IVD instrumentsNucleic acid testing instruments

Nucleic acid testing instruments except micro-arrays

EMDN code W020501

155 manufacturers, 405 models including 402 on the market, 22 countries

On the market in Models on the market only Include accessories and consumables Manufacturer country

Manufacturers registered in Europe (EUDAMED) 155

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a manufacturer to see its full range, a model to open its EUDAMED record.

Manufacturer	Country	Registered models	Class	Contact
Vitrosens	Türkiye	MagFast 16 Genomic DNA Purification Kit from Bacteria MGF11P96 MagFast 16 Genomic DNA Purification Kit From Blood MGF07P48 MagFast 16-Flex Genomic DNA Purification Kit From Blood MGF08P48 MagFast Single-Cartridge Genomic DNA Purification Kit From Bacteria MGF10P48 MagFast Single-Cartridge Genomic DNA Purification Kit From Blood MGF06P48 17 others MagFast Single-Cartridge Genomic DNA Purification Kit From Blood MGF06P96 MagFast 16 Genomic DNA Purification Kit from Bacteria MGF11P48 MagFast 16 Genomic DNA Purification Kit From Blood MGF07P96 MagFast 16 Total Nucleic Acid Purification Kit MGF03P48 MagFast 16 Total Nucleic Acid Purification Kit MGF03P96 MagFast 16-Flex Genomic DNA Purification Kit From Bacteria MGF12P48 MagFast 16-Flex Genomic DNA Purification Kit From Bacteria MGF12P96 MagFast 16-Flex Genomic DNA Purification Kit From Blood MGF08P96 MagFast 16-Flex Total Nucleic Acid Purification Kit MGF04P48 MagFast 16-Flex Total Nucleic Acid Purification Kit MGF04P96 MagFast Genomic DNA Purification Kit From Bacteria MGF09P100 MagFast Genomic DNA Purification Kit From Blood MGF05P100 MagFast Genomic DNA Purification Kit From Blood MGF05P96 MagFast Single-Cartridge Genomic DNA Purification Kit From Bacteria MGF10P96 MagFast Single-Cartridge Nucleic Acid Purification Kit MGF02P48 MagFast Single-Cartridge Nucleic Acid Purification Kit MGF02P96 MagFast Total Nucleic Acid Purification Kit MGF01P100	A IVDR	Website info@vitrosens.com EUDAMED record Report an error
Bioer FDA EU representative : MedNet EC-REP GmbH (Germany)	China	AutoGene 9600 Automatic PCR Analysis System FQD-A9600(EA4), FQD-A9600(EA5), FQD-A9600(EA6)3 refs Automated Nucleic Acid Purification and Real Time PCR System FQD-A1600(EA4), FQD-A1600(EA5), FQD-A1600(EA6)3 refs Automated Nucleic Acid Purification System NPAs-9600,NPAs-96202 refs Bioquant-96m Fluorescent Quantitative Detection System careSTART™ Q1 Amplifier TQA-E00182 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 Report an error
Hybribio EU representative : Kingsmead Service B.V. (Netherlands)	China	Fully Automated Nucleic Acid Extraction and Real-time PCR System HB-IEX96Q HB-2012A HB-IEX96A HB-IEX96S HBHM-3001S 7 others HBHM-9000A HBNP-4801A HBNP-4803A HBNP-9601A HBNP-ME32A HBQW-3200A HHM-3	A IVDR	EUDAMED record Report an error
Xi An Tianlong Science Technology FDA 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 Npex 96 6 others 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 Report an error
Qiagen FDA EU representative : QIAGEN GmbH (Germany)	Germany, United States	EZ2 Connect MDx QIAcube Connect MDx QIAcuityDx Four QIAstat-Dx Analytical Module3 refs QIAstat-Dx Rise 5 others QIAsymphony AS QIAsymphony Connect QIAsymphony SP Rapid Capture System Rotor-Gene Q MDx 5Plex3 refs	A IVDR	Website info@qiagen.com EUDAMED record Report an error
Anatolia Tani Ve Biyoteknoloji Urunleri Arastirma Gelistirme San Ve Tic	Türkiye	Anatolia Geneworks Magnesia 16 Nucleic Acid Extraction Instrument Anatolia Geneworks Magnesia 2448 Nucleic Acid Extraction & PCR Setup Robot Anatolia Geneworks Montania 4896 Real-Time PCR Instrument Anatolia Geneworks UNIO 448 System Anatolia Geneworks Unio 96 Extraction and PCR Setup Robot 4 others Anatolia Geneworks Unio A24S Extraction & PCR Setup System Anatolia Geneworks Unio B24 Extraction System Anatolia Geneworks Unio B48 Extraction System Anatolia Geneworks Unio M32 Extraction System	A IVDR	Website info@anatoliagenetik.com EUDAMED record Report an error
Bioneer FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	Exicycler™ 962 refs ExiCycler™ V5 3843 refs ExiPrep™16 Dx ExiPrep™48 Dx ExiPrep™96 Lite 2 others ExiStation™ FA 384 ExiStation™ FA 96/3842 refs IRON-qPCR™	A IVDR	Website sales@bioneer.com EUDAMED record Report an error
