| Allsheng FDA
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
28 others
|
A
IVDR
|
EUDAMED record
Report an error
|
| Labsim FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
22 others
|
A
IVDR
|
Website
EUDAMED record
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|
| Hitachi FDA
EU representative : Roche Diagnostics GmbH (Germany)
|
Japan
|
17 others
|
A
IVDR
|
ra-contact.aj@hitachi-hightech.com
EUDAMED record
Report an error
|
| Hitachi High-Tech FDA
EU representative : Roche Diagnostics GmbH (Germany)
|
Japan
|
17 others
|
A
IVDR
|
ra-contact.aj@hitachi-hightech.com
EUDAMED record
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|
| Gruppo Strola
|
Italy
|
11 others
|
A
IVDR
|
info@gruppostrola.com
EUDAMED record
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|
| AVE Science & Technology FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
- AVE-26198/79
- AVE-32198/79
- AVE-561A, AVE-561B, AVE-561, AVE-562A, AVE-562B, AVE-562, AVE-563A, AVE-563B, AVE-56398/79
- AVE-631, AVE-631A, AVE-631B, AVE-632, AVE-632A, AVE-632B, AVE-633, AVE-633A, AVE-633B.
- AVE-661, AVE-661A, AVE-661B.
3 others- AVE-731A, AVE-733A, AVE-733B, AVE-734, AVE-734A, AVE-734B, AVE-735, AVE-735A, AVE-735B, AVE-736, AVE-736A, AVE-736B.
- AVE-752, AVE-752A, AVE-752B, AVE-753, AVE-753A, AVE-753B, AVE-754, AVE-754A, AVE-754B, AVE-755, AVE-755A, AVE-755B, AVE-756, AVE-756A, AVE-756B, AVE-757, AVE-757A, AVE-757B.
- AVE-MU01, AVE-MU02, AVE-MU03, AVE-MU04, AVE-MF01, AVE-MF02, AVE-MF03, AVE-MF04, AVE-MB01, AVE-MB02, AVE-MB03, AVE-MB04, AVE-MG01, AVE-MG02, AVE-MG03, AVE-MG04, AVE-MM01, AVE-MM02, AVE-MM03, AVE-MM04, AVE-MH01, AVE-MH02, AVE-MH03, AVE-MH04.
|
A
IVDR, 98/79
|
EUDAMED record
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|
| Jiangsu Mole Bioscience
EU representative : Lotus NL B.V. (Netherlands) and 1 other
|
China
|
2 others
|
A
IVDR
|
EUDAMED record
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|
| Dezhou Guoke Medical Technology
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
1 other
|
A
IVDR
|
office@guoke-medical.com
EUDAMED record
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|
| Wuhan MGI Tech
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
1 other
|
A
IVDR
|
EUDAMED record
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|
| A.S.T
|
Italy
|
|
A
IVDR
|
Website
info@asteng.it
EUDAMED record
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|
| Agilent FDA
EU representative : Agilent Technologies Denmark ApS (Denmark)
|
United States
|
|
A
IVDR
|
Website
info.dk@agilent.com
EUDAMED record
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|
| Capitalbiotech
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Hunan Kangxin Biotechnology
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Hund
|
Germany
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Lansionbio
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Shanghai BioGerm Medical Technology
EU representative : MedNet EC-REP GmbH (Germany) and 1 other
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Siliconbiosystems FDA
EU representative : Menarini Silicon Biosystems S.p.A. (Italy)
|
United States
|
|
A
IVDR, 98/79
|
EUDAMED record
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|
| Tcoag FDA
|
Ireland
|
|
A
IVDR, 98/79
|
Website
EUDAMED record
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|
| Badiusen Biotechnology (Kunshan)
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Guangzhou Richen-Frinse Optical &Electronic
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| Infitek FDA
EU representative : Kingsmead Service B.V. (Netherlands) and 1 other
|
China
|
|
I, A
IVDR, MDR
|
info@infitek.com
EUDAMED record
Report an error
|
| Poweam
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
- Biochemistry Analyzer WHY5000D, WHY5000B, WHY8000D, WHY8000D VET, WHY6000D, WHY7000D, D-06, D-B6, D-C6, D-D6, A6, B6, C6, WHYA7, WHYA83 refs
- HbA1c Analyzer TH6000,THX6000,TH7000A,TH7000B3 refs
- Microplate Reader WHY101S, WHY101ST, WHYM201, WHYM3013 refs
- Microplate Washer WHY100T, WHY100ST, WHYM200, WHYM3003 refs
|
A
IVDR
|
EUDAMED record
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|
| Reetoo
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) and 1 other
|
China
|
|
–
98/79
|
Website
service@reetoo.com.cn
EUDAMED record
Report an error
|
| Winmedic
EU representative : Sungo Cert GmbH (Germany)
|
China
|
|
A
IVDR
|
info@winmedic.cn
EUDAMED record
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|
| Wuhan HealthCare Biotechnology
EU representative : Kingsmead Service B.V. (Netherlands)
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| biosurfit
|
Portugal
|
|
A
IVDR
|
info@biosurfit.com
EUDAMED record
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|
