| Vitrosens
|
Türkiye
|
17 others
|
A
IVDR
|
Website
info@vitrosens.com
EUDAMED record
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|
| Bioer
EU representative : MedNet EC-REP GmbH (Germany)
|
China
|
14 others- CentriDx Automated Nucleic Acid Analyzer CentriDx 200(EA4) , CentriDx 200(EA5) , CentriDx 200(EA6)3 refs
- GeneExplorer Thermal Cycler GE-96G, GE-96S, GE-48DG, GE-384G, GE-4I, GE-48D, GE-48DS,GE-DX3 refs
- GenePure 96 Nucleic Acid Purification System NPA-96, NPA-96T, NPA-96E3 refs
- GenePure Pro 16H Nucleic Acid Purification System NPA-16H
- GenePure Pro 9600 Nucleic Acid Purification System NPAm-9600
- GenePure Pro Nucleic Acid Purification System NPA-32P, NPA-32E2 refs
- LineGene 9600 Plus Fluorescent Quantitative Detection System FQD-96A(EA2), FQD-96A(EA4), FQD-96A(EA5), FQD-96A(EA6)3 refs
- LineGene 9600 Pro Fluorescenct Quantitative Detection System FQD-96A(ED2), FQD-96A(ED4), FQD-96A(ED5), FQD-96A(ED6)3 refs
- LineGene K Plus Fluorescent Quantitative Detection System FQD-48A(EA2), FQD-48A(EA4)2 refs
- LineGene Mini Fluorescent Quantitative Detection System FQD-16A(EA2R), FQD-16A(EA2H), FQD-16A(EA4)3 refs
- LineGene MiniS Fluorescent Quantitative Detection System FQD-16B(EA2) , FQD-16B(EA4)2 refs
- QuantFlex Fluorometer QuantFlex 800
- QuantGene 9600 Fluorescent Quantitative Detection System FQD-96C(EA4), FQD-96C(EA5), FQD-96C(EA6)3 refs
- VitroCycler Fluorescent Quantitative Detection System VIT-VitroCycler
|
A
IVDR
|
Website
ra_oversea@bioer.com.cn
EUDAMED record
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|
| Hybribio
EU representative : Kingsmead Service B.V. (Netherlands)
|
China
|
7 others
|
A
IVDR
|
EUDAMED record
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|
| Ustar Biotechnologies (Hangzhou)
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
7 others
|
A
IVDR
|
Website
service@bioustar.com
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|
| Xi An Tianlong Science Technology
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
- Aurora PANA X6
- Genesy
- Gentier 48E, Gentier 48R, Gentier 96E, Gentier 96T, Gentier 96R, Gentier Mini, Gentier mini+, Gentier X3E, Gentier X3R, Gentier X3S, Gentier X3C, FLUORITE, PowerAmp96™ Dx3 refs
- Gentier Sp96E, Gentier Sp96R, Gentier Sp96X, Gentier Sp96V, Gentier Sp384E, Gentier Sp384R3 refs
- iGenebox 3A
7 others- Npex 96
- Nucleic Acid Extraction System Libex, GeneRotex 24, GeneRotex 48, GeneRotex 96, GeneFlex 16, GeneFlex 32, GeneFlex 48, GeneFlex 96, GeneFlex 192, Npex 192, PowerEXP™ 323 refs
- PANA 9600S, PANA 9600X, PANA 3200S, PANA 3200S+3 refs
- Panall 8000
- Panall X1600
- Rhodonite
- VIRPLEX 8 VX8S
|
A
IVDR
|
EUDAMED record
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|
| Qiagen
EU representative : QIAGEN GmbH (Germany)
|
Germany, United States
|
5 others
|
A
IVDR
|
Website
info@qiagen.com
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|
| Anatolia Tani Ve Biyoteknoloji Urunleri Arastirma Gelistirme San Ve Tic
|
Türkiye
|
4 others
|
A
IVDR
|
Website
info@anatoliagenetik.com
EUDAMED record
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|
| Bioneer
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
|
South Korea
|
2 others
|
A
IVDR
|
Website
sales@bioneer.com
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|
| MagBio Genomics
EU representative : CEpartner4U (Netherlands)
|
United States
|
2 others
|
A
IVDR
|
Website
info@magbiogenomics.com
EUDAMED record
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|
| PentaBase
|
Denmark
|
2 others
|
A
IVDR
|
Website
info@pentabase.com
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|
| Sansure
EU representative : Obelis s.a. (Belgium)
|
China
|
2 others
|
A
IVDR
|
Website
info@sansure.com.cn
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|
| Taiwan Advanced Nanotech
EU representative : mdi Europa GmbH (Germany)
|
Taiwan
|
2 others
|
A
IVDR
|
Website
EUDAMED record
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|
| Targetingone
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
2 others
|
A
IVDR
|
EUDAMED record
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|
| Zhuhai Shineway Biotech
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
2 others
|
A
IVDR
|
Website
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|
| Biocomma
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
1 other
|
A
IVDR
|
Website
sales@biocomma.cn
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|
| Life Technologies Holdings Pte
EU representative : Life Technologies Europe B.V. (Netherlands)
|
Singapore
|
1 other
|
A
IVDR
|
EUDAMED record
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|
| Zybio
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
1 other
|
A
IVDR
|
PMS@zy-ivd.com
EUDAMED record
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|
| Aperbio Technologies (Suzhou)
