| Vitrosens
|
Türkiye
|
163 others
|
B, C
IVDR, 98/79
|
Website
info@vitrosens.com
EUDAMED record
Report an error
|
| AusDiagnostics
EU representative : Advena Limited (Malta) and 1 other
|
Australia
|
88 others
|
–
98/79
|
Website
regulatory@r-biopharm.com.au
EUDAMED record
Report an error
|
| Idilbiotech
|
Türkiye
|
81 others
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇
|
Türkiye
|
52 others
|
B, C
IVDR
|
Website
info@visionbiotechnology.com
EUDAMED record
Report an error
|
| Bioeksen
|
Türkiye
|
28 others
|
–
98/79
|
Website
info@bioeksen.com.tr
EUDAMED record
Report an error
|
| Ant Biyoteknoloji Sanayi Ve Ticaret Anonim Sirketi
|
Türkiye
|
27 others
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Seegene
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
|
South Korea
|
27 others
|
B, C
IVDR, 98/79
|
Website
info@seegene.com
EUDAMED record
Report an error
|
| Poly Diagnostics
|
Luxembourg
|
25 others- Poly Diagnostics C. parapsilosis, C. tropicalis, C. krusei, RNase P Real-Time PCR kit3 refs
- Poly Diagnostics C. parapsilosis, RNase P Real-Time PCR kit3 refs
- Poly Diagnostics C. tropicalis, RNase P Real-Time PCR kit3 refs
- Poly Diagnostics Cryptosporidium spp., E. histolytica, G. lamblia, RNase P Real-Time PCR kit3 refs
- Poly Diagnostics Cryptosporidium spp., RNase P Real-Time PCR kit3 refs
- Poly Diagnostics D. fragilis, B. hominis, C. cayetanensis, RNase P Real-Time PCR kit3 refs
- Poly Diagnostics Dientamoeba fragilis, RNase P Real-Time PCR kit3 refs
- Poly Diagnostics Entamoeba histolytica, RNase P Real-Time PCR kit3 refs
- Poly Diagnostics Enterovirus, Mumps, Parechovirus, RNase P Real-Time PCR kit3 refs
- Poly Diagnostics Gastrointestinal Disease Bacterial Panel III Real-Time PCR kit3 refs
- Poly Diagnostics Gastrointestinal Disease Panel I Real-Time PCR kit3 refs
- Poly Diagnostics Gastrointestinal Disease Parasite Panel IV Real-Time PCR kit3 refs
- Poly Diagnostics Gastrointestinal Disease Viral Panel II Real-Time PCR kit3 refs
- Poly Diagnostics Giardia lamblia, RNase P Real-Time PCR kit3 refs
- Poly Diagnostics Influenza A, Influenza B, RNase P Real-Time PCR kit3 refs
- Poly Diagnostics Influenza A, Influenza B, SARS-CoV-2, RNase P Real-Time PCR kit3 refs
- Poly Diagnostics Influenza A, Influenza B, SARS-CoV-2, RNase P, HRSV a/b Real-Time PCR kit3 refs
- Poly Diagnostics K. pneumoniae, M. catarrhalis, P. aeruginosa, RNase P Real-Time PCR kit3 refs
- Poly Diagnostics Norovirus GI, Norovirus GII+GIV, Astrovirus, RNase P Real-Time PCR kit3 refs
- Poly Diagnostics Respiratory Infection Viral Panel III Real-Time PCR kit3 refs
- Poly Diagnostics Respiratory Infection Viral Panel V Real-Time PCR kit3 refs
- Poly Diagnostics Rhinovirus/Enterovirus, Adenovirus, Bocavirus, HMPV A/B, RNase P Real-Time PCR kit3 refs
- Poly Diagnostics Rhinovirus/Enterovirus, Adenovirus, HRSV a/b, RNase P Real-Time PCR kit3 refs
- Poly Diagnostics Sapovirus GI, II, IV, V, Adenovirus, Rotavirus A, RNase P Real-Time PCR kit3 refs
- Poly Diagnostics Vibrio cholerae, RNase P Real-Time PCR kit3 refs
|
B
IVDR
|
Website
info@polydiagnostics.com
EUDAMED record
Report an error
|
| gerbion
|
Germany
|
24 others
|
–
98/79
|
info@gerbion.com
EUDAMED record
Report an error
|
| Shanghai Zj Bio-Tech
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
24 others
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Healgen
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
