ZytoVision FDA
Germany
47 others
A
IVDR
Website
info@zytovision.com
EUDAMED record
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Diamond Diagnostics FDA
EU representative : Diamond Diagnostics Inc. Magyarországi Fióktelepe (Hungary)
United States
42 others
A
IVDR
Website
EUDAMED record
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Hamilton FDA
EU representative : Johner Medical GmbH (Germany)
Switzerland
32 others
A
IVDR
Website
Contact-PRRC.rob.ch@hamilton.ch
EUDAMED record
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Optimedical FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
12 others
–
98/79
Website
EUDAMED record
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VitalScientific FDA
France
8 others
A
IVDR
Website
support@vitalscientific.com
EUDAMED record
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Euroimmun FDA
Germany
6 others
A
IVDR
Website
info@euroimmun.de
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Hlb Panagene
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
South Korea
6 others
A
IVDR
Website
EUDAMED record
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Junocare
EU representative : Humiss International B.V. (Netherlands)
China
3 others
A
IVDR
Website
EUDAMED record
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Diatrust FDA
EU representative : Wellkang Ltd (Northern Ireland)
China
DiaTrust APG1,APG3,APP1,APP2,APP3,APP5,APP6,APP7,BF0L,BF0N,BF0W,BF1N,BG0H,BG0L,BG1L,BS01,BS02,BS03,BS11,BS12,DP51,DP52,DP53,DP54,ED0F,ED0R,EF0N,EF0W,EF10,EF1G,EF1P,EF2G,EF2P,EF3G,GB01,GB10,GB11,GF0L,GF0S,GF10,GF2N,GF2Y,GF3N,GF3Y,GF51,GF52,GF53,GF54,GF55,GF56. 3 refs DiaTrust CT605,CT615,CT620,CT625,CT626,TC51,TC52,TC53,TC54,TC55,TC56,TC62,TC63,TC64 2 refs DiaTrust HS300,HS400 DiaTrust R1010,R1020,R1030,R110,R120,R2010,R2020,R210,R2110,R220,R230,R240,R250,R260,R3010,R3011,R310,R320,R330,R4010,R4011,R410,R411,R420,R421,R5010,R501,R5011,R502,R503,R5040,R510,R511,R520,R530,R550,R560,R6010,R610,R620,R7010. DiaTrust SJ01,SJ02,SJ03,SJ04,SJ05,SJ06,SJ07,SP10,SP20,SR04,SR05,SR06,SR07,SR61,SR63,SR88,SR89,SS010,SS020,SS103,SS106,SS112,SS122. 3 refs
1 other DiaTrust SM01,SM02,SM03,SM04,SM05,SM06,SM08,SM20,SM21,SM22,SM24,SM50,SM51,SM52,SM53,SM54,SM55,SM56,SM57,SM58,SM59,SM60,SM61,SM67,SM84,SM85,SM86,SM87,SM88,SM89,SM90,SM91.
I, A
IVDR, MDR
EUDAMED record
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Devyser
Sweden
A
IVDR
info@deyvser.com
EUDAMED record
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Sentinel FDA
Italy
A
IVDR
Website
EUDAMED record
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Bindingsite FDA
EU representative : The Binding Site Ireland Limited (Ireland)
United Kingdom (ex Northern Ireland)
1 other
A
IVDR
Website
info@bindingsite.com
EUDAMED record
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Abbott FDA
EU representative : Abbott GmbH (Germany)
Ireland, United States
A
IVDR
Website
ratransfusionmedicine@abbott.com
EUDAMED record
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Haemokinesis
EU representative : Compliance Management Solutions Europe LTD (Bulgaria)
Australia
A
IVDR
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Horiba FDA
France
A
IVDR
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Macherey-Nagel FDA
Germany
A
IVDR
Website
sales@mn-net.com
EUDAMED record
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Merck Millipore
Ireland
A
IVDR
Website
PRRC_Cork@merckgroup.com
EUDAMED record
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Sichuan Orienter Biotechnology
EU representative : Share info GmbH (Germany)
China
Concentrated Cleaning Fluid 10 mL/tube*1, 10 mL/tube *2, 10 mL/tube*5, 10 mL/tube*10, 10 mL/bottle, 50 mL/bottle, 100 mL/bottle, 200 mL/bottle, 500 mL/bottle Flushing Fluid 5L/barrel、10L/barrel、15L/barrel、20L/barrel、25L/barrel Sample Diluent 1.6mL/tube×25, 1.6mL/tube×50, 1.6mL/tube×100, 2.8L/barrel, 5L/barrel, 10L/barrel, 20L/barrel, 2.8L/barrel ×2, 5L/barrel ×2
A
IVDR
Website
info@orienterglobal.com
EUDAMED record
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"Bio-Ksel"
Poland
A
IVDR
Website
EUDAMED record
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Arcdia
Finland
A
IVDR
Website
office@arcdia.com
EUDAMED record
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bioMérieux FDA
EU representative : bioMérieux SA (France)
United States
A
IVDR
EUDAMED record
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Bioway
EU representative : Sungo Cert GmbH (Germany)
China
A
IVDR
EUDAMED record
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C-Luminary Biotechnology
EU representative : Share info GmbH (Germany)
China
A
IVDR
EUDAMED record
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Fischer ANalysen Instrumente FDA
Germany
A
IVDR
Website
EUDAMED record
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Leicabiosystems FDA
EU representative : AR Experts B.V. (Netherlands)
United Kingdom (ex Northern Ireland)
A
IVDR
Website
EUDAMED record
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Nanjing Norman Biological Technology
EU representative : Sungo Cert GmbH (Germany)
China
Specification 1(Substrate 1:100ml,Substrate 2:100ml), Specification 2(Substrate 1:200ml,Substrate 2:200ml), Specification 3(Substrate 1:500ml,Substrate 2:500ml), Specification 4(Substrate 1:1L,Substrate 2:1L) 3 refs Wash buffer 100ml,200ml,500ml,1L,2L,5L 3 refs
A
IVDR
EUDAMED record
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Oxoid FDA
EU representative : Thermo Fisher Diagnostics B.V. (Netherlands)
United Kingdom (ex Northern Ireland)
A
IVDR
Website
EUDAMED record
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Precision System Science FDA
EU representative : Emergo Europe B.V. (Netherlands)
Japan
A
IVDR
service@pss.co.jp
EUDAMED record
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Qiagen FDA
Germany
A
IVDR
Website
info@qiagen.com
EUDAMED record
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R-Biopharm FDA
Germany
A
IVDR
Website
EUDAMED record
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Sarstedt FDA
