
Creativebio EU representative : Obelis s.a. (Belgium) China A IVDR Website Service@creativebio.cn EUDAMED record Report an error
Credence Genomics EU representative : Obelis s.a. (Belgium) Sri Lanka 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
Cyanagen Italy 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
Cytocell FDA EU representative : Sysmex Europe SE (Germany) United Kingdom (ex Northern Ireland) A IVDR Website contact@ogt.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
DasLab Germany I MDR Website contact@daslab.health EUDAMED record Report an error
Datexim France – 98/79 Website contact@datexim.com EUDAMED record Report an error
Demeditec FDA Germany – 98/79 Website info@demeditec.de EUDAMED record Report an error
Dermagnostix Germany – 98/79 Website info@dermagnostix.com EUDAMED record Report an error
Desitec Italy A IVDR Website info@desitec.it EUDAMED record Report an error
Dianext Italy A IVDR EUDAMED record Report an error
Diatech Pharmacogenetics Italy C IVDR Website info@diatechpharmacogenetics.com EUDAMED record Report an error
Dnameter Czechia A IVDR EUDAMED record Report an error
Doasense Germany A IVDR Website info@doasense.de EUDAMED record Report an error
Doctorbox Germany I MDR Website info@doctorbox.de EUDAMED record Report an error
Doctrinus Germany IIa MDR Website 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
Dragon Medical FDA EU representative : MedPath GmbH (Germany) China I MDR EUDAMED record Report an error
DRG Instruments Germany A IVDR Website EUDAMED record Report an error
Drummondsci FDA EU representative : CEpartner4U (Netherlands) United States A IVDR EUDAMED record Report an error
Dynamic Code Sweden A IVDR Website support@dynamiccode.com EUDAMED record Report an error
Ecocare Germany IIa MDR Website service@ecocare.center EUDAMED record Report an error
Edna Türkiye – 98/79 Website EUDAMED record Report an error
Eifelfango Germany A IVDR Website 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
Epiprobe EU representative : MedPath GmbH (Germany) China A IVDR service@epiprobe.com EUDAMED record Report an error
Esco Medical Technologies, UAB FDA Lithuania IIa MDR Website support-medical@escolifesciences.com 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
Factor Medical FDA EU representative : MedEnvoy Global BV (Netherlands) United States IIa MDR EUDAMED record Report an error
FAR Italy – 98/79 order@fardiag.com EUDAMED record Report an error
Farmasino EU representative : Humiss International B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Feinchemie Germany A IVDR Website info@feinchemie.de 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
Filling Germany A IVDR info@orsatec.de EUDAMED record Report an error
Finess Healthcare Group EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR 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
Gammadis Italy A IVDR Website EUDAMED record Report an error
Gaudlitz Germany A IVDR Website info@gaudlitz.de 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
Gencyst Finland A IVDR info@gencyst.com EUDAMED record Report an error
Geneall EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea A IVDR Website sales@geneall.com EUDAMED record Report an error
Geneally EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR info@geneally.com.cn EUDAMED record Report an error
Genebiohealth EU representative : Kingsmead Service B.V. (Netherlands) China A IVDR Website marketing@genebiohealth.com EUDAMED record Report an error
Genedrive EU representative : Advena Limited (Malta) United Kingdom (ex Northern Ireland) A IVDR Website EUDAMED record Report an error
Geneus Technologies (Chengdu) EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Genhawk (Wuhan) Biotech EU representative : SUNGO Europe B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Gentrend Czechia A IVDR Website EUDAMED record Report an error
Geratherm Germany – 98/79 Website info@geratherm.com EUDAMED record Report an error
Ginevri Italy A IVDR Website mail@ginevri.com EUDAMED record Report an error
Goodgut Spain A IVDR Website info@goodgut.eu 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
Guangxihuadu EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR Sales@guangxihuadu.com 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 Huayue Keju Biotech EU representative : SUNGO Europe B.V. (Netherlands) 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
Guanhong plastic steel products factory EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Guizhou Gaoyi Medical Technology Research Development EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR 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
Handan FCH Medical Technology EU representative : MedPath GmbH (Germany) China I MDR EUDAMED record Report an error
Hangzhou Beiwo Medical Technology EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Hangzhou Ciping Medical Devices EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China A IVDR EUDAMED record Report an error
