| Abbott FDA
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
|
Germany, South Korea
|
112 others
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Hangzhou Alltest Biotech FDA
EU representative : MedNet EC-REP GmbH (Germany) and 1 other
|
China
|
71 others
|
B, C
IVDR, 98/79
|
info@alltests.com.cn
EUDAMED record
Report an error
|
| Acro Biotech FDA
EU representative : MedNet EC-REP GmbH (Germany) and 1 other
|
United States
|
61 others
|
–
98/79
|
info@acrobiotech.com
EUDAMED record
Report an error
|
| Vivachek FDA
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
37 others
|
–
98/79
|
info@vivachek.com
EUDAMED record
Report an error
|
| Acesolab FDA
EU representative : VidaQuick Biotech S.L. (Spain)
|
United States
|
35 others
|
–
98/79
|
info@acesolab.com
EUDAMED record
Report an error
|
| Newlink Biotech
EU representative : VidaQuick Biotech S.L. (Spain)
|
China
|
32 others
|
–
98/79
|
Website
info@kylinew.com
EUDAMED record
Report an error
|
| Rapid Labs
EU representative : Advena Limited (Malta) and 1 other
|
United Kingdom (ex Northern Ireland)
|
31 others
|
–
98/79
|
Website
info@rapidlabs.co.uk
EUDAMED record
Report an error
|
| Citest Diagnostics
EU representative : VidaQuick Biotech S.L. (Spain)
|
Canada
|
28 others
|
–
98/79
|
ra02@citestdiagnostics.com
EUDAMED record
Report an error
|
| Actest
EU representative : VidaQuick Biotech S.L. (Spain)
|
China
|
27 others
|
–
98/79
|
info@actest.com.cn
EUDAMED record
Report an error
|
| Tongzhoubio FDA
EU representative : VidaQuick Biotech S.L. (Spain)
|
China
|
26 others
|
–
98/79
|
EUDAMED record
Report an error
|
| Hangzhou Genesis Biodetection Biocontrol FDA
EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other
|
China
|
25 others
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Genesignbio
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) and 1 other
|
China
|
23 others
|
–
98/79
|
info@genesignbio.com
EUDAMED record
Report an error
|
| Bitrumed
EU representative : VidaQuick Biotech S.L. (Spain)
|
China
|
21 others
|
–
98/79
|
info@bitrumed.com.cn
EUDAMED record
Report an error
|
| Clongene FDA
EU representative : HUMISS TRADING S. L. (Spain) and 1 other
|
China
|
19 others
|
–
98/79
|
Website
marketing@clongene.com
EUDAMED record
Report an error
|
| Orientgene FDA
EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other
|
China
|
19 others
|
B, C
IVDR, 98/79
|
EUDAMED record
Report an error
|
| Assure Tech. (Hangzhou)
EU representative : CMC Medical Devices & Drugs SL (Spain) and 2 others
|
China
|
17 others
|
B
IVDR, 98/79
|
Website
contact@diareagent.com
EUDAMED record
Report an error
|
| Wuhan Life Origin Biotech Joint Stock
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
17 others
|
–
98/79
|
EUDAMED record
Report an error
|
| Shanghai BioGerm Medical Technology
EU representative : Medunion S.L. (Spain)
|
China
|
16 others
|
–
98/79
|
EUDAMED record
Report an error
|
| Biotical
|
Spain
|
15 others
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Wondfo FDA
EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other
|
China
|
15 others
|
–
98/79
|
Website
sales@wondfo.com.cn
EUDAMED record
Report an error
|
| Safecare FDA
EU representative : UnicareQ GmbH (Germany) and 1 other
|
China
|
14 others
|
–
98/79
|
EUDAMED record
Report an error
|
| Dezhou Guoke Medical Technology
EU representative : MedPath GmbH (Germany) and 1 other
|
China
|
- Adenovirus Antigen Rapid Test Cassette (Colloidal Gold) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79
- Adenovirus IgM Ab Rapid Test Kit GKPD10098/79
- COVID-19 Antigen Rapid Test Cassette (Colloidal Gold ) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79
- Flu A & Flu B&Respiratory Syncytial Virus&Adenovirus Antigen Rapid Test Cassette(Colloidal Gold) 1T/BOX,10T/BOX,20T/BOX,25T/BOX,40T/BOX,50T/BOX98/79
- HAV IgM Rapid Test Cassette(Colloidal Gold) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79
12 others- Influenza type A and B(Flu A/B) Ag Rapid Test Cassette(Colloidal Gold) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79
