Manufacturer

Singuway

ChinaLegal entities : SINGUWAY BIOTECH INC.

First countries of placing on the market declared in EUDAMED : France, Germany, Greece, Italy, Spain

EU representative : CMC Medical Devices & Drugs SL (Spain)

20 categories, 25 models including 25 on the market, 1 country

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

Category	EMDN code	Registered models	Class	Contact
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus	W0105900101	Nucleic Acid Extraction Reagents(Magnetic Bead) T-16,T-32,T-48,T-64,T-96,T-200,T-9603 refs Nucleic Acid Extraction Reagents(Magnetic Bead) TM-363 refs Nucleic Acid Releaser (For PCR) SR05050, SR10050, SR05080, SR10080,SR05100, SR10100, SR50001, SR100001, SR5L01, SR20L01	A IVDR	EUDAMED record Report an error
Mycobacterial detection by NA reagents	W0105010703	Detection Kit for Mycobacterium Tuberculosis DNA (PCR-Fluorescence Probing) TB001-4898/79 Mycobacterium Tuberculosis and Drug-resistant Gene Nucleic Acid Testing Kit(PCR Fluorescent Probe Method) TB002-4898/79	– 98/79	EUDAMED record Report an error
Nucleic acid testing integrated extraction /amplification /detection systems	W02050116	Real-time PCR Quantitative Analyzer AccuRa Mini Real-time PCR Quantitative Analyzer AccuRa32	A IVDR	EUDAMED record Report an error
Various sample processing instruments - other	W02069099	Nucleic Acid Extractor Singu20 Nucleic Acid Extractor Singu323 refs	A IVDR	EUDAMED record Report an error
Adenovirus - NA reagents	W0105040501	Detection Kit for Adenovirus Nucleic Acids (PCR-Fluorescence Probing) ADV001-4898/79	– 98/79	EUDAMED record Report an error
Automated immunochemistry analysers - low routine (throughput <= 100 test/h)	W0201020101	Fluorescence Immunoassay Analyzer FluoreMini	A IVDR	EUDAMED record Report an error
Coronavirus - NA reagents	W0105041106	Detection Kit For Coronavirus Disease 2019 (COVID-19) (PCR Fluorescence Probe)98/79	– 98/79	EUDAMED record Report an error
Coronavirus igg	W0105041103	COVID-19 Antigen Test Kit (Colloidal Gold) (Cassette)98/79	– 98/79	EUDAMED record Report an error
Human metapneumovirus - NA reagents	W0105040517	Nucleic Acid Detection Kit for Human Metapneumovirus (PCR-Fluorescence Probing)98/79	– 98/79	EUDAMED record Report an error
Influenza & para influenza / respiratory syncytial virus (rsv) / sars-cov - multiplex NA reagents	W0105070304	Detection Kit for Influenza A Virus, Influenza B Virus and Respiratory Syncytial Virus RNA (PCR-Fluorescence Probing)98/79	– 98/79	EUDAMED record Report an error
Monkeypox virus / mpox - NA reagent	W0105040532	Detection Kit for Monkeypox Virus(PCR Fluorescence Probing)98/79	– 98/79	EUDAMED record Report an error
Multiple infectious - multiplex assays - other	W0105070599	Detection Kit for Dengue virus/Zika virus/ Chikungunya virus (PCR-Fluorescence Probing) MBD001-4898/79	– 98/79	EUDAMED record Report an error
Multiple viruses - other	W01050799	Nucleic Acid Detection Kit for Seven respiratory pathogens (PCR-Fluorescence Probing)98/79	– 98/79	EUDAMED record Report an error
Partial genotyping high-risk HPV - NA reagents	W0105041003	Nucleic Acid Detection Kit for High-risk Human Papillomavirus (PCR-Fluorescence Probing)98/79	– 98/79	EUDAMED record Report an error
Plasmodium (malaria) - NA reagents	W0105050309	Detection Kit for Plasmodium Falciparum (PCR Fluorescence Probing) PF001-4898/79	– 98/79	EUDAMED record Report an error
Respiratory syncytial virus (rsv) - NA reagents	W0105040505	Detection Kit for Respiratory Syncytial Virus RNA (PCR Fluorescence Probing)98/79	– 98/79	EUDAMED record Report an error
Samples collection devices - other	W05019099	Disposable Virus Sampling Kit	A IVDR	EUDAMED record Report an error
Samples transport, containers - other	W05020199	Cell Preservation Solution BCY001	A IVDR	EUDAMED record Report an error
Screening high-risk HPV - NA reagents	W0105041002	Nucleic Acid Detection Kit for High-risk Human Papillomavirus (Typing) (PCR-Fluorescence Probing) HPV002-4898/79	– 98/79	EUDAMED record Report an error
Virology reagents - other	W01050499	Detection Kit for 2019-nCOV,Influenza A Virus and Influenza B Virus（PCR Fluorescence Probe）98/79	– 98/79	EUDAMED record Report an error

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