| Biotecnica
|
Italy
|
8 others
|
A
IVDR
|
EUDAMED record
Report an error
|
| Rayto
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
7 others
|
A
IVDR
|
Website
support@rayto.com
EUDAMED record
Report an error
|
| Seamaty
EU representative : MedNet EC-REP GmbH (Germany)
|
China
|
5 others
|
A
IVDR
|
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
|
| Human
|
Germany
|
1 other
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Erba
|
Czechia
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Ral Tecnica Para El Laboratorio
|
Spain
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Riele
|
Germany
|
|
A
IVDR
|
Website
info@riele.de
EUDAMED record
Report an error
|
| Arkray FDA
EU representative : ARKRAY Europe, B.V. (Netherlands)
|
Japan
|
|
A
IVDR, 98/79
|
support_arkrayeurope@arkray.co.jp
EUDAMED record
Report an error
|
| Beckman Coulter FDA
EU representative : Beckman Coulter Ireland Inc. (Ireland)
|
United States
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Biolabo
|
France
|
|
A
IVDR
|
support@biolabo.fr
EUDAMED record
Report an error
|
| Biosystems FDA
|
Spain
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Cormay
|
Poland
|
|
A
IVDR
|
regulatory_affairs@cormay.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
|
| E-LAB Biological Science & Technology
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
- Auto Chemistry Analyzer AS-800, AS-600, AS-480, AS-450, AS-380, AS-350, AS-280, AS-240,AS-160, AS-120, ES-480, ES-400, ES-380, ES-320, ES-2003 refs
- Auto Chemistry Analyzer BT-120,BT-120P,BT-120M,BT-160,BT-160P,BT-160M,BT-200,BT-200P,BT-200M,BT-240,BT-240P,BT-240M,BT-300,BT-300P,BT-300M,BT-330,BT-330P,BT-330M3 refs
- Semi-Auto Chemistry Analyzer ES-105、ES-104、ES-103、ES-102、ES-101C、ES-100P、ES-100C、ES-90C、ES-903 refs
|
A
IVDR
|
EUDAMED record
Report an error
|
| Furuno FDA
EU representative : MedEnvoy Global BV (Netherlands)
|
Japan
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| VitalScientific FDA
|
Netherlands
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Abaxis FDA
EU representative : ABAXIS Europe GmbH (Germany)
|
United States
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| B.P.C. Biosed –
|
Italy
|
|
A
IVDR
|
Website
info@bpcbiosed.it
EUDAMED record
Report an error
|
| Biobase FDA
EU representative : Luxus Lebenswelt GmbH (Germany)
|
China
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| Biomaxima
|
Poland
|
|
A
IVDR
|
Website
info@biomaxima.com
EUDAMED record
Report an error
|
| e-LinkCare Meditech FDA
EU representative : Wellkang Ltd (Northern Ireland)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Genrui Biotech FDA
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
A
IVDR
|
Website
service@genrui-bio.com
EUDAMED record
Report an error
|
| Gmt Sarl
|
France
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Leadmanbio
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| Linear FDA
|
Spain
|
|
A
IVDR
|
Website
info@linear.es
EUDAMED record
Report an error
|
| Lordsmark
EU representative : Obelis s.a. (Belgium)
|
India
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Medconn FDA
EU representative : JOYSUN GROUP S.L.U (Spain)
|
China
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| Meril Diagnostics FDA
EU representative : Obelis s.a. (Belgium)
|
India
|
|
A
IVDR
|
Website
ram.kanoje@merillife.com
EUDAMED record
Report an error
|
| Nano Diagnosis for Health Biotech (Guangzhou)
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| Orientgene FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| Pushkang
EU representative : Sungo Cert GmbH (Germany)
|
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
|
| Spinreact
|
Spain
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Thermofisher FDA
|
Finland
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Urit FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
|
A
IVDR
|
Website
service@uritest.com
EUDAMED record
Report an error
|
| Zybio FDA
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
A
IVDR
|
PMS@zy-ivd.com
EUDAMED record
Report an error
|
| Aikang Diagnostics
EU representative : MedNet EC-REP GmbH (Germany)
|
China
|
|
A
IVDR
|
marketing@aikang-medical.com
EUDAMED record
Report an error
|
| Athenesedx
EU representative : Obelis s.a. (Belgium)
|
India
|
|
A
IVDR
|
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
|
| Biosense
EU representative : MD&D Alliance GmbH (Germany)
|
India
|
|
A
IVDR
|
regulatory.affairs@biosense.in
EUDAMED record
Report an error
|
| Callegari
|
Italy
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| Contecmed FDA
EU representative : Prolinx GmbH (Germany)
|
China
|
|
A
IVDR
|
Website
pms.qms@contecmed.com
EUDAMED record
Report an error
|
| Diagnostics
|
Belgium
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Dialab
|
Austria
|
|
A
IVDR
|
Website
office@dialab.at
EUDAMED record
Report an error
|
| Diatron FDA
|
Hungary
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Dirui FDA
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| Futurlab
|
Italy
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Goldsite
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
A
IVDR
|
Website
export@goldsite.com.cn
EUDAMED record
Report an error
|
| Guangzhou Yunrui Medical Technology
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
|
I
MDR
|
EUDAMED record
Report an error
|
| Horiba FDA
|
France
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| Instrumentation Laboratory FDA
|
Italy
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Jiezibio
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| Locmedt
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| Mr International Healthcare Technology
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| MTD Diagnostics
|
Italy
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| numares FDA
|
Germany
|
|
A
IVDR
|
info@numares.com
EUDAMED record
Report an error
|
| Qualigeninc FDA
EU representative : MDSS GmbH (Germany)
|
United States
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Randox FDA
|
Northern Ireland
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Sanymed
|
Italy
|
|
A
IVDR
|
Website
info@sanymed.it
EUDAMED record
Report an error
|
| Shanghai Kehua Laboratory System FDA
EU representative : Obelis s.a. (Belgium)
|
China
|
- G9800 Automatic Clinical Chemistry Analyzer ZY-400, ZY-450, ZY-460, ZY-480, Polaris c1000, Polaris c1100, Polaris c2000, Polaris c2100, ZY-680, ZY-690, ZY-1200, ZY-1250, ZY-1260, ZY-1280, G9800, ZY-260, ZY-2803 refs
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Shenzhen Tailaored Medical
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
A
IVDR
|
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
|
| Skyla
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
|
Taiwan
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Tecom Science
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| Ukinbio
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
|
A
IVDR
|
sales@ukinbio.com
EUDAMED record
Report an error
|
| Vodenmedical
|
Italy
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Wiener Laboratorios SAIC FDA
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
|
Argentina
|
|
A
IVDR
|
Website
marketing@wiener-lab.com
EUDAMED record
Report an error
|
| 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
|