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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 1 of 3

Device	Model / Reference	Registries	Class	Status
Microalbumin (MALB) Test Kit (Immunofluorescence)	52026213	EUDAMED	IVD General	Active
Cortisol Test Kit (Immunofluorescence)	52026276	EUDAMED	IVD General	Active
β-Human Chorionic Gonadotropin (β-HCG) Quality Control	52105021	EUDAMED	IVD General	Active
CA125 Test Kit (Immunofluorescence)	52026129	EUDAMED	IVD General	Active
Glycosylated Hemoglobin (HbA1c) Quality Control	52105024	EUDAMED	IVD General	Active
Cortisol Test Kit (Immunofluorescence)	52026208	EUDAMED	IVD General	Active
Immunoglobulin E (IgE) Detection Kit (Nephelometry)	32027218	EUDAMED	IVD General	Active
CA19-9 Test Kit (Immunofluorescence)	52026130	EUDAMED	IVD General	Active
Free Kappa Light Chains (Free KAP) Detection Kit	32027220	EUDAMED	IVD General	Active
C-Reactive Protein (CRP) Quality Control	52081005	EUDAMED	IVD General	Active
Lambda Light Chains (LAM) Detection Kit (Nephelometry)	32027207	EUDAMED	IVD General	Active
Free Lambda Light Chains (Free LAM) Detection Kit	32027221	EUDAMED	IVD General	Active
Complement C3 (C3) Detection Kit (Nephelometry)	32027172	EUDAMED	IVD General	Active
KT05A DIL Diluent	22024019	EUDAMED	Class A	Active
Rheumatoid Factor (RF) Test Kit (Immunofluorescence)	52026245	EUDAMED	IVD General	Active
Anti-streptolysin O (ASO) Test Kit (Immunofluorescence)	52026246	EUDAMED	IVD General	Active
C-Reactive Protein (CRP) Detection Kit (Nephelometry)	32028166	EUDAMED	IVD General	Active
Anti-streptolysin O (ASO) Detection Kit (Nephelometry)	32028162	EUDAMED	IVD General	Active
β2-Microglobulin (β2-MG) Detection Kit (Nephelometry)	32027170	EUDAMED	IVD General	Active
Cardiac Troponin I (cTnI) Quality Control	52105055	EUDAMED	IVD General	Active
25-OH Vitamin D (25-OH Vit-D) Test Kit (Immunofluorescence)	52026247	EUDAMED	IVD General	Active
Rheumatoid Factor (RF) Detection Kit (Nephelometry)	32028164	EUDAMED	IVD General	Active
Glycosylated Hemoglobin (HbA1c) Test Kit (Immunofluorescence)	52026278	EUDAMED	IVD General	Active
N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Quality Control	52108036	EUDAMED	IVD General	Active
25-OH Vitamin D (25-OH Vit-D) Quality Control	52105085	EUDAMED	IVD General	Active
CA15-3 Test Kit (Immunofluorescence)	52026235	EUDAMED	IVD General	Active
Immunoglobulin G4 (IgG4) Detection Kit (Nephelometry)	32027190	EUDAMED	IVD General	Active
Interleukin 6 (IL-6) Quality Control	52105076	EUDAMED	IVD General	Active
C-Reactive Protein (CRP) Test Kit (Immunofluorescence)	52026277	EUDAMED	IVD General	Active
Quantitative lmmunoassay Analyzer	FA30	EUDAMED	Class A	Active
Human Micro-albuminuria (mALB) Detection Kit(Nephelometry)	32080007	EUDAMED	IVD General	Active
Interleukin 6 (IL-6) Test Kit (Immunofluorescence)	52027106	EUDAMED	IVD General	Active
Probe Cleanser	22005009	EUDAMED	Class A	Active
Quantitative lmmunoassay Analyzer	FA50	EUDAMED	Class A	Active
Electrolyte Reagent	42043001	EUDAMED	IVD General	Active
Electrolyte Reagent	42035001	EUDAMED	IVD General	Active
KT05 DIFF Lyse	23019007	EUDAMED	Class A	Active
QC Solution	42005004	EUDAMED	IVD General	Active
Anti-streptolysin O (ASO) Detection Kit (Nephelometry)	32026005	EUDAMED	IVD General	Active
Interleukin 6 (IL-6) Test Kit (Immunofluorescence)	52026108	EUDAMED	IVD General	Active
Myoglobin (Myo) Test Kit (Immunofluorescence)	52027003	EUDAMED	IVD General	Active
D-Dimer test kit (Immunofluorescence)	52026017	EUDAMED	IVD General	Active
Immunoglobulin M (IgM) Detection Kit (Nephelometry)	32080011	EUDAMED	IVD General	Active
Electrolyte Analyzer	GE300	EUDAMED	IVD General	Active
Anti-Mullerian Hormone (AMH) Test Kit (Immunofluorescence)	52026117	EUDAMED	IVD General	Active
cTnI/CK-MB/Myo (Cardiac panel) Test Kit (Immunofluorescence)	52026005	EUDAMED	IVD General	Active
Follicle Stimulating Hormone (FSH) Test Kit (Immunofluorescence)	52027075	EUDAMED	IVD General	Active
25-OH Vitamin D (25-OH Vit-D) Test Kit (Immunofluorescence)	52027111	EUDAMED	IVD General	Active
Auto Chemistry Analyzer	GS100	EUDAMED	Class A	Active
C-Reactive Protein (CRP) Test Kit (Immunofluorescence)	52027105	EUDAMED	IVD General	Active

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