MagBio Genomics FDA EU representative : CEpartner4U (Netherlands)	United States	HighPrep PCR - DX (1 mL) Device for post-PCR and post-enzymatic reaction clean-up HighPrep PCR - DX (100 mL) Device for post-PCR and post-enzymatic reaction clean-up HighPrep PCR - DX (1000 mL) Device for post-PCR and post-enzymatic reaction clean-up HighPrep PCR - DX (250 mL) Device for post-PCR and post-enzymatic reaction clean-up HighPrep PCR - DX (5 mL) Device for post-PCR and post-enzymatic reaction clean-up 2 others HighPrep PCR - DX (50 mL) Device for post-PCR and post-enzymatic reaction clean-up HighPrep PCR - DX (500 mL) Device for post-PCR and post-enzymatic reaction clean-up	A IVDR	Website info@magbiogenomics.com EUDAMED record Report an error
PentaBase	Denmark	BasePurifier™ 32 Nucleic Acid Extraction System 32 Oscillating Rods BasePurifier™ 48 Large Volume Nucleic Acid Extraction System 48 Rotating Rods BasePurifier™ 96 Nucleic Acid Extraction System 96 Rotating Rods BaseTyper™ 16.2 Portable Real-Time PCR System BaseTyper™ 48.4 Quiet HRM Real-Time PCR System 2 others BaseTyper™ 96.4 Flexible Real-Time PCR System BaseTyper™ 96.6 Flexible Real-Time PCR System	A IVDR	Website info@pentabase.com EUDAMED record Report an error
Sansure FDA EU representative : Obelis s.a. (Belgium)	China	Fully Automated Nucleic Acid Extraction System S-S13A Nucleic Acid Analysis Device S-Q35C Portable Molecular Diagnostic System S-Q37A2 refs Portable Molecular Workstation S-Q36A, S-Q36B2 refs Portable Molecule Workstation S-Q31A 2 others Portable Molecule Workstation S-Q31B S-S13E-P; S-S13E-P12 refs	A IVDR	Website info@sansure.com.cn EUDAMED record Report an error
Taiwan Advanced Nanotech FDA EU representative : mdi Europa GmbH (Germany)	Taiwan	Maelstrom 24102 refs Maelstrom 48102 refs Maelstrom 8 Autostage3 refs Maelstrom 96002 refs Maelstrom 96102 refs 2 others Maelstrom 9610 LH SLA-E13200	A IVDR	Website EUDAMED record Report an error
Zhuhai Shineway Biotech EU representative : CMC Medical Devices & Drugs SL (Spain)	China	AutoPoc MDx Hand-held Nucleic Acid Detection Analyzer SWSI-023 refs IPOCT-01 MC42-P01 Nucleic Acid Release Reagent NARR-01 2 others PCR Nucleic Acid Analyzer SWM-01 Real-time PCR Nucleic Acid Detection System SWM-02	A IVDR	Website EUDAMED record Report an error
Biocomma EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Biocomma BNP027-5E Biocomma NAES-32 Biocomma NAES-48 Biocomma NAES-96 Biocomma NAES-96Plus 1 other Biocomma NAES-N96	A IVDR	Website sales@biocomma.cn EUDAMED record Report an error
Life Technologies Holdings Pte EU representative : Life Technologies Europe B.V. (Netherlands)	Singapore	3500 Dx Genetic Analyzer Applied Biosystems™ 3500 Dx/3500xL Dx Genetic Analyzers2 refs Applied Biosystems™ SeqStudio™ 24 Flex Dx Genetic Analyzer2 refs Ion OneTouch™ Dx Instrument3 refs Ion Torrent™ Genexus™ Dx Integrated Sequencer3 refs QuantStudio™ 5 Dx Real‑Time PCR Instrument (96-Well 0.2ml Block) QuantStudio™ 5 Dx Real-Time PCR System and Accessories2 refs 1 other QuantStudio™ 7 Pro Dx 384-Well Block QuantStudio™ 7 Pro Dx Real-Time PCR Instrument and Accessories3 refs	A IVDR	EUDAMED record Report an error
Zybio FDA EU representative : Lotus NL B.V. (Netherlands)	China	EXM30002 refs EXM6000, EXM62002 refs EXP 160, EXP 161, EXP 1623 refs EXP 160R, EXP 161R2 refs Quantitative Real-time PCR System EXP 960, EXP 961, EXP 962, EXP 9633 refs 1 other ZIP-96V	A IVDR	PMS@zy-ivd.com EUDAMED record Report an error
Aperbio Technologies (Suzhou) EU representative : Medunion S.L. (Spain)	China	Auto 12 Dx Kingwell 96 Dx Pangaea 3fast/4fast/5fast/6fast3 refs Pangaea Super 8 Pro Dx qMate mini Dx	A IVDR	EUDAMED record Report an error
Daan Gene EU representative : Lotus NL B.V. (Netherlands)	China	Automatic Nucleic Acid Extraction Instrument Swift96，Stream SP96，Ballet X33 refs NAE16 Nucleic Acid Extraction Instrument Smart32 ，Smart32plus Rapid Detection System T-elfie Real-time PCR Detection System Lava96	A IVDR	EUDAMED record Report an error
Dynex	Czechia	AdvanSure AlloView 1.13 refs ADVANSURE ALLOVIEW 2.0 DYNABLOT AUTOMATIC V43 refs DYNABLOT 442 refs DYNABLOT COMFORT DYNABLOT PLUS2 refs	A IVDR	Website EUDAMED record Report an error
Genemind EU representative : Umedwings Netherlands B.V. (Netherlands)	China	FASTASeq 300 Dx GeneMind2 refs GenoLab M Dx Single Molecule DNA Sequencer GenoCare 1600 SURFSeq 5000 Dx	A IVDR	regulatoryaffairs@genemind.com EUDAMED record Report an error
Linear FDA	Spain	NEOS-32 XT Nucleic Acid Extractor System NEOS-48 qPCR Real-Time PCR System 8435287395006 NEOS-96 qPCR Real-Time PCR System. 6 Channels NEOS-96 XT Nucleic Acid Extractor System NEOS-9NEOS-96 qPCR Real-Time PCR System. 4 Channels	A IVDR	Website info@linear.es EUDAMED record Report an error