Hangzhou DIAN Biotechnology EU representative : Lotus NL B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Hangzhou Higene Biotechnology EU representative : Lotus NL B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Hangzhou PathoAl Technology EU representative : BioDomi GmbH (Germany) China A IVDR EUDAMED record Report an error
Hangzhou Testsea Biotechnology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China – 98/79 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
Hanwooltpc FDA EU representative : Javitech Consulting GmbH (Germany) South Korea A IVDR Website EUDAMED record Report an error
Happy Innova Spain A IVDR Website hello@thesmartlollipop.com 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 Chaoran Medical Instruments EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Hebei Free Trade Zone Shenghong Medical Devices EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Hebei Kangning Medical Equipment EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Hebei Kangweishi Medical Technology EU representative : SUNGO Europe B.V. (Netherlands) China I MDR EUDAMED record Report an error
Hebei Simaite Medical Devices EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Heng Rong (Xiamen) Plastic Products EU representative : Wellkang Ltd (Northern Ireland) China A IVDR Website EUDAMED record Report an error
Hessels & Grob Netherlands A IVDR Website info@hesselsgrob.com EUDAMED record Report an error
Heytonmed EU representative : SUNGO Europe B.V. (Netherlands) China I MDR EUDAMED record Report an error
Hidex Finland A IVDR Website 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
Huachenyang (Shenzhen) Technology EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Huchuang FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China I MDR 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
Hygienx EU representative : Salus Cons Kft. (Hungary) Serbia A IVDR Website EUDAMED record Report an error
ID & Italy A IVDR Website EUDAMED record Report an error
Iki France A IVDR contact@iki-diag.com EUDAMED record Report an error
Ilabu Poland I MDR Website EUDAMED record Report an error
ImmuChrom Germany – 98/79 info@immuchrom.de 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
Itaca Italy A IVDR info@itacapharma.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 Changfeng Medical Industry FDA EU representative : Llins Service & Consulting GmbH (Germany) China A IVDR Website info@changfeng-medical.com EUDAMED record Report an error
Jiangsu Comeon Medical Apparatus EU representative : Sungo Cert GmbH (Germany) China A IVDR EUDAMED record Report an error
Jiangsu Jinzhun Biotech EU representative : MedNet EC-REP GmbH (Germany) China A IVDR EUDAMED record Report an error
Jiangsu ME Instruments EU representative : MedPath GmbH (Germany) China A IVDR EUDAMED record Report an error
Jiangsu Kehua Medical Instrument Technology FDA EU representative : Sungo Cert GmbH (Germany) China A IVDR info@jskehua.cn EUDAMED record Report an error
Jiangxi CellGene Biotechnology EU representative : Medunion S.L. (Spain) China – 98/79 marketing@cell-genebio.com EUDAMED record Report an error
Jiangxi Hongda Medical Equipment Group FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China A IVDR Website EUDAMED record Report an error
Jianlinmedical EU representative : Kingsmead Service B.V. (Netherlands) China I MDR sales@jianlinmedical.com 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
K-Med FDA EU representative : MedPath GmbH (Germany) China I MDR INFO@K-MED.COM.CN EUDAMED record Report an error
Karlsson&Novak Medical Sweden I MDR Website info@knmedical.se EUDAMED record Report an error
Keylights EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Ki̇bar Dental Tibbi̇ Malzemeleri̇ Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ Türkiye I MDR 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
Kurabo EU representative : MedNet EC-REP GmbH (Germany) Japan A IVDR Website qa@kurabo-grp.com EUDAMED record Report an error
Lab Diagnostic Systems (SMC) EU representative : SUNGO Europe B.V. (Netherlands) Pakistan – 98/79 info@ldspak.com EUDAMED record Report an error
Labco EU representative : Advena Limited (Malta) United Kingdom (ex Northern Ireland) A IVDR Website enquiries@labco.co.uk EUDAMED record Report an error
Laboindustria Italy A IVDR Website EUDAMED record Report an error
Labonovum Netherlands A IVDR Website info@labonovum.com EUDAMED record Report an error
Laurypath France A IVDR Website contact@laurypath.fr 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
Lgm International FDA EU representative : Wellkang Ltd (Northern Ireland) United States A IVDR Website customerservice@lpalp.com EUDAMED record Report an error
Linhai Chengyuan Glasses FDA EU representative : Debao International GmbH (Germany) China I MDR EUDAMED record Report an error
Linye Health Tech Ningbo EU representative : Sungo Cert GmbH (Germany) China I MDR EUDAMED record Report an error
Livzondiagnostics FDA EU representative : QbD RepS BV (Belgium) China C IVDR Website ra@livzondiagnostics.com EUDAMED record Report an error
LM4med Germany A IVDR Website 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
Lymediagnostics Hungary – 98/79 Website EUDAMED record Report an error
magtivio Netherlands A IVDR info@magtivio.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
