Is this your brand? Sign in to claim ownership.

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 1 of 3

Device	Model / Reference	Registries	Class	Status
Cancer Antigen 15-3 Quantitative Detection KIT (Chemiluminescent Immunoassay)	/	EUDAMED	IVD General	Active
N-acetyl-β-D-glucosaminidase Assay Kit (Rate Method)	/	EUDAMED	IVD General	Active
Neuron-specific Enolase Quantitative Detection KIT (Chemiluminescent Immunoassay)	/	EUDAMED	IVD General	Active
Apolipoprotein E Test Kit (Latex Immunoturbidimetric Method)	/	EUDAMED	IVD General	Active
Rheumatoid Factor Test Kit (Latex Immunoturbidimetric Method)	/	EUDAMED	IVD General	Active
Insulin Quantitative Detection KIT (Chemiluminescent Immunoassay)	/	EUDAMED	IVD General	Active
α-Hydroxybutyrate Dehydrogenase Kit (DGKC Method)	/	EUDAMED	IVD General	Active
Procalcitonin Quantitative Detection KIT (Chemiluminescent Immunoassay)	/	EUDAMED	IVD General	Active
Complement Components C4 Kit (Immunoturbidimetric Assay)	/	EUDAMED	IVD General	Active
Hemoglobin A1c Assay Kit (Latex Immunoturbidimetric Method)	/	EUDAMED	IVD General	Active
Immunoglobulin G Kit (Immunoturbidimetric Assay)	/	EUDAMED	IVD General	Active
Pancreas Amylase Assay Kit (Immunosuppression and EPS Substrate Method)	/	EUDAMED	IVD General	Active
Direct Bilirubin Kit (Vanadate Oxidation Method)	/	EUDAMED	IVD General	Active
Calcium Kit (Arsenazo III Colorimetric Method)	/	EUDAMED	IVD General	Active
Immunology Multi Control	/	EUDAMED	IVD General	Active
Enzyme Multical Control	/	EUDAMED	IVD General	Active
Estradiol Quantitative Detection KIT (Chemiluminescent Immunoassay)	/	EUDAMED	IVD General	Active
Urine Microalbumin Kit (Latex Immunoturbidimetric Method)	/	EUDAMED	IVD General	Active
Heart-type Fatty Acid Binding Protein Assay Kit (Latex Immunoturbidimetric Method)	/	EUDAMED	IVD General	Active
Low Density Lipoprotein Cholesterol Kit (Enzyme Clearance Assay)	/	EUDAMED	IVD General	Active
Inorganic Phosphorous Kit (UV Method)	/	EUDAMED	IVD General	Active
Bilirubin Calibrator Kit (Vanadate Oxidation Method)	/	EUDAMED	IVD General	Active
Free Fatty Acid Assay Kit (Enzymatic Method)	/	EUDAMED	IVD General	Active
Rheumatism Multi Control	/	EUDAMED	IVD General	Active
Inorganic Phosphorous Kit (UV Method)	/	EUDAMED	IVD General	Active
Thyroid-stimulating Hormone Quantitative Detection KIT (Chemiluminescent Immunoassay)	/	EUDAMED	IVD General	Active
Antibodies to Thyroid Peroxidase Quantitative Detection KIT (Chemiluminescent Immunoassay)	/	EUDAMED	IVD General	Active
System Calibrator Level 2	/	EUDAMED	IVD General	Active
Lipase Kit (Rate Assay)	/	EUDAMED	IVD General	Active
α-Amylase Assay Kit (EPS Substrate Method)	/	EUDAMED	IVD General	Active
Pepsinogens ⅡAssay Kit (Latex Immunoturbidimetric Method)	/	EUDAMED	IVD General	Active
D-Dimer Assay Kit (Latex Immunoturbidimetric Method)	/	EUDAMED	IVD General	Active
Enzyme Multical Calibrator	/	EUDAMED	IVD General	Active
β2-Microglobulin Test Kit (Latex Immunoturbidimetric Method)	/	EUDAMED	IVD General	Active
Free Triiodothyronine Quantitative Detection KIT (Chemiluminescent Immunoassay)	/	EUDAMED	IVD General	Active
Lactate Dehydrogenase Kit (Lactate Method)	/	EUDAMED	IVD General	Active
Cystatin C Kit (Immunoturbidimetric Assay)	/	EUDAMED	IVD General	Active
Pepsinogen II Quantitative Detection KIT (Chemiluminescent Immunoassay)	/	EUDAMED	IVD General	Active
Control Serum Level 1	/	EUDAMED	IVD General	Active
Control Serum Level 2	/	EUDAMED	IVD General	Active
α-L-Fucosidase Kit (CNPF Substrate Assay)	/	EUDAMED	IVD General	Active
Angiotensin-converting Enzyme Test Kit (Rate Assay)	/	EUDAMED	IVD General	Active
β-Hydroxybutyric Acid Test Kit (Enzymatic Method)	/	EUDAMED	IVD General	Active
Albumin Kit (Bromocresol Green Method)	/	EUDAMED	IVD General	Active
Ischemia-Modified Albumin Assay Kit (Albumin-cobalt Binding Method)	/	EUDAMED	IVD General	Active
Glucose Kit (GOD-PAP Method)	/	EUDAMED	IVD General	Active
Cholinesterase Kit (Standard Method/DGKC 94’)	/	EUDAMED	IVD General	Active
Testosterone Quantitative Detection KIT (Chemiluminescent Immunoassay)	/	EUDAMED	IVD General	Active
Anti-Cyclic Citrullinated Peptide Antibody Assay Kit (Latex Immunoturbidimetric Method)	/	EUDAMED	IVD General	Active
25-Hydroxyvitamin D Assay Kit (Latex Immunoturbidimetric Method)	/	EUDAMED	IVD General	Active

Related Companies

Authorised Representatives

QbD RepS BV BE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.