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Zhuhai Keyu Biological Engineering Co., Ltd

China·CN-MF-000023195

Last updated September 18, 2026

Information

Country: China
Address: 1/f, 2/f, 5f, 6f building 4, No.605, , Yuge road, Sanzao town, Jinwan district, Zhuhai City, Guangdong Province, P.R. China, Zhuhai, China
Website: en.keyubio.com
This website did not respond when we last checked — the domain may no longer be active. Last checked 2026-09-18.
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +86-756-6821168
PRRC Contact: Youping Sun
EUDAMED SRN: CN-MF-000023195
FDA FEI Number: —
DUNS Number: —

Catalogue (120)

Page 2 of 3

Device	Model / Reference	Registries	Class	Status
KEYU Urine Analyzer Cleaning Solution	KU-C-02	EUDAMED	Class A	Active
KEYU Feces Sediment Quality Control	FFE-QC-B	EUDAMED	IVD General	Active
KEYU Rotavirus Group A Antigen Rapid Test (Colloidal Gold)	RV-R-F	EUDAMED	IVD General	Active
KEYU Sample Collection Container	CUP-D	EUDAMED	Class A	Active
KEYU H. Pylori Rapid Test Kit (Colloidal gold method)	HP-III	EUDAMED	IVD General	Active
KEYU Dry Chemistry Urine Analyzer	KU-500	EUDAMED	Class A	Active
KEYU Rotavirus/Adenovirus Antigen Rapid Test (Colloidal Gold)	RV/ADV-R-G	EUDAMED	IVD General	Active
KEYU Rotavirus Group A/Adenovirus Antigen 2in1 Test Kit (Colloidal Gold)	RV/ADV-III	EUDAMED	IVD General	Active
KEYU Dry Chemistry Strip	C-14	EUDAMED	IVD General	Active
KEYU Fecal Occult Blood Diagnostic Kit (colloidal gold method)	FOB-C	EUDAMED	IVD General	Active
KEYU Fecal Calprotectin Test Kit (Fluorescence Immunochromatography)	FC-F-I	EUDAMED	IVD General	Active
KEYU Norovirus Antigen Test Kit (Colloidal gold method)	NV-II	EUDAMED	IVD General	Active
KEYU FOB Quality Control	FOB-QC-III	EUDAMED	IVD General	Active
KEYU Maintenance Solution	KU-M03	EUDAMED	Class A	Active
KEYU Fluorescent Immunoassay Analyzer	FI-650S	EUDAMED	Class A	Active
KEYU Calprotectin Rapid Test (Colloidal Gold)	FC-R-F	EUDAMED	IVD General	Active
KEYU Urine Sediment QC	C-US-1	EUDAMED	IVD General	Active
KEYU Concentrated Cleaning Solution II	KU-W-01	EUDAMED	Class A	Active
KEYU Sample Collection Container	CUP-C	EUDAMED	Class A	Active
KEYU Feces Analyzer Diluent Solution	R02-A	EUDAMED	Class A	Active
KEYU Sample Diluent	KU-R02-1	EUDAMED	Class A	Active
KEYU Rotavirus/Adenovirus Antigen Rapid Test (Colloidal Gold)	RV/ADV-R-F	EUDAMED	IVD General	Active
KEYU Lactoferrin Rapid Test (Colloidal Gold)	LF-R-F	EUDAMED	IVD General	Active
KEYU FOB multi-level indefinite value controls	Level Ⅲ-Ⅱ	EUDAMED	IVD General	Active
KEYU H. Pylori Rapid Rapid Test (Colloidal Gold)	HP-R-G	EUDAMED	IVD General	Active
KEYU Hemoglobin Quality Control (Quantitative)	FOB-QC-4	EUDAMED	IVD General	Active
KEYU Urine Sediment Analyzer	KU-600	EUDAMED	IVD General	Active
KEYU Norovirus Antigen Test Kit (Colloidal gold method)	NV-I	EUDAMED	IVD General	Active
KEYU Urine Sample Collection Tube	TUBE-U-12-2	EUDAMED	Class A	Active
KEYU ParaSpin™ Intestinal Parasite Concentrator	KU-F05-IV	EUDAMED	Class A	Active
KEYU Feces Analyzer	FS-30	EUDAMED	Class A	Active
KEYU Urine Sediment QC	C-US-2	EUDAMED	IVD General	Active
KEYU Dry Chemistry Urine Analyzer	KU-U200	EUDAMED	Class A	Active
KEYU Feces Formed Element Control	QC-Ⅰ	EUDAMED	IVD General	Active
KEYU Feces Formed Element Control	QC-Ⅲ	EUDAMED	IVD General	Active
KEYU Urine Sediment Analyzer Quality Control	KU-UQC-03	EUDAMED	IVD General	Active
KEYU Urine Sediment Analyzer Quality Control	KU-UQC-04	EUDAMED	IVD General	Active
KEYU Calprotectin Quality Control (Quantitative)	FC-QC-4	EUDAMED	IVD General	Active
KEYU Diluent Solution C	C-D01	EUDAMED	Class A	Active
KEYU Lactoferrin Rapid Test (Colloidal Gold)	LF-R-G	EUDAMED	IVD General	Active
KEYU Dry Chemistry Urine analysis Control	NO.II	EUDAMED	IVD General	Active
KEYU ParaFloat™ Intestinal Parasite Concentrator (Ova)	KU-F05-II	EUDAMED	Class A	Active
KEYU Automatic Urine Analysis System	KU-2800	EUDAMED	IVD General	Active
KEYU Lactoferrin (LF) Test Kit (Colloidal Gold)	LF-II	EUDAMED	IVD General	Active
KEYU Fecal Occult Blood Diagnostic Kit (Fluorescence Immunochromatography)	FOB-F-I	EUDAMED	IVD General	Active
KEYU Sample Collection Tube	C-U-12-2	EUDAMED	Class A	Active
KEYU Calprotectin Test Kit (Colloidal gold method)	FC-II	EUDAMED	IVD General	Active
KEYU Urine Sediment QC	C-US-4	EUDAMED	IVD General	Active
KEYU Lactoferrin (LF) Test Kit (Colloidal Gold)	LF-III	EUDAMED	IVD General	Active
KEYU ParaSpin™ Intestinal Parasite Concentrator	KU-F05-IV	EUDAMED	Class A	Active

Zhuhai Keyu Biological Engineering Co., Ltd

Information

Catalogue (120)

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