Mavie Austria A IVDR Website EUDAMED record Report an error
Mdlsrl FDA Italy A IVDR Website info@mdlsrl.com 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
Medichecks EU representative : CS Life Sciences Europe Ltd (Ireland) United Kingdom (ex Northern Ireland) A IVDR Website qualityandregs@medichecks.com EUDAMED record Report an error
Medimel Μονοπροσωπη Ικε Greece I MDR Website info@medimel.gr EUDAMED record Report an error
Mediset Germany I MDR Website info@mediset.de EUDAMED record Report an error
Medlan Poland A IVDR Website EUDAMED record Report an error
Medspo EU representative : ANTEX MEDI SOLUTION (Germany) Pakistan I MDR Website EUDAMED record Report an error
MEDx (Suzhou) Translational Medicine EU representative : Kingsmead Service B.V. (Netherlands) China – 98/79 ra@medxtmc.com EUDAMED record Report an error
Mehrish EU representative : ANTEX MEDI SOLUTION (Germany) Pakistan I MDR Website EUDAMED record Report an error
Menarinidiagnostics Italy A IVDR Website EUDAMED record Report an error
Metzer Poland 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
Microviable Spain A IVDR Website admin@microviable.com EUDAMED record Report an error
Mikrocerrahialetler Türkiye I MDR Website EUDAMED record Report an error
Millennium Sciences EU representative : AR Experts B.V. (Netherlands) United States 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
Mirnax Biosens Spain A IVDR info@mirnaxbiosens.com EUDAMED record Report an error
Molzym Germany A IVDR info@molzym.com EUDAMED record Report an error
Mondial Italy A IVDR Website info@mondialprod.it EUDAMED record Report an error
Mongopa EU representative : Share info GmbH (Germany) China I MDR EUDAMED record Report an error
Morphlelabs FDA EU representative : Amstermed B.V. (Netherlands) India A IVDR sales@morphlelabs.com EUDAMED record Report an error
Möller Medical FDA Germany I MDR Website info@moeller-medical.com EUDAMED record Report an error
Nanchang Ganda Medical Devices EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Nantong Shunwei Experimental Equipment EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Neomed FDA Italy A IVDR Website EUDAMED record Report an error
nerbe plus Germany A IVDR Website info@nerbe-plus.de EUDAMED record Report an error
Newmars Technologies Kft Hungary IIa 93/42 EUDAMED record Report an error
Newscen EU representative : Wellkang Ltd (Northern Ireland) China D IVDR Website EUDAMED record Report an error
Next Level Italy A IVDR EUDAMED record Report an error
Nightingalehealth Finland A IVDR Website contact@nightingalehealth.com 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
Noex Poland A IVDR Website EUDAMED record Report an error
Norsan Germany A IVDR Website 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
Novogenia FDA Austria A IVDR Website service@novogenia.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
Olgunmedikal Türkiye A IVDR info@olgunmedikal.com EUDAMED record Report an error
Omegametrix Germany A IVDR Website info@omegametrix.eu EUDAMED record Report an error
Ortho Clinical Diagnostics Biotechnology Development (Shanghai) EU representative : Ortho-Clinical Diagnostics France (France) China A IVDR Website EUDAMED record Report an error
Paitzar EU representative : Metridium OÜ (Estonia) Iran A IVDR Website info@paitzar.am EUDAMED record Report an error
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
Pamgene Netherlands A IVDR Website info@pamgene.com 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
Paulmurrayplc EU representative : Murrays Health and Beauty Europe Limited (Ireland) United Kingdom (ex Northern Ireland) A IVDR Website EUDAMED record Report an error
PCL EU representative : Medical Technology Promedt Consulting GmbH (Germany) South Korea A IVDR Website EUDAMED record Report an error
Personalgenome FDA EU representative : Emergo Europe B.V. (Netherlands) United States C IVDR Website EUDAMED record Report an error
Personalis EU representative : QbD RepS BV (Belgium) United States A IVDR EUDAMED record Report an error
Pfaff medical Germany A IVDR info@pfaffmedical.de EUDAMED record Report an error
Phadia FDA Sweden A IVDR Website RegulatoryAffairs.Uppsala.IDD@thermofisher.com EUDAMED record Report an error
Pharmaline Türkiye C IVDR info@pharmaline.com.tr 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
Plastilab EU representative : CEpartner4U (Netherlands) Lebanon A IVDR Website info@plastilab.com EUDAMED record Report an error
PlexBio FDA EU representative : MDSS GmbH (Germany) Taiwan A IVDR EUDAMED record Report an error
Polycohealthline EU representative : International Associates Auditing & Certification Limited (Ireland) United Kingdom (ex Northern Ireland) – 98/79 Website customer.services@polycohealthline.com EUDAMED record Report an error
Poth Hille & FDA EU representative : Advena Limited (Malta) United Kingdom (ex Northern Ireland) A IVDR Website EUDAMED record Report an error
PreciPoint Germany A IVDR Website info@precipoint.de EUDAMED record Report an error
Precision for Medicine FDA EU representative : QbD RepS BV (Belgium) United States A IVDR Website EUDAMED record Report an error
