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Kangsheng Information Technology (Hangzhou) Co. LTD

China·CN-MF-000053775

Last updated June 8, 2026

Information

Country: China
Address: Room 2017, Building 1, No. 5 Shengyi Road, Yuhang District, Hangzhou City, China
Website: —
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Sheldon Xue
EUDAMED SRN: CN-MF-000053775
FDA FEI Number: —
DUNS Number: —

Catalogue (123)

Page 1 of 3

Device	Model / Reference	Registries	Class	Status
Bocavirus Nucleic Acid Detection Kit (Fluorescence)	Fa034	EUDAMED	IVD General	Active
Enterohemorrhagic Escherichia coli Nucleic Acid Detection Kit (Fluorescence)	Fa019	EUDAMED	IVD General	Active
FOB/TF Test Panel	Ir039	EUDAMED	IVD General	Active
Mycobacterium tuberculosis Nucleic Acid Detection Kit	Nc011	EUDAMED	IVD General	Active
Influ A+B/ADV/RSV Ag 4-in-1 Test Panel	Ir046	EUDAMED	IVD General	Active
HDL-C High Density Lipoprotein Cholesterol Test Kit	Ir097	EUDAMED	IVD General	Active
Pneumocystis jirovecii Nucleic Acid Detection Kit	Nc045	EUDAMED	IVD General	Active
Enterovirus (Non-Poliovirus) Nucleic Acid Detection Kit (Fluorescence)	Fa035	EUDAMED	IVD General	Active
cTnI Cardiac Troponin I Test Kit	Ir078	EUDAMED	IVD General	Active
Legionella Nucleic Acid Detection Kit (Fluorescence, Sputum/BALF)	Fa041	EUDAMED	IVD General	Active
Luteinising Hormone (LH) Test Kit	Ir002	EUDAMED	IVD General	Active
Salmonella typhi/paratyphi Nucleic Acid Detection Kit (Fluorescence)	Fa012	EUDAMED	IVD General	Active
COVID-19 (2019n-Cov) Antigen Detection Kit	Ir049	EUDAMED	IVD General	Active
LH Luteinizing Hormone Test Kit	Ir061	EUDAMED	IVD General	Active
Rotavirus Ag Test Kit	Ir034	EUDAMED	IVD General	Active
Multi-Drug Test Panel	Ir070	EUDAMED	IVD General	Active
H.Pylori Ag Test Kit	Ir031	EUDAMED	IVD General	Active
THC Tetrahydrocannabinol Test Kit	Ir066	EUDAMED	IVD General	Active
Bordetella Pertussis (BP) Antigen Detection Kit	Ir050	EUDAMED	IVD General	Active
CRP/PCT Test Panel	Ir077	EUDAMED	IVD General	Active
Measles Virus Nucleic Acid Detection Kit	Nc006	EUDAMED	IVD General	Active
CRP/SAA Test Panel	Ir076	EUDAMED	IVD General	Active
Neisseria gonorrhoeae Antigen Test Kit	Ir019	EUDAMED	IVD General	Active
Salmonella Typhi Ag Test Kit	Ir036	EUDAMED	IVD General	Active
Norovirus Nucleic Acid Detection Kit (Fluorescence)	Fa018	EUDAMED	IVD General	Active
Clostridium Difficile Related Test Kit	Ir042	EUDAMED	IVD General	Active
Vibrio parahaemolyticus Nucleic Acid Detection Kit (Fluorescence)	Fa020	EUDAMED	IVD General	Active
Human Metapneumovirus Nucleic Acid Detection Kit	Nc030	EUDAMED	IVD General	Active
Vibrio parahaemolyticus Nucleic Acid Detection Kit	Nc020	EUDAMED	IVD General	Active
Plasmodium Nucleic Acid Detection Kit	Nc016	EUDAMED	IVD General	Active
Candidiasis Antigen Test Kit	Ir022	EUDAMED	IVD General	Active
Mycoplasma pneumoniae Nucleic Acid Detection Kit	Nc036	EUDAMED	IVD General	Active
AMP Amphetamine Test Kit	Ir069	EUDAMED	IVD General	Active
Monkeypox Virus Nucleic Acid Detection Kit	Nc009	EUDAMED	IVD General	Active
D-Dimer Test Kit	Ir087	EUDAMED	IVD General	Active
Streptococcus pneumoniae Nucleic Acid Detection Kit	Nc039	EUDAMED	IVD General	Active
Parainfluenza Virus (I-IV) Nucleic Acid Detection Kit (Fluorescence)	Fa031	EUDAMED	IVD General	Active
Group A Streptococcus Nucleic Acid Detection Kit (Fluorescence)	Fa037	EUDAMED	IVD General	Active
Typhoid Ab IgM/IgG Test Kit	Ir029	EUDAMED	IVD General	Active
Salmonella typhi/paratyphi Nucleic Acid Detection Kit	Nc012	EUDAMED	IVD General	Active
Human Bladder Tumor Antigen (BTA) Detection Kit	Ir055	EUDAMED	IVD General	Active
Streptococcus pneumoniae Nucleic Acid Detection Kit (Fluorescence)	Fa039	EUDAMED	IVD General	Active
Rhinovirus Nucleic Acid Detection Kit (Fluorescence)	Fa033	EUDAMED	IVD General	Active
West Nile Virus Nucleic Acid Detection Kit (Fluorescence)	Fa022	EUDAMED	IVD General	Active
Alcohol Test Kit	Ir092	EUDAMED	IVD General	Active
cTnI/CK-MB/Myo Test Panel	Ir082	EUDAMED	IVD General	Active
COC Cocaine Test Kit	Ir067	EUDAMED	IVD General	Active
FSH Follicle Stimulating Hormone Test Kit	Ir062	EUDAMED	IVD General	Active
Oropouche Virus Nucleic Acid Detection Kit (Fluorescence)	Fa025	EUDAMED	IVD General	Active
Dengue Virus Nucleic Acid Detection Kit	Nc008	EUDAMED	IVD General	Active

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