ReagentsInfectious diseasesMultiple parameters - (infect. immunology/NAT)

Multiple viruses - other

EMDN code W01050799

9 manufacturers, 23 models including 21 on the market, 3 countries

On the market in Models on the market only Manufacturer country

Manufacturers registered in Europe (EUDAMED) 9

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
Jiangsu Macro & Micro-Test Med-Tech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	SARS-COV-2 and Influenza A/B Antigen Detection Kit (Immunochromatography) 1 test/kit98/79 SARS-COV-2 and Influenza A/B Antigen Detection Kit (Immunochromatography) HWTS-RT096B98/79 SARS-COV-2, Influenza A and Influenza B Antigen Detection Kit (Immunochromatography) 1 test/kit98/79 SARS-COV-2, Influenza A and Influenza B Antigen Detection Kit (Immunochromatography) 20 tests/kit98/79 SARS-CoV-2, Influenza A&B Antigen Combined Detection Kit (Immunochromatography) 1 test/kit98/79 1 other SARS-CoV-2, Influenza A&B Antigen Combined Detection Kit (Immunochromatography) 20 tests/kit98/79	– 98/79	marketing@hongweitest.com EUDAMED record Report an error
Encode EU representative : CMC Medical Devices & Drugs SL (Spain)	China	EnterovirusV71+Coxsackievirus A16 Combo Test 25Tests/Kit98/79 Rotavirus and Adenovirus Antigen Rapid Test RAD-62298/79 Rotavirus Group+Adenovirus+Norovir us G1+Norovirus GII combo Rapid Test98/79	– 98/79	Website EUDAMED record Report an error
Shenzhen Superbio Technology FDA EU representative : QbD RepS BV (Belgium)	China	COVID-19 Ag&Influenza A/B&RSV Ag Combo Test (Immunochromatography Assay)98/79 COVID-19 Ag&Influenza A/B Combo Test (Immunochromatography Assay)98/79 Diagnostic Kit for InFluA/InFluB Ag (Fluorescence Immunochromatographic Assay)98/79	– 98/79	info@sup-bio.com EUDAMED record Report an error
Shenzhen Zijian Biotechnology EU representative : Lotus NL B.V. (Netherlands)	China	Influenza A+B virus & 2019-nCoV (2019-nCoV orf1ab/N Gene) Diagnostic Kit (PCR-Fluorescence Probing) 48 Tests/kit98/79 Respiratory Pathogens Multiplex Nucleic Acid Diagnostic Kit (Multiplex PCR-Fluorescence Probing) 48 Tests/kit98/79 Rhinovirus, Respiratory Syncytial Virus & respiratory Adenovirus Diagnostic Kit (PCR-Fluorescence Probing) 48 Tests/kit98/79	– 98/79	Website sales@szzijian.com EUDAMED record Report an error
Viramed FDA	Germany	Arbovirus ViraChip IgG Antigen Coated Wells Arbovirus Antibodies2 refs Arbovirus ViraChip IgG Deca Kit3 refs Arbovirus ViraChip IgG Positive Control3 refs	B IVDR	Website EUDAMED record Report an error
Anhui Deepblue Medical Technology FDA EU representative : Medunion S.L. (Spain)	China	Rotavirus/Adenovirus Antigen Test Kit (Colloidal Gold) Cassette3 refs98/79	– 98/79	sales@dbluemedical.com EUDAMED record Report an error
Assure Tech. (Hangzhou) EU representative : Lotus NL B.V. (Netherlands)	China	Rotavirus＆Adenovirus Antigen Fecal Combo Test Kit MI-F4200198/79	– 98/79	Website contact@diareagent.com EUDAMED record Report an error
Singuway EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Nucleic Acid Detection Kit for Seven respiratory pathogens (PCR-Fluorescence Probing)98/79	– 98/79	sales@singuway.com EUDAMED record Report an error
Arcdia No model still on the market	Finland	mariPOC® Quick Flu+ test plate (no longer marketed) mariPOC® Respi test plate (no longer marketed)	A IVDR	Website office@arcdia.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.

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