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B&E BIO-TECHNOLOGY CO., LTD.

China·CN-MF-000023256

Last updated September 17, 2026

Information

Country: China
Address: No.11 Jieaisi Road,Laishan District,Yantai City, Shandong Province, China
Website: besic.cn
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: xinlei Liu
EUDAMED SRN: CN-MF-000023256
FDA FEI Number: 3008311438
DUNS Number: —

Catalogue (35)

Device	Model / Reference	Registries	Class	Status
i-Check Cartridge	BG10-Ⅰ	EUDAMED	IVD General	Active
Sheath	Sheath--Ruby 15L	EUDAMED	Class A	Active
i-Check Cartridge	BG9-Ⅰ	EUDAMED	IVD General	Active
Calibration pack for Electrolyte Analyzer	90102	EUDAMED	Class A	Active
Multi Biosensor Module	90101	EUDAMED	Class A	Active
CRP and hs-CRP Test Reagent	25 pieces/box	EUDAMED	IVD General	Active
Electrolyte Control	QC-5 low：2.0mL×5、normal：2.0mL×5、high：2.0mL×5	EUDAMED	IVD General	Active
Sheath	Sheath-sys 20L	EUDAMED	Class A	Active
Hematology Analyzer	80100 80120 80300 80310 80320 80330 80340 8035080200 80500 80301 80400 80600 80900 80910 80920 80930 80360 80370 80380	EUDAMED	Class A	Active
Sheath	Sheath-XN 10L	EUDAMED	Class A	Active
i-Check Cartridge	BG7	EUDAMED	IVD General	Active
Electrolyte Analyzer	CBS-30	EUDAMED	Class A	Active
Glycated Hemoglobin Analyzer	G60	EUDAMED	Class A	Active
Elution Buffer	60101	EUDAMED	Class A	Active
Sheath	Sheath-Ruby 5L	EUDAMED	Class A	Active
CellCleaner (Detergent Rinse)	1360	EUDAMED	Class A	Active
i-Check Cartridge	BG3	EUDAMED	IVD General	Active
i-Check Cartridge	BG9-Ⅱ	EUDAMED	IVD General	Active
Hematology Control	HC-8	EUDAMED	IVD General	Active
Blood Gas/Ion/Metabolite Control	BQC-hct Level 1:2.0ml×5、Level 2:2.0ml×5、Level 3:2.0ml×5	EUDAMED	IVD General	Active
Sheath	Sheath-XN 20L	EUDAMED	Class A	Active
CellLyse	1268	EUDAMED	Class A	Active
i-Check Blood Gas Analyzer, Handheld	i-Check 200	EUDAMED	Class A	Active
Glycated Hemoglobin Analyzer	N/A	EUDAMED	IVD General	Active
CRP and SAA Test Reagent	25 pieces/box	EUDAMED	IVD General	Active
Electrolyte Analyzer	CBS-500	EUDAMED	Class A	Active
Sheath	Sheath-XN 15L	EUDAMED	Class A	Active
GHgb-Lyse	60104	EUDAMED	Class A	Active
i-Check Cartridge	ELE-Ⅲ	EUDAMED	IVD General	Active
Glycated hemoglobin quality control	HbA1c Level 1: 0.1ml×1; Level 2: 0.1ml×1	EUDAMED	IVD General	Active
CellDiluent	697233785Diluent00335	EUDAMED	Class A	Active
Glycated hemoglobin calibrator	HbA1c	EUDAMED	IVD General	Active
Glycated Hemoglobin Analyzer	G21	EUDAMED	Class A	Active
Electrolyte Calibrator	QCB-5 low：2.0mL×4、normal：2.0mL×4、high：2.0mL×4.	EUDAMED	IVD General	Active
Electrolyte Analyzer	CBS-300	EUDAMED	Class A	Active

Related Companies

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SUNGO Europe B.V. NL

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