| Dirui
EU representative : Emergo Europe B.V. (Netherlands) and 1 other
|
China
|
26 others
|
A, B
IVDR, 98/79
|
EUDAMED record
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| Biotecnica
|
Italy
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13 others
|
A
IVDR
|
EUDAMED record
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| Zybio
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
11 others
|
A
IVDR, 98/79
|
PMS@zy-ivd.com
EUDAMED record
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|
| Rayto
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
9 others
|
A
IVDR
|
Website
support@rayto.com
EUDAMED record
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|
| Arkray
EU representative : ARKRAY Europe, B.V. (Netherlands)
|
Japan
|
6 others
|
A
IVDR, 98/79
|
support_arkrayeurope@arkray.co.jp
EUDAMED record
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|
| Seamaty
EU representative : MedNet EC-REP GmbH (Germany)
|
China
|
5 others
|
A
IVDR
|
EUDAMED record
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| Senlo
EU representative : Umedwings Netherlands B.V. (Netherlands)
|
China
|
5 others
|
A
IVDR
|
Website
sales@senlo.com.cn
EUDAMED record
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|
| Siemens Healthcare Diagnostics
EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland)
|
United States
|
5 others
|
A, B
IVDR
|
Website
contact@siemens-healthineers.com
EUDAMED record
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|
| Furuno
EU representative : MedEnvoy Global BV (Netherlands)
|
Japan
|
4 others
|
A
IVDR
|
Website
EUDAMED record
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|
| Hitachi High-Tech
EU representative : Roche Diagnostics GmbH (Germany)
|
Japan
|
4 others
|
A
IVDR
|
ra-contact.aj@hitachi-hightech.com
EUDAMED record
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|
| Urit
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
4 others
|
A, B
IVDR, 98/79
|
Website
service@uritest.com
EUDAMED record
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|
| Beckman Coulter
EU representative : Beckman Coulter Ireland Inc. (Ireland)
|
Japan, United States
|
3 others
|
A
IVDR
|
Website
EUDAMED record
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| Instrumentation Laboratory
|
Italy
|
3 others
|
A
IVDR
|
Website
EUDAMED record
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| Keyubio
EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other
|
China
|
3 others
|
A
IVDR, 98/79
|
Website
export@keyubio.com
EUDAMED record
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|
| Mindray
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
3 others
|
A, B
IVDR
|
Website
EUDAMED record
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| Erba
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Czechia
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2 others
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A, B
IVDR
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Website
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| Human
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Germany
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2 others
|
A
IVDR
|
Website
EUDAMED record
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|
| Sysmex
EU representative : Sysmex Europe SE (Germany)
|
Japan
|
1 other
|
A
IVDR, 98/79
|
ra_archive@sysmex.co.jp
EUDAMED record
Report an error
|
| E-LAB Biological Science & Technology
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
- Auto Chemistry Analyzer : BT-600L, BT-610L, BT-620L, BT-630L, BT-800L, BT-810L, BT-820L, BT-830L3 refs
- 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
- Auto Chemistry Analyzer BT-200L、BT-210L、BT-220L、BT-240L、BT-260L、BT-280L、BT-300L、BT-310L、BT-320L、BT-340L、BT-360L、BT-380L、BT-400L、BT-410L、BT-420L、BT-440L、BT-460L、BT-480L3 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
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|
| Linear
|
Spain
|
|
A
IVDR
|
Website
info@linear.es
EUDAMED record
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|
| Aconbio
EU representative : MedNet EC-REP GmbH (Germany)
|
China
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Biobase
EU representative : Luxus Lebenswelt GmbH (Germany)
|
China
|
|
A
IVDR
|
EUDAMED record
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| Biolabo
|
France
|
|
A
IVDR
|
support@biolabo.fr
EUDAMED record
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|
| Biosystems
|
Spain
|
|
A
IVDR
|
Website
EUDAMED record
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| Cormay
|
Poland
|
|
A
IVDR
|
regulatory_affairs@cormay.com
EUDAMED record
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|
| Infitek
EU representative : Kingsmead Service B.V. (Netherlands) and 1 other
|
China
|
|
A
IVDR
|
info@infitek.com
EUDAMED record
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|
| Lordsmark
EU representative : Obelis s.a. (Belgium)
|
India
|
|
A
IVDR
|
Website
EUDAMED record
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| Ral Tecnica Para El Laboratorio
|
Spain
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A
IVDR
|
Website
EUDAMED record
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| Randox
|
Northern Ireland
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|
A
IVDR
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Website
EUDAMED record
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| Riele
|
Germany
|
|
A
IVDR
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Website
info@riele.de
EUDAMED record
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| Abbott
EU representative : Abbott GmbH (Germany)
|
United States
|
|
A
IVDR
|
Website
EUDAMED record
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| B.P.C. Biosed –
|
Italy
|
|
A
IVDR
|
Website
info@bpcbiosed.it
EUDAMED record
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| Beijing Lepu Medical Technology
EU representative : Lepu Medical (Europe) Cooperatief U.A. (Netherlands)
|
China
|
|
A
IVDR
|
EUDAMED record
