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Sansure Biotech Inc.

China·CN-MF-000011392

Last updated September 17, 2026

Information

Country: China
Address: No.680, Lusong Road, Yuelu District, Changsha, Hunan Province, China
Website: www.sansureglobal.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +86-731-88883176-6116
PRRC Contact: Ren Xiaomei
EUDAMED SRN: CN-MF-000011392
FDA FEI Number: 3016619649
DUNS Number: —

Catalogue (894)

Page 14 of 18

Device	Model / Reference	Registries	Class	Status
Human BRCA1/2 Sequencing Panel Kit(Next Generation Sequencing)	S3062E	EUDAMED	IVD General	Active
B-type Natriuretic Peptide Chemiluminescence Immunoassay Kit	S2130E-150	EUDAMED	IVD General	Active
SARS-CoV-2 P681R Mutation Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3158E-48	EUDAMED	IVD General	Active
Troponin I Chemiluminescence Immunoassay Kit	S2154E-75	EUDAMED	IVD General	Active
Sample Storage Reagent	X1006E-500	EUDAMED	Class A	Active
Alpha fetoprotein Assay Kit (Chemiluminescent Immunoassay)	S2102E-48	EUDAMED	IVD General	Active
Free Testosterone Chemiluminescence Immunoassay Kit	S2139E-200	EUDAMED	IVD General	Active
Free human chorionic gonadotropin Assay Kit (Chemiluminescent Immunoassay)	S2092E-48	EUDAMED	IVD General	Active
Human KRAS Gene 7 Mutations Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)	S3058E	EUDAMED	IVD General	Active
Cortisol Chemiluminescence Immunoassay Kit	S2135E-100	EUDAMED	IVD General	Active
Bordetella Parapertussis Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3147E-48	EUDAMED	IVD General	Active
W0102070103	S2137E-75	EUDAMED	IVD General	Active
Nucleic Acid Extraction-Purification Kit V-VI	S5006E-48A	EUDAMED	Class A	Active
Placental Growth Factor Chemiluminescence Immunoassay Kit	S2047E-50	EUDAMED	IVD General	Active
Severe Fever with Thrombocytopenia Syndrome Bunyavirus（SFTSV） Nucleic Acid Detection Kit(PCR-Fluorescence Probing)	S3251E-24	EUDAMED	IVD General	Active
Neisseria meningitidis (Nm) nucleic acid Diagnostic Kit（PCR-Fluorescence Probing)	S3262E-48	EUDAMED	IVD General	Active
SARS-CoV-2 T478K Mutation Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3146E-24	EUDAMED	IVD General	Active
Nucleic Acid Extraction-Purification Kit	S50016E-32-A	EUDAMED	Class A	Active
Insulin-Like Growth Factor Binding Protein-3 Chemiluminescence Immunoassay Kit	S2031E-50	EUDAMED	IVD General	Active
Multiple Respiratory Pathogens Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3163E-24	EUDAMED	IVD General	Active
Pepsinogen II Assay Kit (Chemiluminescent Immunoassay)	S2114E-48	EUDAMED	IVD General	Active
Adrenocorticotropic Hormone Chemiluminescence Immunoassay Kit	S2129E-25	EUDAMED	IVD General	Active
Pro-gastrin-releasing Peptide Chemiluminescence Immunoassay Kit	S2050E-200	EUDAMED	IVD General	Active
Calcitonin Chemiluminescence Immunoassay Kit	S2131E-100	EUDAMED	IVD General	Active
Helicobacter pylori Universal and CagA Type Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3206E-24	EUDAMED	IVD General	Active
Luteinizing Hormone Chemiluminescence Immunoassay Kit	S2039E-25	EUDAMED	IVD General	Active
Cancer Antigen 125 Chemiluminescence Immunoassay Kit	S2008E-75	EUDAMED	IVD General	Active
Parathyroid hormone Assay Kit (Chemiluminescent Immunoassay)	S2128E-48	EUDAMED	IVD General	Active
Sex Hormone-binding Globulin Chemiluminescence Immunoassay Kit	S2152E-75	EUDAMED	IVD General	Active
Avian Influenza Virus (H7N9) Real Time RT-PCR Diagnostic Kit (PCR-Fluorescence Probing)	S3092E	EUDAMED	IVD General	Active
Human Epididymis Protein 4 Chemiluminescence Immunoassay Kit	S2028E-25	EUDAMED	IVD General	Active
Sample Release Reagent	S1015E-48	EUDAMED	Class A	Active
Human Growth Hormone Assay Kit (Chemiluminescent Immunoassay)	S2126E-48	EUDAMED	IVD General	Active
Monkeypox Virus (MPV) Rapid Antigen Test Kit (Colloidal Gold Method)	S3355E-1	EUDAMED	IVD General	Active
Human Rhinovirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3170E-24	EUDAMED	IVD General	Active
Vitamin B12 Chemiluminescence Immunoassay Kit	S2156E-25	EUDAMED	IVD General	Active
Interleukin-2 Receptor Chemiluminescence Immunoassay Kit	S2034E-100	EUDAMED	IVD General	Active
Salmonella Typhi and Salmonella Paratyphoid Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3282E-24	EUDAMED	IVD General	Active
SARS-CoV-2 Multiplex Nucleic Acid Diagnostic Kit (Isothermal Amplification)	S3343E-15	EUDAMED	IVD General	Active
Campylobacter jejuni / Campylobacter coli / Campylobacter lari Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3277E-24	EUDAMED	IVD General	Active
Carbapenemase Gene KPC Diagnostic Kit (PCR-Fluorescence Probing)	S3079E	EUDAMED	IVD General	Active
Detection Kit for 5 Mutations of SARS-CoV-2 (PCR-Fluorescence Probing)	S3124E-48	EUDAMED	IVD General	Active
C-Peptide Chemiluminescence Immunoassay Kit	S2012E-150	EUDAMED	IVD General	Active
Carcinoembryonic Antigen Chemiluminescence Immunoassay Kit	S2011E-150	EUDAMED	IVD General	Active
Interleukin-1β Chemiluminescence Immunoassay Kit	S2033E-50	EUDAMED	IVD General	Active
Follicle Stimulating Hormone Chemiluminescence Immunoassay Kit	S2019E-50	EUDAMED	IVD General	Active
W0102050103	S2016E-100	EUDAMED	IVD General	Active
Nucleic Acid Extraction-Purification Kit V-VII	S5007E-96	EUDAMED	Class A	Active
Portable Molecule Workstation	S-Q31A	EUDAMED	Class A	Active
Six Respiratory Pathogens Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3066E-24	EUDAMED	Class C	Active

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Sansure Biotech Inc. US