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Xiamen Zeesan Biotech Co., Ltd.

China·CN-MF-000013246

Last updated June 8, 2026

Information

Country: China
Address: No. 884-1 and 884-2 Lianting Road, (Xiang An) Industrial Area, Torch High-Tech Zone, Xiamen City, Fujian Province, 361101, P.R. China, Xiamen, China
Website: zsandx.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Wei Zhan
EUDAMED SRN: CN-MF-000013246
FDA FEI Number: —
DUNS Number: —

Catalogue (77)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Mycobacteria Identification Kit (MMCA)	801210	EUDAMED	IVD General	Active
Respiratory Pathogen Panel (RPP3D)	801115	EUDAMED	IVD General	Active
Sanity-2 Respiratory Pathogen Panel (RPP3)	801114	EUDAMED	IVD General	Active
MTB DNA Extraction Kit (Sanity 2.0)	608815	EUDAMED	Class A	Active
Sanity 2.0 System	505101	EUDAMED	Class A	Active
Mycobacteria Identification Kit (Sanity 2.0)	801180	EUDAMED	IVD General	Active
FFPE DNA Extraction Kit (Model: Lab-Aid 824s)	606904	EUDAMED	Class A	Active
Lab-Aid 808 Nucleic Acid Extraction System	501102	EUDAMED	Class A	Active
Virus RNA Collection Kit	401122	EUDAMED	Class A	Active
Sanity-2 Respiratory Pathogen Panel (RPP4)	801112	EUDAMED	IVD General	Active
MTB/STR Test Kit (MMCA)	801217	EUDAMED	IVD General	Active
SARS-CoV-2 Test Kit (Sanity 2.0)	801305	EUDAMED	IVD General	Active
Lab-Aid 824s Blood DNA Extraction Kit	606101	EUDAMED	Class A	Active
SARS-CoV-2 Test Kit	801304	EUDAMED	IVD General	Active
SARS-CoV-2 Test Kit (Sanity 2.0)	801306	EUDAMED	IVD General	Active
Sanity 2.1 System	505103	EUDAMED	Class A	Active
MTB/EMB Test Kit (MMCA)	801216	EUDAMED	IVD General	Active
Respiratory Pathogen Panel (RPP40D)	801917	EUDAMED	IVD General	Active
Sanity 2.0s System	505102	EUDAMED	Class A	Active
Lab-Aid 824s DNA Extraction Kit	607106	EUDAMED	Class A	Active
Total RNA Blood Kit (Lab-Aid 896)	610105	EUDAMED	Class A	Active
Virus RNA Collection Kit	401120	EUDAMED	Class A	Active
AML1-ETO Detection Kit	803209	EUDAMED	IVD General	Active
MeltArray High Risk HPV Genotyping Assay (Sanity)	801946	EUDAMED	IVD General	Active
Saliva RNA Sample Collection Kit	401115	EUDAMED	Class A	Active
Sanity-2 Respiratory Pathogen Panel (RPP40)	801918	EUDAMED	IVD General	Active
MTB/SL Test Kit (MMCA)	801206	EUDAMED	IVD General	Active
MTB DNA Extraction Kit (Lab-Aid 960)	605105	EUDAMED	Class A	Active
MTB DNA Extraction Kit (Lab-Aid 896)	610103	EUDAMED	Class A	Active
Sanity 2.0-Pathogen Nucleic Acid Extraction Kit	608101	EUDAMED	Class A	Active
Lab-Aid 824s DNA Extraction Kit	606103	EUDAMED	Class A	Active
Lab-Aid 824 MTB DNA Extraction Kit	604109	EUDAMED	Class A	Active
Automated Sample Transfer Processing System	506102	EUDAMED	Class A	Active
MTB DNA Extraction Kit (Sanity 2.0)	608115	EUDAMED	Class A	Active
Sanity-2 Respiratory Pathogen Panel (RPP22)	801949	EUDAMED	IVD General	Active
Sanity 2.0-Pathogen Nucleic Acid Extraction Kit	608501	EUDAMED	Class A	Active
FFPE DNA Extraction Kit (Model: Sanity 2.0)	608817	EUDAMED	Class A	Active
MTB/FQ Test Kit (MMCA)	801205	EUDAMED	IVD General	Active
Respiratory Pathogen Panel (RPP4D)	801113	EUDAMED	IVD General	Active
Virus RNA Collection Kit	401150	EUDAMED	Class A	Active
Total RNA Blood Kit (Lab-Aid)	606106	EUDAMED	Class A	Active
HPV DNA Extraction Kit (Sanity 2.0)	608112	EUDAMED	Class A	Active
Low Risk HPV Genotyping Assay	801013	EUDAMED	IVD General	Active
MTB Test Kit	801219	EUDAMED	IVD General	Active
SARS-CoV-2 Test Kit (Sanity 2.0)	801406	EUDAMED	IVD General	Active
SARS-CoV-2 Test Kit (Sanity 2.0)	801307	EUDAMED	IVD General	Active
High Risk HPV Genotyping Kit (Sanity 2.0)	801170	EUDAMED	IVD General	Active
MDR-TB Test Kit (MMCA)	801213	EUDAMED	IVD General	Active
Lab-Aid Virus RNA Extraction Kit	607104	EUDAMED	Class A	Active
DNA Extraction Kit (Lab-Aid 896)	610102	EUDAMED	Class A	Active

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