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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 9 of 23

Device	Model / Reference	Registries	Class	Status
Dehydroepiandrosterone Sulfate Detection Kit (Chemiluminescence Immunoassay)	3013890	EUDAMED	IVD General	Active
Fibrin (Fibrinogen) Degradation Products Detection Kit(Latex Immunoturbidimetric Assay)	3021614	EUDAMED	IVD General	Active
Neuron-specific Enolase Detection Kit (Chemiluminescence Immunoassay)	3010700	EUDAMED	IVD General	Active
Diluent(BCC-3000)	3003090	EUDAMED	Class A	Active
Total Bilirubin Reagent Kit(surfactant/Diazo Salt Method)	3016522	EUDAMED	IVD General	Active
High Density Lipoprotein Cholesterol Reagent Kit（direct Method）	3000724	EUDAMED	IVD General	Active
Positive Control	3001181	EUDAMED	IVD General	Active
H series urine analyzer Control liquid for Specific gravity	3022314	EUDAMED	IVD General	Active
Carcinoembryonic Antigen Detection Kit (Chemiluminescence Immunoassay)	3013774	EUDAMED	IVD General	Active
Renin Detection Kit (Chemiluminescence Immunoassay)	3010550	EUDAMED	IVD General	Active
Alkaline Phosphatase Reagent Kit（ifcc Method）	3023230	EUDAMED	IVD General	Active
Cancer Antigen 242 Detection Kit (Chemiluminescence Immunoassay)	3014820	EUDAMED	IVD General	Active
Glycohemoglobin A 1c Reagent Kit	3004623	EUDAMED	IVD General	Active
Amylase Reagent Kit（ifcc Method）	3000810	EUDAMED	IVD General	Active
Urea Reagent Kit（enzyme Method）	3023212	EUDAMED	IVD General	Active
Apolipoprotein C2 Reagent Kit (Immunoturbidimetric Assay)	3012770	EUDAMED	IVD General	Active
Human Laminin Detection Kit (Chemiluminescence Immunoassay)	3010528	EUDAMED	IVD General	Active
Complement3 Reagent Kit（immunoturbidimetric Method）	3012487	EUDAMED	IVD General	Active
D-Dimer Detection Kit (Latex Immunoturbidimetric Assay)	3021572	EUDAMED	IVD General	Active
Hypersensitive C-reactive Protein Detection Kit (Chemiluminescence Immunoassay)	3014816	EUDAMED	IVD General	Active
Probe Cleanser	3009273	EUDAMED	Class A	Active
Follicle Stimulating Hormone Detection Kit (Chemiluminescence Immunoassay)	3008719	EUDAMED	IVD General	Active
Treponema Pallidum Antibody Detection Kit (Chemiluminescence Immunoassay)	3010684	EUDAMED	IVD General	Active
H series urine analyzer Control liquid for Specific gravity	3002391	EUDAMED	IVD General	Active
Cleaning liquid (Concentrated type)	3002461	EUDAMED	Class A	Active
FE Dye	1036257	EUDAMED	Class A	Active
Urea Reagent Kit（enzyme Method）	3021561	EUDAMED	IVD General	Active
Glycohemoglobin A 1c Reagent Kit	3016184	EUDAMED	IVD General	Active
Sheath	3009161	EUDAMED	Class A	Active
Multi-Calibrator for Urine Physical and Chemical Analysis	3010757	EUDAMED	IVD General	Active
Alanine Aminotransferase Liquid Kit（ifcc Method）	3002382	EUDAMED	IVD General	Active
Automatic Blood Coagulation Analyzer Detergent I	3017199	EUDAMED	Class A	Active
BCA-3000 Automatic Blood Coagulation Analyzer	3014841	EUDAMED	Class A	Active
ISE blood sample calibrator	3001254	EUDAMED	IVD General	Active
Anti-cyclic Citrullinated Peptide Antibodies Reagent Kit (Latex Immunoturbidimetric Assay)	3021532	EUDAMED	IVD General	Active
Uristik H Series Reagent Strips For Urinalysis	K040703	FDA 510(k)	Class II	Active
Cardiac Troponin I Detection Kit (Chemiluminescence Immunoassay)	3013909	EUDAMED	IVD General	Active
Dirui	Analytical module + Pre-storage tray + Connecting bridge + Reclaiming tray + Sample feeder + Computer	EUDAMED	IVD General	Active
Ammonia Reagent Kit (Glutamate Dehydrogase Assay)	3021681	EUDAMED	IVD General	Active
Microalbumin Reagent Kit（immunoturbidimetric Assay）	3016516	EUDAMED	IVD General	Active
Β2-Microglobulin Reagent Kit（latex Enhanced Immunoturbidimetric Assay）	3021708	EUDAMED	IVD General	Active
Adenosine Deaminase Reagent Kit（enzyme Method）	3002931	EUDAMED	IVD General	Active
Alpha-fetoprotein Detection Kit (Chemiluminescence Immunoassay)	3021080	EUDAMED	Class C	Active
Dirui	3018451	EUDAMED	IVD General	Active
Complement4 Reagent Kit（immunoturbidimetric Method）	3000989	EUDAMED	IVD General	Active
Dirui	3016084	EUDAMED	IVD General	Active
Dirui	3025297	EUDAMED	IVD General	Active
Dirui	3014909	EUDAMED	IVD General	Active
Cs-680	3009665	EUDAMED	Class A	Active
Neutrophil Gelatinase-associated Lipocalin Reagent Kit (Latex Immunoturbidimetric Assay)	3011847	EUDAMED	IVD General	Active

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Emergo Europe B.V. NL
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