United States
|
23 others
|
–
98/79
|
quality@healgen.com
EUDAMED record
Report an error
|
| Sansure
EU representative : Obelis s.a. (Belgium)
|
China
|
23 others
|
C
IVDR, 98/79
|
Website
info@sansure.com.cn
EUDAMED record
Report an error
|
| Beijing Applied Biological Technologies
EU representative : Luxus Lebenswelt GmbH (Germany)
|
China
|
21 others
|
–
98/79
|
EUDAMED record
Report an error
|
| Anatolia Tani Ve Biyoteknoloji Urunleri Arastirma Gelistirme San Ve Tic
|
Türkiye
|
20 others
|
C
IVDR, 98/79
|
Website
info@anatoliagenetik.com
EUDAMED record
Report an error
|
| Orientgene
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
19 others
|
–
98/79
|
EUDAMED record
Report an error
|
| Bioer
EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other
|
China
|
16 others- CentriDxTM Respiratory Pathogen Panel V BSJ84S198/79
- CentriDxTM Sexually Transmitted Disease Panel I BSJ69S198/79
- CentriDxTM Tropical Fever Pathogen Panel Ⅰ BSJ96S198/79
- Enterovirus Universal, Enterovirus 71, Coxsackievirus A6, Coxsackievirus A10 and Coxsackievirus A16 nucleic acid Detection Kit (Fluorescent PCR) BSJ26L198/79
- Enterovirus Universal, Enterovirus 71, Coxsackievirus A6, Coxsackievirus A10 and Coxsackievirus A16 nucleic acid Detection Kit (Fluorescent PCR) BSJ26M198/79
- Neisseria gonorrhoeae, Chlamydia trachomatis Nucleic Acid Detection Kit (Fluorescent PCR) BSJ02S1, BSJ02M1, BSJ02L1, BSJ02S1A, BSJ02M1A, BSJ02L1A3 refs
- Norovirus/Group A Rotavirus/Enteric Adenovirus Nucleic Acid Detection Kit (Fluorescence PCR) BSJ35L198/79
- Norovirus/Group A Rotavirus/Enteric Adenovirus Nucleic Acid Detection Kit (Fluorescence PCR) BSJ35M198/79
- Respiratory Syncytial Virus/ Adenovirus/Parainfluenza Virus Nucleic Acid Detection Kit (Fluorescence PCR) BSJ45L198/79
- Respiratory Syncytial Virus/ Adenovirus/Parainfluenza Virus Nucleic Acid Detection Kit (Fluorescence PCR) BSJ45M198/79
- SARS-CoV-2 / Respiratory Syncytial Virus / Influenza A Virus / Influenza B Virus Lyophilized Nucleic Acid Detection Kit (Fluorescence PCR) BSJ48M198/79
- SARS-CoV-2 / Respiratory Syncytial Virus / Influenza A Virus / Influenza B Virus Lyophilized Nucleic Acid Detection Kit (Fluorescence PCR) BSJ48S198/79
- SARS-CoV-2 / Respiratory Syncytial Virus / Influenza A Virus / Influenza B Virus Nucleic Acid Multiple Detection Kit (Fluorescence PCR) BSJ37L198/79
- SARS-CoV-2 / Respiratory Syncytial Virus / Influenza A Virus / Influenza B Virus Nucleic Acid Multiple Detection Kit (Fluorescence PCR) BSJ37M198/79
- Streptococcus Pneumoniae and Haemophilus Influenzae Nucleic Acid Detection Kit (Fluorescence PCR) BSJ31L198/79
- Streptococcus Pneumoniae and Haemophilus Influenzae Nucleic Acid Detection Kit (Fluorescence PCR) BSJ31M198/79
|
C
IVDR, 98/79
|
Website
ra_oversea@bioer.com.cn
EUDAMED record
Report an error
|
| Ecolidx
|
Czechia
|
15 others
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Vitassay
|
Spain
|
15 others- Vitassay qPCR HSM98/79
- Vitassay qPCR Primary Atypical Pneumonia Vitassay qPCR Sexually Transmitted Infections, 4 tubes x 24 test98/79
- Vitassay qPCR Primary Atypical Pneumonia, high profile, 4x8-well strips98/79
- Vitassay qPCR Primary Atypical Pneumonia, high profile, 8x8-well98/79
- Vitassay qPCR Primary Atypical Pneumonia, high profile, 96-well plate98/79
- Vitassay qPCR Primary Atypical Pneumonia, low profile, 4x8-well strips98/79
