Infectious diseasesOther virology tests (infect. immunology/NAT)Other virology - NA reagents

Enterovirus - NA reagents

EMDN code W0105040502

29 manufacturers, 58 models including 58 on the market, 8 countries

On the market in Manufacturer country

Manufacturers registered in Europe (EUDAMED) 29

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
Sansure FDA EU representative : Obelis s.a. (Belgium)	China	Coxsachievirus A10 Real Time RT-PCR Diagnostic Kit (PCR-Fluorescence Probing)98/79 Coxsachievirus A6 and A10 Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Coxsachievirus A6 Real Time RT-PCR Diagnostic Kit (PCR-Fluorescence Probing)98/79 Diagnostic Kit for Coxsackievirus A16 RNA (PCR-Fluorescence Probing)98/79 Diagnostic Kit for Enterovirus 71 RNA (PCR-Fluorescence Probing)98/79 7 others Diagnostic Kit for Enterovirus RNA (PCR-Fluorescence Probing)98/79 Echovirus E11 Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Echovirus E30 Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Enterococcus Faecalis Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Enterococcus Faecium Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Enterococcus Faeciuma and Enterococcus Faecalis Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Escherichia coli O157 Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79	– 98/79	Website info@sansure.com.cn EUDAMED record Report an error
Bioperfectus FDA EU representative : MedNet EC-REP GmbH (Germany)	China	Enteric Adenovirus Real Time PCR Kit YJC50106NW-25T98/79 Enteric Adenovirus Real Time PCR Kit YJC50106NW-50T98/79 Enterovirus Real Time PCR Kit JC20101NW-25T98/79 Enterovirus Real Time PCR Kit JC20101NW-50T98/79	– 98/79	EUDAMED record Report an error
Daan Gene EU representative : Lotus NL B.V. (Netherlands) and 1 other	China	24 tests/kit2 refs98/79 Large package, 10 tests/kit2 refs98/79 Large package, 48 tests/kit2 refs98/79 Single tube, 10 tests/kit2 refs98/79	– 98/79	EUDAMED record Report an error
gerbion	Germany	alphaCube Entero 2.098/79 SMD lead EnteroRhino98/79 virellaEntero 2.0 TM real time RT-PCR Kit98/79	– 98/79	info@gerbion.com EUDAMED record Report an error
Shanghai Zj Bio-Tech FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Enterovirus 70（EV70）Real Time RT-PCR Kit98/79 Enterovirus 71(EV71) Real Time RT-PCR Kit98/79 Enterovirus Real Time RT-PCR Kit98/79	– 98/79	Website EUDAMED record Report an error
Shenzhen Zijian Biotechnology EU representative : Lotus NL B.V. (Netherlands)	China	Coxsackie virus group A type 16 (CA16) Diagnostic Kit (PCR-Fluorescence Probing) 48 Tests/kit98/79 Enterovirus type 71 (EV71) Diagnostic Kit (PCR-Fluorescence Probing) 48 Tests/kit98/79 Enterovirus Universal Diagnostic Kit (PCR-Fluorescence Probing) 48 Tests/kit98/79	– 98/79	Website sales@szzijian.com EUDAMED record Report an error
Beijing Applied Biological Technologies EU representative : Luxus Lebenswelt GmbH (Germany)	China	Real-Time PCR Detection Kit for Enterovirus98/79 Real-Time PCR Diagnostic Kit for Human Enterovirus 71 (EV71) (TaqMan probe method)98/79	– 98/79	EUDAMED record Report an error
Clonit	Italy	quanty Enterovirus RT-3398/79 quanty Enterovirusqs QS-3398/79	– 98/79	Website info@clonit.it EUDAMED record Report an error
Geneproof	Czechia	GeneProof Enterovirus PCR Kit2 refs98/79 TaqPath™ Menu98/79	– 98/79	Website support@geneproof.com EUDAMED record Report an error
