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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 6 of 23

Device	Model / Reference	Registries	Class	Status
Glycohemoglobin A 1c Reagent Kit	3021678	EUDAMED	IVD General	Active
Lipoprotein-Associated Phospholipase A2 Reagent Kit (Latex Immunoturbidimetric Assay)	3025100	EUDAMED	IVD General	Active
FE Dye	3019942	EUDAMED	Class A	Active
Creatine Kinase Reagent Kit（ifcc Method）	3016558	EUDAMED	IVD General	Active
Clinical Chemistry Calibrator	3025734	EUDAMED	IVD General	Active
Vaginal Infections Analyzer	GMD-S600	EUDAMED	IVD General	Active
Glycohemoglobin A 1c Reagent Kit	3021169	EUDAMED	IVD General	Active
Specific Protein Control	3025082	EUDAMED	IVD General	Active
Urinalysis Hybrid	FUS-2000	EUDAMED	IVD General	Active
β2-Microglobulin Calibrator	3024273	EUDAMED	IVD General	Active
BF-Diluent	3019975	EUDAMED	Class A	Active
ISE Internal Standard Solution	3024569	EUDAMED	IVD General	Active
Clinical Chemistry Calibrator	3025210	EUDAMED	IVD General	Active
Lipoprotein-Associated Phospholipase A2 Reagent Kit (Latex Immunoturbidimetric Assay)	3019798	EUDAMED	IVD General	Active
Glucose Reagent Kit(glucose Oxidase Method)	3021540	EUDAMED	IVD General	Active
Cholesterol Reagent Kit（enzyme Method）	3016524	EUDAMED	IVD General	Active
Glucose Reagent Kit(hexokinase Method)	3021699	EUDAMED	IVD General	Active
Auto-Chemistry Analyzer	CS-2000i	EUDAMED	IVD General	Active
Lactate Dehydrogenase Isoenzyme 1 Reagent Kit (Chemical Inhibition Assay)	3021567	EUDAMED	IVD General	Active
Full Range C-Reactive Protein Reagent Kit (Latex Immunoturbidimetric Assay)	3021735	EUDAMED	IVD General	Active
High Sensitivity C-Reactive Protein Kit (Latex Immunoturbidimetric Assay)	3021719	EUDAMED	IVD General	Active
Glucose Reagent Kit(hexokinase Method)	3021168	EUDAMED	IVD General	Active
Calcium Reagent Kit (arsenazo Iii Method)	3017274	EUDAMED	IVD General	Active
Lipoprotein-Associated Phospholipase A2 Reagent Kit (Latex Immunoturbidimetric Assay)	3025015	EUDAMED	IVD General	Active
Sample Diluent	3019892	EUDAMED	Class A	Active
Auto-Chemistry Analyzer	CS-680	EUDAMED	IVD General	Active
Clinical Chemistry Calibrator	3025724	EUDAMED	IVD General	Active
Ischemic Modified Albumin Reagent Kit (ACB Assay)	3021669	EUDAMED	IVD General	Active
Glycohemoglobin A 1c Reagent Kit	3023219	EUDAMED	IVD General	Active
Integrated System	3012562	EUDAMED	IVD General	Active
Amylase Reagent Kit（ifcc Method）	3019460	EUDAMED	IVD General	Active
Lipoprotein-Associated Phospholipase A2 Reagent Kit (Latex Immunoturbidimetric Assay)	3025076	EUDAMED	IVD General	Active
Glycohemoglobin A 1c Reagent Kit	3021159	EUDAMED	IVD General	Active
Triglycerides Reagent Kit（oxidase Method）	3016552	EUDAMED	IVD General	Active
Clinical Chemistry Calibrator	3025228	EUDAMED	IVD General	Active
Auto-Chemistry Analyzer	CS-1300B	EUDAMED	IVD General	Active
Auto-Chemistry Analyzer	CS-1300A	EUDAMED	IVD General	Active
Creatine Kinase Mb Isoenzyme Reagent Kit（immunoinhibition）	3016519	EUDAMED	IVD General	Active
Urine Sediment Analyzer Reagent Sheath	3019967	EUDAMED	Class A	Active
Adiponectin Reagent Kit (Latex Immunoturbidimetric Assay)	3024996	EUDAMED	IVD General	Active
Triglycerides Reagent Kit（oxidase Method）	3019472	EUDAMED	IVD General	Active
UA Dye	3024589	EUDAMED	Class A	Active
Auto-Chemistry Analyzer	CS-650	EUDAMED	IVD General	Active
C-Reactive Protein Reagent Kit（latex Enhanced Immunoturbidimetric Assay）	3023254	EUDAMED	IVD General	Active
BF-FDO Lyse	3019936	EUDAMED	Class A	Active
Free Fatty Acid Reagent Kit (ACS-ACOD Assay)	3021613	EUDAMED	IVD General	Active
Glycated Albumin Reagent Kit (Ketamine Oxidase Assay)	3021704	EUDAMED	IVD General	Active
Specific Protein Control	3025046	EUDAMED	IVD General	Active
Clinical Chemistry Control	3025196	EUDAMED	IVD General	Active
Creatine Kinase Mb Isoenzyme Reagent Kit（immunoinhibition）	3021721	EUDAMED	IVD General	Active

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Notified Bodies

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Authorities

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