Ningbo HEALTH Gene Technologies EU representative : Lotus NL B.V. (Netherlands) and 1 other	China	A-32 A-32min A-96 ES400 L-20	A IVDR	EUDAMED record Report an error
Optolane FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	LOAA Analyzer ONPOINT LOAA-M Console LOAA-M Module LAM304-01 LOAA-M POWERBOX LAM306-01 LOAA-M Powerbox System LAM306-01	A IVDR	info@optolane.com EUDAMED record Report an error
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 Report an error
3D Biomedicine Science & Technology FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	ANDiS 350 ANDiS 360 ANDiS 396 ANDiS 500	A IVDR	EUDAMED record Report an error
Aitbiotech EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	Singapore	800700 800705 800800 801001	A IVDR	Website EUDAMED record Report an error
Beijing Applied Biological Technologies EU representative : Luxus Lebenswelt GmbH (Germany)	China	ABT-24 Automatic Nucleic Acid Extraction and Real-Time PCR System ABT-24 MagiCube 48 X-Poche 162 refs	A IVDR	EUDAMED record Report an error
DNA-Technology, Research & Production EU representative : Obelis s.a. (Belgium)	Russia	DTprime II 4M13 refs DTstream 12L13 refs Real-time PCR instrument DTlite 4S12 refs Real-time PCR instrument DTprime 4M13 refs	A IVDR	Website EUDAMED record Report an error
Guangdong RunPon Bioscience EU representative : Share info GmbH (Germany)	China	Automatic Nucleic Acid Detection Analyzer Ideal 30 Automatic Nucleic Acid Detection Analyzer Ideal 36 Automatic Nucleic Acid Detection Analyzer Ideal 66 Real-time PCR Instrument P810	A IVDR	Service_RP@fapon.com EUDAMED record Report an error
Molarray EU representative : Caretechion GmbH (Germany)	China	Full-Automatic Nucleic Acid Extraction and qPCR Analysis System MW-1600BL Portable Nucleic Acid Detection Instrument MAtriX-Mini Portable Nucleic Acid Testing Box Mini-Cube Real-time Quantitative Thermal Cycler MA-6000,P30,MA-3200Q,MA-5000,MA-6000P,MA-9600P,MAtrix-6,MAtrix-43 refs	A IVDR	EUDAMED record Report an error
Pilotgene EU representative : Medunion S.L. (Spain)	China	Automated Digital PCR System AD3207 Automated Nucleic Acid Detection Reaction Construction System AP10 Digital PCR Workstation DW3200 Integrated Digital PCR Instrument Pilot1200	A IVDR	EUDAMED record Report an error
Precision System Science FDA EU representative : Emergo Europe B.V. (Netherlands)	Japan	geneLEAD VIII geneLEAD XXIV magLEAD 12gC magLEAD 12gC LiNK3 refs	A IVDR	service@pss.co.jp EUDAMED record Report an error
Rocgene FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	Archimed Mini 16 Archimed X4 Archimed X6 ArchiPure 96 Pro	A IVDR	sale@rocgene.com EUDAMED record Report an error
Vazyme EU representative : Caretechion GmbH (Germany) and 1 other	China	Logilet Logicore System Real-Time Fluorescence Quantitative PCR System Turbo16 Real-Time Quantitative Thermal Cycler FMR3 Vazyme Hybrid System2 refs	A IVDR	EUDAMED record Report an error
Genesystem FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	UF-300 / UF-300P2 refs UF-340 UF-400 UF-150 / UF-150E / F-1503 refs (no longer marketed)	A IVDR	Website ra@genesystem.co.kr EUDAMED record Report an error
Abbott FDA EU representative : Abbott GmbH (Germany)	United States	Alinity Alinity m3 refs M2000RT INSTRUMENT SYSTEM	A IVDR	ratransfusionmedicine@abbott.com EUDAMED record Report an error
Becton Dickinson FDA EU representative : Becton Dickinson Ireland Limited (Ireland)	United States	COR MAX VIPER	A IVDR	Website EUDAMED record Report an error
BioFire Diagnostics FDA EU representative : bioMérieux SA (France)	United States	FilmArray® 2.0 Instrument FilmArray® Torch System2 refs SpotFire®2 refs	A IVDR	EUDAMED record Report an error
Coyotebio EU representative : QbD RepS BV (Belgium)	China	FlashDetect Flash10 FlashDetect Flash20 FlashDetect Nano	A IVDR	sales@coyotebio.com EUDAMED record Report an error
Hangzhou Bio-gener Technology EU representative : MedPath GmbH (Germany)	China	Micro-Spectrophotometer BGNANO-6013 refs Nucleic Acid Purification System BGNA-32P Real-Time PCR System3 refs	A IVDR	info@bio-gener.com EUDAMED record Report an error
Illumina FDA EU representative : Illumina Netherlands B.V. (Netherlands)	United States	Illumina DRAGEN® Server for NextSeq550Dx NextSeq™ 550Dx Instrument2 refs MiSeq™Dx Instrument NovaSeq™ 6000Dx Instrument	A IVDR	Website EUDAMED record Report an error
KH Medical EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	RADI PCR RADICHAMP RADIONE2 refs	A IVDR	Website info@khmedical.co.kr EUDAMED record Report an error