Jiangsu Mole Bioscience EU representative : SUNGO Europe B.V. (Netherlands)	China	EV71, CA16 and Other Enteroviral Nucleic Acid Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)98/79 EV71, CA16 and other enterovirual nucleic acid test kit (Fluorescent Probe-based real-time PCR assay)5 refs98/79	– 98/79	EUDAMED record Report an error
Kangsheng Information Technology (Hangzhou) EU representative : Crealkraft GmbH (Germany)	China	Enterovirus (Non-Poliovirus) Nucleic Acid Detection Kit98/79 Enterovirus (Non-Poliovirus) Nucleic Acid Detection Kit (Fluorescence)98/79	– 98/79	EUDAMED record Report an error
TIB MOLBIOL Syntheselabor	Germany	ModularDx Kit Enterovirus 500 LightMix® Modular Enterovirus 50098/79 ModularDx Kit Enterovirus 640 LightMix® Modular Enterovirus 64098/79	– 98/79	Website EUDAMED record Report an error
Ab Analitica	Italy	REALQUALITY RQ-ENTERO8 refs98/79	– 98/79	customersupport@abanalitica.it EUDAMED record Report an error
altona Diagnostics FDA	Germany	RealStar® Enterovirus RT-PCR Kit 1.098/79	– 98/79	info@altona-diagnostics.com EUDAMED record Report an error
bioMérieux FDA	France	ENTEROVIRUS R-GENE® 69-005B	C IVDR	EUDAMED record Report an error
Coyotebio EU representative : CMC Medical Devices & Drugs SL (Spain)	China	FlashDetect™ LyocartE Enterovirus 71 Assay98/79	– 98/79	sales@coyotebio.com EUDAMED record Report an error
Diapro	Italy	ENTEROVIRUS ONE-STEP ENTERONE.CE98/79	– 98/79	Website info@diapro.it EUDAMED record Report an error
Ecolidx	Czechia	eSens Enterovirus QL PCR kit98/79	– 98/79	Website EUDAMED record Report an error
ElitechGroup FDA	Italy	ENTEROVIRUS - ELITe Positive Control3 refs	C IVDR	Website EUDAMED record Report an error
Idilbiotech	Türkiye	RevoDx Enterovirus/Rhinovirus qPCR Kit2 refs98/79	– 98/79	Website EUDAMED record Report an error
Immundiagnostik FDA	Germany	MutaPLEX® Enterovirus, PCR2 refs98/79	– 98/79	Website info@immundiagnostik.com EUDAMED record Report an error
Ingenetix	Austria	ViroReal® Kit Enterovirus98/79	– 98/79	Website office@ingenetix.com EUDAMED record Report an error
Jiangsu Macro & Micro-Test Med-Tech FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Enterovirus Universal, EV71 and CoxA16 Nucleic Acid Detection Kit (Fluorescence PCR)98/79	– 98/79	marketing@hongweitest.com EUDAMED record Report an error
Ortho-Clinical Diagnostics Dba Quidel EU representative : MDSS GmbH (Germany)	United States	D3 Enterovirus Reagent Duo Pack98/79	– 98/79	Website PRRC@quidelortho.com EUDAMED record Report an error
R-Biopharm FDA	Germany	RIDA®GENE Enterovirus98/79	– 98/79	Website EUDAMED record Report an error
Suzhou TianLong Biotechnology FDA EU representative : Lotus NL B.V. (Netherlands)	China	Enterovirus Universal RNA Detection Kit (Fluorescence PCR Method)98/79	– 98/79	EUDAMED record Report an error
Tellgencorp EU representative : MedNet EC-REP GmbH (Germany)	China	EVU/CoxA16 and EV71 Nucleic Acid Detection Kit based on Cartridge Real-Time PCR Platform98/79	– 98/79	Website sales@tellgen.com EUDAMED record Report an error
Ustar Biotechnologies (Hangzhou) EU representative : Lotus NL B.V. (Netherlands)	China	MultNAT EV Assay	C IVDR	Website service@bioustar.com EUDAMED record Report an error
Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇	Türkiye	ENTEROVIRUS DETECTION KIT VSNMP054	C IVDR	Website info@visionbiotechnology.com EUDAMED record Report an error

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