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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 13 of 23

Device	Model / Reference	Registries	Class	Status
ISE Diluent	3002417	EUDAMED	Class A	Active
Prealbumin Reagent Kit（immunoturbidimetric Method）	3021734	EUDAMED	IVD General	Active
Intact Parathormone Detection Kit (Chemiluminescence Immunoassay)	3013920	EUDAMED	IVD General	Active
Aspartate Aminotransferase Reagent Kit（ifcc Method）	3016545	EUDAMED	IVD General	Active
Pepsinogen II Detection Kit (Chemiluminescence Immunoassay)	3013882	EUDAMED	IVD General	Active
Urinalysis Strips	3000335	EUDAMED	IVD General	Active
Pepsinogen II Detection Kit (Chemiluminescence Immunoassay)	3010396	EUDAMED	IVD General	Active
Dirui	3000428	EUDAMED	IVD General	Active
Dirui	3003002	EUDAMED	IVD General	Active
Monoamine Oxidase Reagent Kit (Glutamate Dehydrogenase Assay)	3011867	EUDAMED	IVD General	Active
Sheath	3020855	EUDAMED	Class A	Active
Dirui	3001001	EUDAMED	IVD General	Active
Urine Sediment Analyzer Detergent	3001169	EUDAMED	Class A	Active
Probe Cleanser	3009274	EUDAMED	Class A	Active
Sample Diluent	3019330	EUDAMED	Class A	Active
Lactate Dehydrogenase Isoenzyme 1 Reagent Kit (Chemical Inhibition Assay)	3011484	EUDAMED	IVD General	Active
Antithrombin Ⅲ Detection Kit (Chromogenic Substrate Assay)	R1: 2×5mL; R2: 1×2mL; OVB Buffer: 1×51 mL; Calibrator: 1×1mL; Control:1×1mL	EUDAMED	IVD General	Active
FE Focus B	3006314	EUDAMED	IVD General	Active
Α-Hydroxybutyric Dehydrogenase Reagent Kit（dgkc Method）	3005692	EUDAMED	IVD General	Active
Human Hyaluronic Acid Detection Kit (Chemiluminescence Immunoassay)	3013739	EUDAMED	IVD General	Active
Folic Acid Detection Kit (Chemiluminescence Immunoassay)	3013989	EUDAMED	IVD General	Active
BF-WFF Dye	3014306	EUDAMED	Class A	Active
Cleaning liquid (Concentrated type)	3002395	EUDAMED	Class A	Active
CM-320 Chemiluminescence Immunoassay Analyzer	3013359	EUDAMED	Class A	Active
Monoamine Oxidase Reagent Kit (Glutamate Dehydrogenase Assay)	3011447	EUDAMED	IVD General	Active
Human Hyaluronic Acid Detection Kit (Chemiluminescence Immunoassay)	3010574	EUDAMED	IVD General	Active
Monoamine Oxidase Reagent Kit (Glutamate Dehydrogenase Assay)	3011590	EUDAMED	IVD General	Active
Dirui	3000622	EUDAMED	IVD General	Active
Control for Reticulocyte	3016131	EUDAMED	IVD General	Active
Dirui	3015906	EUDAMED	IVD General	Active
Fructosamine Reagent Kit ( Nitrotetrazolium-Blue Reduction Method)	3000854	EUDAMED	IVD General	Active
Bile Acid Reagent Kit（enzymatic Cycling Method）	3023548	EUDAMED	IVD General	Active
Γ-Glutamyl Transferase Reagent Kit（ifcc Method）	3023232	EUDAMED	IVD General	Active
Cleaning liquid (Concentrated type)	3001766	EUDAMED	Class A	Active
Sample Diluent	3019331	EUDAMED	Class A	Active
Dirui	3012541	EUDAMED	IVD General	Active
Calcium Reagent Kit（cresolphthalein Complexone Method）	3000822	EUDAMED	IVD General	Active
Mitochondrial Aspartate Aminotransferase Reagent Kit（Immunoinhibition）	3021711	EUDAMED	IVD General	Active
Cs-400	3000084	EUDAMED	Class A	Active
FE Focus B II	3009373	EUDAMED	IVD General	Active
Sodium Reagent Kit(Galactosidase Assay)	3015852	EUDAMED	IVD General	Active
Uric Acid Reagent Kit（uricase Method）	3023234	EUDAMED	IVD General	Active
C-Peptide Detection Kit (Chemiluminescence Immunoassay)	3008776	EUDAMED	IVD General	Active
Dirui	3012525	EUDAMED	IVD General	Active
Myoglobin Reagent Kit（latex Enhanced Immunoturbidimetric Method）	3016165	EUDAMED	IVD General	Active
Total Bilirubin Kit（vanadate Oxidation Method）	3023188	EUDAMED	IVD General	Active
Anti-thyroid Antibodies Control	3013969	EUDAMED	IVD General	Active
CS-T240Plus	3016405	EUDAMED	Class A	Active
Dirui	3012537	EUDAMED	IVD General	Active
BF-RD Diluent	3014303	EUDAMED	Class A	Active

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Notified Bodies

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Authorities

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