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SINGUWAY BIOTECH INC.

China·CN-MF-000027180

Last updated June 8, 2026

Information

Country: China
Address: B1302, Life Science Park, Shen Cheng Tou Innovation Factory, Julongshan A Road, Xiuxin Community, Kengzi Street, Pingshan District, Shenzhen City, China
Website: singuway.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Biyan Dong
EUDAMED SRN: CN-MF-000027180
FDA FEI Number: —
DUNS Number: —

Catalogue (23)

Device	Model / Reference	Registries	Class	Status
Real-time PCR Quantitative Analyzer	052	EUDAMED	Class A	Active
Detection Kit for Plasmodium Falciparum (PCR Fluorescence Probing)	PF001-48	EUDAMED	IVD General	Active
Real-time PCR Quantitative Analyzer	080	EUDAMED	Class A	Active
Fluorescence Immunoassay Analyzer	FluoreMini	EUDAMED	Class A	Active
Nucleic Acid Detection Kit for High-risk Human Papillomavirus (PCR-Fluorescence Probing)	HPV001	EUDAMED	IVD General	Active
Nucleic Acid Extractor	Singu96	EUDAMED	Class A	Active
Mycobacterium Tuberculosis and Drug-resistant Gene Nucleic Acid Testing Kit(PCR Fluorescent Probe Method)	TB002-48	EUDAMED	IVD General	Active
Nucleic Acid Extraction Reagents(Magnetic Beads）	MTQ036A	EUDAMED	Class A	Active
Cell Preservation Solution	BCY001	EUDAMED	Class A	Active
Nucleic Acid Releaser (For PCR)	SR10100	EUDAMED	Class A	Active
Disposable Virus Sampling Kit	BCY002	EUDAMED	Class A	Active
Nucleic Acid Extractor	Singu48	EUDAMED	Class A	Active
Nucleic Acid Extraction Reagents(Magnetic Beads）	T-32	EUDAMED	Class A	Active
Nucleic Acid Extraction Reagents(Magnetic Bead)	MTQB036	EUDAMED	Class A	Active
Detection Kit for Adenovirus Nucleic Acids (PCR-Fluorescence Probing)	ADV001-48	EUDAMED	IVD General	Active
Nucleic Acid Extractor	043	EUDAMED	Class A	Active
Detection Kit for Mycobacterium Tuberculosis DNA (PCR-Fluorescence Probing)	TB001-48	EUDAMED	IVD General	Active
Detection Kit for Dengue virus/Zika virus/ Chikungunya virus (PCR-Fluorescence Probing)	MBD001-48	EUDAMED	IVD General	Active
Nucleic Acid Extraction Reagents(Magnetic Bead)	T-96	EUDAMED	Class A	Active
Nucleic Acid Extraction Reagents(Magnetic Bead)	MTQ064	EUDAMED	Class A	Active
Nucleic Acid Detection Kit for High-risk Human Papillomavirus (Typing) (PCR-Fluorescence Probing)	HPV002-48	EUDAMED	IVD General	Active
Nucleic Acid Extraction Reagents(Magnetic Bead)	MTQM064	EUDAMED	Class A	Active
Nucleic Acid Extraction Reagents(Magnetic Beads）	MTQ064-HS	EUDAMED	Class A	Active

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CMC Medical Devices & Drugs SL ES

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