EU representative : Medunion S.L. (Spain)
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Daan Gene
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Dynex
|
Czechia
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Genemind
EU representative : Umedwings Netherlands B.V. (Netherlands)
|
China
|
|
A
IVDR
|
regulatoryaffairs@genemind.com
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|
| Linear
|
Spain
|
|
A
IVDR
|
Website
info@linear.es
EUDAMED record
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|
| Ningbo HEALTH Gene Technologies
EU representative : Lotus NL B.V. (Netherlands) and 1 other
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Optolane
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
|
South Korea
|
|
A
IVDR
|
info@optolane.com
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|
| Rocgene
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
A
IVDR
|
sale@rocgene.com
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|
| Sikun
EU representative : Obelis s.a. (Belgium)
|
China
|
- Gene Sequencer (Sikun 2000 & Sikun 1000 & Sikun 500 & Sikun 2000 pro & Sikun 1000 pro & Sikun 500 pro)3 refs
- Gene Sequencer Sikun Rapid GS 480
- Library Prep Consumables(for Library Construction) Full-Skirted PCR Plate, Full-Skirted PCR Plate, Round Deep Well Plate, Squarel Deep Well Plate, 7#Tip, 8#Tip, SIKUN Waste Container, Semi-Skirted PCR Plate, Aluminum Sealing Film, Strip Holder, Reagent Reservoir, PCR Sealing Mat3 refs
- Library Prep Consumables(for Nucleic Acid Extraction) 1#Magnetic Bead Sleeves, 2#Magnetic Bead Sleeves2 refs
- Library Prep Consumables(for Quality Control) QC Kit, Qubit Assay Tube, 9#Tip3 refs
|
A
IVDR
|
EUDAMED record
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|
| Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇
|
Türkiye
|
|
A
IVDR
|
Website
info@visionbiotechnology.com
EUDAMED record
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|
| 3D Biomedicine Science & Technology
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Aitbiotech
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
Singapore
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Beijing Applied Biological Technologies
EU representative : Luxus Lebenswelt GmbH (Germany)
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| DNA-Technology, Research & Production
EU representative : Obelis s.a. (Belgium)
|
Russia
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Guangdong RunPon Bioscience
EU representative : Share info GmbH (Germany)
|
China
|
|
A
IVDR
|
Service_RP@fapon.com
EUDAMED record
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|
| igenetech
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
South Korea
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Illumina
EU representative : Illumina Netherlands B.V. (Netherlands)
|
United States
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Molarray
EU representative : Caretechion GmbH (Germany)
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Pilotgene
EU representative : Medunion S.L. (Spain)
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Precision System Science
EU representative : Emergo Europe B.V. (Netherlands)
|
Japan
|
|
A
IVDR
|
service@pss.co.jp
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|
| Shenzhen Everbest Machinery lndustry
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Vazyme
EU representative : Caretechion GmbH (Germany) and 1 other
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Genesystem
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
|
South Korea
|
|
A
IVDR
|
Website
ra@genesystem.co.kr
EUDAMED record
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|
| Abbott
EU representative : Abbott GmbH (Germany)
|
United States
|
|
A
IVDR
|
ratransfusionmedicine@abbott.com
EUDAMED record
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|
| Becton Dickinson
EU representative : Becton Dickinson Ireland Limited (Ireland)
|
United States
|
|
A
IVDR
|
Website
EUDAMED record
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|
| BioFire Diagnostics
EU representative : bioMérieux SA (France)
|
United States
|
|
A
IVDR
|
EUDAMED record
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|
| Bioteke
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
A
IVDR
|
Website
info@bioteke.cn
EUDAMED record
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|
| Coyotebio
EU representative : QbD RepS BV (Belgium)
|
China
|
|
A
IVDR
|
sales@coyotebio.com
EUDAMED record
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|
| Cube Dx
|
Austria
|
|
A
IVDR
|
Website
info@cubedx.com
EUDAMED record
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|
| Hangzhou Bigfish Bio-tech
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Hangzhou Bio-gener Technology
EU representative : MedPath GmbH (Germany)
|
China