- Vitassay qPCR Primary Atypical Pneumonia, low profile, 8x8-well strips98/79
- Vitassay qPCR Primary Atypical Pneumonia, low profile, 96-well plate98/79
- Vitassay qPCR SARS-CoV-2 + Flu A + Flu B98/79
- Vitassay qPCR Sexually Transmitted Infections, high profile, 16x8-well strips98/79
- Vitassay qPCR Sexually Transmitted Infections, high profile, 8x8-well strips98/79
- Vitassay qPCR Sexually Transmitted Infections, low profile, 16x8-well strips98/79
- Vitassay qPCR Sexually Transmitted Infections, low profile, 8x8-well strips98/79
- Vitassay qPCR Tick Borne Disease98/79
- Vitassay qPCR Zika+Dengue+Chikungunya98/79
|
–
98/79
|
Website
info@vitassay.com
EUDAMED record
Report an error
|
| Cesna
|
Türkiye
|
13 others
|
B
IVDR
|
Website
info@cesna.com.tr
EUDAMED record
Report an error
|
| Certest
|
Spain
|
12 others
|
B, C
IVDR, 98/79
|
Website
quality@certest.es
EUDAMED record
Report an error
|
| Hysenbiotech
EU representative : Medunion S.L. (Spain)
|
South Korea
|
11 others
|
–
98/79
|
EUDAMED record
Report an error
|
| Genes2Me
EU representative : Obelis s.a. (Belgium)
|
India
|
10 others
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Microprofit
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
9 others
|
–
98/79
|
EUDAMED record
Report an error
|
| Ablsa
|
Luxembourg
|
7 others
|
–
98/79
|
Website
contact@ablsa.com
EUDAMED record
Report an error
|
| Kogene
EU representative : Obelis s.a. (Belgium)
|
South Korea
|
7 others
|
–
98/79
|
Website
info@kogene.co.kr
EUDAMED record
Report an error
|
| Microbio
EU representative : Qualrep Services B.V. (Netherlands)
|
Australia
|
7 others
|
–
98/79
|
Website
info@microbio.com.au
EUDAMED record
Report an error
|
| Ustar Biotechnologies (Hangzhou)
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
7 others
|
B, C
IVDR, 98/79
|
Website
service@bioustar.com
EUDAMED record
Report an error
|
| Cowingene
EU representative : MedPath GmbH (Germany)
|
China
|
6 others
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| ELITechGroup
|
Italy
|
6 others
|
B, C
IVDR, 98/79
|
Website
EUDAMED record
Report an error
|
| Shenzhen Chenghui Medical Technology
EU representative : HUMISS TRADING S. L. (Spain)
|
China
|
6 others
|
B
IVDR, 98/79
|
EUDAMED record
Report an error
|
| Vircell
|
Spain
|
6 others
|
B, C
IVDR, 98/79
|
EUDAMED record
Report an error
|
| Immundiagnostik
|
Germany
|
5 others
|
–
98/79
|
Website
info@immundiagnostik.com
EUDAMED record
Report an error
|
| bioMérieux
|
France
|
4 others
|
B, C
IVDR, 98/79
|
EUDAMED record
Report an error
|
| Cube Dx
|
Austria
|
4 others
|
–
98/79
|
Website
info@cubedx.com
EUDAMED record
Report an error
|
| FlashDx Shenzhen
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
4 others
|
–
98/79
|
info@flash-dx.com
EUDAMED record
Report an error
|
| Tigsun
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
4 others
|
–
98/79
|
EUDAMED record
Report an error
|
| 3Bblackbio
EU representative : Wellkang Ltd (Northern Ireland)
|
India
|
3 others
|
B, C
IVDR
|
Website
info@3bblackbio.com
EUDAMED record
Report an error
|
| altona Diagnostics
|
Germany
|
3 others
|
B, C
IVDR, 98/79
|
info@altona-diagnostics.com
EUDAMED record
Report an error
|
| BioFire Diagnostics
EU representative : bioMérieux SA (France)
|
United States
|
3 others
|
B, C, D
IVDR
|
EUDAMED record
Report an error
|
| Biosynex
|
France
|
3 others
|
B, C
IVDR, 98/79
|
Website
reglementaire@biosynex.com
