Boditech FDA
EU representative : Obelis s.a. (Belgium)
South Korea
12 others
A
IVDR
Website
marketing@boditech.co.kr
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
Rayto
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
11 others
A
IVDR
Website
support@rayto.com
EUDAMED record
Report an error
Hangzhou Alltest Biotech FDA
EU representative : MedNet EC-REP GmbH (Germany) and 1 other
China
8 others
A
IVDR, 98/79
info@alltests.com.cn
EUDAMED record
Report an error
Illumaxbio
EU representative : MedNet EC-REP GmbH (Germany)
China
7 others
A
IVDR
Website
EUDAMED record
Report an error
Euroimmun FDA
Germany
6 others
A
IVDR
Website
info@euroimmun.de
EUDAMED record
Report an error
Genrui Biotech FDA
EU representative : Lotus NL B.V. (Netherlands)
China
3 others
A
IVDR
Website
service@genrui-bio.com
EUDAMED record
Report an error
Acro Biotech FDA
EU representative : MedNet EC-REP GmbH (Germany)
United States
2 others
A
IVDR
info@acrobiotech.com
EUDAMED record
Report an error
DAS
Italy
2 others
A
IVDR
Website
quality@dasitaly.com
EUDAMED record
Report an error
Human
Germany
2 others
A
IVDR
Website
EUDAMED record
Report an error
Monobind FDA
EU representative : AR Experts B.V. (Netherlands)
United States
2 others
A
IVDR
Website
info@monobind.com
EUDAMED record
Report an error
Aichek FDA
EU representative : SUNGO Europe B.V. (Netherlands)
China
1 other
A
IVDR
ra.rep@aichek.com
EUDAMED record
Report an error
Dynodx
EU representative : HUMISS TRADING S. L. (Spain)
China
1 other
–
98/79
EUDAMED record
Report an error
Lifotronic FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) and 1 other
China
1 other
A
IVDR
Website
EUDAMED record
Report an error
Shenzhen Yhlo Biotech FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
1 other
A
IVDR
Website
info@szyhlo.com
EUDAMED record
Report an error
Vivachek FDA
EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other
China
1 other
A
IVDR
info@vivachek.com
EUDAMED record
Report an error
Abbott FDA
EU representative : Abbott GmbH (Germany) and 1 other
United States
A
IVDR
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
Aikang MedTech FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
A
IVDR
EUDAMED record
Report an error
Autobio FDA
EU representative : Obelis s.a. (Belgium)
China
A
IVDR
Website
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
bioMérieux FDA
France
A
IVDR, 98/79
EUDAMED record
Report an error
Gold Standard Diagnostics FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
A
IVDR
Website
EUDAMED record
Report an error
Hitachi High-Tech FDA
EU representative : Roche Diagnostics GmbH (Germany)
Japan
A
IVDR
ra-contact.aj@hitachi-hightech.com
EUDAMED record
Report an error
Inova Diagnostics FDA
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
United States
A
IVDR
Website
EUDAMED record
Report an error
Maccura
EU representative : Humiss International B.V. (Netherlands)
China
A
IVDR
Website
EUDAMED record
Report an error
Medconn FDA
EU representative : JOYSUN GROUP S.L.U (Spain) and 1 other
China
A
IVDR
EUDAMED record
Report an error
Mindray FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
A
IVDR
Website
EUDAMED record
Report an error
Nanjing Norman Biological Technology
EU representative : Sungo Cert GmbH (Germany)
China
A
IVDR
EUDAMED record
Report an error
Shenzhen New Industries Biomedical Engineering FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
A
IVDR
Website
EUDAMED record
Report an error
Sophonix
EU representative : CMC Medical Devices & Drugs SL (Spain)
China
A
IVDR
EUDAMED record
Report an error
Wesailbio
EU representative : Lotus NL B.V. (Netherlands) and 1 other
China
A
IVDR
EUDAMED record
Report an error
Acesolab FDA
EU representative : VidaQuick Biotech S.L. (Spain)
United States
A
IVDR
info@acesolab.com
EUDAMED record
Report an error
Biobase FDA
EU representative : Luxus Lebenswelt GmbH (Germany)
China
A
IVDR
EUDAMED record
Report an error
