Is this your brand? Sign in to claim ownership.

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 21 of 23

Device	Model / Reference	Registries	Class	Status
Alkaline Phosphatase Reagent Kit（ifcc Method）	3000425	EUDAMED	IVD General	Active
LA-60 Sample Processing System	3016285	EUDAMED	Class A	Active
Free Beta-Human Chorionic Gonadotropin Detection Kit (Chemiluminescence Immunoassay)	3014015	EUDAMED	IVD General	Active
Dirui	3016077	EUDAMED	IVD General	Active
Cs-1200	3009593	EUDAMED	Class A	Active
Dirui	3019731	EUDAMED	IVD General	Active
Antibodies to Thyroglobulin Detection Kit (Chemiluminescence Immunoassay)	3013805	EUDAMED	IVD General	Active
Leucine Aminopeptidase Reagent Kit（substrate Hydrolysis）	3001623	EUDAMED	IVD General	Active
Dirui	3000583	EUDAMED	IVD General	Active
Apolipoprotein E Reagent Kit (Immunoturbidimetric Assay)	3011549	EUDAMED	IVD General	Active
Triiodothyronine Detection Kit (Chemiluminescence Immunoassay)	3013776	EUDAMED	IVD General	Active
Dirui	3009950	EUDAMED	IVD General	Active
Dirui	3011606	EUDAMED	IVD General	Active
Focus	3001156	EUDAMED	IVD General	Active
Cancer Antigen 50 Detection Kit (Chemiluminescence Immunoassay)	3010702	EUDAMED	IVD General	Active
FE ControlⅡPositive Control	3009388	EUDAMED	IVD General	Active
Dirui	Level 1：1×5mL	EUDAMED	IVD General	Active
Heart Fatty Acid-Binding Protein Reagent Kit (Latex Immunoturbidimetric Assay)	3011827	EUDAMED	IVD General	Active
Microalbumin Reagent Kit（immunoturbidimetric Assay）	3001071	EUDAMED	IVD General	Active
Urine Analyzer H-100	3010996	EUDAMED	Class A	Active
Glycohemoglobin A 1c Reagent Kit	3014555	EUDAMED	IVD General	Active
Homocysteine (HCY) Reagent Kit (Enzymatic Cycling Method)	3019755	EUDAMED	IVD General	Active
Calcium Reagent Kit（cresolphthalein Complexone Method）	3003010	EUDAMED	IVD General	Active
Free Thyroxine Detection Kit (Chemiluminescence Immunoassay)	3013782	EUDAMED	IVD General	Active
BCC-3000 Cleanser	3003088	EUDAMED	Class A	Active
5’-Nucleotidase Reagent Kit（enzyme Method）	3001695	EUDAMED	IVD General	Active
Fluorescent Control	3016125	EUDAMED	IVD General	Active
Dirui	Analytical module + sample feeder + computer	EUDAMED	IVD General	Active
Collagen Type Ⅳ Detection Kit (Chemiluminescence Immunoassay)	3010538	EUDAMED	IVD General	Active
Urinalysis Multi-Control	3010243	EUDAMED	IVD General	Active
Urine Sediment Analyzer Reagent Sheath	3001164	EUDAMED	Class A	Active
Free Triiodothyronine Detection Kit (Chemiluminescence Immunoassay)	3013860	EUDAMED	IVD General	Active
Homocysteine Reagent Kit（enzymatic Cycling Method）	3012554	EUDAMED	IVD General	Active
Probe Cleanser I	3009153	EUDAMED	Class A	Active
Cystatin C Reagent Kit（latex Enhanced Immunoturbidimetric Assay）	3004630	EUDAMED	IVD General	Active
LIPOPROTEIN (a) REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY）	3002328	EUDAMED	IVD General	Active
Total Bilirubin Reagent Kit(surfactant/Diazo Salt Method)	3000478	EUDAMED	IVD General	Active
BSP-800 Automated Hematology Smear Slide Processor	3019712	EUDAMED	Class A	Active
Complement4 Reagent Kit（immunoturbidimetric Method）	3012509	EUDAMED	IVD General	Active
Urinary Transferrin Reagent Kit (Latex Immunoturbidimetric Assay)	3021645	EUDAMED	IVD General	Active
Prealbumin Reagent Kit（immunoturbidimetric Method）	3016556	EUDAMED	IVD General	Active
Dehydroepiandrosterone Sulfate Detection Kit (Chemiluminescence Immunoassay)	3010694	EUDAMED	IVD General	Active
D-Dimer Detection Kit (Latex Immunoturbidimetric Assay)	3015064	EUDAMED	IVD General	Active
Control for Hematology Analyzer	3001324	EUDAMED	IVD General	Active
Urinalysis Control	3022334	EUDAMED	IVD General	Active
Ferritin Reagent Kit (Latex Enhanced Immunoturbidimetric Method)	3021188	EUDAMED	IVD General	Active
Dirui	3011370	EUDAMED	IVD General	Active
Vitamin B12 Detection Kit(Chemiluminescence Immunoassay)	3014701	EUDAMED	IVD General	Active
Dirui	3000603	EUDAMED	IVD General	Active
Human Sex Hormone-binding Globulin Detection Kit (Chemiluminescence Immunoassay)	3010697	EUDAMED	IVD General	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL
SUNGO Europe B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.