Is this your brand? Sign in to claim ownership.

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 3 of 3

Device	Model / Reference	Registries	Class	Status
D-Dimer Detection Kit (Nephelometry)	32026001	EUDAMED	IVD General	Active
Immunoglobulin A (IgA) Detection Kit (Nephelometry)	32080010	EUDAMED	IVD General	Active
Free Triiodothyronine (FT3) Test Kit (Immunofluorescence)	52027115	EUDAMED	IVD General	Active
Prolactin (PRL) Test Kit (Immunofluorescence)	52026076	EUDAMED	IVD General	Active
Auto Hematology Analyzer	21000028	EUDAMED	Class B	Active
Auto Hematology Analyzer	KT-6600	EUDAMED	IVD General	Active
KT05A LH Lyse	22013011	EUDAMED	Class A	Active
Auto Hematology Analyzer	KT-42	EUDAMED	IVD General	Active
Glycated Hemoglobin(HbA1c) Detection Kit (Nephelometry)	32028008	EUDAMED	Class C	Active
CK-MB (CK-MB) Test Kit(Immunofluorescence)	52027009	EUDAMED	IVD General	Active
Cystatin C (CYS-C) Detection Kit (Nephelometry)	32080003	EUDAMED	IVD General	Active
Complement C4 (C4) Detection Kit (Nephelometry)	32026012	EUDAMED	IVD General	Active
N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Test Kit(Immunofluorescence)	52027001	EUDAMED	IVD General	Active
Thyroid Stimulating Hormone (TSH) Test Kit (Immunofluorescence)	52026016	EUDAMED	IVD General	Active
Testosterone (Testo) Test Kit (Immunofluorescence)	52026115	EUDAMED	IVD General	Active
Fully-auto Specific Protein Analyzer	31000014	EUDAMED	Class A	Active
Electrolyte Reagent	42047001	EUDAMED	IVD General	Active
Fibrinogen Degradation Product (FDP) Detection Kit (Nephelometry)	32026051	EUDAMED	IVD General	Active
Follicle Stimulating Hormone (FSH) Test Kit (Immunofluorescence)	52026072	EUDAMED	IVD General	Active
Progesterone (Prog) Test Kit (Immunofluorescence)	52026114	EUDAMED	IVD General	Active
Semi-auto Chemistry Analyzer	WP21B	EUDAMED	Class A	Active
KT03A Lyse Solution	22019017	EUDAMED	Class A	Active
Auto Chemistry Analyzer	GS480A	EUDAMED	Class A	Active
Glycated Hemoglobin(HbA1c) Detection Kit (Nephelometry)	32026008	EUDAMED	Class C	Active
Fully-auto Specific Protein Analyzer	PA120	EUDAMED	Class A	Active
KT05 DIFF Lyse	23019008	EUDAMED	Class A	Active
KT05LH Lyse	23013009	EUDAMED	Class A	Active
C-Reactive Protein (CRP) Detection Kit (Nephelometry)	32026009	EUDAMED	IVD General	Active
Coagulation Analyzer	CA51	EUDAMED	Class A	Active
Immunoglobulin G (IgG) Detection Kit (Nephelometry)	32026014	EUDAMED	IVD General	Active
Glycated Hemoglobin(HbA1c) Detection Kit (Nephelometry)	32028151	EUDAMED	Class C	Active
Free Triiodothyronine (FT3) Test Kit (Immunofluorescence)	52026120	EUDAMED	IVD General	Active
Procalcitonin (PCT) Test Kit (Immunofluorescence)	52026007	EUDAMED	IVD General	Active
Auto Chemiluminescence Immunoassay Analyzer	MT60	EUDAMED	Class A	Active
C-Reactive Protein (CRP) Detection Kit (Nephelometry)	32080146	EUDAMED	Class B	Active
Cardiac Troponin I (cTnI) Test Kit (Immunofluorescence)	52027004	EUDAMED	IVD General	Active
Ferritin (FER) Test Kit (Immunofluorescence)	52027107	EUDAMED	IVD General	Active
Luteinizing Hormone (LH)Test Kit (Immunofluorescence)	52027076	EUDAMED	IVD General	Active
High Sensitive C-Reactive Protein (hs-CRP) Test Kit(Immunofluorescence)	52027010	EUDAMED	IVD General	Active
Immunofluorescence Incubator	FI61	EUDAMED	Class A	Active
Complement C3 (C3) Detection Kit (Nephelometry)	32026013	EUDAMED	IVD General	Active
Rheumatoid Factor (RF) Detection Kit (Nephelometry)	32026006	EUDAMED	IVD General	Active
Auto Hematology Analyzer	KT-60	EUDAMED	IVD General	Active

Related Companies

Authorised Representatives

Lotus NL B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.