DiaSorin FDA
Italy
A
IVDR
Website
EUDAMED record
Report an error
Linear FDA
Spain
A
IVDR
Website
info@linear.es
EUDAMED record
Report an error
opTricon
Germany
A
IVDR
Website
info@optricon.de
EUDAMED record
Report an error
Orgentec
Germany
A
IVDR
Website
EUDAMED record
Report an error
R-Biopharm FDA
Germany
A
IVDR
Website
EUDAMED record
Report an error
Rapid Labs
EU representative : Advena Limited (Malta) and 1 other
United Kingdom (ex Northern Ireland)
A
IVDR
Website
info@rapidlabs.co.uk
EUDAMED record
Report an error
Vazyme
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) and 1 other
China
A
IVDR
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
Aucheer
EU representative : MedPath GmbH (Germany)
China
A
IVDR
info_office@aucheer.net
EUDAMED record
Report an error
Celnovte
EU representative : Umedwings Netherlands B.V. (Netherlands)
China
A
IVDR
EUDAMED record
Report an error
D-tek
Belgium
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
Dynex Technologies FDA
EU representative : Acorn Regulatory Consultancy Services Ltd (Ireland)
United States
A
IVDR
Website
EUDAMED record
Report an error
Genobio Pharmaceutical FDA
EU representative : Lotus NL B.V. (Netherlands)
China
A
IVDR
Website
marketing@era-bio.com
EUDAMED record
Report an error
Getein FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
China
A
IVDR
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
Kangrun
EU representative : Sungo Cert GmbH (Germany)
China
A
IVDR
EUDAMED record
Report an error
Newlink Biotech
EU representative : VidaQuick Biotech S.L. (Spain)
China
A
IVDR
Website
info@kylinew.com
EUDAMED record
Report an error
SD Biosensor FDA
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
South Korea
A
IVDR
Website
EUDAMED record
Report an error
Sichuan Orienter Biotechnology
EU representative : Lotus NL B.V. (Netherlands) and 1 other
China
A
IVDR
Website
info@orienterglobal.com
EUDAMED record
Report an error
Siemens Healthcare Diagnostics Products FDA
EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland)
Germany, United Kingdom (ex Northern Ireland)
A
IVDR
Website
contact@siemens-healthineers.com
EUDAMED record
Report an error
Wallac
Finland
A
IVDR
Website
regulatoryaffairs.turku@revvity.com
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
Adaltis
Italy
–
98/79
Website
info@adaltis.net
EUDAMED record
Report an error
Aidian FDA
Finland
A
IVDR
Website
eudamed@aidian.eu
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
BioFynder
EU representative : SUNGO Europe B.V. (Netherlands)
United Kingdom (ex Northern Ireland)
A
IVDR
EUDAMED record
Report an error
B·R·A·H·M·S FDA
Germany
A
IVDR
EUDAMED record
Report an error
Cesna
Türkiye
A
IVDR
Website
info@cesna.com.tr
EUDAMED record
Report an error
Citest Diagnostics
EU representative : VidaQuick Biotech S.L. (Spain)
Canada
A
IVDR
ra02@citestdiagnostics.com
EUDAMED record
Report an error
Diapro
Italy
A
IVDR
Website
info@diapro.it
EUDAMED record
Report an error
Erba
Czechia
A
IVDR
Website
EUDAMED record
Report an error
Hipro FDA
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
China
A
IVDR
EUDAMED record
Report an error
Icarbonx
EU representative : Kingsmead Service B.V. (Netherlands)
China
A
IVDR
EUDAMED record
Report an error
Infitek FDA
EU representative : Kingsmead Service B.V. (Netherlands) and 1 other
China
A
IVDR
info@infitek.com
EUDAMED record
Report an error
Labsystems Diagnostics FDA
Finland
A
IVDR
Website
EUDAMED record
Report an error
MacroArray Diagnostics
Austria
A
IVDR
Website
office@madx.com
EUDAMED record
Report an error
Medcaptain FDA
EU representative : R Sight B.V. (Netherlands)
China
A
IVDR
Website
info@medcaptain.com
EUDAMED record
Report an error
Meril Diagnostics FDA
EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other
India
A
IVDR
Website
ram.kanoje@merillife.com
EUDAMED record
Report an error
Ortho-Clinical Diagnostics Rochester
EU representative : Ortho-Clinical Diagnostics France (France)
