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Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.

China·CN-MF-000024153

Last updated June 8, 2026

About

Shenzhen Kangshengbao Biotechnology Co., Ltd. is a high-tech enterprise specializing in the research, development, manufacturing, and commercialization of in vitro diagnostic (IVD) products. With a strong foundation in advanced diagnostic technologies and a robust quality management system, the company is committed to delivering reliable, high-performance products to global markets. Guided by a customer-centric approach, we strive to maintain the highest standards in quality, regulatory compliance, and service excellence.

From the manufacturer's own website. Source

Information

Country: China
Address: Second Floor, Block 3, An Da Electronic Industrial Park, Fu Hai, Bao An District, Shenzhen, China
Website: www.ksbbiotech.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: ChunHui Liang
EUDAMED SRN: CN-MF-000024153
FDA FEI Number: —
DUNS Number: —

Catalogue (89)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Cortisol Rapid Detect	811045	EUDAMED	IVD General	Active
G17 Rapid Detect	811052	EUDAMED	IVD General	Active
PGⅡ Rapid Detect	811051	EUDAMED	IVD General	Active
SHBG Rapid Detect	811043	EUDAMED	IVD General	Active
Folic Acid Rapid Detect	811047	EUDAMED	IVD General	Active
S100 β Rapid Detect	811044	EUDAMED	IVD General	Active
DHEA-s Rapid Test	811067	EUDAMED	IVD General	Active
C-Peptide Rapid Detect	811058	EUDAMED	IVD General	Active
FA/VB12/Fer Combined Detect	811031	EUDAMED	IVD General	Active
PTH Rapid Detect	811062	EUDAMED	IVD General	Active
Cystatin C Rapid Detect	811065	EUDAMED	IVD General	Active
Inhibin B Rapid Detect	811054	EUDAMED	IVD General	Active
HE4 Rapid Detect	811056	EUDAMED	IVD General	Active
VA/25-OH-VD Combined Detect	811029	EUDAMED	IVD General	Active
HCY Rapid Detect	811055	EUDAMED	IVD General	Active
PGⅠ Rapid Detect	811050	EUDAMED	IVD General	Active
MAU Rapid Detect	811049	EUDAMED	IVD General	Active
Vitamin B12 Rapid Detect	811046	EUDAMED	IVD General	Active
FA/VB12/Fer Combined Test	811030	EUDAMED	IVD General	Active
VA/25-OH-VD Combined Test	811028	EUDAMED	IVD General	Active
Insulin Rapid Detect	811059	EUDAMED	IVD General	Active
Ferritin Rapid Detect	811042	EUDAMED	IVD General	Active
DHEA-s Rapid Detect	811064	EUDAMED	IVD General	Active
Total T3 Rapid Detect	808187	EUDAMED	IVD General	Active
Flu A Rapid Test	808049	EUDAMED	IVD General	Active
FSH Rapid Test	808122	EUDAMED	IVD General	Active
Free T3 Rapid Detect	808177	EUDAMED	IVD General	Active
CRP Rapid Detect	808159	EUDAMED	IVD General	Active
SAA Rapid Detect	808161	EUDAMED	IVD General	Active
cTnI Rapid Detect	808164	EUDAMED	IVD General	Active
InfectCheck NeoPT (quantitative)	K12-NEO	EUDAMED	IVD General	Active
H.pylori Ab Rapid Test	808056	EUDAMED	IVD General	Active
H-FABP quantitative rapid test	808039-1	EUDAMED	IVD General	Active
CA12-5 Rapid Test	808123-1	EUDAMED	IVD General	Active
S100β Rapid Test	811026	EUDAMED	IVD General	Active
CK-MB Rapid Detect	808169	EUDAMED	IVD General	Active
Rotavirus & Adenovirus Rapid Test	808128-1	EUDAMED	IVD General	Active
HbA1c Rapid Detect	808172	EUDAMED	IVD General	Active
AFP Rapid Test	808110-1	EUDAMED	IVD General	Active
E2 Rapid Detect	808180	EUDAMED	IVD General	Active
FSH Rapid Detect	808184	EUDAMED	IVD General	Active
β-HCG Rapid Test	808072	EUDAMED	IVD General	Active
FOB Rapid Test	808052-1	EUDAMED	IVD General	Active
CRP/SAA Rapid Detect	808162	EUDAMED	IVD General	Active
Rotavirus Rapid Test	808091-1	EUDAMED	IVD General	Active
H.pylori Ag Rapid Test	808120	EUDAMED	IVD General	Active
NT-proBNP Rapid Detect	808166	EUDAMED	IVD General	Active
TESTO Rapid Detect	808185	EUDAMED	IVD General	Active
InfectCheck PCT	K12-PCT	EUDAMED	IVD General	Active
cTnI/DD/BNP Rapid Detect	808171	EUDAMED	IVD General	Active

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