Meridian Bioscience FDA EU representative : Meridian Bioscience Europe S.r.l. (Italy)	United States	Alethia Revogene® Revogene® Mock Pie	A IVDR	Website EUDAMED record Report an error
Qitan Taike Biotechnology Chengdu EU representative : MedPath GmbH (Germany)	China	QNome-3841 Nanopore Sequencer QNome-3841hexDx Nanopore Sequencer QPursue-6kDx Nanopore Sequencer	A IVDR	EUDAMED record Report an error
RevoSketch EU representative : CMC Medical Devices & Drugs SL (Spain)	South Korea	isoQuarkF2 isoQuarkM4 SS-7010	A IVDR	Website EUDAMED record Report an error
Suzhou Sym-Bio Lifescience EU representative : Emergo Europe B.V. (Netherlands)	China	Pre-NAT II (SY61-EI) Pre-NAT II SY61 Pre-NAT II SY61-01	A IVDR	quality.taicang@revvity.com EUDAMED record Report an error
Wallac	Finland	Vanadis Core Vanadis Extract Vanadis View	A IVDR	Website regulatoryaffairs.turku@revvity.com EUDAMED record Report an error
Wizbiosolution EU representative : CMC Medical Devices & Drugs SL (Spain)	South Korea	CL0001P1 CL0016 CL2016	A IVDR	EUDAMED record Report an error
Yanengbio EU representative : Obelis s.a. (Belgium)	China	Automatic Hybridization System YN-H48 Automatic Integrated Nucleic Acid Analyzer YN-AHR3210 Fully Automated Nucleic Acid Amplification Hybridization Analyzer YN-HR9600pro	A IVDR	Website EUDAMED record Report an error
Adaltis	Italy	EXTRALAB98/79 MDXlab98/79	– 98/79	Website info@adaltis.net EUDAMED record Report an error
Agilent FDA EU representative : Agilent Technologies Denmark ApS (Denmark)	Singapore	AriaDx Real-Time PCR Instrument K8930A MagnisDx NGS Prep System K1007A	A IVDR	Website info.dk@agilent.com EUDAMED record Report an error
Aikang MedTech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Nucleic Acid Extracting System AiNA32 Nucleic Acid Extracting System AiNP 96	A IVDR	EUDAMED record Report an error
Autobio FDA EU representative : Obelis s.a. (Belgium)	China	AutoMolec 1600 AutoMolec 3000 AutoMolec 1600	A IVDR	Website EUDAMED record Report an error
Avecon Healthcare EU representative : Amstermed B.V. (Netherlands)	India	AutoMax MAXCLEAN	A IVDR	Website EUDAMED record Report an error
Credo Diagnostics Biomedical Pte Taiwan Branch EU representative : MedNet EC-REP GmbH (Germany)	Taiwan	VitaPCR Instrument VitaSIRO solo Instrument	A IVDR	service@credodxbiomed.com EUDAMED record Report an error
Cube Dx	Austria	GINA 5003 refs LINA	A IVDR	Website info@cubedx.com EUDAMED record Report an error
Diagnostics For Real World Europe FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	United Kingdom (ex Northern Ireland)	SAMBA III Assay Module I190007AM SAMBA III Tablet Module I190007TM	A IVDR	Website qa@drw-ltd.com EUDAMED record Report an error
Euroimmun FDA	Germany	EUROArrayProcessor YG 0671-1 EUROArrayScanner YG 0602	A IVDR	Website info@euroimmun.de EUDAMED record Report an error
Geneplus EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Automated Workstation Gene+GIN16 Gene+Box Data Analysis and Management System ED5001	A IVDR	EUDAMED record Report an error
GenMark Diagnostics FDA EU representative : Roche Diagnostics GmbH (Germany)	United States	cobas® eplex system ePlex Instrument	A IVDR	regulatory.rmd_international@roche.com EUDAMED record Report an error
Guangzhou Four E’s Healthcare EU representative : Kingsmead Service B.V. (Netherlands)	China	Nucleic Acid Extractor System MultiEx 032 Nucleic Acid Extractor System MultiEx 096	A IVDR	Website cs4@4e-s.com EUDAMED record Report an error
Hain Lifescience	Germany	GT-Blot 48 TwinCubator	A IVDR	EUDAMED record Report an error
Hangzhou Bigfish Bio-tech EU representative : SUNGO Europe B.V. (Netherlands)	China	BFEX-16、BFEX-32、BFEX-96、BFEX-96E、BFEX-24E、BFEX-32E、BFEX-4E、BFEX-32P、BFEX-16E3 refs FC-96B,FC-96BE,FC-96GE,FC-96D,FC-96G.FC-384G,FC-1536G,FC-48D,FC-48N,FC-48T3 refs	A IVDR	EUDAMED record Report an error
Hlb Panagene EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	PANAMAX™ 16 PANAMAX™ 48	A IVDR	Website EUDAMED record Report an error
Human	Germany	HumaLoop M HumaLoop T	A IVDR	Website EUDAMED record Report an error
Jiangsu Q-Array EU representative : Caretechion GmbH (Germany)	China	Full-Automatic Nucleic Acid Extraction and Purification Instrument MN-9600B Real-time Quantitative Thermal Cycler MA-688，MA-1610Q，MA-1620Q，MA-1630Q，MA-1640Q3 refs	A IVDR	EUDAMED record Report an error
Katsura EU representative : Kingsmead Service B.V. (Netherlands)	Taiwan	Katsura Biological Coporation A-20-M03201 Katsura Biological Coporation S2R16B	A IVDR	Website EUDAMED record Report an error