EUDAMED record
Report an error
|
| Hangzhou Danwei Biotechnology
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
3 others
|
–
98/79
|
ra.danwei@danwei-bio.com
EUDAMED record
Report an error
|
| Pilotgene
EU representative : Medunion S.L. (Spain)
|
China
|
3 others
|
–
98/79
|
EUDAMED record
Report an error
|
| Progenie molecular S.L.U
|
Spain
|
3 others
|
–
98/79
|
EUDAMED record
Report an error
|
| Genetree
EU representative : Obelis s.a. (Belgium)
|
South Korea
|
2 others
|
B, C
IVDR, 98/79
|
Website
ra@genetree.co.kr
EUDAMED record
Report an error
|
| Ingenetix
|
Austria
|
2 others
|
–
98/79
|
Website
office@ingenetix.com
EUDAMED record
Report an error
|
| R-Biopharm
|
Germany
|
2 others
|
C
IVDR, 98/79
|
Website
EUDAMED record
Report an error
|
| Suzhou TianLong Biotechnology
EU representative : Lotus NL B.V. (Netherlands) and 1 other
|
China
|
2 others
|
–
98/79
|
EUDAMED record
Report an error
|
| Vazyme
EU representative : Obelis s.a. (Belgium) and 1 other
|
China
|
2 others
|
–
98/79
|
EUDAMED record
Report an error
|
| Aitbiotech
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
Singapore
|
1 other
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Anhui Deepblue Medical Technology
EU representative : Luxus Lebenswelt GmbH (Germany) and 2 others
|
China
|
1 other
|
C
IVDR, 98/79
|
sales@dbluemedical.com
EUDAMED record
Report an error
|
| Bioperfectus
EU representative : MedNet EC-REP GmbH (Germany) and 1 other
|
China
|
1 other
|
C
IVDR, 98/79
|
EUDAMED record
Report an error
|
| Hologic
EU representative : Hologic BV (Belgium)
|
United States
|
1 other
|
B, C
IVDR
|
EUDAMED record
Report an error
|
| Jiangsu Mole Bioscience
EU representative : Lotus NL B.V. (Netherlands) and 2 others
|
China
|
1 other
|
–
98/79
|
EUDAMED record
Report an error
|
| Eurobio Scientific
|
France
|
|
–
98/79
|
reglementaire@eurobio-scientific.com
EUDAMED record
Report an error
|
| FRIZ Biochem
|
Germany
|
|
B
IVDR
|
Website
info@frizbiochem.de
EUDAMED record
Report an error
|
| Hain Lifescience
|
Germany
|
|
C
IVDR, 98/79
|
EUDAMED record
Report an error
|
| Jiangsu Macro & Micro-Test Med-Tech
EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other
|
China
|
|
B
IVDR, 98/79
|
marketing@hongweitest.com
EUDAMED record
Report an error
|
| Jiangsu Q-Array
EU representative : Caretechion GmbH (Germany)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Qiagen
|
Germany
|
|
C
IVDR, 98/79
|
Website
info@qiagen.com
EUDAMED record
Report an error
|
| Serosep
|
Ireland
|
|
–
98/79
|
Website
info@serosep.com
EUDAMED record
Report an error
|
| Synthgene (Yixing) Health Technology
EU representative : MedPath GmbH (Germany)
|
China
|
|
–
98/79
|
sales@syngenebio.com
EUDAMED record
Report an error
|
| Targetingone
EU representative : Medunion S.L. (Spain)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Genetic Signatures
EU representative : mdi Europa GmbH (Germany)
|
Australia
|
1 other
|
–
98/79
|
Website
RAQA@geneticsignatures.com
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
|
| HEALSTONE Biotech
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
Canada
|
|
–
98/79
|
sales@orientgene.com
EUDAMED record
Report an error
|
| Hybribio
EU representative : Luxus Lebenswelt GmbH (Germany) and 1 other
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Iontek
|
Türkiye
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Limingbio
