| Dymind
EU representative : Eunitor GmbH (Germany)
|
China
|
20 others
|
A, B
IVDR, 98/79
|
regulationdept@dymind.com
EUDAMED record
Report an error
|
| Genegeo
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
11 others
|
A
IVDR, 98/79
|
sales@genegeo.com
EUDAMED record
Report an error
|
| Mindray FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
10 others
|
B
IVDR, 98/79
|
Website
EUDAMED record
Report an error
|
| Horiba FDA
|
France
|
7 others
|
B
IVDR
|
EUDAMED record
Report an error
|
| Rayto
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
7 others
|
B
IVDR, 98/79
|
Website
support@rayto.com
EUDAMED record
Report an error
|
| E-LAB Biological Science & Technology
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
5 others
|
–
98/79
|
EUDAMED record
Report an error
|
| Shenzhen Comen Medical Instruments FDA
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
5 others
|
–
98/79
|
EUDAMED record
Report an error
|
| Sysmex FDA
EU representative : Sysmex Europe SE (Germany)
|
Japan
|
5 others
|
–
98/79
|
ra_archive@sysmex.co.jp
EUDAMED record
Report an error
|
| Beckman Coulter FDA
EU representative : Beckman Coulter Ireland Inc. (Ireland)
|
Ireland, United States
|
4 others
|
–
98/79
|
Website
ra.clare@beckman.com
EUDAMED record
Report an error
|
| Urit FDA
EU representative : Medunion S.L. (Spain) and 1 other
|
China
|
4 others
|
B
IVDR, 98/79
|
Website
service@uritest.com
EUDAMED record
Report an error
|
| Dirui FDA
EU representative : Emergo Europe B.V. (Netherlands)
|
China
|
2 others
|
–
98/79
|
EUDAMED record
Report an error
|
| Edan FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
2 others
|
B
IVDR, 98/79
|
EUDAMED record
Report an error
|
| Drucker Diagnostics FDA
EU representative : Emergo Europe B.V. (Netherlands)
|
United States
|
|
–
98/79
|
Website
regulatory@druckerdiagnostics.com
EUDAMED record
Report an error
|
| Genrui Biotech FDA
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
–
98/79
|
Website
service@genrui-bio.com
EUDAMED record
Report an error
|
| Hunan Ehome Health Technology
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
|
A
IVDR, 98/79
|
EUDAMED record
Report an error
|
| Maccura
EU representative : Humiss International B.V. (Netherlands) and 1 other
|
China
|
|
B
IVDR, 98/79
|
Website
EUDAMED record
Report an error
|
| Ukinbio
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
|
–
98/79
|
sales@ukinbio.com
EUDAMED record
Report an error
|
| Zybio FDA
EU representative : QbD RepS BV (Belgium)
|
China
|
|
B
IVDR
|
PMS@zy-ivd.com
EUDAMED record
Report an error
|
| Abbott FDA
EU representative : Abbott GmbH (Germany)
|
United States
|
|
B
IVDR
|
Website
EUDAMED record
Report an error
|
| Seamaty
EU representative : MedNet EC-REP GmbH (Germany)
|
China
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| Erba
|
Czechia
|
|
B
IVDR
|
Website
EUDAMED record
Report an error
|
| Gmt Sarl
|
France
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Human
|
Germany
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Medconn FDA
EU representative : JOYSUN GROUP S.L.U (Spain)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| NanoEntek FDA
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
|
South Korea
|
|
A
IVDR
|
Website
eudamed@nanoentek.com
EUDAMED record
Report an error
|
| BioFynder
EU representative : SUNGO Europe B.V. (Netherlands)
|
United Kingdom (ex Northern Ireland)
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| Dezhou Guoke Medical Technology
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
|
–
98/79
|
office@guoke-medical.com
EUDAMED record
Report an error
|
| EFA Engineering for All
EU representative : MedNet EC-REP GmbH (Germany)
|
Israel
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Meril Diagnostics FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
India
|
|
A
IVDR
|
Website
ram.kanoje@merillife.com
EUDAMED record
Report an error
|
| NORMA Instruments Zártkörűen Működő Részvénytársaság
|
Hungary
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| Orphée
EU representative : PZ CORMAY Spółka Akcyjna (Poland)
|
Switzerland
|
|
–
98/79
|
ra@orphee-medical.com
EUDAMED record
Report an error
|
| Shandong Bohong Gene Technology
EU representative : Luxus Lebenswelt GmbH (Germany)
|
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
|
| Spinreact
|
Spain
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Wheisman Medical Technology
EU representative : Umedwings Netherlands B.V. (Netherlands)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| ZOVEC diagnostics
|
Germany
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Aconbio
EU representative : MedNet EC-REP GmbH (Germany)
|
China
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Avecon Healthcare
EU representative : Amstermed B.V. (Netherlands)
|
India
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Biobase FDA
EU representative : Luxus Lebenswelt GmbH (Germany)
|
China
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| Boditech FDA
EU representative : Obelis s.a. (Belgium)
|
South Korea
|
|
A
IVDR
|
Website
marketing@boditech.co.kr
EUDAMED record
Report an error
|
| Changchun Chenyu Taikang Medical Laboratory
EU representative : MedPath GmbH (Germany)
|
China
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| Changsha Han Biotechnology
EU representative : Medunion S.L. (Spain)
|
China
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| Cytochipinc FDA
EU representative : Medunion S.L. (Spain)
|
United States
|
|
A
IVDR
|
quality@cytochipinc.com
EUDAMED record
Report an error
|
| Diagon
|
Hungary
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Diatron FDA
|
Hungary
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| HemoCue FDA
|
Sweden
|
|
A
IVDR
|
Website
info@hemocue.se
EUDAMED record
Report an error
|
| High Technology FDA
EU representative : MedEnvoy Global BV (Netherlands)
|
United States
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Lordsmark
EU representative : Obelis s.a. (Belgium)
|
India
|
|
A
IVDR
|
Website
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
|
| Poweam
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| Pushkang
EU representative : Sungo Cert GmbH (Germany)
|
China
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| Shenzhen Cinnaray Life Technology
EU representative : HUMISS TRADING S. L. (Spain)
|
China
|
- X3000, X3100, X5000, X5100, X5200, X5300, CF9600, CH8600CS, CH8600/CRP, CH8500/CRP, CH8300/CRP3 refs
|
A
IVDR
|
EUDAMED record
Report an error
|
| Shenzhen CoooSeee Biomedical
EU representative : MedNet EC-REP GmbH (Germany)
|
China
|
|
B
IVDR
|
service@comenbio.com
EUDAMED record
Report an error
|
| Shenzhen Landwind Biomedical Technology
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
–
98/79
|
sales@landwindmedical.com
EUDAMED record
Report an error
|
| Shenzhen Zijian Biotechnology
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
A
IVDR
|
Website
sales@szzijian.com
EUDAMED record
Report an error
|
| Siemens Healthcare Diagnostics FDA
EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland)
|
United States
|
|
B
IVDR
|
Website
contact@siemens-healthineers.com
EUDAMED record
Report an error
|
| Tcoag FDA
|
Ireland
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Zhongshan Chuangyi Biochemical Engineering
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| Xpenarray
EU representative : CMC Medical Devices & Drugs SL (Spain)
No model still on the market
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Ns Biotec
EU representative : CMC Medical Devices & Drugs SL (Spain)
No model still on the market
|
Egypt
|
|
–
98/79
|
Website
info@nsbiotec.com
EUDAMED record
Report an error
|
| 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
|