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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 13 of 18
DeviceModel / ReferenceRegistriesClassStatus
Bordetella Pertussis DNA Diagnostic Kit (PCR-Fluorescence Probing) S3055E
EUDAMED
IVD GeneralActive
Salmonella Typhi and Salmonella Paratyphoid Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3282E-48
EUDAMED
IVD GeneralActive
Ureaplasma Urealyticum DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) S3004E
EUDAMED
IVD GeneralActive
S100β Protein Chemiluminescence Immunoassay Kit S2053E-50
EUDAMED
IVD GeneralActive
Respiratory Syncytial Virus Rapid Antigen Test (Colloidal Gold Method) S3347E-1
EUDAMED
IVD GeneralActive
Cancer Antigen 242 Chemiluminescence Immunoassay Kit S2132E-75
EUDAMED
IVD GeneralActive
15 High-risk Human Papillomavirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3360E-12-P
EUDAMED
IVD GeneralActive
Estradiol Assay Kit (Chemiluminescent Immunoassay) S2085E-24
EUDAMED
IVD GeneralActive
Mumps Virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3244E-24
EUDAMED
IVD GeneralActive
Entamoeba Histolytica Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3230E-48
EUDAMED
IVD GeneralActive
Influenza A (H5N1) Virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3150E-24
EUDAMED
IVD GeneralActive
Sample Storage Reagent X1004E-24-2
EUDAMED
Class AActive
Pro-Gastrin-Releasing Peptide Assay Kit (Chemiluminescent Immunoassay) S2117E-24
EUDAMED
IVD GeneralActive
Sample Storage Reagent X1004E-48-1
EUDAMED
Class AActive
Total Thyroxine Chemiluminescence Immunoassay Kit S2065E-25
EUDAMED
IVD GeneralActive
Human Coronavirus (MERS) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3174E-48
EUDAMED
IVD GeneralActive
Adrenocorticotropic Hormone Chemiluminescence Immunoassay Kit S2129E-100
EUDAMED
IVD GeneralActive
Group A Streptococcus (GAS) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3260E-24
EUDAMED
IVD GeneralActive
Interleukin-1β Chemiluminescence Immunoassay Kit S2033E-25
EUDAMED
IVD GeneralActive
Chikungunya virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3332E-48
EUDAMED
IVD GeneralActive
Cancer Antigen 50 Chemiluminescence Immunoassay Kit S2133E-150
EUDAMED
IVD GeneralActive
Pepsinogen Ⅰ Chemiluminescence Immunoassay Kit S2044E-150
EUDAMED
IVD GeneralActive
Osteocalcin Chemiluminescence Immunoassay Kit S2146E-75
EUDAMED
IVD GeneralActive
Carbohydrate Antigen50 Assay Kit (Chemiluminescent Immunoassay) S2106E-48
EUDAMED
IVD GeneralActive
Gastrin-17 Assay Kit (Chemiluminescent Immunoassay) S2118E-24
EUDAMED
IVD GeneralActive
Progesterone Assay Kit (Chemiluminescent Immunoassay) S2086E-24
EUDAMED
IVD GeneralActive
Fully Automated Nucleic Acid Extraction System Natch CS3 S-S13B
EUDAMED
Class AActive
Human Metapneumovirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3157E-24
EUDAMED
IVD GeneralActive
Renin Chemiluminescence Immunoassay Kit S2148E-25
EUDAMED
IVD GeneralActive
Six Bacterial Meningitis Pathogens Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3268E-24
EUDAMED
IVD GeneralActive
Progesterone Chemiluminescence Immunoassay Kit S2051E-50
EUDAMED
IVD GeneralActive
Free Thyroxine Chemiluminescence Immunoassay Kit S2020E-50
EUDAMED
IVD GeneralActive
Hepatitis C Virus RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) S3119E-24
EUDAMED
IVD Annex II List AActive
Cortisol Chemiluminescence Immunoassay Kit S2135E-75
EUDAMED
IVD GeneralActive
25-Hydroxy Vitamin D Chemiluminescence Immunoassay Kit S2001E-50
EUDAMED
IVD GeneralActive
Procalcitonin Assay Kit (Chemiluminescent Immunoassay) S2069E-24
EUDAMED
IVD GeneralActive
Interleukin-6 Assay Kit (Chemiluminescent Immunoassay) S2070E-48
EUDAMED
IVD GeneralActive
Human chorionic gonadotropin Assay Kit (Chemiluminescent Immunoassay) S2091E-48
EUDAMED
IVD GeneralActive
Human epididymal protein 4 Assay Kit (Chemiluminescent Immunoassay) S2115E-48
EUDAMED
IVD GeneralActive
Yellow fever virus RNA Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3190E-24
EUDAMED
IVD GeneralActive
Bacterial Vaginosis Pathogen Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3266E-48
EUDAMED
IVD GeneralActive
Nucleic Acid Extraction-Purification Kit S5005E-64-T
EUDAMED
Class AActive
SARS-CoV-2 Nucleic Acid Diagnostic Kit (RT-LAMP) S3281E-48
EUDAMED
IVD GeneralActive
Total Triiodothyronine Chemiluminescence Immunoassay Kit S2066E-50
EUDAMED
IVD GeneralActive
Epstein-Barr virus DNA Quantitative Fluorescence Diagnostic Kit(PCR-Fluorescence Probing) S3015E
EUDAMED
IVD GeneralActive
Plesiomonas Shigelloides Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3216E-48
EUDAMED
IVD GeneralActive
Helicobacter pylori universal Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3204E-24
EUDAMED
IVD GeneralActive
Avian influenza virus H3N2 RNA Diagnostic Kit (PCR-Fluorescence Probing) S3101E
EUDAMED
IVD GeneralActive
Portable Molecular Workstation S-Q36B
EUDAMED
Class AActive
Fully Automated Nucleic Acid Processing System S-S13E-P
EUDAMED
Class AActive

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FDA Establishments (1)

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

  • Sansure Biotech Inc. US