EU representative : Wellkang Ltd (Northern Ireland)
|
China
|
|
–
98/79
|
Website
sales@limingbio.com
EUDAMED record
Report an error
|
| Tellgencorp
EU representative : MedNet EC-REP GmbH (Germany) and 1 other
|
China
|
|
–
98/79
|
Website
sales@tellgen.com
EUDAMED record
Report an error
|
| Abacus Diagnostica
|
Finland
|
|
–
98/79
|
info@abacusdiagnostica.com
EUDAMED record
Report an error
|
| Abiores Technology (Beijing)
EU representative : Sungo Cert GmbH (Germany) and 1 other
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Ademtech
|
France
|
|
B
IVDR
|
Website
EUDAMED record
Report an error
|
| Beijing OriginPoly Bio-Tec
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Credo Diagnostics Biomedical Pte Taiwan Branch
EU representative : MedNet EC-REP GmbH (Germany)
|
Taiwan
|
|
–
98/79
|
service@credodxbiomed.com
EUDAMED record
Report an error
|
| Diasia
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Geneproof
|
Czechia
|
|
C
IVDR, 98/79
|
Website
support@geneproof.com
EUDAMED record
Report an error
|
| Genmark
|
Türkiye
|
|
–
98/79
|
Website
info@genmark.com.tr
EUDAMED record
Report an error
|
| Goldsite
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
–
98/79
|
Website
export@goldsite.com.cn
EUDAMED record
Report an error
|
| Id Solutions
|
France
|
|
–
98/79
|
Website
info@id-solutions.fr
EUDAMED record
Report an error
|
| Igenesis Shanghai
EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other
|
China
|
|
C
IVDR, 98/79
|
support@igenesisbio.com
EUDAMED record
Report an error
|
| Kingcreate
EU representative : Kingsmead Service B.V. (Netherlands)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Operon
|
Spain
|
|
–
98/79
|
Website
infoeudamed@operon.es
EUDAMED record
Report an error
|
| Ortho-Clinical Diagnostics Dba Quidel
EU representative : MDSS GmbH (Germany)
|
United States
|
|
–
98/79
|
Website
PRRC@quidelortho.com
EUDAMED record
Report an error
|
| Pluslife
EU representative : Kingsmead Service B.V. (Netherlands) and 1 other
|
China
|
|
–
98/79
|
Website
ra@pluslife.com
EUDAMED record
Report an error
|
| SD Biosensor
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
|
South Korea
|
|
B, C
IVDR, 98/79
|
Website
EUDAMED record
Report an error
|
| SpeeDx
EU representative : MedEnvoy Global BV (Netherlands)
|
Australia
|
|
B, C
IVDR
|
Website
regulatory@speedx.com.au
EUDAMED record
Report an error
|
| Vitro
|
Spain
|
|
C
IVDR
|
Website
regulatory@vitro.bio
EUDAMED record
Report an error
|
| Viuick
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Vivachek
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
–
98/79
|
info@vivachek.com
EUDAMED record
Report an error
|
| Abbott
EU representative : Abbott GmbH (Germany)
|
United States
|
|
B, C
IVDR
|
EUDAMED record
Report an error
|
| Appolon Bioteck
|
France
|
|
B, C
IVDR
|
Website
contact@appolonbioteck.com
EUDAMED record
Report an error
|
| Atlas Medical
|
Germany
|
|
–
98/79
|
Website
info@atlas-medical.com
EUDAMED record
Report an error
|
| BioFynder
EU representative : SUNGO Europe B.V. (Netherlands)
|
United Kingdom (ex Northern Ireland)
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Cepheid
EU representative : Cepheid AB (Sweden)
|
Sweden, United States
|
|
B
IVDR, 98/79
|
Website
EUDAMED record
Report an error
|
| Clongene
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
|
–
98/79
|
Website
marketing@clongene.com
EUDAMED record
Report an error
|
| Cybereagen
