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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 22 of 23

Device	Model / Reference	Registries	Class	Status
25-Hydroxyvitamin D Detection Kit (Chemiluminescence Immunoassay)	3010688	EUDAMED	IVD General	Active
Direct Bilirubin Reagent Kit (Diazo Salt Method)	3015093	EUDAMED	IVD General	Active
PIVKA-II Detection Kit (Chemiluminescence Immunoassay)	3010686	EUDAMED	IVD General	Active
Procalcitonin Detection Kit (Chemiluminescence Immunoassay)	3013780	EUDAMED	IVD General	Active
Multi-Calibrator for Urine Physical and Chemical Analysis	3024165	EUDAMED	IVD General	Active
Alanine Aminotransferase Liquid Kit（ifcc Method）	3023198	EUDAMED	IVD General	Active
Glycohemoglobin A 1c Reagent Kit	3009802	EUDAMED	IVD General	Active
Dirui	3005504	EUDAMED	IVD General	Active
Β2-Microglobulin Reagent Kit（latex Enhanced Immunoturbidimetric Assay）	3021652	EUDAMED	IVD General	Active
Control for Automatic Hematology Analyzer (5-part)	3001375	EUDAMED	IVD General	Active
Control for Body Liquid	3016128	EUDAMED	IVD General	Active
Total Bilirubin Reagent Kit(surfactant/Diazo Salt Method)	3024547	EUDAMED	IVD General	Active
Thyroid Stimulating Hormone Detection Kit (Chemiluminescence Immunoassay)	3008743	EUDAMED	IVD General	Active
Dirui	3004616	EUDAMED	IVD General	Active
Dirui	3012540	EUDAMED	IVD General	Active
BF Detergent	3019124	EUDAMED	Class A	Active
Dirui	3000412	EUDAMED	IVD General	Active
Sample Pretreatment Reagent	3016190	EUDAMED	Class A	Active
Dirui	3003153	EUDAMED	IVD General	Active
Dirui	3012532	EUDAMED	IVD General	Active
Calibrator for Automatic Hematology Analyzer (5-part)	3003116	EUDAMED	IVD General	Active
Prealbumin Reagent Kit（immunoturbidimetric Method）	3023216	EUDAMED	IVD General	Active
Aspartate Aminotransferase Reagent Kit（ifcc Method）	3019374	EUDAMED	IVD General	Active
Urinalysis Control	3022321	EUDAMED	IVD General	Active
Folic Acid Detection Kit (Chemiluminescence Immunoassay)	3014016	EUDAMED	IVD General	Active
Retinol-Binding protein Reagent Kit (Latex Enhanced Immunoturbidimetric Method)	3009839	EUDAMED	IVD General	Active
Luteinizing Hormone Detection Kit (Chemiluminescence Immunoassay)	3013830	EUDAMED	IVD General	Active
Human Growth Hormone Detection Kit (Chemiluminescence Immunoassay)	3010514	EUDAMED	IVD General	Active
Glycylproline Depeptidyl Aminopeptidase Reagent Kit (P-nitroaniline Assay )	3011531	EUDAMED	IVD General	Active
FE Calibrator	3006338	EUDAMED	IVD General	Active
Α1-Microglobulin Reagent Kit（latex Enhanced Immunoturbidimetric Method）	3004649	EUDAMED	IVD General	Active
Calcium Reagent Kit (arsenazo Iii Method)	3000837	EUDAMED	IVD General	Active
Β2-Microglobulin Reagent Kit（latex Enhanced Immunoturbidimetric Assay）	3023552	EUDAMED	IVD General	Active
Insulin Antibody Detection Kit (Chemiluminescence Immunoassay)	3010689	EUDAMED	IVD General	Active
D-Dimer Detection Kit (Latex Immunoturbidimetric Assay)	R1: 5×5mL; R2: 5×5mL; D-Dimer Diluent:1×50mL; Calibrator: 1×1mL; Control Low value:1×1mL; Control High value: 1×1mL	EUDAMED	IVD General	Active
H series urine analyzer Calibration liquid for Specific gravity	3022357	EUDAMED	IVD General	Active
Cancer Antigen 15-3 Detection Kit (Chemiluminescence Immunoassay)	3008782	EUDAMED	IVD General	Active
FE Control	3006329	EUDAMED	IVD General	Active
Monoamine Oxidase Reagent Kit (Glutamate Dehydrogenase Assay)	3011708	EUDAMED	IVD General	Active
Urine Sediment Analyzer Detergent	3001170	EUDAMED	Class A	Active
Immunoglobulin M Kit（immunoturbidimetric Method）	3012519	EUDAMED	IVD General	Active
Dirui	3013015	EUDAMED	IVD General	Active
Thyroxine Detection Kit (Chemiluminescence Immunoassay)	3013827	EUDAMED	IVD General	Active
Urinalysis Strips	3000321	EUDAMED	IVD General	Active
Microalbumin Reagent Kit（immunoturbidimetric Assay）	3019349	EUDAMED	IVD General	Active
Β2-Microglobulin Reagent Kit（latex Enhanced Immunoturbidimetric Assay）	3023568	EUDAMED	IVD General	Active
Cystatin C Reagent Kit（latex Enhanced Immunoturbidimetric Assay）	3023582	EUDAMED	IVD General	Active
Urinalysis Strips	3000241	EUDAMED	IVD General	Active
α-L-Fucosidase Reagent Kit (CNPF Substrate Method)	3023566	EUDAMED	IVD General	Active
Dirui	3000654	EUDAMED	IVD General	Active

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Authorised Representatives

Emergo Europe B.V. NL
SUNGO Europe B.V. NL

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