| Cirdan FDA
|
Northern Ireland
|
|
A
IVDR
|
Website
info@cirdan.com
EUDAMED record
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|
| Joinstar
EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Seramun
|
Germany
|
|
A
IVDR
|
info@seramun.com
EUDAMED record
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|
| Actim FDA
|
Finland
|
|
A
IVDR
|
Website
support@actimtest.com
EUDAMED record
Report an error
|
| Aucheer
EU representative : MedPath GmbH (Germany)
|
China
|
|
A
IVDR
|
info_office@aucheer.net
EUDAMED record
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|
| CellSolutions FDA
EU representative : CellSolutions GmbH (Germany)
|
United States
|
|
–
98/79
|
Website
EUDAMED record
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|
| Chongqing NanFang Numerical ControlEquipment
EU representative : Medunion S.L. (Spain)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Citotest FDA
EU representative : Wellkang Ltd (Northern Ireland)
|
China
|
|
I
MDR
|
Website
info@citotest.com
EUDAMED record
Report an error
|
| CompAI MedTech(Suzhou)
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
A
IVDR
|
Website
support@comp-ai.com
EUDAMED record
Report an error
|
| DRG Instruments
|
Germany
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Dyameo
|
France
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Guangzhou Naturn Medical Devices
EU representative : MedPath GmbH (Germany)
|
China
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| Ikonisys FDA
EU representative : Emergo Europe B.V. (Netherlands)
|
United States
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Institut de Biotechnologies Jacques Boy
|
France
|
|
A
IVDR
|
Website
contact@ibjb.fr
EUDAMED record
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|
| Isiabio
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Kangrun
EU representative : Sungo Cert GmbH (Germany)
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Mindray FDA
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Mpbio FDA
EU representative : MP Biomedicals Germany GmbH (Germany)
|
Singapore
|
|
A
IVDR
|
EUDAMED record
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|
| Ningbo HEALTH Gene Technologies
EU representative : Medunion S.L. (Spain)
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Otsukael FDA
EU representative : Emergo Europe B.V. (Netherlands)
|
Japan
|
|
A, B
IVDR
|
Website
EUDAMED record
Report an error
|
| Rocgene FDA
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
A
IVDR
|
sale@rocgene.com
EUDAMED record
Report an error
|
| Shenzhen Sciarray Biotech
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
–
98/79
|
EUDAMED record
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|
| Slee FDA
|
Germany
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| Tencent
EU representative : Kingsmead Service B.V. (Netherlands)
|
China
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| Trukera FDA
EU representative : Emergo Europe B.V. (Netherlands)
|
United States
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Alivedx
EU representative : Emergo Europe B.V. (Netherlands)
|
Switzerland
|
|
A
IVDR
|
Website
EUDAMED record
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|
| ALPIT Consulting
|
Italy
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Axel Löser Messtechnik
|
Germany
|
|
A
IVDR
|
Website
info@loeser-osmometer.de
EUDAMED record
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|
| Bedia
|
France
|
|
A
IVDR
|
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 Richen-force Science&Technology
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Bio Logbook
|
France
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Biobase FDA
EU representative : Luxus Lebenswelt GmbH (Germany)
|
China
|
|
I
MDR
|
EUDAMED record
Report an error
|
| Biocare Medical
EU representative : Emergo Europe B.V. (Netherlands)
|
United States
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Bioeksen
|
Türkiye
|
|
A
IVDR
|
Website
info@bioeksen.com.tr
EUDAMED record
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|
| Biosynex
|
France
|
|
A
IVDR
|
Website
reglementaire@biosynex.com
EUDAMED record
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|
| Celisbiotech
EU representative : MedPath GmbH (Germany)
|
China
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| Celltivity FDA
EU representative : AR Experts B.V. (Netherlands)
|
United States
|
|
A
IVDR
|
Website
info@celltivity.com
EUDAMED record
Report an error
|
| Clinical
EU representative : MedEnvoy Global BV (Netherlands)
|
United Kingdom (ex Northern Ireland)
|
|
A
IVDR
|
Website
info@clinical.design
EUDAMED record
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|
| Cyvek
