| Gold Standard Diagnostics
|
Germany
|
19 others
|
–
98/79
|
info.frankfurt@eu.goldstandarddiagnostics.com
EUDAMED record
Report an error
|
| Vitrosens
|
Türkiye
|
13 others
|
C
IVDR, 98/79
|
Website
info@vitrosens.com
EUDAMED record
Report an error
|
| Lifotronic
EU representative : Umedwings Netherlands B.V. (Netherlands)
|
China
|
11 others
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| TestLine Clinical Diagnostics s.r.o
|
Czechia
|
11 others
|
C
IVDR, 98/79
|
Website
info@testlinecd.com
EUDAMED record
Report an error
|
| Acro Biotech
EU representative : MedNet EC-REP GmbH (Germany)
|
United States
|
5 others
|
–
98/79
|
info@acrobiotech.com
EUDAMED record
Report an error
|
| Hangzhou Alltest Biotech
EU representative : MedNet EC-REP GmbH (Germany) and 1 other
|
China
|
5 others
|
–
98/79
|
info@alltests.com.cn
EUDAMED record
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|
| Euroimmun
|
Germany
|
4 others
|
–
98/79
|
Website
info@euroimmun.de
EUDAMED record
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|
| Rapid Labs
EU representative : Advena Limited (Malta)
|
United Kingdom (ex Northern Ireland)
|
4 others
|
–
98/79
|
Website
info@rapidlabs.co.uk
EUDAMED record
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|
| Vircell
|
Spain
|
4 others
|
C
IVDR, 98/79
|
EUDAMED record
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|
| Hangzhou Laihe Biotech
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
2 others
|
–
98/79
|
office@lyher.com
EUDAMED record
Report an error
|
| Healgen
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
United States
|
2 others
|
–
98/79
|
quality@healgen.com
EUDAMED record
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|
| Ab Analitica
|
Italy
|
1 other
|
–
98/79
|
customersupport@abanalitica.it
EUDAMED record
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|
| Clonit
|
Italy
|
1 other
|
–
98/79
|
Website
info@clonit.it
EUDAMED record
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|
| Cybereagen
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
1 other
|
–
98/79
|
info@cybereagen.com
EUDAMED record
Report an error
|
| DiaSorin
EU representative : DiaSorin Italia S.p.A. (Italy)
|
Italy, United States
|
1 other
|
C
IVDR, 98/79
|
Website
ivdr_dsm@diasorin.com
EUDAMED record
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|
| Orgentec
|
Germany
|
1 other
|
–
98/79
|
Website
EUDAMED record
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|
| Orientgene
EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other
|
China
|
1 other
|
–
98/79
|
EUDAMED record
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|
| Realytech
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
1 other
|
–
98/79
|
Website
info@realytech.com
EUDAMED record
Report an error
|
| Vela Operations Singapore Pte
EU representative : Vela Diagnostics Germany GmbH (Germany)
|
Singapore
|
1 other
|
–
98/79
|
Website
infoAPAC@veladx.com
EUDAMED record
Report an error
|
| Diesse
|
Italy
|
|
C
IVDR
|
Website
EUDAMED record
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|
| Microprofit
EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Shanghai Zj Bio-Tech
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Vidia
|
Czechia
|
|
–
98/79
|
Website
EUDAMED record
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|
| Abbott
|
Ireland
|
|
C
IVDR
|
Website
EUDAMED record
Report an error
|
| Aesku
|
Germany
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Autobio Diagnostics
EU representative : QbD RepS BV (Belgium)
|
China
|
|
C
IVDR
|
info@autobio-diagnostics.com
EUDAMED record
Report an error
|
| Genesignbio
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
|
–
98/79
|
info@genesignbio.com
EUDAMED record
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|
| Getein
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
–
98/79
|
EUDAMED record
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|
| Hightopbio
EU representative : MedNet EC-REP GmbH (Germany)
|
China
|
|
–
98/79
|
Website
EUDAMED record
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|
| Maccura
EU representative : Humiss International B.V. (Netherlands) and 1 other
|
China
|
|
–
98/79
|
Website
EUDAMED record
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|
| Mindray
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
|
C
IVDR
|
Website
EUDAMED record
Report an error
|
| Rayto
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
|
–
98/79
|
Website
support@rayto.com
EUDAMED record
Report an error
|
| Shenzhen Yhlo Biotech
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
|
C
IVDR
|
Website
info@szyhlo.com
EUDAMED record
Report an error
|
| Vivachek
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
–
98/79
|
info@vivachek.com
EUDAMED record
Report an error
|
| Wondfo
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
–
98/79
|
Website
sales@wondfo.com.cn
EUDAMED record
Report an error
|
| Ant Biyoteknoloji Sanayi Ve Ticaret Anonim Sirketi
|
Türkiye
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Geneproof
|
Czechia
|
|
C
IVDR, 98/79
|
Website
support@geneproof.com
EUDAMED record
Report an error
|
| Technogenetics
|
Italy
|
|
C
IVDR
|
Website
QA@TECHNOGENETICS.IT
EUDAMED record
Report an error
|
| Trinitybiotech
EU representative : TrinityBiotech (Ireland)
|
United States