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| BioFynder
EU representative : SUNGO Europe B.V. (Netherlands)
|
United Kingdom (ex Northern Ireland)
|
|
A
IVDR
|
EUDAMED record
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| Contecmed
EU representative : Prolinx GmbH (Germany)
|
China
|
|
A
IVDR
|
Website
pms.qms@contecmed.com
EUDAMED record
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|
| Drophil
EU representative : MedNet EC-REP GmbH (Germany)
|
China
|
|
A
IVDR
|
info@drophil.com
EUDAMED record
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|
| Fujifilm
EU representative : FUJIFILM Healthcare Europe GmbH (Germany)
|
Japan
|
|
A
IVDR
|
EUDAMED record
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|
| Maccura
EU representative : Humiss International B.V. (Netherlands)
|
China
|
|
A, B
IVDR
|
Website
EUDAMED record
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|
| Macherey-Nagel
|
Germany
|
|
A
IVDR
|
Website
sales@mn-net.com
EUDAMED record
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|
| Pushkang
EU representative : Sungo Cert GmbH (Germany)
|
China
|
|
A
IVDR
|
EUDAMED record
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| Sanymed
|
Italy
|
|
A
IVDR
|
Website
info@sanymed.it
EUDAMED record
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| VitalScientific
|
Netherlands
|
|
A
IVDR
|
Website
EUDAMED record
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| Abaxis
EU representative : ABAXIS Europe GmbH (Germany)
|
United States
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Autobio
EU representative : Obelis s.a. (Belgium)
|
China
|
|
A
IVDR
|
Website
EUDAMED record
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|
| AVE Science & Technology
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
- AVE-762A, AVE-762C, AVE-762D, AVE-764A, AVE-764B, AVE-764C, AVE-766, etc.98/79
- AVE-772, AVE-772A, AVE-772B, AVE-772C, AVE-773, AVE-773A, AVE-773B, AVE-773C, AVE-774, AVE-774A, AVE-774B, AVE-774C, AVE-775, AVE-775A, AVE-775B, AVE-775C98/79
|
–
98/79
|
EUDAMED record
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|
| Biomaxima
|
Poland
|
|
A
IVDR
|
Website
info@biomaxima.com
EUDAMED record
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|
| Boditech
EU representative : Obelis s.a. (Belgium)
|
South Korea
|
|
A
IVDR
|
Website
marketing@boditech.co.kr
EUDAMED record
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|
| Diagnostics
|
Belgium
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Diasia
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Diatron
|
Hungary
|
|
A
IVDR
|
Website
EUDAMED record
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|
| e-LinkCare Meditech
EU representative : Wellkang Ltd (Northern Ireland)
|
China
|
|
–
98/79
|
EUDAMED record
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|
| Genrui Biotech
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
A
IVDR
|
Website
service@genrui-bio.com
EUDAMED record
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|
| Gmt Sarl
|
France
|
|
A
IVDR
|
Website
EUDAMED record
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|
| High Technology
EU representative : MedEnvoy Global BV (Netherlands)
|
United States
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Horiba
|
France
|
|
A
IVDR
|
EUDAMED record
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|
| Leadmanbio
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Medconn
EU representative : JOYSUN GROUP S.L.U (Spain)
|
China
|
|
A
IVDR
|
EUDAMED record
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| Meril Diagnostics
EU representative : Obelis s.a. (Belgium)
|
India
|
|
A
IVDR
|
Website
ram.kanoje@merillife.com
EUDAMED record
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|
| Mr International Healthcare Technology
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
|
A
IVDR
|
EUDAMED record
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| Nano Diagnosis for Health Biotech (Guangzhou)
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Orientgene
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
A
IVDR
|
EUDAMED record
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| Otsukael
EU representative : Emergo Europe B.V. (Netherlands)
|
Japan
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Shandong Bohong Gene Technology
EU representative : Luxus Lebenswelt GmbH (Germany)
|
China
|
|
A
IVDR
|
EUDAMED record
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| Shenzhen Tailaored Medical
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Shenzhen Yhlo Biotech
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
|
A
IVDR
|
Website
info@szyhlo.com
EUDAMED record
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|
| Sinseng
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) and 1 other
|
China
|
|
A
IVDR
|
service@sinseng.com.cn
EUDAMED record
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| Spinreact
|
Spain
|
|
A
IVDR
|
Website
EUDAMED record
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| TestCard
EU representative : CS Life Sciences Europe Ltd (Ireland)
|
United Kingdom (ex Northern Ireland)
|
|
A
IVDR
|
Website
info@testcard.com
EUDAMED record
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| Thermofisher
|
Finland
|
|
A
IVDR
|
Website
EUDAMED record
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| Wiener Laboratorios SAIC
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
|
Argentina
|
|
A
IVDR
|
Website
marketing@wiener-lab.com
EUDAMED record
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|
| Aikang Diagnostics
EU representative : MedNet EC-REP GmbH (Germany)
|
China
|
|
A
IVDR
|
marketing@aikang-medical.com
EUDAMED record
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|
| Anbio
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
|
A
IVDR
|
info@anbio.com
EUDAMED record
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|
| Athenesedx
EU representative : Obelis s.a. (Belgium)
|
India
|
|
A
IVDR
|
Website
EUDAMED record
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| Avecon Healthcare