Preox Germany – 98/79 Website sales@preox.de EUDAMED record Report an error
PreTect FDA Norway A IVDR Website EUDAMED record Report an error
PrivaPath Diagnostics FDA Ireland A IVDR Website support@letsgetchecked.com EUDAMED record Report an error
Probe & go Labordiagnostica Germany A IVDR Website info@probe-go.de EUDAMED record Report an error
ProciseDx FDA EU representative : QbD RepS BV (Belgium) United States A IVDR Website EUDAMED record Report an error
Proteome EU representative : Propath bv (Belgium) United Kingdom (ex Northern Ireland) A IVDR Website EUDAMED record Report an error
Pujiang Jianyu Sanitary Products FDA EU representative : SUNGO Europe B.V. (Netherlands) China I MDR EUDAMED record Report an error
Qingdao Huaren Medical Product EU representative : Lotus NL B.V. (Netherlands) China – 98/79 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
QuinTron Instrument FDA EU representative : Emergo Europe B.V. (Netherlands) United States A IVDR Website regulatory@quintron-usa.com 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
RBCBioscience EU representative : Obelis s.a. (Belgium) Taiwan A IVDR Website EUDAMED record Report an error
REAL Digital International FDA EU representative : Casus Europe B.V. (Netherlands) United Kingdom (ex Northern Ireland) A IVDR EUDAMED record Report an error
Rehaforum Germany I MDR Website info@rehaforum.com EUDAMED record Report an error
Reingenuity FDA EU representative : Eurolink Europe Compliance Limited (Ireland) United Kingdom (ex Northern Ireland) A IVDR Website info@reingenuity.com EUDAMED record Report an error
Reliance Medical FDA EU representative : Reliance Medical (Ireland) (Ireland) United Kingdom (ex Northern Ireland) A IVDR Website regulatory@reliancemedical.co.uk EUDAMED record Report an error
Reme-D For Laboratory Equipment Chemicals EU representative : Qualitech International B.V. (Netherlands) Egypt 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
Ritter FDA Germany A IVDR Website EUDAMED record Report an error
RM Life Science EU representative : Javitech Consulting GmbH (Germany) South Korea A IVDR EUDAMED record Report an error
Rocket Medical FDA United Kingdom (ex Northern Ireland) IIa MDR Website customerservices@rocketmedical.com EUDAMED record Report an error
Roylance Scientific EU representative : Casus Europe B.V. (Netherlands) United Kingdom (ex Northern Ireland) A IVDR Website EUDAMED record Report an error
Runpubio EU representative : R Sight B.V. (Netherlands) China A IVDR Website EUDAMED record Report an error
Sanmen Minsheng Medical Appliances EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Sanway Gene Tech EU representative : Obelis s.a. (Belgium) China – 98/79 Website info@sansure.com.cn EUDAMED record Report an error
Screen Italia Italy – 98/79 Website info@screenitalia.it 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
Shandong Chengwu Huabo Medical Equipment EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Shandong Chengwu Ronghua Biotechnology EU representative : Lotus NL B.V. (Netherlands) China I MDR EUDAMED record Report an error
Shanghai Bize Import Export EU representative : SUNGO Europe B.V. (Netherlands) China I MDR info@bizemed.com 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 Zymetas Medtech EU representative : SUNGO Europe B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Shenyang Bokan Biotechnology EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Shenzhen Freecom Technology EU representative : SUNGO Europe B.V. (Netherlands) China – 98/79 EUDAMED record Report an error
Shenzhen Huiyan Sci-Tech Biotechnology EU representative : Medunion S.L. (Spain) China – 98/79 sales@szhykc.com EUDAMED record Report an error
Shenzhen Medsoon Medical Laboratory Technology EU representative : SUNGO Europe 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 Nucleus Biotechnology EU representative : Kingsmead Service B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Shenzhen Wellgrow Biotech EU representative : SUNGO Europe B.V. (Netherlands) China – 98/79 Website 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
Shinkwang EU representative : Medical Technology Promedt Consulting GmbH (Germany) India A IVDR Website quality@shinkwang.co.in 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
Sichuan Xincheng Biological EU representative : CMC Medical Devices & Drugs SL (Spain) China – 98/79 EUDAMED record Report an error
Sinobiocan EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China I MDR EUDAMED record Report an error
Sinymedical EU representative : REP Europe GmbH (Germany) China I MDR Website sales@sinymedical.com EUDAMED record Report an error
Skgmed EU representative : SUNGO Europe B.V. (Netherlands) China 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
Suesse Germany A IVDR info@suesse.de 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 lingyan medical technology EU representative : SUNGO Europe 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
Suzhou Sunmed FDA EU representative : SUNGO Europe B.V. (Netherlands) China I MDR 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
