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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 2 of 6

Device	Model / Reference	Registries	Class	Status
ISE Detergent	9909Y	EUDAMED	Class A	Active
III Type Procollagen Kit (CLIA)	FG1153Y	EUDAMED	IVD General	Active
Anti-Streptolysin O Kit (Latex-Enhanced Immunoturbidimetric Method)	MJ407Y	EUDAMED	IVD General	Active
Automated Hematology Analyzer Diluent	XQ9006Y	EUDAMED	Class A	Active
Growth Hormone Kit (CLIA)	FG1422Y	EUDAMED	IVD General	Active
Triiodothyronine Kit (CLIA)	FG1100Y	EUDAMED	IVD General	Active
Insulin Kit (CLIA)	FG1171Y	EUDAMED	IVD General	Active
Potassium electrode	DJ8002P	EUDAMED	IVD General	Active
Multi Calibrator	JZ903TY	EUDAMED	IVD General	Active
β2-Microglobin Kit (Latex-Enhanced Immunoturbidimetric Method)	MJ410Y	EUDAMED	IVD General	Active
Growth Stimulation Expressed Gene2 Protein FIA KIT	YG2013Y	EUDAMED	IVD General	Active
hCG Pregnancy Rapid Test	CG2500Y1	EUDAMED	IVD General	Active
Comprehensive biochemistry of liver and kidney glycolipid	DC2207Y	EUDAMED	IVD General	Active
Electrolyte Multiple Quality Control (Direct Method)	BK0130P	EUDAMED	IVD General	Active
ISE Internal Standard	ISE030Y	EUDAMED	IVD General	Active
Calcium Kit (Arsenazo III Method)	MJ303Y	EUDAMED	IVD General	Active
Total Protein Kit (Biuret Method)	MJ102Y	EUDAMED	IVD General	Active
Cystatin C Kit (Latex-Enhanced Immunoturbidimetric Method)	MJ419Y	EUDAMED	IVD General	Active
Lactate Dehydrogenase Kit (Kinetic Method)	MJ008Y	EUDAMED	IVD General	Active
Bicarbonate Kit (Enzymatic Method)	MJ020Y	EUDAMED	IVD General	Active
Cardiac Troponin I Calibrator	JZ423Y	EUDAMED	IVD General	Active
Glycated Hemoglobin A1c Kit (Enzymatic Method)	MJ420Y	EUDAMED	IVD General	Active
Urea Kit (Enzymatic Method)	MJ106Y	EUDAMED	IVD General	Active
Squamous Cell Carcinoma Antigen Kit (CLIA)	FG1209Y	EUDAMED	IVD General	Active
Apolipoprotein E Kit (Immunoturbidimetric Method)	MJ428Y	EUDAMED	IVD General	Active
Laminin Kit (CLIA)	FG1152Y	EUDAMED	IVD General	Active
Automated Hematology Analyzer Lyse	XQ9013Y	EUDAMED	Class A	Active
Insulin Kit (Latex-Enhanced Immunoturbidimetric Method)	MJ448Y	EUDAMED	IVD General	Active
SARS-CoV-2 RT-PCR Test Kit	PCR5101Y1	EUDAMED	IVD General	Active
Carcinoembryonic Antigen Kit (CEA) (Latex-Enhanced Immunoturbidimetric Method)	MJ456Y	EUDAMED	IVD General	Active
Gastrin-17 Kit(CLIA)	FG1902Y	EUDAMED	IVD General	Active
Thyroglobulin Kit (CLIA)	FG1105Y	EUDAMED	IVD General	Active
D-Dimer Calibrator	JZ424Y	EUDAMED	IVD General	Active
5'-Nucleotidase Kit (Colorimetric Method with Peroxidase)	MJ015Y	EUDAMED	IVD General	Active
Triglycerides Kit (GPO-PAP Method)	MJ201Y	EUDAMED	IVD General	Active
Retinol Binding Protein Kit (Latex-Enhanced Immunoturbidimetric Method)	MJ425Y	EUDAMED	IVD General	Active
Lipoprotein (a) Kit (Latex-Enhanced Immunoturbidimetric Method)	MJ412Y	EUDAMED	IVD General	Active
Fibronectin Kit (Latex-Enhanced Immunoturbidimetric Method)	MJ459Y	EUDAMED	IVD General	Active
Immunoglobin A Kit (Immunoturbidimetric Method)	MJ416Y	EUDAMED	IVD General	Active
Human Epididymal Protein 4 Kit (CLIA)	FG1214Y	EUDAMED	IVD General	Active
Haptoglobin Kit (Immunoturbidimetric Method)	MJ457Y	EUDAMED	IVD General	Active
Non-Esterified Fatty Acids Kit (ACS-ACOD Method)	MJ444Y	EUDAMED	IVD General	Active
Influenza A+B Rapid Test Cassette	CG2303TY	EUDAMED	IVD General	Active
α-Hydroxybutyrate Dehydrogenase Kit (Kinetic Method)	MJ010Y	EUDAMED	IVD General	Active
Insulin Calibrator	JZ448Y	EUDAMED	IVD General	Active
Glucose Kit (Hexokinase Method)	MJ108Y	EUDAMED	IVD General	Active
Microalbuminuria Kit (Immunoturbidimetric Method)	MJ414Y	EUDAMED	IVD General	Active
Ischemia-Modified Albumin Kit (Albumin Cobalt Binding Method)	MJ430Y	EUDAMED	IVD General	Active
Magnesium Kit (Arsenazo I Method)	MJ304Y	EUDAMED	IVD General	Active
Apolipoprotein B Kit (Immunoturbidimetric Method)	MJ402Y	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