|
|
A
IVDR
|
info@bio-gener.com
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|
| KH Medical
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
|
South Korea
|
|
A
IVDR
|
Website
info@khmedical.co.kr
EUDAMED record
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|
| Meridian Bioscience
EU representative : Meridian Bioscience Europe S.r.l. (Italy)
|
United States
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Pluslife
EU representative : PureCE B.V. (Netherlands) and 1 other
|
China
|
|
A
IVDR
|
Website
ra@pluslife.com
EUDAMED record
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|
| Qitan Taike Biotechnology Chengdu
EU representative : MedPath GmbH (Germany)
|
China
|
|
A
IVDR
|
EUDAMED record
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| RevoSketch
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
South Korea
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Shanghai Chuangkun Biotech
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Suzhou Sym-Bio Lifescience
EU representative : Emergo Europe B.V. (Netherlands)
|
China
|
|
A
IVDR
|
quality.taicang@revvity.com
EUDAMED record
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|
| Wallac
|
Finland
|
|
A
IVDR
|
Website
regulatoryaffairs.turku@revvity.com
EUDAMED record
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| Wizbiosolution
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
South Korea
|
|
A
IVDR
|
EUDAMED record
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|
| Yanengbio
EU representative : Obelis s.a. (Belgium)
|
China
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Adaltis
|
Italy
|
|
–
98/79
|
Website
info@adaltis.net
EUDAMED record
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|
| Agilent
EU representative : Agilent Technologies Denmark ApS (Denmark)
|
Singapore
|
|
A
IVDR
|
Website
info.dk@agilent.com
EUDAMED record
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|
| Aikang MedTech
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
|
A
IVDR
|
EUDAMED record
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| Autobio
EU representative : Obelis s.a. (Belgium)
|
China
|
|
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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|
| Credo Diagnostics Biomedical Pte Taiwan Branch
EU representative : MedNet EC-REP GmbH (Germany)
|
Taiwan
|
|
A
IVDR
|
service@credodxbiomed.com
EUDAMED record
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|
| Diagnostics For Real World Europe
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
|
United Kingdom (ex Northern Ireland)
|
|
A
IVDR
|
Website
qa@drw-ltd.com
EUDAMED record
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|
| Euroimmun
|
Germany
|
|
A
IVDR
|
Website
info@euroimmun.de
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|
| FlashDx Shenzhen
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
|
A
IVDR
|
info@flash-dx.com
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| Geneplus
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
|
|
A
IVDR
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EUDAMED record
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| Genes2Me
EU representative : Obelis s.a. (Belgium)
|
India
|
|
A
IVDR
|
Website
EUDAMED record
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|
| GenMark Diagnostics
EU representative : Roche Diagnostics GmbH (Germany)
|
United States
|
|
A
IVDR
|
regulatory.rmd_international@roche.com
EUDAMED record
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|
| Guangzhou Deaou Gene Technology
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
A
IVDR
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EUDAMED record
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| Guangzhou Four E’s Healthcare
EU representative : Kingsmead Service B.V. (Netherlands)
|
China
|
|
A
IVDR
|
Website
cs4@4e-s.com
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|
| Hain Lifescience
|
Germany
|
|
A
IVDR
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EUDAMED record
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| Healgen
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
United States
|
|
–
98/79
|
quality@healgen.com
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| Hlb Panagene
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
|
South Korea
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|
A
IVDR
|
Website
EUDAMED record
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|
| Human
|
Germany
|
|
A
IVDR
|
Website
EUDAMED record
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| Hysenbiotech
EU representative : Medunion S.L. (Spain)
|
South Korea
|
|
A
IVDR
|
EUDAMED record
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| Infitek
EU representative : Kingsmead Service B.V. (Netherlands) and 1 other
|
China
|
|
