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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 11 of 18
DeviceModel / ReferenceRegistriesClassStatus
Growth Hormone Chemiluminescence Immunoassay Kit S2024E-75
EUDAMED
IVD GeneralActive
Analysis Software for Novel Coronavirus Genom San-ncov-Seq
EUDAMED
IVD GeneralActive
Collagen Type Ⅲ N-peptide Chemiluminescence Immunoassay Kit S2134E-200
EUDAMED
IVD GeneralActive
Intact Parathyroid Hormone Chemiluminescence Immunoassay Kit S2143E-75
EUDAMED
IVD GeneralActive
Ebola Virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3154E-24
EUDAMED
IVD GeneralActive
Novel Coronavirus(2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3102E
EUDAMED
IVD GeneralActive
Anti-Müllerian hormone Assay Kit (Chemiluminescent Immunoassay) S2088E-24
EUDAMED
IVD GeneralActive
Norovirus GI/GII/Sapovirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3221E-48
EUDAMED
IVD GeneralActive
Follicle-stimulating hormone Assay Kit (Chemiluminescent Immunoassay) S2083E-48
EUDAMED
IVD GeneralActive
Mycoplasma Pneumoniae Rapid Antigen Test (Colloidal Gold Method) S3346E-25
EUDAMED
IVD GeneralActive
C-Reactive Protein Chemiluminescence Immunoassay Kit S2136E-75
EUDAMED
IVD GeneralActive
Human Rotavirus B Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3240E-48
EUDAMED
IVD GeneralActive
B-type Natriuretic Peptide Chemiluminescence Immunoassay Kit S2130E-25
EUDAMED
IVD GeneralActive
Heart-type Fatty Acid Binding Protein Chemiluminescence Immunoassay Kit S2140E-100
EUDAMED
IVD GeneralActive
Multi-type Sample DNA/RNA Extraction-Purification Kit (Magnetic beads method) S1006E-96
EUDAMED
Class AActive
Brucella Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3261E-48
EUDAMED
IVD GeneralActive
Cortisol Chemiluminescence Immunoassay Kit S2135E-150
EUDAMED
IVD GeneralActive
Free Testosterone Chemiluminescence Immunoassay Kit S2139E-50
EUDAMED
IVD GeneralActive
Nucleic Acid Extraction-Purification Kit S50015E-48C
EUDAMED
Class AActive
Norovirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3202E-24
EUDAMED
IVD GeneralActive
Cytokeratin-19-fragment Assay Kit (Chemiluminescent Immunoassay) S2112E-24
EUDAMED
IVD GeneralActive
Avian influenza virus H7 RNA Diagnostic Kit (PCR-Fluorescence Probing) S3166E-24
EUDAMED
IVD GeneralActive
Nipah Virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3284E-48
EUDAMED
IVD GeneralActive
Respiratory Syncytial Virus RNA Diagnostic Kit (PCR-Fluorescence Probing) S3048E
EUDAMED
IVD GeneralActive
Six Diarrhea Virus Nucleic Acid Detection Kit (PCR-Fluorescence Probing) S3245E-48
EUDAMED
IVD GeneralActive
Procalcitonin Chemiluminescence Immunoassay Kit S2049E-200
EUDAMED
IVD GeneralActive
Nucleic Acid (RNA) Extraction or Purification Kit (Magnetic beads method) S1001E-48A
EUDAMED
Class AActive
Hyaluronic Acid Chemiluminescence Immunoassay Kit S2142E-200
EUDAMED
IVD GeneralActive
Vibrio Cholerae O1 and O139 Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3224E-24
EUDAMED
IVD GeneralActive
Nucleic Acid Extraction-Purification Kit V-VII S5007E-64-T
EUDAMED
Class AActive
Insulin-Like Growth Factor Binding Protein-3 Chemiluminescence Immunoassay Kit S2031E-100
EUDAMED
IVD GeneralActive
Portable Molecular Diagnostic System S-Q37B
EUDAMED
Class AActive
Mycoplasma genitalium DNA Diagnostic Kit(PCR-Fluorescence Probing) S3065E
EUDAMED
IVD GeneralActive
Salmonella/Yersinia Enterocolitica/Campylobacter Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3226E-48
EUDAMED
IVD GeneralActive
Drug Resistant Bordetella pertussis Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3136E-24
EUDAMED
IVD GeneralActive
Respiratory Syncytial Virus Rapid Antigen Test (Colloidal Gold Method) S3347E-50
EUDAMED
IVD GeneralActive
Troponin T Assay Kit (Chemiluminescent Immunoassay) S2081E-24
EUDAMED
IVD GeneralActive
Anti-Thyroid Peroxidase Antibody Chemiluminescence Immunoassay Kit S2006E-75
EUDAMED
IVD GeneralActive
Serum Amyloid A Chemiluminescence Immunoassay Kit S2151E-150
EUDAMED
IVD GeneralActive
Toxigenic Clostridium difficile DNA Diagnostic Kit (PCR-Fluorescence Probing) S3350E-24
EUDAMED
IVD GeneralActive
Human Rotavirus A Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3239E-24
EUDAMED
IVD GeneralActive
Resistant Gene KPC and CMY-2 Diagnostic Kit (PCR-Fluorescence Probing) S3155E-24
EUDAMED
IVD GeneralActive
Influenza A Virus RNA Diagnostic Kit (PCR-Fluorescence Probing) S3044E
EUDAMED
IVD GeneralActive
SARS-CoV-2 IgM Antibody Test Kit (Chemiluminescence Immunoassay) S2055E-100
EUDAMED
IVD GeneralActive
Tumor Necrosis Factor α Chemiluminescence Immunoassay Kit S2067E-150
EUDAMED
IVD GeneralActive
Interleukin-6 Chemiluminescence Immunoassay Kit S2035E-50
EUDAMED
IVD GeneralActive
JC Virus DNA Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3186E-24
EUDAMED
IVD GeneralActive
Measles and Rubella virus (MeV/RV) RNA Diagnostic Kit (PCR-Fluorescence Probing) S3278E-48
EUDAMED
IVD GeneralActive
Testosterone Assay Kit (Chemiluminescent Immunoassay) S2087E-48
EUDAMED
IVD GeneralActive
Growth Hormone Chemiluminescence Immunoassay Kit S2024E-25
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