Germany
A
IVDR
Website
EUDAMED record
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Stratec FDA
Austria
A
IVDR
EUDAMED record
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Suzhou Hokapi Biomedical Engineering
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
China
A
IVDR
EUDAMED record
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Alere San Diego FDA
EU representative : Abbott Rapid Dx International Limited (Ireland)
United States
A
IVDR
Website
EUDAMED record
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Alfresa Pharma FDA
EU representative : Emergo Europe B.V. (Netherlands)
Japan
A
IVDR
EUDAMED record
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Alifax FDA
Italy
A
IVDR
Website
regulatory@alifax.com
EUDAMED record
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Alivedx
EU representative : Emergo Europe B.V. (Netherlands)
Switzerland
A
IVDR
Website
EUDAMED record
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Arraytech
Spain
A
IVDR
Website
EUDAMED record
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Biodatacorp
EU representative : mdi Europa GmbH (Germany)
United States
A
IVDR
Website
customer.service@biodatacorp.com
EUDAMED record
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Biotype
Germany
A
IVDR
Website
info@biotype.de
EUDAMED record
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CellPath FDA
EU representative : Emergo Europe B.V. (Netherlands)
United Kingdom (ex Northern Ireland)
A
IVDR
Website
info@cellpath.com
EUDAMED record
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Celltivity FDA
EU representative : AR Experts B.V. (Netherlands)
United States
A
IVDR
Website
info@celltivity.com
EUDAMED record
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Citotest FDA
EU representative : Wellkang Ltd (Northern Ireland)
China
A
IVDR
Website
info@citotest.com
EUDAMED record
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Fluxergy FDA
EU representative : CMC Medical Devices & Drugs SL (Spain)
United States
A
IVDR
Website
info@fluxergy.com
EUDAMED record
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Gold Standard Diagnostics FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
A
IVDR
Website
EUDAMED record
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Hunan Ehome Health Technology
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
China
A
IVDR
EUDAMED record
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inno-train Diagnostik
Germany
A
IVDR
Website
info@inno-train.de
EUDAMED record
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Jadesci
EU representative : Obelis s.a. (Belgium)
United States
A
IVDR
Website
customerservice@jadesci.com
EUDAMED record
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Jiangsu Comeon Medical Apparatus
EU representative : Sungo Cert GmbH (Germany)
China
A
IVDR
EUDAMED record
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Jiangsu CoWin Biotech
EU representative : CMC Medical Devices & Drugs SL (Spain)
China
A
IVDR
EUDAMED record
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Jiangsu Kangjie Medical Devices
EU representative : SUNGO Europe B.V. (Netherlands)
China
I
MDR
EUDAMED record
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Jokoh
EU representative : MDSS GmbH (Germany)
Japan
A
IVDR
Website
EUDAMED record
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Life Technologies
EU representative : Life Technologies Europe B.V. (Netherlands)
United States
A
IVDR
EUDAMED record
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MA-COM d.o.o.Stolac
EU representative : Advena Limited (Malta)
Bosnia & Herzegovina
A
IVDR
Website
info@ma-com.net
EUDAMED record
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magtivio
Netherlands
A
IVDR
info@magtivio.com
EUDAMED record
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Marfour
Poland
A
IVDR
Website
info@marfour.com.pl
EUDAMED record
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Medconn FDA
EU representative : Kingsmead Service B.V. (Netherlands)
China
A
IVDR
EUDAMED record
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Medtronic FDA
EU representative : Medtronic B.V. (Netherlands)
United States
A
IVDR
EUDAMED record
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Micropointbio
EU representative : Obelis s.a. (Belgium)
China
A
IVDR
Website
EUDAMED record
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Oxford Immunotec FDA
EU representative : Wallac Oy (Finland)
United Kingdom (ex Northern Ireland)
A
IVDR
regulatory.oxford@revvity.com
EUDAMED record
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QuinTron Instrument FDA
EU representative : Emergo Europe B.V. (Netherlands)
United States
A
IVDR
Website
regulatory@quintron-usa.com
EUDAMED record
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Randox FDA
Northern Ireland
A
IVDR
Website
EUDAMED record
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Remel FDA
EU representative : Thermo Fisher Diagnostics B.V. (Netherlands)
United States
A
IVDR
Website
EUDAMED record
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Remel Europe FDA
EU representative : Thermo Fisher Diagnostics B.V. (Netherlands)
United Kingdom (ex Northern Ireland)
A
IVDR
Website
EUDAMED record
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Richard-Allan Scientific
EU representative : Epredia Netherlands B.V. (Netherlands)
United States
A
IVDR
EUDAMED record
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SD Biosensor FDA
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
South Korea
A
IVDR
Website
EUDAMED record
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Streck FDA
EU representative : MediMark Europe Sarl. (France)
United States
A
IVDR
Website
EUDAMED record
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Viramed FDA
Germany
A
IVDR
Website
EUDAMED record
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Vircell
Spain
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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