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
–
98/79
|
info@cybereagen.com
EUDAMED record
Report an error
|
| Dianabiotech
|
Czechia
|
|
–
98/79
|
Website
info@dianabiotech.com
EUDAMED record
Report an error
|
| Dynamiker
EU representative : JOYSUN GROUP S.L.U (Spain)
|
China
|
|
–
98/79
|
Website
marketing@dynamiker.com
EUDAMED record
Report an error
|
| Elisabeth
|
Czechia
|
|
–
98/79
|
Website
info@elisabeth.cz
EUDAMED record
Report an error
|
| Euroimmun
|
Germany
|
|
–
98/79
|
Website
info@euroimmun.de
EUDAMED record
Report an error
|
| GeneMatrix
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
|
South Korea
|
|
–
98/79
|
Website
support@genematrix.net
EUDAMED record
Report an error
|
| Getein
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
C
IVDR
|
EUDAMED record
Report an error
|
| Guangzhou Biotron Technology
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Guangzhou Deaou Gene Technology
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Hangzhou Alltest Biotech
EU representative : VidaQuick Biotech S.L. (Spain)
|
China
|
|
–
98/79
|
info@alltests.com.cn
EUDAMED record
Report an error
|
| Hangzhou Zhunxin Biotechnology
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Kangsheng Information Technology (Hangzhou)
EU representative : Crealkraft GmbH (Germany)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Luminex Molecular Diagnostics
EU representative : DiaSorin Italia S.p.A. (Italy)
|
Canada
|
|
B
IVDR, 98/79
|
Website
regulatoryaffairs@luminexcorp.com
EUDAMED record
Report an error
|
| Luminexcorp
EU representative : DiaSorin Italia S.p.A. (Italy)
|
United States
|
|
C
IVDR
|
Website
regulatoryaffairs@luminexcorp.com
EUDAMED record
Report an error
|
| PentaBase
|
Denmark
|
|
–
98/79
|
Website
info@pentabase.com
EUDAMED record
Report an error
|
| Rapid Labs
EU representative : VidaQuick Biotech S.L. (Spain)
|
United Kingdom (ex Northern Ireland)
|
|
–
98/79
|
Website
info@rapidlabs.co.uk
EUDAMED record
Report an error
|
| Rocgene
EU representative : Medunion S.L. (Spain)
|
China
|
|
–
98/79
|
sale@rocgene.com
EUDAMED record
Report an error
|
| Shenzhen Zijian Biotechnology
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
–
98/79
|
Website
sales@szzijian.com
EUDAMED record
Report an error
|
| Vacure
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Wells Bio
EU representative : MDSS GmbH (Germany)
|
South Korea
|
|
–
98/79
|
Website
info@wellsbio.net
EUDAMED record
Report an error
|
| ZeptoMetrix
EU representative : Emergo Europe B.V. (Netherlands)
|
United States
|
|
B
IVDR
|
Website
EUDAMED record
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|
| -Diagnostics
EU representative : mdi Europa GmbH (Germany)
|
United States
|
|
–
98/79
|
Website
EUDAMED record
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|
| 1drop
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
|
South Korea
|
|
–
98/79
|
Website
sales@1drop.co.kr
EUDAMED record
Report an error
|
| Atlas Link Technology
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
|
China
|
|
C
IVDR
|
Website
EUDAMED record
Report an error
|
| Beijing Jinwofu Bioengineering Technology
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
–
98/79
|
EUDAMED record
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|
| Clonit
|
Italy
|
|
–
98/79
|
Website
info@clonit.it
EUDAMED record
Report an error
|
| DiaSorin