- Mumps Virus IgM Ab Rapid Test Kit GKPD10198/79
- Neisseria Gonorrheae(NGH) AntigenRapid TestStrip(ColloidalGold) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79
- Nipah Virus Ag Rapid Test Kit98/79
- Nipah Virus IgG/IgM Ab Rapid Test Kit98/79
- Noroviruses Rapid Test Cassette(Colloidal Gold) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79
- Rotavirus & Adenovirus Antigen Rapid Test Cassette (Colloidal Gold) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79
- Rotavirus Antigen Rapid Test Cassette(Colloidal Gold) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79
- SARS-CoV-2&Respiratory Syncytial Virus&Flu A & Flu B Antigen Rapid Test Cassette(Colloidal Gold) 1T/BOX,10T/BOX,20T/BOX,25T/BOX,40T/BOX,50T/BOX98/79
- Strep A Antigen Rapid Test Cassette (Colloidal Gold) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79
- Syphilis (Tp) Ab Rapid Test Cassette (Colloidal Gold) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79
- Yellow Fever Virus IgG/IgM Antibody Rapid Test Kit98/79
|
–
98/79
|
office@guoke-medical.com
EUDAMED record
Report an error
|
| Jiangsu Macro & Micro-Test Med-Tech FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
11 others
|
–
98/79
|
marketing@hongweitest.com
EUDAMED record
Report an error
|
| Wuhan Easydiagnosis Biomedicine
EU representative : MedNet EC-REP GmbH (Germany) and 1 other
|
China
|
18 others
|
–
98/79
|
EUDAMED record
Report an error
|
| Beijing Kewei Clinical Diagnostic Reagent
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
10 others
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Shenzhen Superbio Technology FDA
EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other
|
China
|
10 others
|
–
98/79
|
info@sup-bio.com
EUDAMED record
Report an error
|
| Certest
|
Spain
|
9 others
|
B
IVDR
|
Website
quality@certest.es
EUDAMED record
Report an error
|
| AccuBioTech
EU representative : MDSS GmbH (Germany)
|
China
|
8 others
|
–
98/79
|
sales@accubiotech.com
EUDAMED record
Report an error
|
| Shenzhen Zijian Biotechnology
EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other
|
China
|
8 others
|
–
98/79
|
Website
sales@szzijian.com
EUDAMED record
Report an error
|
| Bioantibody Biotechnology
EU representative : Medunion S.L. (Spain)
|
China
|
7 others
|
–
98/79
|
EUDAMED record
Report an error
|
| Hightopbio FDA
EU representative : MedNet EC-REP GmbH (Germany)
|
China
|
7 others
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Zhejiang Greylynx Biotech
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
6 others
|
–
98/79
|
info@vivachek.com
EUDAMED record
Report an error
|
| Cesna
|
Türkiye
|
5 others
|
B
IVDR
|
Website
info@cesna.com.tr
EUDAMED record
Report an error
|
| Farmasino
EU representative : Humiss International B.V. (Netherlands)
|
China
|
5 others
|
–
98/79
|
EUDAMED record
Report an error
|
| Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇
|
Türkiye
|
5 others
|
B, C
IVDR
|
Website
info@visionbiotechnology.com
EUDAMED record
Report an error
|
| Bioperfectus FDA
EU representative : MedNet EC-REP GmbH (Germany)
|
China
|
4 others
|
–
98/79
|
EUDAMED record
Report an error
|
| HangZhou Biotest Biotech FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
4 others
|
–
98/79
|
info@biotests.com.cn
EUDAMED record
Report an error
|
| Hangzhou Laihe Biotech FDA
EU representative : Medunion S.L. (Spain) and 1 other
|
China
|
4 others
|
B
IVDR, 98/79
|
office@lyher.com
EUDAMED record
Report an error
|
| Healgen FDA
EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other
|
United States
|
4 others
|
–
98/79
|
quality@healgen.com
EUDAMED record
Report an error
|
| Jiangsu Medomics Medical Technology FDA
EU representative : Mega Eurostar Sp. z o.o. (Poland) and 2 others
|
China
|
4 others
|
C
IVDR, 98/79
|
Website
info@medomics-dx.com
EUDAMED record
Report an error
|
| Shenzhen Huian Biosci Technology
EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other
|
China
|
4 others
|
–
98/79
|
info@huiantech.com
EUDAMED record
