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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 4 of 18
DeviceModel / ReferenceRegistriesClassStatus
Procalcitonin Chemiluminescence Immunoassay Kit S2049E-75
EUDAMED
IVD GeneralActive
Folate Assay Kit (Chemiluminescent Immunoassay) S2124E-24
EUDAMED
IVD GeneralActive
Fully Automated Nucleic Acid Extraction System S12C
EUDAMED
Class AActive
Prolactin Chemiluminescence Immunoassay Kit S2052E-25
EUDAMED
IVD GeneralActive
Nucleic Acid (DNA/RNA) Extraction or Purification Kit (Magnetic beads method) S1002E-24
EUDAMED
Class AActive
Respiratory Adenovirus DNA Diagnostic Kit (PCR-Fluorescence Probing) S3029E
EUDAMED
IVD GeneralActive
Neisseria meningitidis (Nm) nucleic acid Diagnostic Kit(PCR-Fluorescence Probing) S3262E-24
EUDAMED
IVD GeneralActive
Testosterone Chemiluminescence Immunoassay Kit S2060E-75
EUDAMED
IVD GeneralActive
Autoantibody against Thyroglobulin Assay Kit (Chemiluminescent Immunoassay) S2101E-24
EUDAMED
IVD GeneralActive
Staphylococcus Aureus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3143E-48
EUDAMED
IVD GeneralActive
Sample Release Reagent S1013E-12A-P
EUDAMED
Class AActive
Monkeypox virus Nucleic Acid Diagnostic Kit (LAMP) S3361E-48
EUDAMED
IVD GeneralActive
SARS Virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3173E-48
EUDAMED
IVD GeneralActive
Human epididymal protein 4 Assay Kit (Chemiluminescent Immunoassay) S2115E-24
EUDAMED
IVD GeneralActive
Testosterone Chemiluminescence Immunoassay Kit S2060E-100
EUDAMED
IVD GeneralActive
Procalcitonin Chemiluminescence Immunoassay Kit S2049E-50
EUDAMED
IVD GeneralActive
Mycoplasma Pneumoniae Rapid Antigen Test (Colloidal Gold Method) S3346E-1
EUDAMED
IVD GeneralActive
SARS-CoV-2 Neutralizing Antibody ELISA Assay Kit S3272E-96
EUDAMED
IVD GeneralActive
Nucleic Acid Extraction-Purification Kit IV-IX S4009E-48A
EUDAMED
Class AActive
Helicobacter pylori typingl Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3205E-48
EUDAMED
IVD GeneralActive
D-Dimer Chemiluminescence Immunoassay Kit S2015E-50
EUDAMED
IVD GeneralActive
Ebola Virus and Lassa Fever Virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3139E-24
EUDAMED
IVD GeneralActive
SARS-CoV-2 Neutralizing Antibody Chemiluminescence Immunoassay Kit S2056E-100
EUDAMED
IVD GeneralActive
Parainfluenza Virus type 1, 2 and 3 Nucleic Acid Diagnostic Kit (PCR Fluorescence Probing) S3149E-24-P
EUDAMED
IVD GeneralActive
Troponin I Chemiluminescence Immunoassay Kit S2154E-25
EUDAMED
IVD GeneralActive
Six Respiratory Pathogens Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3066E
EUDAMED
IVD GeneralActive
SARS-CoV-2, Influenza Virus and Respiratory Syncytial Virus Multiple Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3148E-48
EUDAMED
IVD GeneralActive
Helicobacter pylori typingl Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3205E-24
EUDAMED
IVD GeneralActive
Anti-Mullerian Hormone Chemiluminescence Immunoassay Kit S2004E-25
EUDAMED
IVD GeneralActive
Cancer Antigen 50 Chemiluminescence Immunoassay Kit S2133E-200
EUDAMED
IVD GeneralActive
Neutrophil Gelatinase-associated Lipocalin Chemiluminescence Immunoassay Kit S2157E-200
EUDAMED
IVD GeneralActive
Follicle Stimulating Hormone Chemiluminescence Immunoassay Kit S2019E-25
EUDAMED
IVD GeneralActive
Adenovirus and Adenovirus 3/7 Subtypes Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3137E-48
EUDAMED
IVD GeneralActive
Follicle Stimulating Hormone Chemiluminescence Immunoassay Kit S2019E-150
EUDAMED
IVD GeneralActive
Plasmodium Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3187E-24
EUDAMED
IVD GeneralActive
Fibrin/fibrinogen Degradation Products Chemiluminescence Immunoassay Kit S2018E-25
EUDAMED
IVD GeneralActive
Haemophilus influenzae (HI) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3280E-48
EUDAMED
IVD GeneralActive
S100β Protein Chemiluminescence Immunoassay Kit S2053E-200
EUDAMED
IVD GeneralActive
Resistant Gene KPC and CMY-2 Diagnostic Kit (PCR-Fluorescence Probing) S3155E-48
EUDAMED
IVD GeneralActive
Sample Storage Reagent X1006E-50
EUDAMED
Class AActive
SARS-CoV-2/InFluA/InFluB Rapid Antigen Test (Colloidal Gold Method) S3305E-25
EUDAMED
IVD GeneralActive
SARS-CoV-2 Rapid Antigen Test (Saliva) S3134E-5
EUDAMED
IVD GeneralActive
SARS-CoV-2 Mutation Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3122E-48
EUDAMED
IVD GeneralActive
Novel Coronavirus(SARS-CoV-2) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3125E-24
EUDAMED
IVD GeneralActive
Coxsachievirus A6 Real Time RT-PCR Diagnostic Kit (PCR-Fluorescence Probing) S3074E
EUDAMED
IVD GeneralActive
Prolactin Chemiluminescence Immunoassay Kit S2052E-200
EUDAMED
IVD GeneralActive
Anti-Thyroid Peroxidase Antibody Chemiluminescence Immunoassay Kit S2006E-50
EUDAMED
IVD GeneralActive
SARS-CoV-2 IgG Antibody Test Kit (Chemiluminescence Immunoassay) S2054E-100
EUDAMED
IVD GeneralActive
D-Dimer Assay Kit (Chemiluminescent Immunoassay) S2080E-24
EUDAMED
IVD GeneralActive
Mycoplasma Pneumoniae Rapid Antigen Test (Colloidal Gold Method) S3346E-50
EUDAMED
IVD GeneralActive

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FDA Establishments (1)

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  • Sansure Biotech Inc. US