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

Rotavirus - NA reagents

EMDN code W0105040506

15 manufacturers, 23 models including 21 on the market, 7 countries

On the market in Models on the market only Manufacturer country

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
Shanghai Zj Bio-Tech EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Rotavirus (Group B) Real Time RT-PCR Kit98/79 Rotavirus (Group C) Real Time RT-PCR Kit98/79 Rotavirus Real Time RT-PCR Kit98/79	– 98/79	Website EUDAMED record Report an error
Sansure EU representative : Obelis s.a. (Belgium)	China	Human Rotavirus A and B Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Human Rotavirus A/B/C Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 Human Rotavirus A Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 (no longer marketed) Human Rotavirus B Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)2 refs98/79 (no longer marketed)	– 98/79	Website info@sansure.com.cn EUDAMED record Report an error
Bioperfectus EU representative : MedNet EC-REP GmbH (Germany)	China	Rotavirus A B C Real Time PCR Kit YJC50301NW-25T98/79 Rotavirus A B C Real Time PCR Kit YJC50301NW-50T98/79	– 98/79	EUDAMED record Report an error
Suzhou TianLong Biotechnology EU representative : SUNGO Europe B.V. (Netherlands)	China	Rotavirus Genotype A/B/C Nucleic Acid Detection Kit (Fluorescence PCR Method)98/79 Rotavirus Universal RNA Detection Kit (Fluorescence PCR Method)98/79	– 98/79	EUDAMED record Report an error
Vitrosens	Türkiye	ChainFor Rotavirus Detection qPCR Kit CFP4298/79 LyoSens Rotavirus Detection qPCR Kit LYO1698/79	– 98/79	Website info@vitrosens.com EUDAMED record Report an error
altona Diagnostics	Germany	RealStar® Rotavirus RT-PCR Kit 1.098/79	– 98/79	info@altona-diagnostics.com EUDAMED record Report an error
Certest	Spain	VIASURE Rotavirus Real Time PCR Detection Kit3 refs	B IVDR	Website quality@certest.es EUDAMED record Report an error
Genes2Me EU representative : Obelis s.a. (Belgium)	India	Rota-Q Real Time PCR Kit for Rotavirus G2M80162198/79	– 98/79	Website EUDAMED record Report an error
Idilbiotech	Türkiye	RevoDx Rotavirus A qPCR Kit2 refs98/79	– 98/79	Website EUDAMED record Report an error
Nanjing Synthgene Medical Technology EU representative : Lotus NL B.V. (Netherlands)	China	Rotavirus Antigen Rapid Test Kit (Colloidal gold method) CR03298/79	– 98/79	Website sales@syngenebio.com EUDAMED record Report an error
Poly Diagnostics	Luxembourg	Poly Diagnostics Rotavirus A, RNase P Real-Time PCR kit3 refs	B IVDR	Website info@polydiagnostics.com EUDAMED record Report an error
Shenzhen Zijian Biotechnology EU representative : Lotus NL B.V. (Netherlands)	China	Rotavirus (group A/B/C) Diagnostic Kit (PCR-Fluorescence Probing) 48 Tests/kit98/79	– 98/79	Website sales@szzijian.com EUDAMED record Report an error
TIB MOLBIOL Syntheselabor	Germany	ModularDx Kit Rotavirus A98/79	– 98/79	Website EUDAMED record Report an error
Vela Operations Singapore Pte EU representative : Vela Diagnostics Germany GmbH (Germany)	Singapore	Sentosa SA Rotavirus RT-PCR Test (4x24) 30019298/79	– 98/79	Website infoAPAC@veladx.com EUDAMED record Report an error
Vitassay	Spain	Vitassay qPCR Rotavirus98/79	– 98/79	Website info@vitassay.com EUDAMED record Report an error

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