Maccura EU representative : Humiss International B.V. (Netherlands)	China	Automatic Nucleic Acid Extraction System N 32，N 962 refs Real-Time PCR System N 904	A IVDR	Website EUDAMED record Report an error
Pluslife EU representative : PureCE B.V. (Netherlands) and 1 other	China	MiniDock Ultra PM001 Ultra Pluslife Dock Pro 8 PM008	A IVDR	Website ra@pluslife.com EUDAMED record Report an error
Shandong Bohong Gene Technology EU representative : Luxus Lebenswelt GmbH (Germany)	China	Nucleic Acid Extractor BH003 Real-time PCR System LEIA series2 refs	A IVDR	EUDAMED record Report an error
Shanghai LeChen Biotechnology EU representative : Everbiz GmbH (Austria)	China	CP-II CP-II-32	A IVDR	EUDAMED record Report an error
Shenzhen YOUYI Bioscience EU representative : Umedwings Netherlands B.V. (Netherlands)	China	EUYI Nucleic Acid Extraction Reagent (Manual method)2 refs Molecular Hybridizer MH48	A IVDR	EUDAMED record Report an error
Shenzhen Zijian Biotechnology EU representative : Lotus NL B.V. (Netherlands)	China	Automatic Nucleic Acid Extractor NEX-3298/79 Automatic Nucleic Acid Extractor NEX-9698/79	– 98/79	Website sales@szzijian.com EUDAMED record Report an error
Singleragenomics EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) and 1 other	China	Nucleic Acid Purification System CaptureRevo NAE24 Nucleic Acid Purification System NAE24 PIus	A IVDR	RA@singleragenomics.com EUDAMED record Report an error
Singuway EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Real-time PCR Quantitative Analyzer AccuRa Mini Real-time PCR Quantitative Analyzer AccuRa32	A IVDR	sales@singuway.com EUDAMED record Report an error
Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇	Türkiye	Q14-53 VIS-MAG EXTRACTION SYSTEM 32	A IVDR	Website info@visionbiotechnology.com EUDAMED record Report an error
Wuxi Opulen Technology EU representative : SUNGO Europe B.V. (Netherlands) and 1 other	China	Real time fluorescence quantitative PCR Device OP-qPCR1600C Real-time Fluorescence Quantitative PCR lnstrument OPqPCR1600	A IVDR	EUDAMED record Report an error
Xiamen Zeesan Biotech FDA EU representative : Lotus NL B.V. (Netherlands)	China	Lab-Aid 808 Nucleic Acid Extraction System3 refs Sanity 2.0 System3 refs	A IVDR	info@zsandx.com EUDAMED record Report an error
Ab Analitica	Italy	GENEQUALITY 2050	A IVDR	customersupport@abanalitica.it EUDAMED record Report an error
AD Nucleis	France	Sequence Evolution IVD2 refs	A IVDR	Website EUDAMED record Report an error
Aigene EU representative : SUNGO Europe B.V. (Netherlands)	South Korea	AIamp Arcus96S, AIamp Arcus96L	A IVDR	EUDAMED record Report an error
Anhui Wanyi Science Technology EU representative : Eunitor GmbH (Germany)	China	Real-Time PCR System GT-96	A IVDR	Website EUDAMED record Report an error
Appolon Bioteck	France	Smart GUARD	A IVDR	Website contact@appolonbioteck.com EUDAMED record Report an error
Attomol	Germany	attomol® Attosorb 3x96	A IVDR	Website info@attomol.de EUDAMED record Report an error
AusDiagnostics EU representative : R-Biopharm AG (Germany)	Australia	MT-Prep 24 System3 refs	A IVDR	Website regulatory@r-biopharm.com.au EUDAMED record Report an error
Beijing Lepu Medical Technology EU representative : Lepu Medical (Europe) Cooperatief U.A. (Netherlands)	China	Real-Time PCR System Lepgen-96	A IVDR	EUDAMED record Report an error
Beijing North Institute of Biotechnology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Microplate Washer NBI 0120E	A IVDR	EUDAMED record Report an error
Bgi	Denmark	BGI SI-POCT-02	A IVDR	Website EUDAMED record Report an error
BGI Hangzhou CycloneSEQ Technology EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Genetic Sequencer G100-E	A IVDR	EUDAMED record Report an error
Biobase FDA EU representative : Luxus Lebenswelt GmbH (Germany)	China	Automatic Nucleic Acid Extraction System BK-HS32mini3 refs	A IVDR	EUDAMED record Report an error
Biocartis FDA	Belgium	Idylla™ Console Idylla™ System3 refs	A IVDR	Website regulatory@biocartis.com EUDAMED record Report an error
BioChain (Beijing) Science & Technology EU representative : Medunion S.L. (Spain)	China	METHYSMART-12S	A IVDR	EUDAMED record Report an error
Bioda Diagnostics (Wuhan) EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Bioda	A IVDR	EUDAMED record Report an error
Bioeksen	Türkiye	Bioeksen 4LAB Molecular Analysis Instrument	A IVDR	Website info@bioeksen.com.tr EUDAMED record Report an error
Bioteke FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	AU1001,AU1001S,AU1001-963 refs	A IVDR	Website info@bioteke.cn EUDAMED record Report an error