EU representative : Amstermed B.V. (Netherlands)
|
India
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Bgi
|
Denmark
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Bioantibody Biotechnology
EU representative : Medunion S.L. (Spain)
|
China
|
|
A
IVDR
|
EUDAMED record
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| Biolis Medical
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
|
Japan
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Biosense
EU representative : MD&D Alliance GmbH (Germany)
|
India
|
|
A
IVDR
|
regulatory.affairs@biosense.in
EUDAMED record
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| Callegari
|
Italy
|
|
A
IVDR
|
EUDAMED record
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| Dialab
|
Austria
|
|
A
IVDR
|
Website
office@dialab.at
EUDAMED record
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| Doasense
|
Germany
|
|
A
IVDR
|
Website
info@doasense.de
EUDAMED record
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|
| Funotec
EU representative : GRZAN GROUP SL (Spain)
|
China
|
|
A
IVDR
|
EUDAMED record
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| Futurlab
|
Italy
|
|
A
IVDR
|
Website
EUDAMED record
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|
| 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
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|
| Healthy
EU representative : AR Experts B.V. (Netherlands)
|
Israel
|
|
–
98/79
|
Website
EUDAMED record
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|
| Hivis Medical Technology
EU representative : Sungo Cert GmbH (Germany)
|
China
|
|
–
98/79
|
EUDAMED record
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|
| Humadx
EU representative : Human Gesellschaft für Biochemica und Diagnostica mbH (Germany)
|
China
|
|
A
IVDR
|
service@humadx.com.cn
EUDAMED record
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|
| Iki
|
France
|
|
A
IVDR
|
contact@iki-diag.com
EUDAMED record
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|
| Jeol Mf
EU representative : JEOL(Europe)BV AR (Netherlands)
|
Japan
|
|
A
IVDR
|
EUDAMED record
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|
| Jiangsu Jinzhun Biotech
EU representative : MedNet EC-REP GmbH (Germany)
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Jiezibio
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
A
IVDR
|
EUDAMED record
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| Konsung
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
|
A
IVDR
|
EUDAMED record
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| Locmedt
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
A
IVDR
|
EUDAMED record
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| MTD Diagnostics
|
Italy
|
|
–
98/79
|
Website
EUDAMED record
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|
| Ningbo MedicalSystem Biotechnology
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
- Automated Chemistry Analyzer MS-420P,MS-400P,MS-380P,MS-420,MS-400,MS-380,MS-480,MS-450,MS-520,MS-600,MS-6803 refs
|
A
IVDR
|
EUDAMED record
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|
| numares
|
Germany
|
|
A
IVDR
|
info@numares.com
EUDAMED record
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|
| Ortho Clinical Diagnostics Biotechnology Development (Shanghai)
EU representative : Ortho-Clinical Diagnostics France (France)
|
China
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Ortho-Clinical Diagnostics Rochester
EU representative : Ortho-Clinical Diagnostics France (France)
|
United States
|
|
A
IVDR
|
Website
PRRC@quidelortho.com
EUDAMED record
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|
| Pinnacles (Suzhou) Medical Technology
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Poweam
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Qualigeninc
EU representative : MDSS GmbH (Germany)
|
United States
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Quimica Clinica Aplicada
|
Spain
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Shanghai Kehua Laboratory System
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
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|
| Shenzhen Landwind Biomedical Technology
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
A
IVDR
|
sales@landwindmedical.com
EUDAMED record
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|
| Shenzhen Zijian Biotechnology
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
A
IVDR
|
Website
sales@szzijian.com
EUDAMED record
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|
| Skyla
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
|
Taiwan
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Sugentech
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
|
South Korea
|
|
B
IVDR
|
ra@sugentech.com
EUDAMED record
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|
| Taizhou Zecen Biotech
EU representative : MedPath GmbH (Germany)
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Tecom Science
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Ukinbio
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
|
A
IVDR
|
sales@ukinbio.com
EUDAMED record
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|
| Vodenmedical
|
Italy
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Yercon Diagnostic
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
- YE-100P, YE-100F, YE-100H, YE-100S, YE-120B, YE-120F, YE-120H, YE-120S, YE-300A, YE-300F, YE-300H, YE-300S3 refs
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Ailex
EU representative : CMC Medical Devices & Drugs SL (Spain)
No model still on the market
|
China
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| Chongqing Aolun Technology
EU representative : CMC Medical Devices & Drugs SL (Spain)
No model still on the market
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| 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
|
| Vivachek
EU representative : Lotus NL B.V. (Netherlands)
No model still on the market
|
China
|
|
A
IVDR
|
info@vivachek.com
EUDAMED record
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|