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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
LinkedIn
—
Facebook
—
Phone
+86-731-88883176-6116
PRRC Contact
Ren Xiaomei
EUDAMED SRN
CN-MF-000011392
FDA FEI Number
3016619649
DUNS Number
—

Catalogue (894)

Page 18 of 18
DeviceModel / ReferenceRegistriesClassStatus
Forest encephalitis Virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3258E-24
EUDAMED
IVD GeneralActive
Thyroglobulin Chemiluminescence Immunoassay Kit S2153E-150
EUDAMED
IVD GeneralActive
Total Thyroxine Chemiluminescence Immunoassay Kit S2065E-75
EUDAMED
IVD GeneralActive
Lipoprotein-associated Phospholipase A2 Chemiluminescence Immunoassay Kit S2038E-75
EUDAMED
IVD GeneralActive
Pepsinogen II Chemiluminescence Immunoassay Kit S2045E-100
EUDAMED
IVD GeneralActive
S100β Protein Chemiluminescence Immunoassay Kit S2053E-75
EUDAMED
IVD GeneralActive
Aerobic Vaginitis Pathogen Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3267E-24
EUDAMED
IVD GeneralActive
Hepatitis C Virus Genotype Diagnostic Kit (PCR-Fluorescence Probing) S3034E
EUDAMED
IVD GeneralActive
Myoglobin Chemiluminescence Immunoassay Kit S2041E-25
EUDAMED
IVD GeneralActive
Sample Release Reagent S1014E-24
EUDAMED
Class AActive
Cancer Antigen 50 Chemiluminescence Immunoassay Kit S2133E-75
EUDAMED
IVD GeneralActive
Dengue virus, Zika virus, and Chikungunya virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3333E-12-S
EUDAMED
IVD GeneralActive
Estradiol Chemiluminescence Immunoassay Kit S2016E-200
EUDAMED
IVD GeneralActive
SARS-CoV-2 Neutralizing Antibody Chemiluminescence Immunoassay Kit S2056E-150
EUDAMED
IVD GeneralActive
Human ALDH2 Genetic Polymorphism Detection Kit (PCR-Fluorescence Probing) S3085E
EUDAMED
IVD GeneralActive
Nucleic Acid Extraction-Purification Kit S50015E-64-T
EUDAMED
Class AActive
Methicillin-resistant Staphylococcus aureus mecA Gene Diagnostic Kit (PCR-Fluorescence Probing) S3151E-24
EUDAMED
IVD GeneralActive
Carbohydrate Antigen 19-9 Chemiluminescence Immunoassay Kit S2010E-200
EUDAMED
IVD GeneralActive
Cancer Antigen 125 Chemiluminescence Immunoassay Kit S2008E-25
EUDAMED
IVD GeneralActive
Nucleic Acid Extraction-Purification Kit IV-IX S4009E-48
EUDAMED
Class AActive
Cyfra 21-1 Chemiluminescence Immunoassay Kit S2014E-100
EUDAMED
IVD GeneralActive
Folate Chemiluminescence Immunoassay Kit S2137E-25
EUDAMED
IVD GeneralActive
Free triiodothyronine Assay Kit (Chemiluminescent Immunoassay) S2096E-48
EUDAMED
IVD GeneralActive
Novel Coronavirus (SARS-CoV-2)/Respiratory Pathogens Multiplex Panel Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3112E-48
EUDAMED
IVD GeneralActive
Gastrin-17 Chemiluminescence Immunoassay Kit S2022E-75
EUDAMED
IVD GeneralActive
Osteocalcin Chemiluminescence Immunoassay Kit S2146E-50
EUDAMED
IVD GeneralActive
Astrovirus/Sapovirus/Enteric Adenovirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3218E-48
EUDAMED
IVD GeneralActive
Astrovirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3228E-24
EUDAMED
IVD GeneralActive
Yersinia Enterocolitica Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3238E-48
EUDAMED
IVD GeneralActive
Norovirus GI/GII/Sapovirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3221E-24
EUDAMED
IVD GeneralActive
Neutrophil Gelatinase-associated Lipocalin Chemiluminescence Immunoassay Kit S2158E-25
EUDAMED
IVD GeneralActive
Influenza BV/BY RNA Diagnostic Kit(PCR-Fluorescence Probing) S3165E-48
EUDAMED
IVD GeneralActive
Squamous Cell Carceinoma Antigen Assay Kit (Chemiluminescent Immunoassay) S2111E-48
EUDAMED
IVD GeneralActive
Six Respiratory Pathogens Multiplex Nucleic Acid Diagnostic Kit (Multiplex PCR-Fluorescence Probing) S3310E-12-S
EUDAMED
IVD GeneralActive
Adenovirus Rapid Antigen Test (Colloidal Gold Method) S3348E-50
EUDAMED
IVD GeneralActive
Carbapenemase Gene KPC Diagnostic Kit (PCR-Fluorescence Probing) S3079E
EUDAMED
IVD GeneralActive
Insulin Chemiluminescence Immunoassay Kit S2030E-75
EUDAMED
IVD GeneralActive
Reverse Triiodothyronine Chemiluminescence Immunoassay Kit S2149E-100
EUDAMED
IVD GeneralActive
25-Hydroxy Vitamin D Chemiluminescence Immunoassay Kit S2001E-150
EUDAMED
IVD GeneralActive
SARS-CoV-2 Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3123E-24
EUDAMED
IVD GeneralActive
Analysis Software for PCR-Fluorescence Detection Data PCRAnalyzer-100
EUDAMED
IVD GeneralActive
Sample Storage Reagent S10013E-48A
EUDAMED
Class AActive
SARS-CoV-2 Rapid Antigen Test(Immunochromatography Assay) S3120E-25
EUDAMED
IVD GeneralActive
5 Encephalitis related Viruses Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3286E-24
EUDAMED
IVD GeneralActive

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

  • Sansure Biotech Inc. US