United States
A
IVDR
Website
PRRC@quidelortho.com
EUDAMED record
Report an error
Protia
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
South Korea
A
IVDR
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
Shenzhen Drawray Biotech
EU representative : Lotus NL B.V. (Netherlands)
China
A
IVDR
Website
info@szdrawray.com
EUDAMED record
Report an error
Shinjin Medics
EU representative : Obelis s.a. (Belgium)
South Korea
A
IVDR
Website
EUDAMED record
Report an error
Siemens Healthcare Diagnostics FDA
EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland)
United States
A
IVDR
Website
contact@siemens-healthineers.com
EUDAMED record
Report an error
SSI Diagnostica FDA
Denmark
A
IVDR, 98/79
Website
info@ssidiagnostica.com
EUDAMED record
Report an error
Stratec FDA
Germany
A
IVDR
Website
info@stratec.com
EUDAMED record
Report an error
Sugentech FDA
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
South Korea
A
IVDR
ra@sugentech.com
EUDAMED record
Report an error
Suzhou Hokapi Biomedical Engineering
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
A
IVDR
EUDAMED record
Report an error
Sysmex FDA
EU representative : Sysmex Europe SE (Germany)
Japan
A
IVDR
ra_archive@sysmex.co.jp
EUDAMED record
Report an error
Ukinbio
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
China
A
IVDR
sales@ukinbio.com
EUDAMED record
Report an error
Wuhan BGI Biomedical Engineering
EU representative : MedPath 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
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
Aconbio
EU representative : MedNet EC-REP GmbH (Germany)
China
A
IVDR
Website
EUDAMED record
Report an error
Actest
EU representative : VidaQuick Biotech S.L. (Spain)
China
A
IVDR
info@actest.com.cn
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
Anbio
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
China
A
IVDR
info@anbio.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
Becton Dickinson FDA
EU representative : Becton Dickinson Ireland Limited (Ireland)
United States
A
IVDR
Website
EUDAMED record
Report an error
Beijing Lepu Medical Technology
EU representative : Lepu Medical (Europe) Cooperatief U.A. (Netherlands)
China
A
IVDR
EUDAMED record
Report an error
Beijing North Institute of Biotechnology
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
China
A
IVDR
EUDAMED record
Report an error
Bio-Novum
Poland
A
IVDR
Website
EUDAMED record
Report an error
Biobase Biogrand
EU representative : Luxus Lebenswelt GmbH (Germany)
China
A
IVDR
EUDAMED record
Report an error
Biobase Diagnostic Technology (Shandong)
EU representative : Luxus Lebenswelt GmbH (Germany)
China
A
IVDR
EUDAMED record
Report an error
BioChain (Beijing) Science & Technology
EU representative : Medunion S.L. (Spain)
China
A
IVDR
EUDAMED record
Report an error
biomed Dr. Wieser
Austria
A
IVDR
Website
office@biomed-technics.com
EUDAMED record
Report an error
Blusense Diagnostics Aps
Denmark
A
IVDR
Website
info@blusense-diagnostics.com
EUDAMED record
Report an error
Bosonbio FDA
EU representative : MedPath GmbH (Germany)
China
A
IVDR
Website
EUDAMED record
Report an error
Cavanbio
EU representative : HyperCert Limited B.V. (Netherlands)
China
A
IVDR
EUDAMED record
Report an error
Cormay
Poland
A
IVDR
regulatory_affairs@cormay.com
EUDAMED record
Report an error
Diagreat
EU representative : Medunion S.L. (Spain)
China
A
IVDR
Website
info@diagreat.com
EUDAMED record
Report an error
Diesse FDA
Italy
A
IVDR
Website
EUDAMED record
Report an error
Draeger FDA
Germany
–
98/79
Website
EUDAMED@draeger.com
EUDAMED record
Report an error
Dymind
EU representative : Eunitor GmbH (Germany)
China
A
IVDR
regulationdept@dymind.com
EUDAMED record
Report an error
Dynex
Czechia
A
IVDR
Website
EUDAMED record
Report an error
E-LAB Biological Science & Technology
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
China
