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DIRUI INDUSTRIAL CO., LTD

China·CN-MF-000001891

Last updated June 8, 2026

Information

Country: China
Address: 95 Yunhe Street, 95 Yunhe Street New & High Tech. Development Zone Changchun, Jilin 130012 P.R. China, Changchun, China
Website: dirui.com.cn
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Haohui He
EUDAMED SRN: CN-MF-000001891
FDA FEI Number: —
DUNS Number: —

Catalogue (1123)

Page 8 of 23

Device	Model / Reference	Registries	Class	Status
β2-Microglobulin Control	3024314	EUDAMED	IVD General	Active
Creatine Kinase Mb Isoenzyme Reagent Kit（immunoinhibition）	3021555	EUDAMED	IVD General	Active
Adiponectin Reagent Kit (Latex Immunoturbidimetric Assay)	3024995	EUDAMED	IVD General	Active
ISE Reference Solution	3021677	EUDAMED	IVD General	Active
Anti-Streptolysin O Kit（latex Enhanced Immunoturbidimetric Assay）	3021690	EUDAMED	IVD General	Active
Urine Analyzer	H-1800	EUDAMED	IVD General	Active
Clinical Chemistry Control	3025221	EUDAMED	IVD General	Active
Glycohemoglobin A 1c Reagent Kit	3001059	EUDAMED	IVD General	Active
Immunoglobulin A Kit (immunoturbidimetric Method)	3023540	EUDAMED	IVD General	Active
Apolipoprotein C3 Reagent Kit (Immunoturbidimetric Assay)	3021586	EUDAMED	IVD General	Active
Low Density Lipoprotein Cholesterol Reagent Kit（direct Method）	3023259	EUDAMED	IVD General	Active
Complement C1q Reagent Kit (Immunoturbidimetric Assay)	3025061	EUDAMED	IVD General	Active
β-Hydroxybutyrate Reagent Kit（β-hydroxybutyrate Dehydrogenase Assay）	3021600	EUDAMED	IVD General	Active
Carbon Dioxide Reagent Kit(enzymatic Method)	3023573	EUDAMED	IVD General	Active
Rheumatoid Factor Kit（latex Enhanced Immunoturbidimetric Assay）	3016534	EUDAMED	IVD General	Active
Creatine Kinase Reagent Kit（ifcc Method）	3023222	EUDAMED	IVD General	Active
Complement C1q Reagent Kit (Immunoturbidimetric Assay)	3019804	EUDAMED	IVD General	Active
Lipoprotein-Associated Phospholipase A2 Reagent Kit (Latex Immunoturbidimetric Assay)	3025083	EUDAMED	IVD General	Active
Serum Amyloid A Protein Reagent Kit (Latex Immunoturbidimetric Assay)	3021691	EUDAMED	IVD General	Active
Integrated System	CSM-8000	EUDAMED	IVD General	Active
Anti-Streptolysin O Kit（latex Enhanced Immunoturbidimetric Assay）	3016506	EUDAMED	IVD General	Active
Auto-Chemistry Analyzer	CS-680	EUDAMED	IVD General	Active
Urine Analyzer	H-1800	EUDAMED	IVD General	Active
Sialic Acid Reagent Kit（Lactate Dehydrogenase Assay）	3021551	EUDAMED	IVD General	Active
Cholesterol Reagent Kit（enzyme Method）	3021193	EUDAMED	IVD General	Active
Immunoglobulin G Kit（immunoturbidimetric Method）	3012499	EUDAMED	IVD General	Active
FUS Series Urinalysis Hybrid Sheath II	3009267	EUDAMED	Class A	Active
Total Protein Reagent Kit (biuret Method)	3023193	EUDAMED	IVD General	Active
Collagen Type Ⅳ Detection Kit (Chemiluminescence Immunoassay)	3010540	EUDAMED	IVD General	Active
H series urine analyzer Control liquid for Turbidity	3002399	EUDAMED	IVD General	Active
Thyroglobulin Detection Kit (Chemiluminescence Immunoassay)	3008737	EUDAMED	IVD General	Active
Squamous Cell Carcinoma Antigen Detection Kit (Chemiluminescence Immunoassay)	3013442	EUDAMED	IVD General	Active
Glycylproline Depeptidyl Aminopeptidase Reagent Kit (P-nitroaniline Assay )	3012849	EUDAMED	IVD General	Active
Urine Sediment Analyzer Reagent Sheath	3019038	EUDAMED	Class A	Active
BCC-3D Diluent	3019113	EUDAMED	Class A	Active
BCA-1000 Automatic Blood Coagulation Analyzer	3017197	EUDAMED	Class A	Active
Isocitrate Dehydrogenase Reagent Kit（the Substrate Method）	3021612	EUDAMED	IVD General	Active
Kit for Urine Sediment Analyzer	3002402	EUDAMED	IVD General	Active
Neuron-specific Enolase Detection Kit (Chemiluminescence Immunoassay)	3010680	EUDAMED	IVD General	Active
Α1-Microglobulin Reagent Kit（latex Enhanced Immunoturbidimetric Method）	3014905	EUDAMED	IVD General	Active
Alkaline Phosphatase Reagent Kit（ifcc Method）	3000427	EUDAMED	IVD General	Active
Fructosamine Reagent Kit ( Nitrotetrazolium-Blue Reduction Method)	3000853	EUDAMED	IVD General	Active
Tumor Marker Multi Control Ⅰ	3013948	EUDAMED	IVD General	Active
Low Density Lipoprotein Cholesterol Reagent Kit（direct Method）	3000741	EUDAMED	IVD General	Active
Multi-Control for Urine Physical and Chemical Analysis	3010753	EUDAMED	IVD General	Active
BSP-800 Automated Hematology Smear Slide Processor	3019711	EUDAMED	Class A	Active
Cleaning liquid (Concentrated type)	3007277	EUDAMED	Class A	Active
Ferritin Reagent Kit (Latex Enhanced Immunoturbidimetric Method)	3016502	EUDAMED	IVD General	Active
Automatic Blood Coagulation Analyzer Detergent II	3010043	EUDAMED	Class A	Active
Cleaning liquid (Concentrated type)	3010773	EUDAMED	Class A	Active

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