| Abbott FDA
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
|
South Korea
|
12 others
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Euroimmun FDA
|
Germany
|
5 others
|
B
IVDR, 98/79
|
Website
info@euroimmun.de
EUDAMED record
Report an error
|
| Gold Standard Diagnostics FDA
|
Germany
|
2 others
|
–
98/79
|
info.frankfurt@eu.goldstandarddiagnostics.com
EUDAMED record
Report an error
|
| Boditech FDA
EU representative : Obelis s.a. (Belgium)
|
South Korea
|
1 other
|
B
IVDR, 98/79
|
Website
marketing@boditech.co.kr
EUDAMED record
Report an error
|
| Vitrosens
|
Türkiye
|
1 other
|
C
IVDR, 98/79
|
Website
info@vitrosens.com
EUDAMED record
Report an error
|
| BeijingModern GaoDa Biotechnology
EU representative : Medunion S.L. (Spain)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Acro Biotech FDA
EU representative : MedNet EC-REP GmbH (Germany) and 1 other
|
United States
|
|
–
98/79
|
info@acrobiotech.com
EUDAMED record
Report an error
|
| Hangzhou Alltest Biotech FDA
EU representative : MedNet EC-REP GmbH (Germany)
|
China
|
|
–
98/79
|
info@alltests.com.cn
EUDAMED record
Report an error
|
| Inbios FDA
EU representative : AR Experts B.V. (Netherlands)
|
United States
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Neomedica
EU representative : Wellkang Ltd (Northern Ireland)
|
Serbia
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Orientgene FDA
EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Vircell
|
Spain
|
|
–
98/79
|
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
|
| bioMérieux FDA
|
France
|
|
B, C
IVDR
|
EUDAMED record
Report an error
|
| Dezhou Guoke Medical Technology
EU representative : MedPath GmbH (Germany) and 1 other
|
China
|
- Dengue IgG/IgM Detection Kit (Immunofluorescence Chromatography)98/79
- Dengue IgG/lgM Antibody Rapid Test Cassette (Colloidal Gold) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79
- Dengue NS1 Antigen Rapid Test Cassette (Colloidal Gold) 1T/BOX,10T/BOX,20T/BOX,25T/BOX,40T/BOX,50T/BOX98/79
|
–
98/79
|
office@guoke-medical.com
EUDAMED record
Report an error
|
| Diagreat
EU representative : Medunion S.L. (Spain)
|
China
|
|
B, C
IVDR
|
Website
info@diagreat.com
EUDAMED record
Report an error
|
| Encode
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Getein FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Hangzhou Immuno Biotech
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
–
98/79
|
info@jgbiotech.com
EUDAMED record
Report an error
|
| Hightopbio FDA
EU representative : MedNet EC-REP GmbH (Germany) and 1 other
|
China
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| NanoEntek FDA
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
|
South Korea
|
|
–
98/79
|
Website
eudamed@nanoentek.com
EUDAMED record
Report an error
|
| Shenzhen Huian Biosci Technology
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
–
98/79
|
info@huiantech.com
EUDAMED record
Report an error
|
| Synthgene (Yixing) Health Technology
EU representative : MedPath GmbH (Germany)
|
China
|
|
–
98/79
|
sales@syngenebio.com
EUDAMED record
Report an error
|
| Toda Pharma
|
France
|
|
–
98/79
|
Website
qualite@todapharma.com
EUDAMED record
Report an error
|
| Wondfo FDA
EU representative : QbD RepS BV (Belgium)
|
China
|
|
–
98/79
|
Website
sales@wondfo.com.cn
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
|
| Campmedica
|
Romania
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Cybereagen
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
–
98/79
|
info@cybereagen.com
EUDAMED record
Report an error
|
| Human
|
Germany
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Hunan Kangxin Biotechnology
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Isiabio
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Jiangsu Macro & Micro-Test Med-Tech FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
|
–
98/79
|
marketing@hongweitest.com
EUDAMED record
Report an error
|
| Ningbo BESTest Bio-technology
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
B, C
IVDR
|
EUDAMED record
Report an error
|
| Anhui Formaster Biosci
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Assure Tech. (Hangzhou)
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
B
IVDR
|
Website
contact@diareagent.com
EUDAMED record
Report an error
|
| Beijing Applied Biological Technologies
EU representative : Luxus Lebenswelt GmbH (Germany)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Bio-Rad FDA
|
France
|
|
C
IVDR
|
Website
contact@bio-rad.com
EUDAMED record
Report an error
|
| Biopanda
|
Northern Ireland
|
|
–
98/79
|
Website
info@biopanda.co.uk
EUDAMED record
Report an error
|
| CTK Biotech FDA
EU representative : MDSS GmbH (Germany)
|
United States
|
|
C
IVDR
|
Website
info@ctkbiotech.com
EUDAMED record
Report an error
|
| Diapro
|
Italy
|
|
–
98/79
|
Website
info@diapro.it
EUDAMED record
Report an error
|
| Fanttest
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
|
–
98/79
|
info@fanttest.com
EUDAMED record
Report an error
|
| Mpbio FDA
|
Germany
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Nanjing Synthgene Medical Technology FDA
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
–
98/79
|
Website
sales@syngenebio.com
EUDAMED record
Report an error
|
| Rapid Labs
EU representative : Advena Limited (Malta)
|
United Kingdom (ex Northern Ireland)
|
|
–
98/79
|
Website
info@rapidlabs.co.uk
EUDAMED record
Report an error
|
| Realytech
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
–
98/79
|
Website
info@realytech.com
EUDAMED record
Report an error
|
| Shenzhen Superbio Technology FDA
EU representative : QbD RepS BV (Belgium)
|
China
|
|
–
98/79
|
info@sup-bio.com
EUDAMED record
Report an error
|
| Biotime
EU representative : Medunion S.L. (Spain)
No model still on the market
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Nantong EgensBiotechnology FDA
EU representative : SUNGO Europe B.V. (Netherlands)
No model still on the market
|
China
|
|
–
98/79
|
qa@egens-bio.cn
EUDAMED record
Report an error
|
| Wuhan Easydiagnosis Biomedicine
EU representative : MedNet EC-REP GmbH (Germany)
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
|