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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 20 of 23

Device	Model / Reference	Registries	Class	Status
Lactate Dehydrogenase Reagent Kit（the Substrate Method）	3000789	EUDAMED	IVD General	Active
Human Epididymal Protein 4 Detection Kit (Chemiluminescence Immunoassay)	3013429	EUDAMED	IVD General	Active
Direct Bilirubin Reagent Kit(diazo Salt Method)	3000499	EUDAMED	IVD General	Active
Amylase Reagent Kit（ifcc Method）	3000812	EUDAMED	IVD General	Active
Concentrated Washing Buffer	3019965	EUDAMED	Class A	Active
Complement4 Reagent Kit（immunoturbidimetric Method）	3004607	EUDAMED	IVD General	Active
Direct Bilirubin Reagent Kit(diazo Salt Method)	3016507	EUDAMED	IVD General	Active
Probe Cleanser I	3019126	EUDAMED	Class A	Active
Albumin Reagent Kit (bromcresol Green Method)	3023229	EUDAMED	IVD General	Active
PepsinogenⅠDetection Kit (Chemiluminescence Immunoassay)	3010384	EUDAMED	IVD General	Active
Urinalysis Strips	3000292	EUDAMED	IVD General	Active
N-Acetyl-Β-D-Glucosaminidase Reagent Kit (mpt-Nag Method)	3004652	EUDAMED	IVD General	Active
Treponema Pallidum Antibody Detection Kit (Chemiluminescence Immunoassay)	3010664	EUDAMED	IVD General	Active
Urine Sediment Analyzer Reagent Sheath	3018645	EUDAMED	Class A	Active
Direct Bilirubin Kit（vanadate Oxidation Method）	3023202	EUDAMED	IVD General	Active
Prolactin Detection Kit (Chemiluminescence Immunoassay)	3013733	EUDAMED	IVD General	Active
17α-Hydroxyprogesterone Detection Kit (Chemiluminescence Immunoassay)	3013741	EUDAMED	IVD General	Active
Progesterone Detection Kit (Chemiluminescence Immunoassay)	3008722	EUDAMED	IVD General	Active
Apolipoprotein C2 Reagent Kit (Immunoturbidimetric Assay)	3011774	EUDAMED	IVD General	Active
Total Bilirubin Reagent Kit(surfactant/Diazo Salt Method)	3021538	EUDAMED	IVD General	Active
Dirui	3012827	EUDAMED	IVD General	Active
Prolactin Detection Kit (Chemiluminescence Immunoassay)	3013732	EUDAMED	IVD General	Active
Total Protein In Urine Reagent Kit (turbidimetric Method)	3016535	EUDAMED	IVD General	Active
Sodium Reagent Kit(Galactosidase Assay)	3016007	EUDAMED	IVD General	Active
Neutrophil Gelatinase-associated Lipocalin Reagent Kit (Latex Immunoturbidimetric Assay)	3011568	EUDAMED	IVD General	Active
Creatine Kinase Mb Isoenzyme Reagent Kit（immunoinhibition）	3004690	EUDAMED	IVD General	Active
α-L-Fucosidase Reagent Kit (CNPF Substrate Method)	3023539	EUDAMED	IVD General	Active
Adenosine Deaminase Reagent Kit（enzyme Method）	3023574	EUDAMED	IVD General	Active
Complement3 Reagent Kit（immunoturbidimetric Method）	3000981	EUDAMED	IVD General	Active
Albumin Reagent Kit (bromcresol Green Method)	3023209	EUDAMED	IVD General	Active
Myoglobin Reagent Kit（latex Enhanced Immunoturbidimetric Method）	3004448	EUDAMED	IVD General	Active
Adrenocorticotropic Hormone Detection Kit (Chemiluminescence Immunoassay)	3010588	EUDAMED	IVD General	Active
Cancer Antigen 19-9 Detection Kit (Chemiluminescence Immunoassay)	3014129	EUDAMED	IVD General	Active
Antibodies to Thyroid Peroxidase Detection Kit (Chemiluminescence Immunoassay)	3008749	EUDAMED	IVD General	Active
Urinary Immunoglobulin G Reagent Kit (Immunoturbidimetric Assay)	3021728	EUDAMED	IVD General	Active
Dirui	3011636	EUDAMED	IVD General	Active
Total Bilirubin Reagent Kit(surfactant/Diazo Salt Method)	3000476	EUDAMED	IVD General	Active
Creatinine Reagent Kit（enzyme Method）	3016513	EUDAMED	IVD General	Active
BCC-3D Diluent	3009144	EUDAMED	Class A	Active
Fibrin (Fibrinogen) Degradation Products Detection Kit(Latex Immunoturbidimetric Assay)	3021664	EUDAMED	IVD General	Active
Direct Bilirubin Kit（vanadate Oxidation Method）	3017285	EUDAMED	IVD General	Active
Human Cortisol Detection Kit (Chemiluminescence Immunoassay)	3013841	EUDAMED	IVD General	Active
Rheumatoid Factor Kit（latex Enhanced Immunoturbidimetric Assay）	3012518	EUDAMED	IVD General	Active
Estradiol Detection Kit (Chemiluminescence Immunoassay)	3013801	EUDAMED	IVD General	Active
Dirui	Level 1:3×1mL	EUDAMED	IVD General	Active
Ferritin Reagent Kit (Latex Enhanced Immunoturbidimetric Method)	3009787	EUDAMED	IVD General	Active
Glucose Reagent Kit(hexokinase Method)	3000581	EUDAMED	IVD General	Active
Cs-2000	3012227	EUDAMED	Class A	Active
Dirui	3001276	EUDAMED	IVD General	Active
"Beta-Human Chorionic Gonadotropin Detection Kit (Chemiluminescence Immunoassay)"	3008761	EUDAMED	IVD General	Active

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