Sykehusapotekene Norway A IVDR Website EUDAMED record Report an error
Taizhou Huangyan Fangye Technology Development EU representative : Sungo Cert GmbH (Germany) China A IVDR EUDAMED record Report an error
Taizhou Jiaojiang Rongteng Glasses Factory EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China I MDR EUDAMED record Report an error
Taizhou Yongfang Hygiene Supplies Factory EU representative : MedPath GmbH (Germany) China A IVDR EUDAMED record Report an error
tanit evolution France I MDR Website EUDAMED record Report an error
Tecan FDA Austria A IVDR Website regulatory.affairs.at@tecan.com EUDAMED record Report an error
Techno-path Manufacturing FDA Ireland C IVDR Website EUDAMED record Report an error
Tecnobilife Italy A IVDR EUDAMED record Report an error
Tecom Science EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Teletest Spain A IVDR Website 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
Tianjin Readybio Medical Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China A IVDR EUDAMED record Report an error
TimeTeller Germany A IVDR EUDAMED record Report an error
Toby's Netherlands A IVDR Website info@tobys.nl 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
Trime Czechia IIa MDR EUDAMED record Report an error
True Dose Sweden A IVDR Website info@truedose.se EUDAMED record Report an error
Unicoproducts FDA EU representative : Everbiz GmbH (Germany) China I MDR EUDAMED record Report an error
Utsat Türkiye A IVDR Website info@utsat.com.tr EUDAMED record Report an error
Vacutest Kima FDA Italy – 98/79 Website EUDAMED record Report an error
Vector Surgical FDA EU representative : MDSS GmbH (Germany) United States A IVDR Website regulatory@vectorsurgical.com EUDAMED record Report an error
Veracyte FDA EU representative : Veracyte Global BV (Netherlands) France, United States A IVDR Website EUDAMED record Report an error
Vigilant Biosciences FDA EU representative : Vigilant Biosciences GmbH (Germany) United States A IVDR EUDAMED record Report an error
Vignyburke Trading FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China I MDR EUDAMED record Report an error
Virtue Diagnostics (Suzhou) EU representative : Kingsmead Service B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Vitapaw Tech Hk EU representative : Maybon Noxa OÜ (Estonia) Hong Kong SAR China A IVDR EUDAMED record Report an error
Vodenmedical Italy A IVDR Website EUDAMED record Report an error
VWR International FDA Netherlands A IVDR EUDAMED record Report an error
Waters FDA EU representative : Emergo Europe B.V. (Netherlands) United States A IVDR EUDAMED record Report an error
Weihai Weigao Blood Collection Supplies EU representative : MedNet EC-REP GmbH (Germany) China
  • /14 refs
A IVDR 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
Wuhan Ammunition Life-tech EU representative : Medunion S.L. (Spain) 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
WuHan LanYuan Protective 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
Xiamen Zhixuan Biotech EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Xprecia Testing Pty EU representative : MediMark Europe Sarl. (France) Australia – 98/79 Website EUDAMED record Report an error
Yancheng Huida Medical Instruments FDA 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
Yiwu City Ange Medical Instrument EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR EUDAMED record Report an error
Yiwu Xuanbao Trading EU representative : HUMISS TRADING S. L. (Spain) China I MDR EUDAMED record Report an error
Yongkang Jinkang Health Equipment Factory FDA EU representative : Lotus NL B.V. (Netherlands) China I MDR sales02@chinajinkang.com EUDAMED record Report an error
YOUspan Germany IIa MDR EUDAMED record Report an error
Zacros FDA EU representative : MDSS GmbH (Germany) Japan – 98/79 EUDAMED record Report an error
Zafena Sweden – 98/79 Website info@zafena.se EUDAMED record Report an error
Zhejiang RonMai Medical Technology EU representative : SUNGO Europe B.V. (Netherlands) China A IVDR 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
Zhucheng Binfei Medi-Tek EU representative : CMC Medical Devices & Drugs SL (Spain) China I MDR admin@binfei-medtek.com EUDAMED record Report an error
Zinexts EU representative : Obelis s.a. (Belgium) Taiwan A IVDR Website EUDAMED record Report an error
Vitro Scient EU representative : MDSS GmbH (Germany) No model still on the market Egypt
44 others
– 98/79 Website info@vitroscient.com EUDAMED record Report an error
Biotime EU representative : Lotus NL B.V. (Netherlands) and 2 others No model still on the market China
12 others
A IVDR, 98/79 EUDAMED record Report an error
Mobidiag No model still on the market Finland
9 others
A IVDR, 98/79 Website sales.mob@hologic.com EUDAMED record Report an error
Nantong EgensBiotechnology FDA EU representative : SUNGO Europe B.V. (Netherlands) and 1 other No model still on the market China
7 others
– 98/79 qa@egens-bio.cn EUDAMED record Report an error
Ns Biotec EU representative : CMC Medical Devices & Drugs SL (Spain) No model still on the market Egypt
7 others
– 98/79 Website info@nsbiotec.com EUDAMED record Report an error
Princeton BioMeditech FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) No model still on the market United States