Auto Chemiluminescence Immunoassay Analyzer IA120, IA121, IA122, IA150, IA151, IA152, IA180, IA181, IA182, IA1200, IA201, IA202 3 refs
A
IVDR
EUDAMED record
Report an error
Eiken FDA
EU representative : Advena Limited (Malta)
Japan
A
IVDR
regulatoryaffairs@eiken.co.jp
EUDAMED record
Report an error
Elitbiotech
EU representative : CMC Medical Devices & Drugs SL (Spain)
China
A
IVDR
EUDAMED record
Report an error
Eurolyser
Austria
A
IVDR
Website
EUDAMED record
Report an error
Eurospital FDA
Italy
A
IVDR
regulatory@eurospital.it
EUDAMED record
Report an error
General Biologicals
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
Taiwan
A
IVDR
sales.group@gbc.com.tw
EUDAMED record
Report an error
Guangzhou KOFA Biotechnology
EU representative : Medunion S.L. (Spain)
China
A
IVDR
EUDAMED record
Report an error
Guangzhou LBP Medicine Science & Technology
EU representative : Kingsmead Service 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
Hebei Sanxin Pharmaceutical Technology
EU representative : SUNGO Europe B.V. (Netherlands)
China
A
IVDR
EUDAMED record
Report an error
Hidex
Finland
A
IVDR
Website
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
Hycor Biomedical FDA
EU representative : Advena Limited (Malta)
United States
A
IVDR
Website
info@hycorbiomedical.com
EUDAMED record
Report an error
Immundiagnostik FDA
Germany
A
IVDR
Website
info@immundiagnostik.com
EUDAMED record
Report an error
ImmunoDiagnostic Systems France FDA
France
A
IVDR
Website
EUDAMED record
Report an error
Jiangsu Macro & Micro-Test Med-Tech FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
A
IVDR
marketing@hongweitest.com
EUDAMED record
Report an error
Jiezibio
EU representative : SUNGO Europe B.V. (Netherlands)
China
A
IVDR
EUDAMED record
Report an error
Joinstar
EU representative : Lotus NL B.V. (Netherlands)
China
A
IVDR
EUDAMED record
Report an error
Keylights
EU representative : SUNGO Europe B.V. (Netherlands)
China
A
IVDR
EUDAMED record
Report an error
Keyubio
EU representative : CMC Medical Devices & Drugs SL (Spain)
China
A
IVDR
Website
export@keyubio.com
EUDAMED record
Report an error
Lituo
EU representative : CMC Medical Devices & Drugs SL (Spain)
China
A
IVDR
EUDAMED record
Report an error
Lordsmark
EU representative : Obelis s.a. (Belgium)
India
A
IVDR
Website
EUDAMED record
Report an error
Medical FDA
EU representative : Obelis s.a. (Belgium)
Japan
A
IVDR
Website
EUDAMED record
Report an error
Mpbio FDA
Germany
A
IVDR
Website
EUDAMED record
Report an error
nal von minden
Germany
A
IVDR
Website
info@nal-vonminden.com
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
Neomedica
EU representative : Wellkang Ltd (Northern Ireland)
Serbia
A
IVDR
Website
EUDAMED record
Report an error
Next Level
Italy
A
IVDR
EUDAMED record
Report an error
Paitzar
EU representative : Metridium OÜ (Estonia)
Iran
A
IVDR
Website
info@paitzar.am
EUDAMED record
Report an error
PCL
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
South Korea
A
IVDR
Website
EUDAMED record
Report an error
Phadia FDA
Sweden
A
IVDR
Website
RegulatoryAffairs.Uppsala.IDD@thermofisher.com
EUDAMED record
Report an error
Pushkang
EU representative : Sungo Cert GmbH (Germany)
China
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
Radiometer FDA
Denmark
A
IVDR
Website
radiometerra_eu@radiometer.dk
EUDAMED record
Report an error
Randox FDA
Northern Ireland
A
IVDR
Website
EUDAMED record
Report an error
Realmindbio
EU representative : Sungo Cert GmbH (Germany)
China
A
IVDR
EUDAMED record
Report an error
Renderbio
EU representative : SUNGO Europe B.V. (Netherlands)
China
A
IVDR
EUDAMED record
Report an error
Responsebio FDA
EU representative : Emergo Europe B.V. (Netherlands)
Canada
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
Sansure FDA
EU representative : Obelis s.a. (Belgium)
China
A
IVDR
Website
info@sansure.com.cn
EUDAMED record
Report an error
Seamaty
EU representative : MedNet EC-REP GmbH (Germany)
China