Brightbiomed EU representative : MedPath GmbH (Germany)	China	Automatic Nucleic Acid Extraction and Real-Time PCR System2 refs	A IVDR	info@brightbiomed.com EUDAMED record Report an error
Cellomics (Shenzhen) EU representative : Lotus NL B.V. (Netherlands)	China	Digital PCR Reader	A IVDR	EUDAMED record Report an error
Cepheid FDA EU representative : Cepheid AB (Sweden)	United States	GeneXpert5 refs	A IVDR	Website EUDAMED record Report an error
Chengdu One-Chip Biotechnology EU representative : Share info GmbH (Germany)	China	eTrust® Semiconductor Gene Sequencer ATGC-4H	A IVDR	EUDAMED record Report an error
Chongqing ME Instruments Technology EU representative : MedPath GmbH (Germany)	China	Real-time fluorescence quantitative PCR analyzer	A IVDR	EUDAMED record Report an error
Chroma Ate FDA EU representative : MedNet EC-REP GmbH (Germany)	Taiwan	Chroma ATE GenXplore q4800	A IVDR	Website info@chromaate.com EUDAMED record Report an error
Dartmon FDA EU representative : Umedwings Netherlands B.V. (Netherlands)	China	In-situ Denaturation and Hybridization Processor DH1003 refs	A IVDR	Website EUDAMED record Report an error
Delbio EU representative : Emergo Europe B.V. (Netherlands)	Taiwan	DELBIO Automated Nucleic Acid Analysis System3 refs	A IVDR	Website EUDAMED record Report an error
Dermagnostix	Germany	PsorX-LabDisk98/79	– 98/79	Website info@dermagnostix.com EUDAMED record Report an error
DiagCor Life Science EU representative : SUNGO Europe B.V. (Netherlands)	Hong Kong SAR China	92002	A IVDR	QARA@diagcorlifescience.com EUDAMED record Report an error
DiaSorin FDA	Italy	LIAISON® MDX	A IVDR	Website EUDAMED record Report an error
Ecolidx	Czechia	ePure	A IVDR	Website EUDAMED record Report an error
Element Biosciences EU representative : QbD RepS BV (Belgium)	United States	AVITI Dx 880-00008	A IVDR	support@elembio.com EUDAMED record Report an error
ElitechGroup FDA	Italy	ELITe BeGenius®2 refs	A IVDR	Website EUDAMED record Report an error
EntroGen FDA EU representative : TANJA TOPOVSEK S.P. (Slovenia)	United States	Benchbot® 4800	A IVDR	Website contact@entrogen.com EUDAMED record Report an error
Geneproof	Czechia	myCROBE® Fully Automated Instrument	A IVDR	Website support@geneproof.com EUDAMED record Report an error
Genomictree EU representative : KTR Europe GmbH (Germany)	South Korea	GT NUCLEIC ACID PREP KIT GT-PREP-12 refs	A IVDR	Website EUDAMED record Report an error
Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH	Germany	PoET Instrument	A IVDR	Website info@gfeblut.de EUDAMED record Report an error
Grifols FDA EU representative : Diagnostic Grifols, S.A. (Spain)	United States	Procleix Panther System2 refs	A IVDR	Website RegulatoryAffairs_DxBU@grifols.com EUDAMED record Report an error
Hangzhou MiYin Biotechnology EU representative : SUNGO Europe B.V. (Netherlands)	China	AUTO-MAGec 32	A IVDR	EUDAMED record Report an error
Hangzhou Zhunxin Biotechnology EU representative : Lotus NL B.V. (Netherlands)	China	Nucleic Acid Amplification Analyzer AIMDX 1800	A IVDR	EUDAMED record Report an error
Hanwooltpc FDA EU representative : Javitech Consulting GmbH (Germany)	South Korea	Advansure E3 system3 refs	A IVDR	Website EUDAMED record Report an error
Healgen FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	United States	MNAP0198/79	– 98/79	quality@healgen.com EUDAMED record Report an error
Hyris	Italy	bCUBE3	A IVDR	Website support@hyris.net EUDAMED record Report an error
Hysenbiotech EU representative : Medunion S.L. (Spain)	South Korea	HysenD30H	A IVDR	EUDAMED record Report an error
Igenesis Shanghai EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Galaxy Lite3 refs	A IVDR	support@igenesisbio.com EUDAMED record Report an error
Infitek FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Real-time PCR3 refs	A IVDR	EUDAMED record Report an error
Intron EU representative : Obelis s.a. (Belgium)	South Korea	AutoXT Total gDNA Kit2 refs	A IVDR	EUDAMED record Report an error
Jiangsu Bojia Biomedical Technology EU representative : MedPath GmbH (Germany)	China	BJB Rapid Gene Detection System2 refs	A IVDR	EUDAMED record Report an error
Jiangsu CoWin Biotech EU representative : CMC Medical Devices & Drugs SL (Spain)	China	CWX901/CWX902/CWX9033 refs	A IVDR	EUDAMED record Report an error
Jiangsu ME Instruments EU representative : MedPath GmbH (Germany)	China	Automated NGS Library Preparation System	A IVDR	EUDAMED record Report an error
