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MEDICALSYSTEM BIOTECHNOLOGY CO., LTD.

China·CN-MF-000010246

Last updated September 17, 2026

Information

Country: China
Address: No.299, Qiming South Road, Yinzhou District, 315104 Ningbo, China., Ningbo, China
Website: nbmedicalsystem.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Jingxi Liu
EUDAMED SRN: CN-MF-000010246
FDA FEI Number: 3013654096
DUNS Number: —

Catalogue (284)

Page 3 of 6

Device	Model / Reference	Registries	Class	Status
Glycated Hemoglobin A1c Control	ZK420Y1	EUDAMED	IVD General	Active
Renin Kit (CLIA)	FG1423Y	EUDAMED	IVD General	Active
Anti-Cyclic Citrullinated Peptide Antibodies Kit (Latex-Enhanced Immunoturbidimetric Method)	MJ458Y	EUDAMED	IVD General	Active
SARS-CoV-2 Neutralizing Antibody Test Kit	FG1999Y	EUDAMED	IVD General	Active
Iron Kit (Ferrozine Method)	MJ309Y	EUDAMED	IVD General	Active
Automated Hematology Analyzer Lyse	XQ9002Y	EUDAMED	Class A	Active
Urinalysis Sheath Fluid	NY4001Y1	EUDAMED	Class A	Active
Cholyglycine Kit (Latex-Enhanced Immunoturbidimetric Method)	MJ447Y	EUDAMED	IVD General	Active
Treponema Pallidum Antibodies Kit(CLIA)	FG1506Y	EUDAMED	IVD General	Active
Immunoglobulin E Kit (Latex-Enhanced Immunoturbidimetric Method)	MJ466Y	EUDAMED	IVD General	Active
Complement C4 Kit (Immunoturbidimetric Method)	MJ404Y	EUDAMED	IVD General	Active
COVID-19 Ag Rapid Test Cassette	CG2302TY1	EUDAMED	IVD General	Active
Total Bile Acid Kit (Enzyme Cycling Method)	MJ101Y	EUDAMED	IVD General	Active
Enhanced Wash Buffer	CF1007Q	EUDAMED	Class A	Active
Follicle Stimulating Hormone Kit (CLIA)	FG1301Y	EUDAMED	IVD General	Active
Hemoglobin A1c Dry Chemistry Control	ZK2204Y1	EUDAMED	IVD General	Active
Zinc Kit (Colorimetric Method with 5-Brom-PAPS)	MJ308Y	EUDAMED	IVD General	Active
Complement C1q Kit (Immunoturbidimetric Method)	MJ469Y	EUDAMED	IVD General	Active
Anti-Glutamic Acid Decarboxylase Antibodies Kit(CLIA)	FG1175Y	EUDAMED	IVD General	Active
Hemoglobin A1c FIA KIT	YG2012Y	EUDAMED	IVD General	Active
Apolipoprotein C2 Kit (Immunoturbidimetric Method)	MJ488Y	EUDAMED	IVD General	Active
Enhanced Wash Buffer	CF1007P	EUDAMED	Class A	Active
Specific Protein Calibrator	JZ901Y	EUDAMED	IVD General	Active
Creatine Kinase MB Isozyme Kit (CLIA)	FG1404Y	EUDAMED	IVD General	Active
Cortisol Kit (CLIA)	FG1424Y	EUDAMED	IVD General	Active
N-Acetyl-β-D-Glucosaminidase Kit (MPT Method)	MJ016Y	EUDAMED	IVD General	Active
25-Hydroxy Vitamin D Kit (Latex-Enhanced Immunoturbidimetric Method)	MJ454Y	EUDAMED	IVD General	Active
Bile Acids Kit(LC-MS/MS)	ZY3078P	EUDAMED	IVD General	Active
Testosterone Kit (CLIA)	FG1304Y	EUDAMED	IVD General	Active
Hemoglobin A1c Dry Chemistry Control	ZK2204Y2	EUDAMED	IVD General	Active
Heart-Type Fatty Acid Binding Protein Kit (Latex-Enhanced Immunoturbidimetric Method)	MJ449Y	EUDAMED	IVD General	Active
Trigger Solution	CA1002P	EUDAMED	Class A	Active
S100 Protein Kit (CLIA)	FG1216Y	EUDAMED	IVD General	Active
Adrenocorticotropic Hormone Kit (CLIA)	FG1421Y	EUDAMED	IVD General	Active
γ-Glutamyltransferase Kit (GCANA Method)	MJ005Y	EUDAMED	IVD General	Active
CA72-4 Kit (CLIA)	FG1207Y	EUDAMED	IVD General	Active
C-Reactive Protein Kit (Latex-Enhanced Immunoturbidimetric Method)	MJ408Y	EUDAMED	IVD General	Active
Transferrin Kit (Immunoturbidimetric Method)	MJ418Y	EUDAMED	IVD General	Active
Adenosine Deaminase Kit (Peroxidase Method)	MJ014Y	EUDAMED	IVD General	Active
Anti-Müllerian Hormone Kit (CLIA)	FG1307Y	EUDAMED	IVD General	Active
Lactate Kit (Enzymatic UV Method)	MJ434Y	EUDAMED	IVD General	Active
D-Dimer FIA KIT	YG2010Y	EUDAMED	IVD General	Active
Sodium Kit (Enzymatic Method)	MJ432Y	EUDAMED	IVD General	Active
Seven Glycosidone Lipids Biochemistry	DC2208Y	EUDAMED	IVD General	Active
Connecting Peptide Kit (CLIA)	FG1170Y	EUDAMED	IVD General	Active
Automated Hematology Analyzer Lyse	XQ9003Y	EUDAMED	Class A	Active
α-L-Fucosidase Kit (Kinetic Method)	MJ013Y	EUDAMED	IVD General	Active
Creatinine Kit (Enzymatic Method)	MJ105Y	EUDAMED	IVD General	Active
CA125 Kit (CLIA)	FG1208Y	EUDAMED	IVD General	Active
Anti-Cyclic Citrullinated Peptide Antibodies Kit(CLIA)	FG1903Y	EUDAMED	IVD General	Active

Related Companies

Authorised Representatives

Lotus NL B.V. NL
Medunion S.L. ES

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Medicalsystem Biotechnology Co., Ltd. US