Report an error
|
| Zhejiang Wantaifu Biotechnology
EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other
|
China
|
4 others
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Anhui Deepblue Medical Technology FDA
EU representative : Luxus Lebenswelt GmbH (Germany) and 1 other
|
China
|
3 others
|
B, C
IVDR, 98/79
|
sales@dbluemedical.com
EUDAMED record
Report an error
|
| Salofa FDA
|
Finland
|
3 others
|
–
98/79
|
Website
info@salofa.com
EUDAMED record
Report an error
|
| Bosonbio FDA
EU representative : Lotus NL B.V. (Netherlands) and 1 other
|
China
|
2 others
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Core Technology FDA
EU representative : Medunion S.L. (Spain) and 1 other
|
China
|
2 others
|
–
98/79
|
EUDAMED record
Report an error
|
| nal von minden
|
Germany
|
2 others
|
–
98/79
|
Website
info@nal-vonminden.com
EUDAMED record
Report an error
|
| Neo-nostics (Suzhou) Bioengineering
EU representative : Medunion S.L. (Spain)
|
China
|
2 others
|
–
98/79
|
EUDAMED record
Report an error
|
| Abiores Technology (Beijing)
EU representative : Sungo Cert GmbH (Germany)
|
China
|
1 other
|
–
98/79
|
EUDAMED record
Report an error
|
| Konsung FDA
EU representative : Lotus NL B.V. (Netherlands) and 1 other
|
China
|
1 other
|
–
98/79
|
info@konsung.com
EUDAMED record
Report an error
|
| Operon FDA
|
Spain
|
1 other
|
B
IVDR, 98/79
|
Website
infoeudamed@operon.es
EUDAMED record
Report an error
|
| Tauns
EU representative : Emergo Europe B.V. (Netherlands)
|
Japan
|
1 other
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Aichek FDA
EU representative : Medunion S.L. (Spain) and 1 other
|
China
|
|
–
98/79
|
ra.rep@aichek.com
EUDAMED record
Report an error
|
| Ameritech Diagnostic Reagent (Jiaxing)
EU representative : CEpartner4U (Netherlands)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Biobase FDA
EU representative : Luxus Lebenswelt GmbH (Germany)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Biomaxima
|
Poland
|
|
B
IVDR
|
Website
info@biomaxima.com
EUDAMED record
Report an error
|
| Sejoy FDA
EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other
|
China
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Singclean
EU representative : Obelis s.a. (Belgium) and 1 other
|
China
|
|
C
IVDR, 98/79
|
Website
EUDAMED record
Report an error
|
| Anbio
EU representative : Lotus NL B.V. (Netherlands) and 1 other
|
China
|
|
–
98/79
|
info@anbio.com
EUDAMED record
Report an error
|
| Avioq Bio-tech
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Bioteke FDA
EU representative : Medunion S.L. (Spain)
|
China
|
|
C
IVDR, 98/79
|
Website
info@bioteke.cn
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
|
| Innovacon
EU representative : MDSS GmbH (Germany)
|
United States
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Medotexbio
EU representative : Llins Service & Consulting GmbH (Germany)
|
China
|
|
B
IVDR, 98/79
|
Website
EUDAMED record
Report an error
|
| Microprofit
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
C
IVDR, 98/79
|
EUDAMED record
Report an error
|
| Phasescientific FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
Hong Kong SAR China
|
|
–
98/79
|
Website
info@phasesci.com
EUDAMED record
Report an error
|
| Reagena
|
Finland
|
|
B
IVDR, 98/79
|
Website
info@reagena.com
EUDAMED record
Report an error
|
| Triplex International Biosciences (China)
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
–
98/79
|
Website
info@tibchina.com
EUDAMED record
Report an error
|
| Wesailbio
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Aconbio
EU representative : MedNet EC-REP GmbH (Germany)
|
China
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Artronlab FDA
EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other
|
Canada
|
|
–
98/79
|
Website
info@artronlab.com
EUDAMED record
Report an error
|
| Labnovation
EU representative : MedNet EC-REP GmbH (Germany)
|
China
|
|
–
98/79
|
Website
info@labnovation.com
EUDAMED record
Report an error
|
| Shenzhen Kang Sheng Bao Bio-Technology