A
IVDR
|
info@infitek.com
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| Jiangsu Q-Array
EU representative : Caretechion GmbH (Germany)
|
China
|
|
A
IVDR
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EUDAMED record
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| Katsura
EU representative : Kingsmead Service B.V. (Netherlands)
|
Taiwan
|
|
A
IVDR
|
Website
EUDAMED record
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| Lifereal
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
A
IVDR
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EUDAMED record
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| Maccura
EU representative : Humiss International B.V. (Netherlands)
|
China
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|
A
IVDR
|
Website
EUDAMED record
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| Ortho-Clinical Diagnostics Dba Quidel
EU representative : MDSS GmbH (Germany)
|
United States
|
|
A
IVDR
|
Website
PRRC@quidelortho.com
EUDAMED record
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| Qingdao MGI Tech
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
|
A
IVDR
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EUDAMED record
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| Shandong Bohong Gene Technology
EU representative : Luxus Lebenswelt GmbH (Germany)
|
China
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|
A
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| Shanghai LeChen Biotechnology
EU representative : Everbiz GmbH (Austria)
|
China
|
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| Shenzhen YOUYI Bioscience
EU representative : Umedwings Netherlands B.V. (Netherlands)
|
China
|
|
A
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| Shenzhen Zijian Biotechnology
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
–
98/79
|
Website
sales@szzijian.com
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|
| Singleragenomics
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) and 1 other
|
China
|
|
A
IVDR
|
RA@singleragenomics.com
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| Singuway
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
A
IVDR
|
sales@singuway.com
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| Wuxi Opulen Technology
EU representative : SUNGO Europe B.V. (Netherlands) and 1 other
|
China
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| Wuxi Qitian Biological Science Instrument
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
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|
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| Xiamen Zeesan Biotech
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
A
IVDR
|
info@zsandx.com
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| Ab Analitica
|
Italy
|
|
A
IVDR
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customersupport@abanalitica.it
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| AD Nucleis
|
France
|
|
A
IVDR
|
Website
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| Affymetrix
EU representative : Life Technologies Europe B.V. (Netherlands)
|
United States
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| Aigene
EU representative : SUNGO Europe B.V. (Netherlands)
|
South Korea
|
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A
IVDR
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EUDAMED record
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| Anhui Wanyi Science Technology
EU representative : Eunitor GmbH (Germany)
|
China
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Appolon Bioteck
|
France
|
|
A
IVDR
|
Website
contact@appolonbioteck.com
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| Attomol
|
Germany
|
|
A
IVDR
|
Website
info@attomol.de
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| AusDiagnostics
EU representative : R-Biopharm AG (Germany)
|
Australia
|
|
A
IVDR
|
Website
regulatory@r-biopharm.com.au
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| Baybio
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
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| Beijing Lepu Medical Technology
EU representative : Lepu Medical (Europe) Cooperatief U.A. (Netherlands)
|
China
|
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A
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| Beijing North Institute of Biotechnology
EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)
|
China
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|
A
IVDR
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EUDAMED record
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| Bgi
|
Denmark
|
|
A
IVDR
|
Website
EUDAMED record
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| BGI Hangzhou CycloneSEQ Technology
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
|
A
IVDR
