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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 (129)

Page 2 of 3

Device	Model / Reference	Registries	Class	Status
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
CEA Carcinoma Embryonic Ag Test Kit	Ir052	EUDAMED	IVD General	Active
SAA Serum Amyloid A Test Kit	Ir074	EUDAMED	IVD General	Active
Bordetella pertussis Nucleic Acid Detection Kit (Unvaccinated)	Nc038	EUDAMED	IVD General	Active
KET Ketamine Test Kit	Ir065	EUDAMED	IVD General	Active
TC Total Cholesterol Test Kit	Ir095	EUDAMED	IVD General	Active
Malaria Ag Test Kit	Ir028	EUDAMED	IVD General	Active
Bordetella pertussis Nucleic Acid Detection Kit	Nc014	EUDAMED	IVD General	Active
Adenovirus/Rotavirus Ag Test Panel	Ir035	EUDAMED	IVD General	Active
PT Prothrombin Time Test Kit	Ir083	EUDAMED	IVD General	Active
Zika Virus Nucleic Acid Detection Kit (Fluorescence)	Fa023	EUDAMED	IVD General	Active
Corynebacterium diphtheriae Nucleic Acid Detection Kit (Fluorescence)	Fa015	EUDAMED	IVD General	Active
Adenovirus (Respiratory Type) Nucleic Acid Detection Kit (Fluorescence)	Fa029	EUDAMED	IVD General	Active
PT/APTT Test Panel	Ir088	EUDAMED	IVD General	Active
Haemophilus influenzae Nucleic Acid Detection Kit (Fluorescence)	Fa040	EUDAMED	IVD General	Active
FIB Fibrinogen Test Kit	Ir086	EUDAMED	IVD General	Active
GLU Glucose Test Kit	Ir093	EUDAMED	IVD General	Active
Calprotectin (Calp) Detection Kit	Ir041	EUDAMED	IVD General	Active
Dengue NS1/IgM/IgG Test Panel	Ir027	EUDAMED	IVD General	Active
Rhinovirus Nucleic Acid Detection Kit (Nasopharyngeal Swab)	Nc033	EUDAMED	IVD General	Active
Neisseria meningitidis Nucleic Acid Detection Kit	Nc013	EUDAMED	IVD General	Active
PCT Procalcitonin Test Kit	Ir073	EUDAMED	IVD General	Active
Bordetella pertussis Nucleic Acid Detection Kit (Fluorescence, Unvaccinated)	Fa038	EUDAMED	IVD General	Active
Respiratory Syncytial Virus (A/B) Nucleic Acid Detection Kit	Nc028	EUDAMED	IVD General	Active
Cryptococcus Nucleic Acid Detection Kit (CSF)	Nc044	EUDAMED	IVD General	Active
West Nile Virus Nucleic Acid Detection Kit	Nc022	EUDAMED	IVD General	Active
Follicle Stimulating Hormone (FSH) Test Kit	Ir003	EUDAMED	IVD General	Active
Adenovirus Ag Test Kit	Ir033	EUDAMED	IVD General	Active
Dengue Virus Genotyping Nucleic Acid Detection Kit	Nc047	EUDAMED	IVD General	Active
CK-MB Creatine Kinase-MB Test Kit	Ir079	EUDAMED	IVD General	Active
Shigella/Entamoeba histolytica Nucleic Acid Detection Kit (Fluorescence)	Fa010	EUDAMED	IVD General	Active
Corynebacterium diphtheriae Nucleic Acid Detection Kit	Nc015	EUDAMED	IVD General	Active
Norovirus Nucleic Acid Detection Kit	Nc018	EUDAMED	IVD General	Active
Pneumocystis jirovecii Nucleic Acid Detection Kit (Fluorescence, BALF)	Fa045	EUDAMED	IVD General	Active
Mycoplasma Pneumoniae Ab Test Kit	Ir047	EUDAMED	IVD General	Active
Myo Myoglobin Test Kit	Ir080	EUDAMED	IVD General	Active
Klebsiella pneumoniae Nucleic Acid Detection Kit	Nc042	EUDAMED	IVD General	Active
Gardneralla Vaginalis Rapid Test	Ir023	EUDAMED	IVD General	Active
Shigella/Entamoeba histolytica Nucleic Acid Detection Kit	Nc010	EUDAMED	IVD General	Active
Japanese Encephalitis Virus Nucleic Acid Detection Kit	Nc007	EUDAMED	IVD General	Active
Human Coronavirus (OC43/229E/HKU1/NL63) Nucleic Acid Detection Kit	Nc032	EUDAMED	IVD General	Active
Influenza A/B Virus Nucleic Acid Detection Kit (Fluorescence)	Fa017	EUDAMED	IVD General	Active
Treponema pallidum Antibody Test Kit	Ir016	EUDAMED	IVD General	Active
Plasmodium Nucleic Acid Detection Kit (Fluorescence)	Fa016	EUDAMED	IVD General	Active
FOB Fecal Occult Blood Test Kit	Ir037	EUDAMED	IVD General	Active

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