A
IVDR
EUDAMED record
Report an error
Shenzhen AmTech Bioengineering
EU representative : SUNGO Europe B.V. (Netherlands)
China
A
IVDR
EUDAMED record
Report an error
Shenzhen Dake Medical Technology
EU representative : SUNGO Europe B.V. (Netherlands)
China
Bright i60 Series (including Bright i30, Bright i36, Bright i38, Bright i39,Bright i60, Bright i66, Bright i68, Bright i69 models); Bright i100 Series (includingBright i100, Bright i160, Bright i180, Bright i190 models); etc 2 refs
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
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
Shenzhen Zijian Biotechnology
EU representative : CMC Medical Devices & Drugs SL (Spain)
China
A
IVDR
Website
sales@szzijian.com
EUDAMED record
Report an error
Singuway
EU representative : CMC Medical Devices & Drugs SL (Spain)
China
A
IVDR
sales@singuway.com
EUDAMED record
Report an error
Sinseng
EU representative : Sungo Cert GmbH (Germany)
China
A
IVDR
service@sinseng.com.cn
EUDAMED record
Report an error
Skyla
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
Taiwan
A
IVDR
Website
EUDAMED record
Report an error
Strumed FDA
EU representative : Amstermed B.V. (Netherlands)
India
–
98/79
Website
EUDAMED record
Report an error
Sunlant
EU representative : MedPath GmbH (Germany)
China
A
IVDR
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 Helmen Precision Insturments
EU representative : Lotus NL B.V. (Netherlands)
China
A
IVDR
Website
EUDAMED record
Report an error
Suzhou Sym-Bio Lifescience
EU representative : Emergo Europe B.V. (Netherlands)
China
A
IVDR
quality.taicang@revvity.com
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
EUDAMED record
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Tecan FDA
Austria
A
IVDR
Website
regulatory.affairs.at@tecan.com
EUDAMED record
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Technogenetics FDA
Italy
A
IVDR
Website
QA@TECHNOGENETICS.IT
EUDAMED record
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Tosoh FDA
EU representative : Tosoh Europe N.V. (Belgium)
Japan
A
IVDR
csc@tosoh.co.jp
EUDAMED record
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Urit FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
A
IVDR
Website
service@uritest.com
EUDAMED record
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Vigilant Biosciences FDA
EU representative : Vigilant Biosciences GmbH (Germany)
United States
A
IVDR
EUDAMED record
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Virtue Diagnostics (Suzhou)
EU representative : Kingsmead Service B.V. (Netherlands)
China
A
IVDR
EUDAMED record
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Vitrosens
Türkiye
A
IVDR
Website
info@vitrosens.com
EUDAMED record
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Wizbiotech
EU representative : QbD RepS BV (Belgium)
China
A
IVDR
EUDAMED record
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Wondfo FDA
EU representative : QbD RepS BV (Belgium)
China
A
IVDR
Website
sales@wondfo.com.cn
EUDAMED record
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Zhejiang Gewuzhizhi Biotechnology
EU representative : Llins Service & Consulting GmbH (Germany)
China
A
IVDR
Website
EUDAMED record
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Zhongshan Chuangyi Biochemical Engineering
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
A
IVDR
EUDAMED record
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Chemclin
EU representative : MedNet EC-REP GmbH (Germany)
No model still on the market
China
A
IVDR
Website
EUDAMED record
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QuantaMatrix
EU representative : KTR Europe GmbH (Germany)
No model still on the market
South Korea
–
98/79
EUDAMED record
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Salofa FDA
No model still on the market
Finland
–
98/79
Website
info@salofa.com
EUDAMED record
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