7 others
– 98/79 Website info@pbmc.com EUDAMED record Report an error
Chemclin EU representative : MedNet EC-REP GmbH (Germany) No model still on the market China
6 others
A, C IVDR, 98/79 Website EUDAMED record Report an error
Uniogen No model still on the market Finland
5 others
A IVDR, 98/79 info@uniogen.com EUDAMED record Report an error
Xpenarray EU representative : CMC Medical Devices & Drugs SL (Spain) No model still on the market China
5 others
– 98/79 EUDAMED record Report an error
Anouve EU representative : Obelis s.a. (Belgium) No model still on the market China A IVDR Website EUDAMED record Report an error
Chemelex No model still on the market Spain – 98/79 Website EUDAMED record Report an error
Hangzhou ShengTing Medical Technology EU representative : Medunion S.L. (Spain) No model still on the market China – 98/79 EUDAMED record Report an error
Labquality No model still on the market Finland – 98/79 Website EUDAMED record Report an error
Deben Diagnostics EU representative : EU-UK Authorised Representative Ltd (Northern Ireland) No model still on the market United Kingdom (ex Northern Ireland) – 98/79 Website info@debendiagnostics.co.uk EUDAMED record Report an error
IDL Biotech No model still on the market Sweden – 98/79 Website EUDAMED record Report an error
Raingene EU representative : Lotus NL B.V. (Netherlands) No model still on the market China – 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
AccuBio EU representative : Advena Limited (Malta) No model still on the market United Kingdom (ex Northern Ireland) – 98/79 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
Biosci Healthcare EU representative : CMC Medical Devices & Drugs SL (Spain) No model still on the market India
  • Biovac3 refs (no longer marketed)
A IVDR Website info@bioscihealthcare.com 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
Exact Sciences FDA EU representative : Emergo Europe B.V. (Netherlands) No model still on the market United States – 98/79 regulatoryaffairs@exactsciences.com EUDAMED record Report an error
Innobiochips No model still on the market France – 98/79 Website EUDAMED record Report an error
MolGen No model still on the market Netherlands A IVDR Website info@molgen.com EUDAMED record Report an error
Omega Diagnostics EU representative : Advena Limited (Malta) No model still on the market United Kingdom (ex Northern Ireland)
  • SCP12 (no longer marketed)
A IVDR Website 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
Rossix FDA No model still on the market Sweden – 98/79 Website info@rossix.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) 1,680

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)
Sarstedt Aktiengesellschaft & Co.KG – Microvette® 100 K3E Microvette® 200 Z Microvette® 500 Z Microvette® 200 Z-Gel Microvette® 300 Z Microvette® 200 LH registered
Epitomics Inc. – Rabbit Monoclonal Anti-Human ER Alpha Antibody, EP1 Rabbit Monoclonal Anti-Human MSH6 Antibody, EP49 Rabbit Monoclonal Anti-Human HER2 / ErbB2 Antibody, EP3 Rabbit Monoclonal Anti-Human Estrogen Receptor Antibody, EP220 Rabbit Monoclonal Anti-Human Progesterone Receptor Antibody, EP2 Rabbit Monoclonal Anti-Human c-Kit/CD117 Antibody, EP10 registered
SCC SOFT COMPUTER United States SoftPathDx SoftBiochemistry SoftHLA SoftLab SoftCytogenetics SoftMolecular registered
MEDEGEN MEDICAL PRODUCTS, LLC United States Medegen Medical Products, LLC registered
BIOGENEX LABORATORIES United States i6000™ Infinity Xmatrx® Nano Xmatrx® MINI Xmatrx® Elite NanoVIP® i6000™ Diagnostics registered
Lonza Verviers – ProCHO5 w/Pluronic w/o L-Gln or HT, 1L PowerCHO-2 CD - 50L bag X-Vivo 20 w/o Genta, PR w/ U1,Optiferrin LONZA MEDIUM BASE 1 - 100 g ProCHO5 w/Pluronic w/o L-Gln or HT, 200L BPMSS L1_5M NaCl- 500 L bag registered
Life Technologies Corporation United States Ion Torrent Ion Torrent™ Dx Total NA Isolation Kit (-20 C) Ion Torrent™ Dx cDNA Synthesis Kit This is to test the length of the brand field and what it looks like in the GUDI Ion Torrent™ Dx RNA Quantification Kit Ion Torrent™ Dx DNA Quantification Kit K241806 (2025)
Fisher Scientific Co., LLC United States Fisherbrand Sure-Vue K860919 (1986)
Fuzhou Maixin Biotech Co., Ltd. China Mouse Monoclonal Anti-Human Desmin(MX046) Antibody Mouse Monoclonal Anti-Human TdT(MX010) Antibody Mouse Monoclonal Anti-Human Calretinin(MX027) Antibody Rabbit Monoclonal Anti-Human pan-TRK(MXR032) Antibody Mouse Monoclonal Anti-Human Galectin-3(MX060) Antibody Rabbit Monoclonal Anti-Human CD4(MXR036) Antibody registered
MetaSystems Probes GmbH Germany MetaSystems Probes 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 K251697 (2025)
Slmp, LLC – IHC KT ™ Premium Slides registered
MEDLINE INDUSTRIES, INC. Present in Europe in other categories United States Medline MEDLINE INDUSTRIES Medline Industries, Inc. Centurion Medical Products Corp registered
Yancheng Jingwei Chemicals Co., Ltd China TANNER HARETA RANKIN PATHSUPLLY CANCER PATHSUPPLY registered
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)
Cardinal Health 200, LLC Present in Europe in other categories United States CARDINAL HEALTH Dover Precision Kendall Monoject OEM CUSTOMER SPECIFIC registered