Kogene EU representative : Obelis s.a. (Belgium)	South Korea	PowerEXP™ 48LH	A IVDR	Website info@kogene.co.kr EUDAMED record Report an error
Lifereal EU representative : SUNGO Europe B.V. (Netherlands)	China	LifeReady 1000	A IVDR	EUDAMED record Report an error
Longgene EU representative : MedPath GmbH (Germany)	China	Real-time qPCR System3 refs	A IVDR	info@longgene.com EUDAMED record Report an error
Luminexcorp FDA EU representative : DiaSorin Italia S.p.A. (Italy)	United States	LIAISON PLEX® Chassis2 refs	A IVDR	Website regulatoryaffairs@luminexcorp.com EUDAMED record Report an error
Masmec FDA	Italy	PRIME MDX	A IVDR	Website EUDAMED record Report an error
Medcaptain FDA EU representative : R Sight B.V. (Netherlands)	China	AutoMated Nucleic Acid Extraction System GeneX E6, GeneX E6s2 refs	A IVDR	Website info@medcaptain.com EUDAMED record Report an error
Mgitech	Latvia	Genetic Sequencer DNBSEQ-G400 DNBSEQ-G400, DNBSEQ-G99, DNBSEQ-G99A3 refs	A IVDR	Website EUDAMED record Report an error
Ortho-Clinical Diagnostics Dba Quidel EU representative : MDSS GmbH (Germany)	United States	Solana Instrument	A IVDR	Website PRRC@quidelortho.com EUDAMED record Report an error
Personalgenome FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	PGDx elio tissue complete2 refs	C IVDR	Website EUDAMED record Report an error
Qingdao MGI Tech EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Genetic Sequencer DNBSEQ-E25 DNBSEQ-E25, DNBSEQ-E25A, DNBSEQ-T20×23 refs	A IVDR	EUDAMED record Report an error
Quantidx Hong Kong EU representative : MedPath GmbH (Germany)	Hong Kong SAR China	Real-Time qPCR System2 refs	A IVDR	EUDAMED record Report an error
R-Biopharm FDA	Germany	RIDA®UNITY	A IVDR	Website EUDAMED record Report an error
Rgbio EU representative : SUNGO Europe B.V. (Netherlands)	China	BHP9609	A IVDR	EUDAMED record Report an error
SD Biosensor FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	STANDARD™ M10 Console M10-01S2 refs	A IVDR	Website EUDAMED record Report an error
Seegene FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	SGRT	A IVDR	Website info@seegene.com EUDAMED record Report an error
Shanghai Chuangkun Biotech EU representative : SUNGO Europe B.V. (Netherlands)	China	CHK Biotech CHK-3200 CHK-16S CHK-800	A IVDR	EUDAMED record Report an error
Shanghai Rendu Biotechnology EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Automatic Nucleic Acid Detection and Analysis System2 refs	A IVDR	EUDAMED record Report an error
Shanghai Zj Bio-Tech FDA EU representative : Lotus NL B.V. (Netherlands)	China	QG28800	A IVDR	Website EUDAMED record Report an error
Shenzhen MGI Biological Electronic Technology EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Genetic Sequencer DNBSEQ-T1+	A IVDR	EUDAMED record Report an error
Shenzhen Uni-medica Technology EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Uni-medica NFAST 96, NFAST 32A2 refs	A IVDR	Website marketing@uni-medica.com EUDAMED record Report an error
Surgnova FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Electroporation Fixator support N30003 refs	IIb MDR	qara@surgnova.com EUDAMED record Report an error
Suzhou Sniper Medical Technologies FDA EU representative : MedPath GmbH (Germany)	China	All-in-one Digital PCR Device DQ24-Dx	A IVDR	Website EUDAMED record Report an error
Sysmex FDA EU representative : Sysmex Europe SE (Germany)	Japan	Gene Amplification Detector RD-210	A IVDR	ra_archive@sysmex.co.jp EUDAMED record Report an error
Tosoh FDA EU representative : Tosoh Europe N.V. (Belgium)	Japan	Automated TRCR Real-time Monitor TRCReady-80	A IVDR	csc@tosoh.co.jp EUDAMED record Report an error
Viramed FDA	Germany	ViraCam3 refs	A IVDR	Website EUDAMED record Report an error
Wondfo FDA 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 Report an error
Wuhan MGI Tech EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Genetic Sequencer DNBSEQ-G400 DNBSEQ-G50, DNBSEQ-G400, DNBSEQ-T7, DNBSEQ-G99, DNBSEQ-G99A, HELICON® G400, HELICON® G503 refs	A IVDR	EUDAMED record Report an error
Zinexts EU representative : Obelis s.a. (Belgium)	Taiwan	NeXgen 16HP	A IVDR	Website EUDAMED record Report an error
Mobidiag No model still on the market	Finland	Novodiag Instrument3 refs (no longer marketed)	A IVDR	Website sales.mob@hologic.com EUDAMED record Report an error
Uniogen No model still on the market	Finland	GenomEra CDX Software CDX-102 refs (no longer marketed)	A IVDR	info@uniogen.com EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

Other manufacturers known in the United States (FDA) 53

Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.

