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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 10 of 23

Device	Model / Reference	Registries	Class	Status
Urinalysis Multi-Control	3010254	EUDAMED	IVD General	Active
Direct Bilirubin Reagent Kit(diazo Salt Method)	3000502	EUDAMED	IVD General	Active
H Series Urine Analyzer Cleaning Liquid for Refractometer and Turbidimeter	3010772	EUDAMED	Class A	Active
Dirui	3012989	EUDAMED	IVD General	Active
Dirui	3012976	EUDAMED	IVD General	Active
Dirui	3009794	EUDAMED	IVD General	Active
Total Protein In Urine Reagent Kit (turbidimetric Method)	3004411	EUDAMED	IVD General	Active
Dirui	3009961	EUDAMED	IVD General	Active
Dirui	3009952	EUDAMED	IVD General	Active
Aspartate Aminotransferase Reagent Kit（ifcc Method）	3000411	EUDAMED	IVD General	Active
Dirui	3012505	EUDAMED	IVD General	Active
Dirui	1 biochemistry module + 1 immunoassay module + 1 sample unit +1ISE module+ 1 detergent proportioning module etc	EUDAMED	IVD General	Active
Cancer Antigen 15-3 Detection Kit (Chemiluminescence Immunoassay)	3013793	EUDAMED	IVD General	Active
Uric Acid Reagent Kit（uricase Method）	3019372	EUDAMED	IVD General	Active
ISE Internal Standard Solution	3013323	EUDAMED	IVD General	Active
Dirui	3015090	EUDAMED	IVD General	Active
Acid Trigger Reagent	3023060	EUDAMED	Class A	Active
Total Protein Reagent Kit (biuret Method)	3023215	EUDAMED	IVD General	Active
Thrombin Time Detection Kit (Coagulation Assay)	R: 10×2.2mL; TT Reconstitution Fluid: 1×30.	EUDAMED	IVD General	Active
Dirui	3012892	EUDAMED	IVD General	Active
Apolipoprotein A2 Reagent Kit (Immunoturbidimetric Assay)	3011777	EUDAMED	IVD General	Active
Cleaning liquid II (Concentrated type)	3009311	EUDAMED	Class A	Active
Dirui	3009948	EUDAMED	IVD General	Active
FE CalibratorⅡ	3009399	EUDAMED	IVD General	Active
H series urine analyzer Calibration liquid for Turbidity	3002401	EUDAMED	IVD General	Active
Renin Detection Kit (Chemiluminescence Immunoassay)	3013844	EUDAMED	IVD General	Active
Cystatin C Reagent Kit（latex Enhanced Immunoturbidimetric Assay）	3001114	EUDAMED	IVD General	Active
Dirui	3016491	EUDAMED	IVD General	Active
Procalcitonin Detection Kit (Chemiluminescence Immunoassay)	3010020	EUDAMED	IVD General	Active
Rheumatoid Factor Kit（latex Enhanced Immunoturbidimetric Assay）	3001015	EUDAMED	IVD General	Active
Phospholipid Reagent Kit (Choline Oxide Assay)	3011603	EUDAMED	IVD General	Active
Neuron-specific Enolase Detection Kit (Chemiluminescence Immunoassay)	3013899	EUDAMED	IVD General	Active
Dirui	3014907	EUDAMED	IVD General	Active
Concentrated Washing Buffer	3019966	EUDAMED	Class A	Active
Dirui	3002192	EUDAMED	IVD General	Active
Dehydroepiandrosterone Sulfate Detection Kit (Chemiluminescence Immunoassay)	3010674	EUDAMED	IVD General	Active
Sheath	3020856	EUDAMED	Class A	Active
Cystatin C Reagent Kit（latex Enhanced Immunoturbidimetric Assay）	3021608	EUDAMED	IVD General	Active
Phospholipid Reagent Kit (Choline Oxide Assay)	3013019	EUDAMED	IVD General	Active
CS-2000i	3012225	EUDAMED	Class A	Active
Dirui	R1:4×40mL R1:2×20mL Calibrator:1×1mL Control :2×1mL	EUDAMED	IVD General	Active
BF-Diluent	3019123	EUDAMED	Class A	Active
Cancer Antigen 242 Detection Kit (Chemiluminescence Immunoassay)	3010701	EUDAMED	IVD General	Active
Dirui	3014167	EUDAMED	IVD General	Active
Dirui	3000788	EUDAMED	IVD General	Active
Urinalysis Strips	3000350	EUDAMED	IVD General	Active
Dirui	3012507	EUDAMED	IVD General	Active
Ischemic Modified Albumin Reagent Kit (ACB Assay)	3011892	EUDAMED	IVD General	Active
Cancer Antigen 242 Detection Kit (Chemiluminescence Immunoassay)	3010681	EUDAMED	IVD General	Active
Dirui	3009949	EUDAMED	IVD General	Active

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