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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 15 of 23

Device	Model / Reference	Registries	Class	Status
Fibrinogen Detection Kit (Coagulation Assay)	R: 10×2.2mL; FIB Buffer: 1×51mL; FIB Reconstitution Fluid: 1×30mL; Calibrator: 1×1mL	EUDAMED	IVD General	Active
Alpha-fetoprotein Detection Kit (Chemiluminescence Immunoassay)	3013695	EUDAMED	IVD General	Active
Creatine Kinase MB Detection Kit (Chemiluminescence Immunoassay)	3013856	EUDAMED	IVD General	Active
Dirui	H-1800	EUDAMED	IVD General	Active
Human Laminin Detection Kit (Chemiluminescence Immunoassay)	3010526	EUDAMED	IVD General	Active
Cardiac Marker Multi Control	3013949	EUDAMED	IVD General	Active
Cystatin C Reagent Kit（latex Enhanced Immunoturbidimetric Assay）	3021177	EUDAMED	IVD General	Active
Dirui	3000811	EUDAMED	IVD General	Active
Inorganic Phosphorus Reagent Kit(direct Uv Method)	3000880	EUDAMED	IVD General	Active
Dirui	3019733	EUDAMED	IVD General	Active
Γ-Glutamyl Transferase Reagent Kit（ifcc Method）	3000442	EUDAMED	IVD General	Active
Cytokeratin 19 Fragments Detection Kit (Chemiluminescence Immunoassay)	3013796	EUDAMED	IVD General	Active
C-Reactive Protein Reagent Kit (latex Enhanced Immunoturbidimetric Assay)	3009260	EUDAMED	IVD General	Active
BF-5D Diluent	3009143	EUDAMED	Class A	Active
Albumin Reagent Kit (bromcresol Green Method)	3023088	EUDAMED	IVD General	Active
Total Protein Reagent Kit (biuret Method)	3021197	EUDAMED	IVD General	Active
Glycylproline Depeptidyl Aminopeptidase Reagent Kit (P-nitroaniline Assay )	3021577	EUDAMED	IVD General	Active
Ammonia Reagent Kit (Glutamate Dehydrogase Assay)	3021682	EUDAMED	IVD General	Active
Dirui	3011407	EUDAMED	IVD General	Active
Haptoglobin Reagent Kit (Immunoturbidimetric Assay)	3021553	EUDAMED	IVD General	Active
Prealbumin Reagent Kit（immunoturbidimetric Method）	3001710	EUDAMED	IVD General	Active
Alanine Aminotransferase Liquid Kit（ifcc Method）	3016544	EUDAMED	IVD General	Active
Dirui	3000580	EUDAMED	IVD General	Active
FUS Series Urinalysis Hybrid Sheath II	3009269	EUDAMED	Class A	Active
Dirui	3011415	EUDAMED	IVD General	Active
Magnesium Reagent Kit（xylidyl Blue Method）	3001688	EUDAMED	IVD General	Active
Urine Sediment Analyzer Reagent Diluent	3007269	EUDAMED	Class A	Active
Γ-Glutamyl Transferase Reagent Kit（ifcc Method）	3000446	EUDAMED	IVD General	Active
CM-320i Chemiluminescence Immunoassay Analyzer	3013370	EUDAMED	Class A	Active
Dirui	3002854	EUDAMED	IVD General	Active
Dirui	3019853	EUDAMED	IVD General	Active
Prothrombin Time Detection Kit (Coagulation Assay)	R: 10×2.2mL; PT Reconstitution Fluid: 1×30mL; Calibrator: 1×1mL	EUDAMED	IVD General	Active
Dirui	3000639	EUDAMED	IVD General	Active
Free Fatty Acid Reagent Kit (ACS-ACOD Assay)	3011903	EUDAMED	IVD General	Active
Dirui	3000426	EUDAMED	IVD General	Active
PepsinogenⅠDetection Kit (Chemiluminescence Immunoassay)	3010382	EUDAMED	IVD General	Active
Cs-T180	3007316	EUDAMED	Class A	Active
α-L-Fucosidase Reagent Kit (CNPF Substrate Method)	3021149	EUDAMED	IVD General	Active
Dirui	3015826	EUDAMED	IVD General	Active
Urine Conductivity Analysis Calibrator	3008146	EUDAMED	IVD General	Active
Sample Diluent	3019901	EUDAMED	Class A	Active
Dirui	3011463	EUDAMED	IVD General	Active
Dirui	3019792	EUDAMED	IVD General	Active
Serum Amyloid A Protein Detection Kit (Chemiluminescence Immunoassay)	3014814	EUDAMED	IVD General	Active
Dirui	3002384	EUDAMED	IVD General	Active
Α-Hydroxybutyric Dehydrogenase Reagent Kit（dgkc Method）	3000801	EUDAMED	IVD General	Active
ISE Urine Control	3012119	EUDAMED	IVD General	Active
Adenosine Deaminase Reagent Kit（enzyme Method）	3023545	EUDAMED	IVD General	Active
CM-180 Chemiluminescence Immunoassay Analyzer	3015506	EUDAMED	Class A	Active
Glucose Reagent Kit(glucose Oxidase Method)	3000601	EUDAMED	IVD General	Active

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