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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 2 of 18
DeviceModel / ReferenceRegistriesClassStatus
Heart-type Fatty Acid Binding Protein Chemiluminescence Immunoassay Kit S2140E-150
EUDAMED
IVD GeneralActive
Sample Storage Reagent X1004E-48-6
EUDAMED
Class AActive
Herpes Simplex Virus DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) S3028E
EUDAMED
IVD GeneralActive
Laminin Chemiluminescence Immunoassay Kit S2144E-100
EUDAMED
IVD GeneralActive
Estradiol Chemiluminescence Immunoassay Kit S2016E-25
EUDAMED
IVD GeneralActive
Coxsachievirus A6 and A10 Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3203E-48
EUDAMED
IVD GeneralActive
Portable Molecule Workstation S-Q31B
EUDAMED
Class AActive
Mycoplasma genitalium DNA Diagnostic Kit(PCR-Fluorescence Probing) S3065E
EUDAMED
IVD GeneralActive
Human Rhinovirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3170E-48
EUDAMED
IVD GeneralActive
Hepatitis E Virus RNA Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3183E-24
EUDAMED
IVD GeneralActive
Vitamin B12 Assay Kit (Chemiluminescent Immunoassay) S2125E-48
EUDAMED
IVD GeneralActive
Thrombomodulin Chemiluminescence Immunoassay Kit S2062E-100
EUDAMED
IVD GeneralActive
15 High-risk Human Papillomavirus DNA (Genotype) Diagnostic Kit (PCR-Fluorescence Probing) S3069E
EUDAMED
IVD GeneralActive
C-Reactive Protein Chemiluminescence Immunoassay Kit S2136E-100
EUDAMED
IVD GeneralActive
5 Diarrhea Escherichia coli Nucleic Acid Detection Kit (PCR-Fluorescence Probing) S3246E-24
EUDAMED
IVD GeneralActive
Methicillin-resistant Staphylococcus aureus mecA Gene Diagnostic Kit (PCR-Fluorescence Probing) S3151E-48
EUDAMED
IVD GeneralActive
Influenza A/B Virus Nucleic Acid Diagnostic Kit ( PCR-Fluorescence Probing) S3353E-24-P
EUDAMED
IVD GeneralActive
Sample Storage Reagent XI X1011E-48A-3
EUDAMED
Class AActive
Luteinizing Hormone Chemiluminescence Immunoassay Kit S2039E-75
EUDAMED
IVD GeneralActive
Inhibin B Assay Kit (Chemiluminescent Immunoassay) S2089E-48
EUDAMED
IVD GeneralActive
Human Epididymis Protein 4 Chemiluminescence Immunoassay Kit S2028E-100
EUDAMED
IVD GeneralActive
Bordetella Parapertussis Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3147E-24
EUDAMED
IVD GeneralActive
Human Papillomavirus DNA (26 Genotypes) Diagnostic Kit (PCR-Fluorescence Probing) S3068E
EUDAMED
IVD GeneralActive
Human CYP2C9 and VKORC1 Genetic Polymorphism Detection Kit (PCR-Fluorescence Probing) S3088E
EUDAMED
IVD GeneralActive
Human Chorionic Gonadotropin plus the hCG β-subunit Chemiluminescence Immunoassay Kit S2027E-25
EUDAMED
IVD GeneralActive
Autoantibody against Thyroid peroxidase Assay Kit (Chemiluminescent Immunoassay) S2099E-48
EUDAMED
IVD GeneralActive
Mycoplasma pneumoniae Nucleic Acid And Drug Resistence Diagnostic Kit (PCR-Fluorescence Probing) S3097E
EUDAMED
IVD GeneralActive
Cancer Antigen CA 72-4 Chemiluminescence Immunoassay Kit S2009E-100
EUDAMED
IVD GeneralActive
D-Dimer Chemiluminescence Immunoassay Kit S2015E-25
EUDAMED
IVD GeneralActive
SARS-CoV-2 L452Q Mutation Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3144E-48
EUDAMED
IVD GeneralActive
Portable Molecular Workstation S-Q36A
EUDAMED
Class AActive
Tumor Necrosis Factor α Chemiluminescence Immunoassay Kit S2067E-25
EUDAMED
IVD GeneralActive
Triiodothyronine Assay Kit (Chemiluminescent Immunoassay) S2095E-24
EUDAMED
IVD GeneralActive
Soluble Growth Stimulation Expressed Gene 2 Chemiluminescence Immunoassay Kit S2058E-100
EUDAMED
IVD GeneralActive
Poliovirus type 1, type 2, and type 3 Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3271E-48
EUDAMED
IVD GeneralActive
Red Blood Cell Folate Chemiluminescence Immunoassay Kit S2138E-100
EUDAMED
IVD GeneralActive
Nucleic Acid Extraction-Purification Kit V-VII S5007E-48A
EUDAMED
Class AActive
SARS-CoV-2 D950N Mutation Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3160E-48
EUDAMED
IVD GeneralActive
SARS-CoV-2 Neutralizing Antibody Chemiluminescence Immunoassay Kit S2056E-25
EUDAMED
IVD GeneralActive
Detection Kit for 5 Mutations of SARS-CoV-2 (PCR-Fluorescence Probing) S3124E-24
EUDAMED
IVD GeneralActive
Glycated Hemoglobin Chemiluminescence Immunoassay Kit S2023E-25
EUDAMED
IVD GeneralActive
Cryptosporidium/Entamoeba histolytica/Giardia lamblia Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3227E-24
EUDAMED
IVD GeneralActive
Six Respiratory Pathogens Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3066E
EUDAMED
IVD GeneralActive
SARS-CoV-2 IgG Antibody Test Kit (Chemiluminescence Immunoassay) S2054E-150
EUDAMED
IVD GeneralActive
N-terminal pro-B-type Natriuretic Peptide Chemiluminescence Immunoassay Kit S2043E-200
EUDAMED
IVD GeneralActive
Pneumocystis Jiroveci Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3159E-24
EUDAMED
IVD GeneralActive
Cancer Antigen 50 Chemiluminescence Immunoassay Kit S2133E-25
EUDAMED
IVD GeneralActive
12 Human Gut Bacteria Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3243E-24
EUDAMED
IVD GeneralActive
Helicobacter pylori Metronidazole Resistant Nucleic Acid Detection Kit (PCR-Fluorescence Probing) S3255E-48
EUDAMED
IVD GeneralActive
β2-microglobulin Chemiluminescence Immunoassay Kit S2145E-100
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