Manufacturer	Country	Brands	FDA clearance
Life Technologies Corporation	United States	SAE Admin Console Dx Software V1.0 Kit Diomni™ Software, V3.1.0 QuantStudio Dx Software V1.0.3, Kit SAE Admin Console Dx Software V1.2.0 Kit appliedbiosystems QuantStudioTM 7 Pro Dx Software DIOMNI SW V2.0.0 USB KIT	K191030 (2020)
Roche Molecular Systems, Inc.	United States	cobas®4800 System Liquid Cytology Preparation Kit cobas® 4800 System Wash Buffer Kit cobas® 4800 HPV Amplification/Detection Kit cobas HPV Positive Control cobas®4800 HPV Controls Kit cobas HPV	P100020 (2026)
Zhejiang CuraWay Medical Technology Co., Ltd. Present in Europe in other categories	China	Curaway	K222001 (2023)
AngioDynamics, Inc.	United States	NanoKnife	K253198 (2026)
Hologic, Inc. Present in Europe in other categories	United States	Panther Fusion® Panther®	P080015 (2018)
ANITOA BIOTECHNOLOGY(HANGZHOU)CO.,LTD.	–	Fluorescence Quantitative PCR Detection System	registered
Alere Scarborough, Inc.	United States	Alere™ i Instrument ID NOW™ Instrument ID NOW Strep A 2 Control Swab Kit ID NOW RSV ID NOW RSV Control Swab Kit ID NOW Strep A 2	K151690 (2015)
Galvanize Therapeutics, Inc.	United States	INUMI Flex Needle Aliya Needle Aliya EX Generator Aliya Electrode Aliya PEF Ablation Pack Aliya Generator-Recertified	K253826 (2026)
GREAT BASIN SCIENTIFIC, INC.	United States	Group B Strep Assay Shiga Toxin Direct Test Bordetella Direct Test Stool Bacterial Pathogens Panel Staph ID/R Blood Culture Panel	registered
DIAGNOSTIC HYBRIDS, INC.	United States	Savanna Lyra	registered
TargetingOne Technology (Beijing) Corporation Present in Europe in other categories	–	TARGETINGONE	registered
APPLIED BIOCODE, INC.	United States	Gastrointestinal Pathogen Panel (GPP) Kit BioCode MDx 3000	registered
Getein Biotech,Inc Present in Europe in other categories	China	GN 7000 Akso PCR System GN 7120 Akso PCR System	registered
Inflammatix, Inc.	–	Myrna TriVerity	registered
QUARK BIOSCIENCES TAIWAN, INC. (HSINCHU PLANT)	–	QuarkBio®	registered
Elitechgroup Mdx LLC	–	HSV 1&2 ELITe MGB Assay for CE-IVD	registered
GENETIC SIGNATURES LIMITED Present in Europe in other categories	Australia	EasyScreen™ Gastrointestinal Parasite PCR Positive Control	registered
Genepoc, Inc.	Canada	revogene™	K170558 (2017)
Luminex Molecular Diagnostics, Inc. Present in Europe in other categories	Canada	NxTAG® Respiratory Pathogen Panel	registered
Quidel Corp.	United States	Lyra	registered
Us Medical Innovations, LLC	United States	US Medical Innovations	K240297 (2024)
Autonomous Medical Devices Incorporated	United States	–	registered
Biobase Biodustry(Shandong)Co., Ltd.	China	–	registered
Diamond Diagnostics Inc. Present in Europe in other categories	United States	–	registered
Diatron MI Plc	Hungary	–	registered
ENERCON TECHNOLOGIES	United States	–	registered
ENERGENX MEDICAL LTD.	China	–	registered
Guangzhou Four E's Scientific Co., Ltd. Present in Europe in other categories	China	–	registered
HITACHI HIGH-TECH CORP. Present in Europe in other categories	Japan	–	registered
Hangzhou Ruidi Biotechnology , Ltd. Present in Europe in other categories	China	–	K253846 (2026)
IGEA S.p.A. Present in Europe in other categories	Italy	–	registered
Inflammatix (1 650-443-3030)	United States	–	registered
LRE MEDICAL GMBH	Germany	–	registered
Labpeak Co.,Ltd	China	–	registered
Meddux Development Corporation LLC	United States	–	registered
PLEXUS CORP.	United States	–	registered
Planet Innovation Products, Inc.	United States	–	registered
QIAGEN Manchester Ltd	United Kingdom	–	registered
Qiagen Gaithersburg, Inc.	–	–	P890064 (2023)
QuidelOrtho Corporation	United States	–	registered
Roche Diagnostics Operations Inc.	United States	–	registered
STRATEC SE Present in Europe in other categories	Germany	–	registered
STRATEC Switzerland AG c/o STRATEC SE	Germany	–	registered
STS Corporation	United States	–	registered
Sanicure BV	Netherlands	–	registered
Sanmina Corporation	United States	–	registered
Scitek Global Co.,Ltd	China	–	registered
Shenzhen Everbest Machinery Industry Co., Ltd.	China	–	registered
Tecan U.S., Ltd. Present in Europe in other categories	United States	–	registered
VWR INTERNATIONAL, LLC Present in Europe in other categories	United States	–	registered
Vantage Medtech	United States	–	registered
Wuxi Nest Biotechnology Co., Ltd. Present in Europe in other categories	China	–	registered
YAMURA ELECTRIC INDUSTRY CO., LTD.	Japan	–	registered

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