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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 11 of 23

Device	Model / Reference	Registries	Class	Status
Dirui	3002999	EUDAMED	IVD General	Active
Negative Control	3001182	EUDAMED	IVD General	Active
ISE Internal Standard Solution	3002414	EUDAMED	IVD General	Active
Dirui	3012493	EUDAMED	IVD General	Active
Digoxin Detection Kit (Chemiluminescence Immunoassay)	3014022	EUDAMED	IVD General	Active
Dirui	3016061	EUDAMED	IVD General	Active
Human Hyaluronic Acid Detection Kit (Chemiluminescence Immunoassay)	3010576	EUDAMED	IVD General	Active
Dirui	3012529	EUDAMED	IVD General	Active
Zinc Reagent Kit（colorimetric Method）	3000892	EUDAMED	IVD General	Active
Bone Glaprotein Detection Kit (Chemiluminescence Immunoassay)	3010562	EUDAMED	IVD General	Active
Anti-cyclic Citrullinated Peptide Antibodies Reagent Kit (Latex Immunoturbidimetric Assay)	3021689	EUDAMED	IVD General	Active
BF-Diluent	3003096	EUDAMED	Class A	Active
Dirui	3012826	EUDAMED	IVD General	Active
Urea Reagent Kit（enzyme Method）	3012241	EUDAMED	IVD General	Active
Dirui	3012238	EUDAMED	IVD General	Active
Dirui	3012555	EUDAMED	IVD General	Active
Β2-Microglobulin Reagent Kit（latex Enhanced Immunoturbidimetric Assay）	3001084	EUDAMED	IVD General	Active
Dirui	3009953	EUDAMED	IVD General	Active
Urine Analyzer H-100	3009740	EUDAMED	Class A	Active
Triiodothyronine Detection Kit (Chemiluminescence Immunoassay)	3008725	EUDAMED	IVD General	Active
CS-ISE Diluent	3002460	EUDAMED	Class A	Active
Sodium Reagent Kit(Galactosidase Assay)	3015967	EUDAMED	IVD General	Active
Sangtec-100 Detection Kit (Chemiluminescence Immunoassay)	3013435	EUDAMED	IVD General	Active
Dirui	3000710	EUDAMED	IVD General	Active
Standard Solution	3001149	EUDAMED	IVD General	Active
Urea Reagent Kit（enzyme Method）	3016546	EUDAMED	IVD General	Active
β2-Microglobulin Detection Kit (Chemiluminescence Immunoassay)	3010670	EUDAMED	IVD General	Active
Dirui	3012187	EUDAMED	IVD General	Active
Dirui	3003009	EUDAMED	IVD General	Active
Dirui	3011822	EUDAMED	IVD General	Active
Dirui	3011802	EUDAMED	IVD General	Active
Dirui	3012523	EUDAMED	IVD General	Active
Dirui	1×100 test/kit R1:1×4mL; R2:1×5mL; R3:1×5mL Calibrator High value:1×1mL; Calibrator Low value:1×1mL etc	EUDAMED	IVD General	Active
Urine Sediment Analyzer Reagent Sheath	3001165	EUDAMED	Class A	Active
Urea Reagent Kit（enzyme Method）	3021590	EUDAMED	IVD General	Active
Cardiac Troponin I Detection Kit (Chemiluminescence Immunoassay)	3008764	EUDAMED	IVD General	Active
Aldosterone Detection Kit (Chemiluminescence Immunoassay)	3010675	EUDAMED	IVD General	Active
Progesterone Detection Kit (Chemiluminescence Immunoassay)	3013880	EUDAMED	IVD General	Active
Monoamine Oxidase Reagent Kit (Glutamate Dehydrogenase Assay)	3011445	EUDAMED	IVD General	Active
ISE Reference Solution	3013344	EUDAMED	IVD General	Active
Triiodothyronine Detection Kit (Chemiluminescence Immunoassay)	3013754	EUDAMED	IVD General	Active
Automatic Blood Coagulation Analyzer Detergent II	3014946	EUDAMED	Class A	Active
Urine Sediment Analyzer Reagent Sheath	3019031	EUDAMED	Class A	Active
Multi-Calibrator for Urine Physical and Chemical Analysis	3010759	EUDAMED	IVD General	Active
H series urine analyzer Color Control	3002398	EUDAMED	IVD General	Active
Testosterone Detection Kit (Chemiluminescence Immunoassay)	3013831	EUDAMED	IVD General	Active
Cs-480	3007058	EUDAMED	Class A	Active
Dirui	3025292	EUDAMED	IVD General	Active
Haptoglobin Reagent Kit (Immunoturbidimetric Assay)	3011785	EUDAMED	IVD General	Active
Dirui	3009944	EUDAMED	IVD General	Active

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Authorities

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