EU representative : MedEnvoy Global BV (Netherlands)
|
United States
|
|
A
IVDR
|
Website
EUDAMED record
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|
| DeepMega Intelligent Technology
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Dermagnostix
|
Germany
|
|
A
IVDR
|
Website
info@dermagnostix.com
EUDAMED record
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|
| Dx365
|
Germany
|
|
A
IVDR
|
Website
info@dx365.world
EUDAMED record
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|
| Dyonmed
|
Greece
|
|
A
IVDR
|
Website
customerservice@dyonmedical.com
EUDAMED record
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|
| Euroimmun FDA
|
Germany
|
|
A
IVDR
|
Website
info@euroimmun.de
EUDAMED record
Report an error
|
| EzDiaTech
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
South Korea
|
|
A
IVDR
|
Website
ra@ezdiatech.co.kr
EUDAMED record
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|
| Fianostics
|
Austria
|
|
A
IVDR
|
Website
office@fianostics.at
EUDAMED record
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|
| Fujirebio FDA
|
Belgium
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Genolution FDA
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
|
South Korea
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Hangzhou Immuno Biotech
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
A
IVDR
|
info@jgbiotech.com
EUDAMED record
Report an error
|
| inno-train Diagnostik
|
Germany
|
|
A
IVDR
|
Website
info@inno-train.de
EUDAMED record
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|
| Innovative Biotechnology Organization Trade
|
Türkiye
|
|
A
IVDR
|
Website
info@tibobio.org
EUDAMED record
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|
| Inpeco FDA
EU representative : QbD RepS BV (Belgium)
|
Switzerland
|
|
A
IVDR
|
Regulatory.Affairs@inpeco.com
EUDAMED record
Report an error
|
| Jiangsu ME Instruments
EU representative : Luxus Lebenswelt GmbH (Germany)
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Jiangsu Yuli Medical Instrument
EU representative : Sungo Cert GmbH (Germany)
|
China
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| Jiaxing CRED Medical Instrument
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Laboveritas
|
Latvia
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Leicabiosystems FDA
EU representative : AR Experts B.V. (Netherlands)
|
United States
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Libbot
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Lipidica
|
Czechia
|
|
–
98/79
|
info@lipidica.cz
EUDAMED record
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|
| Maccura
EU representative : Humiss International B.V. (Netherlands)
|
China
|
|
A
IVDR
|
Website
EUDAMED record
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|
| MeMed Diagnostics FDA
EU representative : QbD RepS BV (Belgium)
|
Israel
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Noxygen
|
Germany
|
|
–
98/79
|
Website
info@noxygen.de
EUDAMED record
Report an error
|
| Pulso
|
Spain
|
|
I
MDR
|
Website
EUDAMED record
Report an error
|
| Qingdao MGI Tech
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| QuinTron Instrument FDA
EU representative : Emergo Europe B.V. (Netherlands)
|
United States
|
|
A
IVDR
|
Website
regulatory@quintron-usa.com
EUDAMED record
Report an error
|
| RAM THz Solutions
|
Germany
|
|
–
98/79
|
Website
info@ramthzsolutions.com
EUDAMED record
Report an error
|
| Reagena
|
Finland
|
|
A
IVDR
|
Website
info@reagena.com
EUDAMED record
Report an error
|
| Samantree FDA
EU representative : SamanTree Medical France SASU (France)
|
Switzerland
|
|
A
IVDR
|
Website
info@samantree.com
EUDAMED record
Report an error
|
| Screenmed
|
Poland
|
|
A
IVDR
|
Website
office@screenmed.pl
EUDAMED record
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|
| Shanghai Zj Bio-Tech FDA
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Shenzhen Beacon Display Technology FDA
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| Shenzhen Shengqiang Technology
EU representative : HUMISS TRADING S. L. (Spain)
|
China
|
|
A
IVDR
|
Website
EUDAMED record
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|
| X-ZELL Biotech Pte
EU representative : X-ZELL Biotech GmbH (Germany)
|
Singapore
|
|
A
IVDR
|
Website
support@x-zell.com
EUDAMED record
Report an error
|
| Xeos FDA
|
Belgium
|
|
A
IVDR
|
Website
info@xeos.care
EUDAMED record
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|
| Xuzhou Qibo Electronic Technology
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Zhejiang Enmiles Intelligent Digital Medical
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| Lynsight
No model still on the market
|
Finland
|
|
–
98/79
|
Website
EUDAMED record
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|