CAPlugs Present in Europe in other categories United States Caplugs/Evergreen registered
Minigrip Commercial LLC United States MINIGRIP COMMERCIAL Minigrip Commercial LLC registered
Asp Global, LLC United States ASP MEDICAL NEW YORK PRESBYTERIAN QUEST THERAPACK, LLC LABCORP GBF,INC. registered
Lonza Walkersville, Inc. United States GLS CHO Feed F CHO Feed Base L TheraPRO® CHO Feed UltraCulture Lonza Medium Base 1 CHO Feed Base F registered
ICU MEDICAL, INC. Present in Europe in other categories United States Portex Jelco K881201 (1988)
RESEARCH AND DIAGNOSTIC SYSTEMS, INC. – Research and Diagnostic Systems R&D CBC-XR Hematology Control registered
NOVODIAX, INC. Present in Europe in other categories United States Q-STAIN® X Autostainer QSX-Enh-P ER (ASR) QSX-Enh-P PR (ASR) QSX-Enh-P HER2 (ASR) DAB Kit ihcDirect® AE1/AE3 Abs registered
HARDY DIAGNOSTICS United States ClikSeal™ StaphTEX™ StrepPRO™ HardyDisk™ OxiSticks™ OxiStrips™ K233534 (2024)
MCKESSON MEDICAL-SURGICAL INC. – McKesson registered
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)
Alpha-TEC Systems, Inc. United States Alpha-Tec Systems PVA (Zn) Fix/10% Formalin 25 sets K890861 (1989)
Thermo Electron LED GmbH – Thermo Scientific Fisher Scientific Cardinal Fisherbrand registered
Genbio United States ImmunoFLOW Negative Control Mycoplasma IgM IMMUNOFLOW™ Mycoplasma pneumoniae IgM Test ImmunoFLOW Mycoplasma IgM Positive Control ImmunoWELL™ MYCOPLASMA PNEUMONIAE ANTIBODY (IgG) TEST ImmunoWELL™ MYCOPLASMA PNEUMONIAE ANTIBODY (IgM) TEST GenDx-LongMix K963054 (1997)
Scientific Device Laboratory, Inc. United States Scientific Device Laboratory K884069 (1988)
Corning Incorporated United States Corning® Corning Falcon A Corning Brand registered
IMMUNALYSIS CORP – Immunalysis Immunalysis Corporation registered
CLARK LABORATORIES, INC. United States Trinity Biotech MarDx Bartels Phoenix Biotech BIO-RAD Bio-Stat K980596 (1998)
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)
Helena Laboratories United States APTT-SA (Soluble Activator) Reagent Kit 0.25 M Calcium Chloride AB-TROL 2 Coagulation Control Coagulation S.A.C.-2 (Specialty Assay Control) AB-Trol 3 Coagulation Control Coagulation S.A.R.P (Specialty Assayed Reference Plasma) K192931 (2022)
HENRY SCHEIN, INC. Present in Europe in other categories United States Henry Schein CardioChek registered
MARDX DIAGNOSTICS, INC. United States Trinity Biotech K951709 (1996)
Elitechgroup Mdx LLC – MGB Alert® EBV Probe Mix ASR - 480 Reactions MGB Alert® BKV ASR v3.0 Probe Mix MGB Alert HSV Ensemble Probe Mix ASR - 480 rxn MGB Alert® CMV 3.0 Primer Mix ASR - 480 Reaction DSQ Alert® HT Pneumocystis jirovecii Probe Mix DSQ Alert HT Norovirus GII Primer Mix ASR registered
BTNX Inc – Rapid Response registered
Roche Molecular Systems, Inc. United States COBAS®TaqMan® 48 Analyzer COBAS® TaqMan® cobas® cfDNA Sample Preparation Kit COBAS® AmpliPrep Instrument cobas&#x00AE prime Pre-analytical System AVENIO Edge System K260021 (2026)
Dynarex Corporation United States LabChoice Specimen Containers, Sterile, 60 mL LabChoice Specimen Container, Screw-On, Leak-Resistant Lid, Tamper-Ever Seal LabChoice Urine Transfer Devices, For Urine Tube, 100 mL, Sterile LabChoice Stool Specimen Container, With Spoon, 60 mL, Sterile LabChoice Specimen Container, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal Stool Specimen Container 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. LW Scientific registered
POREX CORPORATION United States Fisherbrand Serum Filter Filter Sampler Blood Serum Filters Fisherband Serum Filter Filter Sampler Blood Serum Filter Filter Sampler Dispense Filter Filter Sampler Dispense+ Filter registered
George King Bio-Medical, Inc. United States George King Factor VIII Deficient Plasma with Inhibitor George King Factor XIII Deficient Plasma George King Positive Lupus Anticoagulant George King von Willebrand Plasma, Type 2A George King von Willebrand Plasma Type 3 George King von Willebrand Plasma Type 1 K161316 (2017)
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
DIAGNOSTIC HYBRIDS, INC. United States D3 Ultra D3 Fastpoint D3 D3 Duet Quidel Molecular Lyra K092882 (2009)
Cardinal Health, Inc. Present in Europe in other categories United States Precision Dover Monoject Corvac Covidien registered
BIOSEAL United States Bioseal Inc. registered
Fort Worth Diagnostics, LLC United States Fort Worth Diagnostics registered
Miltenyi Biotec B.V. & Co. KG Present in Europe in other categories – Anti-TCRg/d-PE-Vio770 CD2-VioBlue CD11b-APC CD45-APC CD117-APC CD66c-PE 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)
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
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)
Phoenix Diagnostics, Inc. United States PHOENIX DIAGNOSTICS, INC. Phoenix Diagnostics K020364 (2002)
Anaerobe Systems United States PRAS Dilution Blanks PRAS Reinforced Clostridial Broth (RCB) PRAS Peptone Yeast Extract Broth w/ Glucose (PYG) PRAS Peptone Yeast Extract Broth (PY) PRAS Thioglycollate Broth (THIO) PRAS Peptone Yeast Extract Broth w/ Adonitol (PY ADONITOL) K844383 (1985)