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Human
|
Germany
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Aichek
EU representative : Medunion S.L. (Spain)
|
China
|
|
–
98/79
|
ra.rep@aichek.com
EUDAMED record
Report an error
|
| altona Diagnostics
|
Germany
|
|
C
IVDR, 98/79
|
info@altona-diagnostics.com
EUDAMED record
Report an error
|
| Bioperfectus
EU representative : MedNet EC-REP GmbH (Germany)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Diapro
|
Italy
|
|
–
98/79
|
Website
info@diapro.it
EUDAMED record
Report an error
|
| Dirui
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| ELITechGroup
|
Italy
|
|
C
IVDR
|
Website
EUDAMED record
Report an error
|
| Hangzhou Danwei Biotechnology
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
–
98/79
|
ra.danwei@danwei-bio.com
EUDAMED record
Report an error
|
| Idilbiotech
|
Türkiye
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Qiagen
|
Germany
|
|
–
98/79
|
Website
info@qiagen.com
EUDAMED record
Report an error
|
| Sansure
EU representative : Obelis s.a. (Belgium)
|
China
|
|
–
98/79
|
Website
info@sansure.com.cn
EUDAMED record
Report an error
|
| Siemens Healthcare Diagnostics
EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland)
|
United States
|
|
C
IVDR
|
Website
contact@siemens-healthineers.com
EUDAMED record
Report an error
|
| Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇
|
Türkiye
|
|
C
IVDR
|
Website
info@visionbiotechnology.com
EUDAMED record
Report an error
|
| Zhejiang QL Biotech
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Advanced Molecular Diagnostics
EU representative : Advena Limited (Malta)
|
United Kingdom (ex Northern Ireland)
|
|
–
98/79
|
Website
info@am-diagnostics.co.uk
EUDAMED record
Report an error
|
| Agilent
EU representative : Agilent Technologies Denmark ApS (Denmark)
|
Singapore
|
|
–
98/79
|
Website
info.dk@agilent.com
EUDAMED record
Report an error
|
| Anatolia Tani Ve Biyoteknoloji Urunleri Arastirma Gelistirme San Ve Tic
|
Türkiye
|
|
–
98/79
|
Website
info@anatoliagenetik.com
EUDAMED record
Report an error
|
| Anchor Diagnostics
|
Germany
|
|
–
98/79
|
info@anchor-diagnostics.com
EUDAMED record
Report an error
|
| Biocare Medical
EU representative : Emergo Europe B.V. (Netherlands)
|
United States
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| bioMérieux
|
France
|
|
C
IVDR
|
EUDAMED record
Report an error
|
| Cowingene
EU representative : MedPath GmbH (Germany)
|
China
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Coyotebio
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
–
98/79
|
sales@coyotebio.com
EUDAMED record
Report an error
|
| DiagCor Life Science
EU representative : SUNGO Europe B.V. (Netherlands)
|
Hong Kong SAR China
|
|
–
98/79
|
QARA@diagcorlifescience.com
EUDAMED record
Report an error
|
| Ecolidx
|
Czechia
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Encode
EU representative : Medunion S.L. (Spain)
|
China
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Genekam
|
Germany
|
|
–
98/79
|
Website
office@genekam.de
EUDAMED record
Report an error
|
| Genes2Me
EU representative : Obelis s.a. (Belgium)
|
India
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Hain Lifescience
|
Germany
|
|
–
98/79
|
EUDAMED record
Report an error
|
| HangZhou Biotest Biotech
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
|
–
98/79
|
info@biotests.com.cn
EUDAMED record
Report an error
|
| Hangzhou Immuno Biotech
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
–
98/79
|
info@jgbiotech.com
EUDAMED record
Report an error
|
| Hologic
EU representative : Hologic BV (Belgium)
|
United States
|
|
C
IVDR
|
EUDAMED record
Report an error
|
| Jiangsu Mole Bioscience
EU representative : Medunion S.L. (Spain)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Meridian Bioscience
EU representative : Meridian Bioscience Europe S.r.l. (Italy)
|
United States
|
|
C
IVDR
|
Website
EUDAMED record
Report an error
|
| Mikrogen
|
Germany
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Nanjing Synthgene Medical Technology
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
–
98/79
|
Website
sales@syngenebio.com
EUDAMED record
Report an error
|
| Oxoid
EU representative : Thermo Fisher Diagnostics B.V. (Netherlands)
|
United Kingdom (ex Northern Ireland)
|
|
C
IVDR
|
Website
EUDAMED record
Report an error
|
| Remel Europe
EU representative : Thermo Fisher Diagnostics B.V. (Netherlands)
|
United Kingdom (ex Northern Ireland)
|
|
C
IVDR
|
Website
EUDAMED record
Report an error
|
| Siemens Healthcare Diagnostics Products
EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland)
|
United Kingdom (ex Northern Ireland)
|
|
C
IVDR
|
Website
contact@siemens-healthineers.com
EUDAMED record
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|
| Suzhou TianLong Biotechnology
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
–
98/79
|
EUDAMED record
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|
| Ustar Biotechnologies (Hangzhou)
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
C
IVDR
|
Website
service@bioustar.com
EUDAMED record
Report an error
|
| Viuick
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Zhejiang Anji Saianfu Biotechnology
EU representative : Lotus NL B.V. (Netherlands)
No model still on the market
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|