EU representative : QbD RepS BV (Belgium)
|
China
|
|
–
98/79
|
Website
info@ksbbiotech.com
EUDAMED record
Report an error
|
| Zhongshan Bio-Tech
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Abcerion Diagnostics
|
Germany
|
|
–
98/79
|
Website
info@abcerion-diagnostics.de
EUDAMED record
Report an error
|
| Beijing Jinwofu Bioengineering Technology
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Chemtronbio
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Jiangsu Mole Bioscience
EU representative : Medunion S.L. (Spain)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Kangsheng Information Technology (Hangzhou)
EU representative : Crealkraft GmbH (Germany)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Nano Diagnosis for Health Biotech (Guangzhou)
EU representative : MedPath GmbH (Germany)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| R-Biopharm FDA
|
Germany
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Vircell
|
Spain
|
|
B
IVDR
|
EUDAMED record
Report an error
|
| Vitrosens
|
Türkiye
|
|
B
IVDR, 98/79
|
Website
info@vitrosens.com
EUDAMED record
Report an error
|
| Wizbiotech
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Sansure FDA
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
2 others
|
–
98/79
|
Website
info@sansure.com.cn
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
|
| Aidian FDA
|
Finland
|
|
–
98/79
|
Website
eudamed@aidian.eu
EUDAMED record
Report an error
|
| Biodetect
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| BioFynder
EU representative : SUNGO Europe B.V. (Netherlands)
|
United Kingdom (ex Northern Ireland)
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Bioinova
|
Czechia
|
|
–
98/79
|
Website
info@bioinova.cz
EUDAMED record
Report an error
|
| Biosynex
EU representative : BIOSYNEX (France)
|
Switzerland
|
|
–
98/79
|
Website
reglementaire@biosynex.com
EUDAMED record
Report an error
|
| CorDx FDA
EU representative : Luxus Lebenswelt GmbH (Germany)
|
United States
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Dyonmed
|
Greece
|
|
–
98/79
|
Website
customerservice@dyonmedical.com
EUDAMED record
Report an error
|
| Equinox Biotech FDA
EU representative : MedNet EC-REP GmbH (Germany)
|
China
|
|
–
98/79
|
Website
sales@runbio-bio.com
EUDAMED record
Report an error
|
| Erasinovasyon
|
Türkiye
|
|
C
IVDR
|
Website
EUDAMED record
Report an error
|
| Fanttest
EU representative : Cares Testtech GmbH (Germany)
|
China
|
|
–
98/79
|
info@fanttest.com
EUDAMED record
Report an error
|
| Guangzhou Deaou Gene Technology
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Hangzhou DIAN Biotechnology
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Heyer Medical
|
Germany
|
|
C
IVDR
|
Website
EUDAMED record
Report an error
|
| Innovita
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
C
IVDR
|
Website
info@innovita.com.cn
EUDAMED record
Report an error
|
| New Gene (Hangzhou) Bioengineering
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
–
98/79
|
Website
marketing@new-gene.com
EUDAMED record
Report an error
|
| Ortho-Clinical Diagnostics Summers Ridge San Diego
EU representative : MDSS GmbH (Germany)
|
United States
|
|
–
98/79
|
Website
PRRC@quidelortho.com
EUDAMED record
Report an error
|
| Pantest
|
Portugal
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Qingdao Huaren Medical Product
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Reagen
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
–
98/79
|
Website
info@reagenus.com
EUDAMED record
Report an error
|
| Targetingone
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Biotime
EU representative : Lotus NL B.V. (Netherlands)
No model still on the market
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Zhejiang Anji Saianfu Biotechnology
EU representative : Lotus NL B.V. (Netherlands)
No model still on the market
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Arcdia
No model still on the market
|
Finland
|
|
–
98/79
|
Website
office@arcdia.com
EUDAMED record
Report an error
|