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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 7 of 18
DeviceModel / ReferenceRegistriesClassStatus
Sample Diluent Y1001E-96
EUDAMED
Class AActive
Human TPMT Genetic Polymorphism Nucleic Acid Detection Kit (PCR-Fluorescence Probing) S3211E-24
EUDAMED
IVD GeneralActive
Procalcitonin Chemiluminescence Immunoassay Kit S2049E-100
EUDAMED
IVD GeneralActive
Gastrin-17 Chemiluminescence Immunoassay Kit S2022E-200
EUDAMED
IVD GeneralActive
Diagnostic Kit for Influenza A (H1N1) Virus(PCR-Fluorescence Probing) S3156E-24
EUDAMED
IVD GeneralActive
Epstein-Barr virus DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) S3213E-48
EUDAMED
Class CActive
Japanese Encephalitis virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3253E-48
EUDAMED
IVD GeneralActive
Lipoprotein-associated phospholipase A2 Assay Kit (Chemiluminescent Immunoassay) S2079E-24
EUDAMED
IVD GeneralActive
Thyroxine Assay Kit (Chemiluminescent Immunoassay) S2097E-48
EUDAMED
IVD GeneralActive
Mumps Virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3244E-48
EUDAMED
IVD GeneralActive
Epstein-Barr Virus(EBV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3349E-12-P
EUDAMED
IVD GeneralActive
Monkeypox virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3352E-24-P
EUDAMED
IVD GeneralActive
Osteocalcin Chemiluminescence Immunoassay Kit S2146E-100
EUDAMED
IVD GeneralActive
Mycobacterium tuberculosis (MTB) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3274E-24
EUDAMED
IVD GeneralActive
MBGV/RVFV/CHIKV Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3169E-24
EUDAMED
IVD GeneralActive
SARS-CoV-2 S-protein RBD IgG Antibody Test Kit (Chemiluminescence Immunoassay) S2150E-75
EUDAMED
IVD GeneralActive
Japanese Encephalitis Virus/Tick-Borne Encephalitis Virus/West Nile Virus/Dengue Virus (JEV/TBEV/WNV/DFV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3285E-48
EUDAMED
IVD GeneralActive
Interleukin-10 Chemiluminescence Immunoassay Kit S2037E-200
EUDAMED
IVD GeneralActive
Nucleic Acid Extraction-Purification Kit S50015E-32-A
EUDAMED
Class AActive
Heparin Binding Protein Chemiluminescence Immunoassay Kit S2025E-150
EUDAMED
IVD GeneralActive
Echovirus E11 Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3232E-48
EUDAMED
IVD GeneralActive
Avian influenza virus H3 RNA Diagnostic Kit (PCR-Fluorescence Probing) S3094E
EUDAMED
IVD GeneralActive
Prolactin Chemiluminescence Immunoassay Kit S2052E-50
EUDAMED
IVD GeneralActive
Diagnostic Kit for Enterovirus RNA (PCR-Fluorescence Probing) S3021E
EUDAMED
IVD GeneralActive
Monkeypox Virus (MPV) Rapid Antibody Test Kit (Immunochromatography Assay) S3358E-50
EUDAMED
IVD GeneralActive
Human Immunodeficiency Virus Type 1 RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) S3046E-48
EUDAMED
IVD Annex II List AActive
Human EGFR Gene E746_A750 Deletion Mutation Detection Kit (Digital PCR) S3290E-24
EUDAMED
IVD GeneralActive
Talaromyces marneffei DNA Diagnostic Kit (PCR-Fluorescence Probing) S3337E-24
EUDAMED
IVD GeneralActive
Carbohydrate antigen 72-4 Assay Kit (Chemiluminescent Immunoassay) S2109E-24
EUDAMED
IVD GeneralActive
SARS-CoV-2 L452R/E484Q/P681R/E484K Mutation Nucleic Acid Detection Kit ( PCR-Fluorescence Probing) S3128E-48
EUDAMED
IVD GeneralActive
Automated CLEIA system Surelite 8
EUDAMED
Class AActive
Fully Automated Nucleic Acid Extraction System S-S13A
EUDAMED
Class AActive
Respiratory Pathogens Multiplex Nucleic Acid Diagnostic Kit (Multiplex PCR-Fluorescence Probing) S3081E
EUDAMED
IVD GeneralActive
Vascular Endothelial Growth Factor Chemiluminescence Immunoassay Kit S2068E-75
EUDAMED
IVD GeneralActive
Carbohydrate antigen 242 Assay Kit (Chemiluminescent Immunoassay) S2116E-48
EUDAMED
IVD GeneralActive
Human Rotavirus A/B/C Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3242E-48
EUDAMED
IVD GeneralActive
Pneumocystis Jiroveci Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3159E-48
EUDAMED
IVD GeneralActive
Interleukin-2 Receptor Chemiluminescence Immunoassay Kit S2034E-25
EUDAMED
IVD GeneralActive
Human Coronavirus 229E, NL63, OC43, HKU1, MERS, SARS Multiple Nucleic Acid Diagnostic Kit (Multiple Fluorescence PCR) S3168E-48
EUDAMED
IVD GeneralActive
Neisseria Gonorrhoeae DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) S3003E
EUDAMED
IVD GeneralActive
SARS-CoV-2 Neutralizing Antibody Chemiluminescence Immunoassay Kit S2056E-200
EUDAMED
IVD GeneralActive
Sample Storage Reagent X1002E-96-1
EUDAMED
Class AActive
Listeria Monocytogenes Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3197E-48
EUDAMED
IVD GeneralActive
Middle East Respiratory Syndrome Coronaviruses Diagnostic Kit (PCR-Fluorescence Probing) S3091E
EUDAMED
IVD GeneralActive
Giardia Lamblia Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) This product is manufactured by Sansure Biotech Inc..
EUDAMED
IVD GeneralActive
Heart-type Fatty Acid Binding Protein Chemiluminescence Immunoassay Kit S2140E-50
EUDAMED
IVD GeneralActive
Chlamydia Trachomatis/Ureaplasma Urealyticum/Neisseria Gonorrhoeae DNA Diagnostic Kit (PCR-Fluorescence Probing) S3050E
EUDAMED
IVD Annex II List BActive
Nucleic Acid Extraction-Purification Kit S50016E-48
EUDAMED
Class AActive
Escherichia coli O157 Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3237E-48
EUDAMED
IVD GeneralActive
SARS-CoV-2 S-RBD Antibodies Test (Colloidal Gold) S3132E-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