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Shanghai Kehua Bio-engineering Co., Ltd.

China·CN-MF-000026756

Last updated June 8, 2026

Information

Country: China
Address: 1189, North Qinzhou Road, Shanghai, China
Website: skhb.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Xiaofang Zhu
EUDAMED SRN: CN-MF-000026756
FDA FEI Number: —
DUNS Number: —

Catalogue (124)

Page 3 of 3

Device	Model / Reference	Registries	Class	Status
Total Cholesterol Kit (CHOD–PAP Method)	/	EUDAMED	IVD General	Active
Creatine Kinase MB Isozyme Calibrator	/	EUDAMED	IVD General	Active
Triglycerides Kit (GPO–PAP Method)	/	EUDAMED	IVD General	Active
5’-Nucleotidase Test Kit (Rate Assay)	/	EUDAMED	IVD General	Active
Total Bile Acids Kit (Enzyme Cycling Method)	/	EUDAMED	IVD General	Active
Immunoglobulin A Kit (Immunoturbidimetric Assay)	/	EUDAMED	IVD General	Active
Prealbumin Kit (Immunoturbidimetric Assay)	/	EUDAMED	IVD General	Active
Glycated Albumin Assay Kit (Enzymatic Method)	/	EUDAMED	IVD General	Active
Lipoprotein (a) Test Kit (Latex Immunoturbidimetric Method)	/	EUDAMED	IVD General	Active
Follicle-stimulating Hormone Quantitative Detection KIT (Chemiluminescent Immunoassay)	/	EUDAMED	IVD General	Active
Myoglobin Kit (Latex Immunoturbidimetric Method)	/	EUDAMED	IVD General	Active
Carbon Dioxide Kit (PEPC Method)	/	EUDAMED	IVD General	Active
Creatine Kinase Kit (NAC Method)	/	EUDAMED	IVD General	Active
Retinol Binding Protein Assay Kit (Latex Immunoturbidimetric Method)	/	EUDAMED	IVD General	Active
Urinary Control	/	EUDAMED	IVD General	Active
Transferrin Kit (Immunoturbidimetric Method)	/	EUDAMED	IVD General	Active
Aspartate Aminotransferase Kit (UV-MDH Method)	/	EUDAMED	IVD General	Active
Lipid Quality Control	/	EUDAMED	IVD General	Active
PepsinogensⅠAssay Kit (Latex Immunoturbidimetric Method)	/	EUDAMED	IVD General	Active
Adenosine Deaminase Test Kit (Rate Assay)	/	EUDAMED	IVD General	Active
Total Protein Kit (Biuret Method)	/	EUDAMED	IVD General	Active
Carcinoembryonic Antigen Quantitative Detection KIT (Chemiluminescent Immunoassay)	/	EUDAMED	IVD General	Active
Progesterone Quantitative Detection KIT (Chemiluminescent Immunoassay)	/	EUDAMED	IVD General	Active
Apolipoprotein B Kit (Immunoturbidimetric Assay)	/	EUDAMED	IVD General	Active

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