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EUDAMED record
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| BioArray Solutions
EU representative : IMMUCOR Medizinische Diagnostik GmbH (Germany)
|
United States
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|
A
IVDR
|
Website
EUDAMED record
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| Biobase
EU representative : Luxus Lebenswelt GmbH (Germany)
|
China
|
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A
IVDR
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EUDAMED record
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| Biocartis
|
Belgium
|
|
A
IVDR
|
Website
regulatory@biocartis.com
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| BioChain (Beijing) Science & Technology
EU representative : Medunion S.L. (Spain)
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Bioda Diagnostics (Wuhan)
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Bioeksen
|
Türkiye
|
|
A
IVDR
|
Website
info@bioeksen.com.tr
EUDAMED record
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|
| Brightbiomed
EU representative : MedPath GmbH (Germany)
|
China
|
|
A
IVDR
|
info@brightbiomed.com
EUDAMED record
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|
| Cellomics (Shenzhen)
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Cepheid
EU representative : Cepheid AB (Sweden)
|
United States
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Chengdu One-Chip Biotechnology
EU representative : Share info GmbH (Germany)
|
China
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| Chongqing ME Instruments Technology
EU representative : MedPath GmbH (Germany)
|
China
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| Chroma Ate
EU representative : MedNet EC-REP GmbH (Germany)
|
Taiwan
|
|
A
IVDR
|
Website
info@chromaate.com
EUDAMED record
Report an error
|
| Cowingene
EU representative : MedPath GmbH (Germany)
|
China
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Dartmon
EU representative : Umedwings Netherlands B.V. (Netherlands)
|
China
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Delbio
EU representative : Emergo Europe B.V. (Netherlands)
|
Taiwan
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Dermagnostix
|
Germany
|
|
–
98/79
|
Website
info@dermagnostix.com
EUDAMED record
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|
| DiagCor Life Science
EU representative : SUNGO Europe B.V. (Netherlands)
|
Hong Kong SAR China
|
|
A
IVDR
|
QARA@diagcorlifescience.com
EUDAMED record
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|
| DiaSorin
|
Italy
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Ecolidx
|
Czechia
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Element Biosciences
EU representative : QbD RepS BV (Belgium)
|
United States
|
|
A
IVDR
|
support@elembio.com
EUDAMED record
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|
| ELITechGroup
|
Italy
|
|
A
IVDR
|
Website
EUDAMED record
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|
| EntroGen
EU representative : TANJA TOPOVSEK S.P. (Slovenia)
|
United States
|
|
A
IVDR
|
Website
contact@entrogen.com
EUDAMED record
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|
| Genedrive
EU representative : Advena Limited (Malta)
|
United Kingdom (ex Northern Ireland)
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Geneproof
|
Czechia
|
|
A
IVDR
|
Website
support@geneproof.com
EUDAMED record
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|
| Geneus Technologies (Chengdu)
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Genomictree
EU representative : KTR Europe GmbH (Germany)
|
South Korea
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH
|
Germany
|
|
A
IVDR
|
Website
info@gfeblut.de
EUDAMED record
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|
| Grifols
EU representative : Diagnostic Grifols, S.A. (Spain)
|
United States
|
|
A
IVDR
|
Website
RegulatoryAffairs_DxBU@grifols.com
EUDAMED record
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|
| Guangzhou Four E’s Scientific
EU representative : Humiss Beratung GmbH (Germany)
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Hangzhou MiYin Biotechnology
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Hangzhou Zhunxin Biotechnology
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Hanwooltpc
EU representative : Javitech Consulting GmbH (Germany)
|
South Korea
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Hyris
|
Italy
|
|
A
IVDR
|
Website
support@hyris.net
EUDAMED record
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|
| Icarbonx
EU representative : Kingsmead Service B.V. (Netherlands)
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Igenesis Shanghai
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
A
IVDR
|
support@igenesisbio.com
EUDAMED record
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|
