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Genrui Biotech Inc.

China·CN-MF-000017351

Last updated September 18, 2026

What Genrui Biotech Inc. makes

Genrui Biotech Inc. manufactures diagnostic test kits and quality control products for laboratory use, including immunofluorescence-based assays for markers such as microalbumin, cortisol, CA125, and CA19-9. Their portfolio also includes nephelometry-based detection kits for immunoglobulin E, free kappa light chains, and lambda light chains, alongside quality controls for β-human chorionic gonadotropin, glycosylated hemoglobin, and C-reactive protein.

The company’s devices are classified under EU IVD regulations as Class A, B, C, and IVD General, with relevant products registered in the EU’s eudamed database. Genrui Biotech Inc. is based in China and adheres to regulatory frameworks governing in vitro diagnostic medical devices.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: China
Address: 4-10F, Building 3, Geya Technology Park, Guangming District, Shenzhen, China
Website: www.genrui-bio.com
LinkedIn: linkedin.com/company/genrui-biotech-inc
Facebook: facebook.com/genrui2004
Email: [email protected]
Phone: +86-755-26678255
PRRC Contact: Yiping Li
EUDAMED SRN: CN-MF-000017351
FDA FEI Number: —
DUNS Number: —

Catalogue (143)

Page 2 of 3

Device	Model / Reference	Registries	Class	Status
Quality Control Solution (QC Solution)	42082006	EUDAMED	IVD General	Active
Free Thyroxine (FT4) Test Kit (Immunofluorescence)	52027116	EUDAMED	IVD General	Active
C-Reactive Protein (CRP) Test Kit (Immunofluorescence)	52026107	EUDAMED	IVD General	Active
High Sensitive C-Reactive Protein (hs-CRP) Test Kit (Immunofluorescence)	52026010	EUDAMED	IVD General	Active
DS-Ref Ref. Filling Solution	42046001	EUDAMED	Class A	Active
Auto Hematology Analyze	KT-6510	EUDAMED	IVD General	Active
Glycated Hemoglobin(HbA1c) Detection Kit (Nephelometry)	32080147	EUDAMED	Class C	Active
Specific Protein Analyzer	PA54	EUDAMED	Class A	Active
Coagulation Analyzer	CA54	EUDAMED	Class A	Active
Procalcitonin (PCT) Test Kit (Immunofluorescence)	52027007	EUDAMED	IVD General	Active
Handheld Dry Fluorescence Immunoassay Analyzer	FA20	EUDAMED	Class A	Active
KT03 Diluent	22024002	EUDAMED	Class A	Active
Myoglobin (Myo) Test Kit (Immunofluorescence)	52026003	EUDAMED	IVD General	Active
Progesterone (Prog) Test Kit (Immunofluorescence)	52027109	EUDAMED	IVD General	Active
PVC Electrode Activating Solution	42005002	EUDAMED	Class A	Active
Free Thyroxine (FT4) Test Kit (Immunofluorescence)	52026121	EUDAMED	IVD General	Active
Auto Chemiluminescence Immunoassay Analyzer	MT60S	EUDAMED	Class A	Active
Immunoglobulin M (IgM) Detection Kit (Nephelometry)	32026011	EUDAMED	IVD General	Active
Pepsinogen II (PGII) Detection Kit (Nephelometry)	32080066	EUDAMED	IVD General	Active
Cystatin C (CYS-C) Detection Kit (Nephelometry)	32026003	EUDAMED	IVD General	Active
Glycated Hemoglobin (HbA1c) Detection Kit (Nephelometry)	32026008	EUDAMED	IVD General	Active
KT05A LH Lyse	22013010	EUDAMED	Class A	Active
Rheumatoid Factor (RF) Detection Kit (Nephelometry)	32080006	EUDAMED	IVD General	Active
Ferritin (FER) Test Kit (Immunofluorescence)	52026113	EUDAMED	IVD General	Active
Human Micro-albuminuria (mALB) Detection Kit (Nephelometry)	32026007	EUDAMED	IVD General	Active
Auto Hematology Analyzer	KT-40	EUDAMED	Class B	Active
KT05A LD Lyse	22020017	EUDAMED	Class A	Active
KT03 Lyse Solution	22019001	EUDAMED	Class A	Active
Probe Cleaning Solution	32107002	EUDAMED	Class A	Active
Wash Solution	32021003	EUDAMED	Class A	Active
KT03A Diluent	22024018	EUDAMED	Class A	Active
E-Z Cleanser	22005004	EUDAMED	Class A	Active
Complement C3 (C3) Detection Kit (Nephelometry)	32080013	EUDAMED	IVD General	Active
Electrolyte Reagent	42041001	EUDAMED	IVD General	Active
Urine Diluent	42005007	EUDAMED	Class A	Active
Deproteinizer	42011003	EUDAMED	Class A	Active
Glycosylated Hemoglobin (HbA1c) Test Kit (Immunofluorescence)	52027008	EUDAMED	IVD General	Active
Auto Chemistry Analyzer	GS300Plus	EUDAMED	Class A	Active
Sample Diluent	32021005	EUDAMED	Class A	Active
Probe Cleanser	22008009	EUDAMED	Class A	Active
Thyroxine (T4) Test Kit (Immunofluorescence)	52026015	EUDAMED	IVD General	Active
β-Human Chorionic Gonadotropin (β-HCG) Test Kit(Immunofluorescence)	52026018	EUDAMED	IVD General	Active
DS-ISE ISE Filling Solution	42045001	EUDAMED	Class A	Active
Immunoglobulin A (IgA) Detection Kit (Nephelometry)	32026010	EUDAMED	IVD General	Active
Luteinizing Hormone (LH)Test Kit (Immunofluorescence)	52026073	EUDAMED	IVD General	Active
Anti-cyclic Citrullinated Peptide Antibody (Anti-CCP) Detection Kit (Nephelometry)	32026004	EUDAMED	IVD General	Active
Triiodothyronine (T3) Test Kit (Immunofluorescence)	52026050	EUDAMED	IVD General	Active
Concentrated Cleaning Solution	32019080	EUDAMED	Class A	Active
Pepsinogen II (PGII) Detection Kit (Nephelometry)	32028066	EUDAMED	IVD General	Active
Cleaning solution	42005005	EUDAMED	Class A	Active

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