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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 12 of 23

Device	Model / Reference	Registries	Class	Status
Dirui	3011811	EUDAMED	IVD General	Active
Haptoglobin Reagent Kit (Immunoturbidimetric Assay)	3012968	EUDAMED	IVD General	Active
Free Fatty Acid Reagent Kit (ACS-ACOD Assay)	3012810	EUDAMED	IVD General	Active
Alkaline Trigger Reagent	3019964	EUDAMED	Class A	Active
Cholinsterase Reagent Kit（butyryl Thiocholine Substrate Method）	3021576	EUDAMED	IVD General	Active
B-Z Cleanser	3003092	EUDAMED	Class A	Active
BF Detergent	3003095	EUDAMED	Class A	Active
Ferritin Reagent Kit (Latex Enhanced Immunoturbidimetric Method)	3016554	EUDAMED	IVD General	Active
Apolipoprotein A1 Reagent Kit（immunoturbidimetric Method）	3002327	EUDAMED	IVD General	Active
Dirui	3012497	EUDAMED	IVD General	Active
Phospholipid Reagent Kit (Choline Oxide Assay)	3011803	EUDAMED	IVD General	Active
Cholinsterase Reagent Kit（butyryl Thiocholine Substrate Method）	3023551	EUDAMED	IVD General	Active
Dr-7000d	3000070	EUDAMED	Class A	Active
Creatine Kinase Mb Isoenzyme Reagent Kit（immunoinhibition）	3012553	EUDAMED	IVD General	Active
Dirui	3019752	EUDAMED	IVD General	Active
Follicle Stimulating Hormone Detection Kit (Chemiluminescence Immunoassay)	3013785	EUDAMED	IVD General	Active
Dirui	R1:1×45mL R2:1×15mL Calibrator :1×1mL Control :1×1mL	EUDAMED	IVD General	Active
Chloride Reagent Kit (thiocyanate Method)	3001678	EUDAMED	IVD General	Active
Cancer Antigen 15-3 Detection Kit (Chemiluminescence Immunoassay)	3013711	EUDAMED	IVD General	Active
High Density Lipoprotein Cholesterol Reagent Kit（direct Method）	3000726	EUDAMED	IVD General	Active
Glucose Reagent Kit(glucose Oxidase Method)	3000602	EUDAMED	IVD General	Active
Dirui	3012952	EUDAMED	IVD General	Active
Dirui	3001277	EUDAMED	IVD General	Active
H series urine analyzer Control liquid for Specific gravity	3022339	EUDAMED	IVD General	Active
Creatinine Reagent Kit（enzyme Method）	3021164	EUDAMED	IVD General	Active
Alanine Aminotransferase Liquid Kit（ifcc Method）	3019413	EUDAMED	IVD General	Active
LIPOPROTEIN (a) REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY）	3014896	EUDAMED	IVD General	Active
B-type Natriuretic Peptide Detection Kit (Chemiluminescence Immunoassay)	3013758	EUDAMED	IVD General	Active
Dirui	Type A：5×0.5mmL（level 1, level 2, level 3, level 4, level 5）	EUDAMED	IVD General	Active
Vaginal Secretions Analysis Strip	3018415	EUDAMED	IVD General	Active
Antibodies to Thyroglobulin Detection Kit (Chemiluminescence Immunoassay)	3013799	EUDAMED	IVD General	Active
Urea Reagent Kit（enzyme Method）	3023221	EUDAMED	IVD General	Active
Diluent	3005383	EUDAMED	Class A	Active
Vaginal Secretions Analysis Detergent	1036251	EUDAMED	Class A	Active
Dirui	3009946	EUDAMED	IVD General	Active
Carbon Dioxide Reagent Kit(enzymatic Method)	3001699	EUDAMED	IVD General	Active
Dirui	3012933	EUDAMED	IVD General	Active
Carbon Dioxide Reagent Kit(enzymatic Method)	3000914	EUDAMED	IVD General	Active
Probe Conditioning Solution	3023058	EUDAMED	Class A	Active
Squamous Cell Carcinoma Antigen Detection Kit (Chemiluminescence Immunoassay)	3013433	EUDAMED	IVD General	Active
Dirui	3015835	EUDAMED	IVD General	Active
Fluorescent Calibrator	3016098	EUDAMED	IVD General	Active
N-Acetyl-Β-D-Glucosaminidase Reagent Kit (mpt-Nag Method)	3014897	EUDAMED	IVD General	Active
Dirui	3000915	EUDAMED	IVD General	Active
C-Reactive Protein Reagent Kit (latex Enhanced Immunoturbidimetric Assay)	3009261	EUDAMED	IVD General	Active
Glucose Reagent Kit(glucose Oxidase Method)	3002389	EUDAMED	IVD General	Active
Dirui	3004640	EUDAMED	IVD General	Active
Vaginal Secretions Analysis Control	3006198	EUDAMED	IVD General	Active
Dirui	3000443	EUDAMED	IVD General	Active
Creatinine Reagent Kit（enzyme Method）	3023192	EUDAMED	IVD General	Active

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Importers

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Notified Bodies

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Authorities

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