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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 4 of 23

Device	Model / Reference	Registries	Class	Status
Urinalysis Hybrid	FUS-1000	EUDAMED	IVD General	Active
LIPOPROTEIN (a) REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY）	3021646	EUDAMED	IVD General	Active
Calcium Reagent Kit (arsenazo Iii Method)	3019474	EUDAMED	IVD General	Active
Apolipoprotein E Reagent Kit (Immunoturbidimetric Assay)	3021588	EUDAMED	IVD General	Active
Glycohemoglobin A 1c Reagent Kit	3009801	EUDAMED	IVD General	Active
Potassium Reagent Kit(Pyruvate Kinase Assay)	3021583	EUDAMED	IVD General	Active
Immunoglobulin G Kit（immunoturbidimetric Method）	3021183	EUDAMED	IVD General	Active
Chloride Reagent Kit (thiocyanate Method)	3021642	EUDAMED	IVD General	Active
Free Fatty Acid Reagent Kit (ACS-ACOD Assay)	3021585	EUDAMED	IVD General	Active
ISE blood sample calibrator	3025277	EUDAMED	IVD General	Active
Creatine Kinase Mb Isoenzyme Reagent Kit（immunoinhibition）	3023191	EUDAMED	IVD General	Active
α2-macroglobulin Reagent Kit (Immunoturbidimetric Assay)	3011376	EUDAMED	IVD General	Active
C-Reactive Protein Reagent Kit（latex Enhanced Immunoturbidimetric Assay）	3021574	EUDAMED	IVD General	Active
Lactate Dehydrogenase Isoenzyme 1 Reagent Kit (Chemical Inhibition Assay)	3012983	EUDAMED	IVD General	Active
Glycohemoglobin A 1c Reagent Kit	3021596	EUDAMED	IVD General	Active
Glycated Albumin Reagent Kit (Ketamine Oxidase Assay)	3021739	EUDAMED	IVD General	Active
Auto-Chemistry Analyzer	CS-400	EUDAMED	IVD General	Active
Phospholipid Reagent Kit (Choline Oxide Assay)	3021726	EUDAMED	IVD General	Active
ISE blood quality control	3025280	EUDAMED	IVD General	Active
Auto-Chemistry Analyzer	CS-1200	EUDAMED	IVD General	Active
Α-Hydroxybutyric Dehydrogenase Reagent Kit（dgkc Method）	3023554	EUDAMED	IVD General	Active
Adiponectin Reagent Kit (Latex Immunoturbidimetric Assay)	3025052	EUDAMED	IVD General	Active
Inorganic Phosphorus Reagent Kit(direct Uv Method)	3016550	EUDAMED	IVD General	Active
Apolipoprotein A1 Reagent Kit（immunoturbidimetric Method）	3021533	EUDAMED	IVD General	Active
Apolipoprotein A1 Reagent Kit（immunoturbidimetric Method）	3021723	EUDAMED	IVD General	Active
Kappa Light Chain Reagent Kit (Immunoturbidimetric Assay)	3015855	EUDAMED	IVD General	Active
Immunoglobulin M Kit（immunoturbidimetric Method）	3021696	EUDAMED	IVD General	Active
Clinical Chemistry Control	3025229	EUDAMED	IVD General	Active
Auto-Chemistry Analyzer	CS-T180	EUDAMED	IVD General	Active
Magnesium Reagent Kit（xylidyl Blue Method）	3021160	EUDAMED	IVD General	Active
Lipoprotein-Associated Phospholipase A2 Reagent Kit (Latex Immunoturbidimetric Assay)	3019797	EUDAMED	IVD General	Active
BF-RF Dye	3019899	EUDAMED	Class A	Active
Homocysteine Reagent Kit（enzymatic Cycling Method）	3023575	EUDAMED	IVD General	Active
High Density Lipoprotein Cholesterol Reagent Kit（direct Method）	3021687	EUDAMED	IVD General	Active
Carbon Dioxide Reagent Kit(enzymatic Method)	3016500	EUDAMED	IVD General	Active
Urine Analyzer	H-1800	EUDAMED	IVD General	Active
Apolipoprotein B Reagent Kit（immunoturbidimetric Method）	3021641	EUDAMED	IVD General	Active
Retinol Binding Protein (RBP) Reagent Kit (Latex Immunoturbidimetric Assay)	3021630	EUDAMED	IVD General	Active
Inorganic Phosphorus Reagent Kit(direct Uv Method)	3021605	EUDAMED	IVD General	Active
Adiponectin Reagent Kit (Latex Immunoturbidimetric Assay)	3025098	EUDAMED	IVD General	Active
Auto-Chemistry Analyzer	CS-1600	EUDAMED	IVD General	Active
Immunoglobulin A Kit (immunoturbidimetric Method)	3021644	EUDAMED	IVD General	Active
Retinol Binding Protein (RBP) Reagent Kit (Latex Immunoturbidimetric Assay)	3014901	EUDAMED	IVD General	Active
Complement4 Reagent Kit（immunoturbidimetric Method）	3021575	EUDAMED	IVD General	Active
Lipoprotein-Associated Phospholipase A2 Reagent Kit (Latex Immunoturbidimetric Assay)	3025030	EUDAMED	IVD General	Active
Auto-Chemistry Analyzer	CS-1300B	EUDAMED	IVD General	Active
BF-SLS-I Lyse	3019948	EUDAMED	Class A	Active
Calcium Reagent Kit（cresolphthalein Complexone Method）	3021713	EUDAMED	IVD General	Active
Clinical Chemistry Calibrator	3025264	EUDAMED	IVD General	Active
BCC-3000 Cleanser	3019974	EUDAMED	Class A	Active

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