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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 3 of 18
DeviceModel / ReferenceRegistriesClassStatus
Enteropathogenic Escherichia Coli Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3288E-24
EUDAMED
IVD GeneralActive
Placental Growth Factor Chemiluminescence Immunoassay Kit S2047E-150
EUDAMED
IVD GeneralActive
Tissue Plasminogen Activator/ Plasminogen Activator Inhibitor-1 Complex Chemiluminescence Immunoassay Kit S2064E-75
EUDAMED
IVD GeneralActive
Human Cytomegalovirus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) S3014E
EUDAMED
IVD Annex II List BActive
D-Dimer Assay Kit (Chemiluminescent Immunoassay) S2080E-48
EUDAMED
IVD GeneralActive
Sample Storage Reagent X1006E-200
EUDAMED
Class AActive
Sample Release Reagent S1011E-48-I
EUDAMED
Class AActive
Squamous Cell Carcinoma Antigen Chemiluminescence Immunoassay Kit S2059E-50
EUDAMED
IVD GeneralActive
Sample Release and Storage Reagent X1009E-24D-2
EUDAMED
Class AActive
Serum Amyloid A Chemiluminescence Immunoassay Kit S2151E-25
EUDAMED
IVD GeneralActive
15 High-risk Human Papillomavirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3360E-48
EUDAMED
IVD GeneralActive
Adrenocorticotropic Hormone Chemiluminescence Immunoassay Kit S2129E-200
EUDAMED
IVD GeneralActive
Sample Storage Reagent X1002E-24-3
EUDAMED
Class AActive
Helicobacter pylori Clarithromycin resistant Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3207E-48
EUDAMED
IVD GeneralActive
Adenovirus 40 and 41 Nucleic Acid Detection Kit (PCR-Fluorescence Probing) S3331E-24
EUDAMED
IVD GeneralActive
Norovirus GI and GII Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3220E-48
EUDAMED
IVD GeneralActive
Free triiodothyronine Assay Kit (Chemiluminescent Immunoassay) S2096E-24
EUDAMED
IVD GeneralActive
Coxsachievirus A10 Real Time RT-PCR Diagnostic Kit (PCR-Fluorescence Probing) S3073E
EUDAMED
IVD GeneralActive
Campylobacter fetus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3210E-48
EUDAMED
IVD GeneralActive
Nucleic Acid (RNA) Extraction or Purification Kit (Magnetic beads method) S1001E-64-T
EUDAMED
Class AActive
Laminin Chemiluminescence Immunoassay Kit S2144E-75
EUDAMED
IVD GeneralActive
SARS-CoV-2 Rapid Antigen Test (Immunochromatography Assay) S3120E-5-H
EUDAMED
IVD devices for self-testingActive
Thrombin-Antithrombin III Complex Chemiluminescence Immunoassay Kit S2061E-50
EUDAMED
IVD GeneralActive
Cancer Antigen 242 Chemiluminescence Immunoassay Kit S2132E-100
EUDAMED
IVD GeneralActive
Human ALDH2 Genetic Polymorphism Detection Kit (PCR-Fluorescence Probing) S3351E-24-P
EUDAMED
IVD GeneralActive
C-Reactive Protein Chemiluminescence Immunoassay Kit S2136E-50
EUDAMED
IVD GeneralActive
Treponema Pallidum DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) S3070E
EUDAMED
IVD GeneralActive
Heparin Binding Protein Chemiluminescence Immunoassay Kit S2025E-25
EUDAMED
IVD GeneralActive
SARS-CoV-2 Neutralizing Antibody Assay Kit (ELISA) S3130E-96
EUDAMED
IVD GeneralActive
Sample Storage Reagent X1006E-100
EUDAMED
Class AActive
Enterococcus Faeciuma and Enterococcus Faecalis Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3200E-24
EUDAMED
IVD GeneralActive
Sample Storage Reagent XI X1011E-48-1
EUDAMED
Class AActive
SARS-CoV-2 and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3113E-48
EUDAMED
IVD GeneralActive
Group B Streptococcus DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) S3056E
EUDAMED
IVD GeneralActive
Clostridium difficile DNA Diagnostic Kit (PCR-Fluorescence Probing) S3096E
EUDAMED
IVD GeneralActive
Carcinoembryonic antigen Assay Kit (Chemiluminescent Immunoassay) S2103E-24
EUDAMED
IVD GeneralActive
Sample Storage Reagent XI X1011E-96-1
EUDAMED
Class AActive
Legionella pneumophila Nucleic Acid Diagnostic Kit (PCR Fluorescence Probing) S3313E-48
EUDAMED
IVD GeneralActive
Prolactin Chemiluminescence Immunoassay Kit S2052E-75
EUDAMED
IVD GeneralActive
Enterococcus Faeciuma and Enterococcus Faecalis Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3200E-48
EUDAMED
IVD GeneralActive
Fibrin/fibrinogen Degradation Products Chemiluminescence Immunoassay Kit S2018E-50
EUDAMED
IVD GeneralActive
Red Blood Cell Folate Chemiluminescence Immunoassay Kit S2138E-200
EUDAMED
IVD GeneralActive
Human CYP2C19 Genetic Polymorphism Detection Kit (PCR-Fluorescence Probing) S3084E
EUDAMED
IVD GeneralActive
Matrix Metalloproteinase-3 Chemiluminescence Immunoassay Kit S2040E-75
EUDAMED
IVD GeneralActive
Mycobacterium tuberculosis DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) S3354E-48
EUDAMED
Class CActive
Nucleic Acid Extraction-Purification Kit V-VII S5007E-48
EUDAMED
Class AActive
Avian influenza virus H7 RNA Diagnostic Kit (PCR-Fluorescence Probing) S3166E-48
EUDAMED
IVD GeneralActive
Listeria Monocytogenes Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3197E-24
EUDAMED
IVD GeneralActive
Cancer Antigen 50 Chemiluminescence Immunoassay Kit S2133E-50
EUDAMED
IVD GeneralActive
Forest encephalitis Virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3258E-48
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