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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 2 of 3

Device	Model / Reference	Registries	Class	Status
Urea Kit (UV-GLDH Method)	/	EUDAMED	IVD General	Active
Human Epididymis Protein 4 Quantitative Detection KIT (Chemiluminescent Immunoassay)	/	EUDAMED	IVD General	Active
Interleukin-6 Quantitative Detection KIT (Chemiluminescent Immunoassay)	/	EUDAMED	IVD General	Active
Prolactin Quantitative Detection KIT (Chemiluminescent Immunoassay)	/	EUDAMED	IVD General	Active
Total Thyroxine Quantitative Detection KIT (Chemiluminescent Immunoassay)	/	EUDAMED	IVD General	Active
Homocysteine Assay Kit (Enzymatic Cycling Method)	/	EUDAMED	IVD General	Active
Uric Acid Kit (Uricase-PAP Method)	/	EUDAMED	IVD General	Active
α1-Microglobulin Assay Kit (Latex Immunoturbidimetric Method)	/	EUDAMED	IVD General	Active
Nucleic Acid Extraction Kit 96	KH-G-M-573-96-CE	EUDAMED	Class A	Active
High Density Lipoprotein Cholesterol Kit (Enzyme Clearance Assay)	/	EUDAMED	IVD General	Active
Apolipoprotein A1 Kit (Immunoturbidimetric Assay)	/	EUDAMED	IVD General	Active
Antibody to Thyroglobulin Quantitative Detection KIT (Chemiluminescent Immunoassay)	/	EUDAMED	IVD General	Active
γ-Glutamyltransferase Kit (L-γ-glutamyl-3-carboxy-4-nitroanilide Method)	/	EUDAMED	IVD General	Active
Alpha1-fetoprotein Quantitative Detection KIT (Chemiluminescent Immunoassay)	/	EUDAMED	IVD General	Active
Creatine Kinase-MB Isoenzyme Kit (Immunoinhibition Method)	/	EUDAMED	IVD General	Active
Sialic Acid Assay Kit (Enzymatic Method)	/	EUDAMED	IVD General	Active
Creatinine Kit (Sarcosine Oxidase –PAP Method)	/	EUDAMED	IVD General	Active
Ultra Sensitive C-Reactive Protein Kit (Immunoturbidimetric Assay)	/	EUDAMED	IVD General	Active
Total Bilirubin Kit (Vanadate Oxidation Method)	/	EUDAMED	IVD General	Active
Complement Components C3 Kit (Immunoturbidimetric Assay)	/	EUDAMED	IVD General	Active
Connecting Peptide Quantitative Detection KIT (Chemiluminescent Immunoassay)	/	EUDAMED	IVD General	Active
Immunoglobulin M Kit (Immunoturbidimetric Assay)	/	EUDAMED	IVD General	Active
Carbohydrate Antigen 19-9 Quantitative Detection KIT (Chemiluminescent Immunoassay)	/	EUDAMED	IVD General	Active
Magnesium Assay Kit (Xylidyl Blue Method)	/	EUDAMED	IVD General	Active
Thyroglobulin Quantitative Detection KIT (Chemiluminescent Immunoassay)	/	EUDAMED	IVD General	Active
Serum Amyloid Protein A Assay Kit (Latex Immunoturbidimetric Method)	/	EUDAMED	IVD General	Active
Free Thyroxine Quantitative Detection KIT (Chemiluminescent Immunoassay)	/	EUDAMED	IVD General	Active
Cyfra21-1 Quantitative Detection KIT (Chemiluminescent Immunoassay)	/	EUDAMED	IVD General	Active
Pepsinogen I Quantitative Detection KIT (Chemiluminescent Immunoassay)	/	EUDAMED	IVD General	Active
N-terminal Pro B-type Natriuretic Peptide Quantitative Detection KIT (Chemiluminescent Immunoassay)	/	EUDAMED	IVD General	Active
Mitochondrial Aspartate Transaminase Test Kit (Immunosuppressive Assay)	/	EUDAMED	IVD General	Active
Alanine Aminotransferase Kit (UV-LDH Method)	/	EUDAMED	IVD General	Active
α-Amylase Kit (CNPG3 Method)	/	EUDAMED	IVD General	Active
Alkaline Phosphatase Kit (AMP Buffer Method)	/	EUDAMED	IVD General	Active
Cardiac Markers Plus Control	/	EUDAMED	IVD General	Active
Beta Human Chorionic Gonadotropin Quantitative Detection KIT (Chemiluminescent Immunoassay)	/	EUDAMED	IVD General	Active
Glucose Kit (HK Method)	/	EUDAMED	IVD General	Active
Hemoglobin A1c Kit (Enzymatic Method)	/	EUDAMED	IVD General	Active
Neutrophil Gelatinase-Associated Lipocalin Assay Kit (Latex Immunoturbidimetric Method)	/	EUDAMED	IVD General	Active
Cholyglycine Kit (Homogeneous Enzyme Immunoassay Method)	/	EUDAMED	IVD General	Active
Cancer Antigen 125 Quantitative Detection KIT (Chemiluminescent Immunoassay)	/	EUDAMED	IVD General	Active
C-Reactive Protein Kit (Immunoturbidimetric Assay)	/	EUDAMED	IVD General	Active
Total Triiodothyronine Quantitative Detection KIT (Chemiluminescent Immunoassay)	/	EUDAMED	IVD General	Active
Ferritin Quantitative Detection KIT (Chemiluminescent Immunoassay)	/	EUDAMED	IVD General	Active
Glycylproline Dipeptidyl Aminopeptidase Assay Kit (Rate Method)	/	EUDAMED	IVD General	Active
Squamous-cell Carcinoma Quantitative Detection KIT (Chemiluminescent Immunoassay)	/	EUDAMED	IVD General	Active
Whole C-Reactive Protein Assay Kit (Latex Immunoturbidimetric Method)	/	EUDAMED	IVD General	Active
Anti Streptolysin-O Test Kit (Latex Immunoturbidimetric Method)	/	EUDAMED	IVD General	Active
Nucleic Acid Extraction Kit	KH-G-M-565-48-CE	EUDAMED	Class A	Active
Luteotropic Hormone Quantitative Detection KIT (Chemiluminescent Immunoassay)	/	EUDAMED	IVD General	Active

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