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)
MARKETLAB INC. United States Marketlab MarketLab, Inc. Marketlab Inc Marketlab, Inc registered
DREW SCIENTIFIC, INC. United Kingdom JAS Diagnostics Drew Scientific Drew K070704 (2007)
EXACT DIAGNOSTICS, LLC – Exact Diagnostics registered
CENTURION MEDICAL PRODUCTS CORPORATION United States Centurion MEDLINE registered
Biobase Biodustry(Shandong)Co., Ltd. China BIOBASE BIOBASEBK200mini registered
Avaline Medical NJ Limited Liability Company – Avaline Medical NJ LLC registered
Immunostics Company, Inc United States Detector UA 2GP Detector UA 10SG Detector UA 10 Detector UA 5 Detector UA 2 hemochroma PLUS Control K182298 (2018)
MOORE MEDICAL LLC – Moore Medical registered
AnalytiChem USA, Inc. United States Redipor Cell Pro registered
JANT PHARMACAL CORPORATION – Accustrip 10-Parameter Urine Reagent Strip Accutest Accustrip URS Strips + Reader LipidPlus® Meter LipidPlus® Glucose Test Strips Accutest Value+ Strep A Rapid Test Strip registered
KB Medical (group), Inc. – KBMED registered
Starplex Scientific, Inc. Canada Leakbuster StarCLICK 100 Leakbuster 3 Starplex Specimen Container Histoplex registered
Primus Corp. United States Trinity Biotech K062658 (2007)
DEROYAL INDUSTRIES, INC. Present in Europe in other categories United States DeRoyal registered
Magnolia Medical Technologies United States Steripath Micro Steripath Flow Steripath SteriPath Gen2, 23G, BD SteriPath Gen2, 21G, BD SteriPath Gen2, 23G K251812 (2025)
Fisher Diagnostics United States Thermo Scientific Pacific Hemostasis® Thermo Scientific Nerl® Thermo Scientific Protocol™ Parasitology System K013397 (2002)
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
Alere Scarborough, Inc. United States BinaxNOW RSV BinaxNOW Nasopharyngeal Swab Accessory Kit BinaxNOW RSV Control Swab Kit BinaxNOW Strep A Card BinaxNOW Strep A Control Swab Pack BinaxNOW Streptococcus pneumoniae Antigen Card K173932 (2018)
Quidel Corp. United States QuickVue Sofia QuickVue In-Line QuickVue+ InflammaDry Solana K230349 (2023)
KOVA INTERNATIONAL, INC. – KOVA registered
Diagnostic Automation, Inc. – QMedix™ InstaTest Diagnostic Automation, Inc. Diagnostic Automation AccuDiag ™ registered
GENOLUTION. INC. Present in Europe in other categories South Korea NX Universal DNA Kit B NUE962 NX-Duo Universal DNA Kit A DUE961 NX Stool NA Kit A CSN231 NX Genomic DNA Kit A NGD041 NX-Duo Genomic DNA Kit A DGD961 NX-Duo cfDNA Kit A DCF242 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
Innovative Medical Technologies, Inc. United States UltraFlo-C QUICK-DRAW HEPARIN ADAPTER QUICK-DRAW EDTA ADAPTER QUICK-DRAW PLAIN ADAPTER ULTRAFLO-R ULTRAFLO-PB K220458 (2023)
Jiangsu Caina Medical Co.,Ltd China icu medical Kawasumi Unimed Wttod caina SafeTPoint K232781 (2024)
FUJIFILM IRVINE SCIENTIFIC, INC. – Chang Medium C Chang Medium in SITU Chang Amnio Chang Medium MF with Gentamicin Chang Medium BMC with Gentamicin Chang Medium D registered
Pretium Canada Packaging ULC Canada Leakbuster Starplex Pinworm Collector Starswab Multitrans System Starswab II Bacteriology Culture Collection and Transport System Histoplex registered
Quest Intl., Inc. United States ReQuest SeraQuest K162276 (2016)
Shenzhen Yuwen E-Commerce Co., Ltd. China AUVON registered
Nalge Nunc International Corporation Present in Europe in other categories – Samco™ Bio-Tite™ Wide Mouth, ST 120mL, 53mm, w/lab, NAT Cap Samco™ Clicktainer™ Vials, ST 120mL, 53mm, O/R Pouch, WHT Cap Samco™ Bio-Tite™, ST, 120mL, 53mm Midstream Kit No Funnel Samco™ Bio-Tite™, ST, 90mL, 48mm Midstream Kit with Funnel Samco™ Bio-Tite™ Wide Mouth, ST 120mL, 53mm, no lab, ORG Cap Fisherbrand™ 60mL, 48mm, ST w/lab and temp strip, WHT Cap 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)
INFRARED LABORATORY SYSTEMS LLC United States Synermed® registered
MEDICAL CHEMICAL CORPORATION United States Formalin / C&S / Clean Stool Collection Kits O&P Collection Vials Formalin/C&S Kits Z-PVA / Formalin / C&S / Clean O&P Collection Kits Total-Fix / Formalin / C&S / Clean O&P Collection Kits O&P Collection Vials Zinc PVA / Formalin / C&S Kits Bone Marrow Kit K150887 (2015)
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)
Premium Plus International Limited China Premium Plus registered
TRIVIDIA HEALTH, INC. United States TRUEtrack TRUEbalance TRUEplus TRUE METRIX TRUE FOCUS TRUEcontrol registered
YSI INCORPORATED United States YSI Incorporated K210933 (2024)
BIONIME CORPORATION Present in Europe in other categories United States GE Rightest ODM RIGHTEST GT333 Control Solution K133003 (2013)
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
Mechatronics USA LLC – Starrsed RPI registered
Medzah Industries United States SnapnSeal Ditek Urine Collection Cup MNG Buccal Swab SQM Intl - NIPT EU Kit MNG 5-Tube CSF Collection MNG - PTC Collection Kit registered
OMNIS HEALTH, LLC – Embrace Gestational Diabetes Package - LARGE (9 vials) Embrace 50ct Test Strip Embrace Value Kit (50ct Included) Embrace Gestational Diabetes Package - SMALL (5 vials) Embrace Gestational Diabetes - Strips Refill Bundle (4 vials) Embrace Pro Meter registered

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