EU representative : DiaSorin Italia S.p.A. (Italy)
|
United States
|
|
B
IVDR
|
Website
ivdr_dsm@diasorin.com
EUDAMED record
Report an error
|
| Fanttest
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
|
–
98/79
|
info@fanttest.com
EUDAMED record
Report an error
|
| Genemind
EU representative : Medunion S.L. (Spain)
|
China
|
|
–
98/79
|
regulatoryaffairs@genemind.com
EUDAMED record
Report an error
|
| GenMark Diagnostics
EU representative : Roche Diagnostics GmbH (Germany)
|
United States
|
|
B
IVDR
|
regulatory.rmd_international@roche.com
EUDAMED record
Report an error
|
| Hangzhou Laihe Biotech
EU representative : Medunion S.L. (Spain)
|
China
|
|
C
IVDR
|
office@lyher.com
EUDAMED record
Report an error
|
| Hunan Kangxin Biotechnology
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| KH Medical
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
|
South Korea
|
|
–
98/79
|
Website
info@khmedical.co.kr
EUDAMED record
Report an error
|
| Molbio Diagnostics
EU representative : QbD RepS BV (Belgium)
|
India
|
|
C
IVDR
|
Website
customersupport@molbiodiagnostics.com
EUDAMED record
Report an error
|
| OSANG Healthcare
EU representative : Obelis s.a. (Belgium)
|
South Korea
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Reetoo
EU representative : Umedwings Netherlands B.V. (Netherlands)
|
China
|
|
–
98/79
|
Website
service@reetoo.com.cn
EUDAMED record
Report an error
|
| Sanway Gene Tech
EU representative : Obelis s.a. (Belgium)
|
China
|
|
–
98/79
|
Website
info@sansure.com.cn
EUDAMED record
Report an error
|
| Singuway
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
–
98/79
|
sales@singuway.com
EUDAMED record
Report an error
|
| Suny (Xiamen) Biotechnology
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| TIB MOLBIOL Syntheselabor
|
Germany
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Vela Operations Singapore Pte
EU representative : Vela Diagnostics Germany GmbH (Germany)
|
Singapore
|
|
–
98/79
|
Website
infoAPAC@veladx.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
|
| Wwhsbio
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
–
98/79
|
Website
info@wwhsbio.com
EUDAMED record
Report an error
|
| Yanengbio
EU representative : Obelis s.a. (Belgium)
|
China
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Zhejiang Greylynx Biotech
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
–
98/79
|
info@vivachek.com
EUDAMED record
Report an error
|
| Zhuhai Shineway Biotech
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|
| Zybio
EU representative : QbD RepS BV (Belgium)
|
China
|
|
C
IVDR
|
PMS@zy-ivd.com
EUDAMED record
Report an error
|
| Mobidiag
No model still on the market
|
Finland
|
4 others
|
–
98/79
|
Website
sales.mob@hologic.com
EUDAMED record
Report an error
|
| Wuhan Easydiagnosis Biomedicine
EU representative : CMC Medical Devices & Drugs SL (Spain)
No model still on the market
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Uniogen
No model still on the market
|
Finland
|
|
–
98/79
|
info@uniogen.com
EUDAMED record
Report an error
|
| Arcdia
No model still on the market
|
Finland
|
|
A
IVDR
|
Website
office@arcdia.com
EUDAMED record
Report an error
|
| Raingene
EU representative : Lotus NL B.V. (Netherlands)
No model still on the market
|
China
|
|
–
98/79
|
EUDAMED record
Report an error
|
| Innobiochips
No model still on the market
|
France
|
|
–
98/79
|
Website
EUDAMED record
Report an error
|