| Intron
EU representative : Obelis s.a. (Belgium)
|
South Korea
|
|
A
IVDR
|
EUDAMED record
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|
| Jiangsu Bojia Biomedical Technology
EU representative : MedPath 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 ME Instruments
EU representative : MedPath GmbH (Germany)
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Kogene
EU representative : Obelis s.a. (Belgium)
|
South Korea
|
|
A
IVDR
|
Website
info@kogene.co.kr
EUDAMED record
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|
| Longgene
EU representative : MedPath GmbH (Germany)
|
China
|
|
A
IVDR
|
info@longgene.com
EUDAMED record
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|
| Luminexcorp
EU representative : DiaSorin Italia S.p.A. (Italy)
|
United States
|
|
A
IVDR
|
Website
regulatoryaffairs@luminexcorp.com
EUDAMED record
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|
| Masmec
|
Italy
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Medcaptain
EU representative : R Sight B.V. (Netherlands)
|
China
|
|
A
IVDR
|
Website
info@medcaptain.com
EUDAMED record
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|
| Mgitech
|
Latvia
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Personalgenome
EU representative : Emergo Europe B.V. (Netherlands)
|
United States
|
|
C
IVDR
|
Website
EUDAMED record
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|
| Quantidx Hong Kong
EU representative : MedPath GmbH (Germany)
|
Hong Kong SAR China
|
|
A
IVDR
|
EUDAMED record
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|
| R-Biopharm
|
Germany
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Randox
|
Northern Ireland
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Rgbio
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| SD Biosensor
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
|
South Korea
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Seegene
EU representative : Medical Technology Promedt Consulting GmbH (Germany)
|
South Korea
|
|
A
IVDR
|
Website
info@seegene.com
EUDAMED record
Report an error
|
| Sense Biodetection
EU representative : Emergo Europe B.V. (Netherlands)
|
United Kingdom (ex Northern Ireland)
|
|
–
98/79
|
Website
info@sense-bio.com
EUDAMED record
Report an error
|
| Shanghai Rendu Biotechnology
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Shanghai Zj Bio-Tech
EU representative : Lotus NL B.V. (Netherlands)
|
China
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Shenzhen MGI Biological Electronic Technology
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
|
A
IVDR
|
EUDAMED record
Report an error
|
| Shenzhen Uni-medica Technology
EU representative : CMC Medical Devices & Drugs SL (Spain)
|
China
|
|
A
IVDR
|
Website
marketing@uni-medica.com
EUDAMED record
Report an error
|
| Surgnova
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
|
IIb
MDR
|
qara@surgnova.com
EUDAMED record
Report an error
|
| Suzhou Changhe Biotech
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Suzhou Sniper Medical Technologies
EU representative : MedPath GmbH (Germany)
|
China
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Sysmex
EU representative : Sysmex Europe SE (Germany)
|
Japan
|
|
A
IVDR
|
ra_archive@sysmex.co.jp
EUDAMED record
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|
| Toroivd Technology
EU representative : SUNGO Europe B.V. (Netherlands)
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Tosoh
EU representative : Tosoh Europe N.V. (Belgium)
|
Japan
|
|
A
IVDR
|
csc@tosoh.co.jp
EUDAMED record
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|
| Viramed
|
Germany
|
|
A
IVDR
|
Website
EUDAMED record
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|
| Winnoz
EU representative : MedNet EC-REP GmbH (Germany)
|
Taiwan
|
|
A
IVDR
|
Website
service@winnoz.com
EUDAMED record
Report an error
|
| Wondfo
EU representative : QbD RepS BV (Belgium)
|
China
|
- U-CardDxTM 200 WonDx-1001, WonDx-1002, WonDx-1003, WonDx-1004, WonDx-1005, WonDx-1006, WonDx-1007, WonDx-1008, U-CardDx 200-1001, U-CardDx 200-1002, U-CardDx 200-1003, U-CardDx 200-1004,U-CardDx 200-1005,U-CardDx 200-1006, U-CardDx 200-1007,U-CardDx 200-10083 refs
|
A
IVDR
|
Website
sales@wondfo.com.cn
EUDAMED record
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|
| Wuhan MGI Tech
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
|
China
|
|
A
IVDR
|
EUDAMED record
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|
| Zinexts
EU representative : Obelis s.a. (Belgium)
|
Taiwan
|
|
A
IVDR
|
Website
EUDAMED record
Report an error
|
| Mobidiag
No model still on the market
|
Finland
|
|
A
IVDR
|
Website
sales.mob@hologic.com
EUDAMED record
Report an error
|
| Uniogen
No model still on the market
|
Finland
|
|
A
IVDR
|
info@uniogen.com
EUDAMED record
Report an error
|