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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 6 of 18
DeviceModel / ReferenceRegistriesClassStatus
Progesterone Chemiluminescence Immunoassay Kit S2051E-200
EUDAMED
IVD GeneralActive
Adrenocorticotropic Hormone Chemiluminescence Immunoassay Kit S2129E-150
EUDAMED
IVD GeneralActive
Fibrin/fibrinogen Degradation Products Chemiluminescence Immunoassay Kit S2018E-200
EUDAMED
IVD GeneralActive
Human Coronavirus HCoV-OC43 Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3178E-48
EUDAMED
IVD GeneralActive
Trypanosoma DNA Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3192E-24
EUDAMED
IVD GeneralActive
Novel Coronavirus (COVID-19)Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3326E-24
EUDAMED
IVD GeneralActive
Measles and Rubella virus (MeV/RV) RNA Diagnostic Kit (PCR-Fluorescence Probing) S3278E-24
EUDAMED
IVD GeneralActive
Shigella/Salmonella/Escherichia coli O157 Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3229E-24
EUDAMED
IVD GeneralActive
N-terminal pro-B-type Natriuretic Peptide Chemiluminescence Immunoassay Kit S2043E-50
EUDAMED
IVD GeneralActive
Progesterone Chemiluminescence Immunoassay Kit S2051E-150
EUDAMED
IVD GeneralActive
Anti-Mullerian Hormone Chemiluminescence Immunoassay Kit S2004E-75
EUDAMED
IVD GeneralActive
SARS-CoV-2 Rapid Antigen Test (Colloidal Gold Method) S3109E
EUDAMED
IVD GeneralActive
SARS-CoV-2 T76I Mutation Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3153E-24
EUDAMED
IVD GeneralActive
SARS-CoV-2 E484Q Mutation Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3152E-48
EUDAMED
IVD GeneralActive
Cancer Antigen CA 72-4 Chemiluminescence Immunoassay Kit S2009E-50
EUDAMED
IVD GeneralActive
SARS-CoV-2 Antigen Test Kit (Immunochromatography Assay) S3270E-25
EUDAMED
IVD GeneralActive
Ferritin Chemiluminescence Immunoassay Kit S2017E-50
EUDAMED
IVD GeneralActive
West Nile Virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3259E-48
EUDAMED
IVD GeneralActive
Human ALDH2 and ADH1B Genetic Polymorphism Nucleic Acid Detection Kit (PCR-Fluorescence Probing) S3212E-24
EUDAMED
IVD GeneralActive
B-type Natriuretic Peptide Chemiluminescence Immunoassay Kit S2130E-100
EUDAMED
IVD GeneralActive
C-Reactive Protein Chemiluminescence Immunoassay Kit S2136E-200
EUDAMED
IVD GeneralActive
SARS-CoV-2 Antigen Test Kit (Immunochromatography Assay) S3270E-5
EUDAMED
IVD GeneralActive
Cancer Antigen 15-3 Chemiluminescence Immunoassay Kit S2007E-100
EUDAMED
IVD GeneralActive
Adenovirus 41 Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3330E-24
EUDAMED
IVD GeneralActive
Fully Automated Nucleic Acid Extraction System S-S14A
EUDAMED
Class AActive
SARS-CoV-2 F490S Mutation Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3138E-24
EUDAMED
IVD GeneralActive
25-Hydroxy Vitamin D Assay Kit (Chemiluminescent Immunoassay) S2127E-24
EUDAMED
IVD GeneralActive
Anti-Mullerian Hormone Chemiluminescence Immunoassay Kit S2004E-50
EUDAMED
IVD GeneralActive
SARS-CoV-2 and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (Isothermal Amplification) S3344E-15
EUDAMED
IVD GeneralActive
Pneumocystis Jiroveci, Cryptococcus Neoformans and Aspergillus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3140E-24
EUDAMED
IVD GeneralActive
Novel Coronavirus(SARS-CoV-2) Nucleic Acid Diagnostic Kit (Sequencing By Reversible Termination) C090-24
EUDAMED
IVD GeneralActive
Human Chorionic Gonadotropin plus the hCG β-subunit Chemiluminescence Immunoassay Kit S2027E-100
EUDAMED
IVD GeneralActive
S100β Protein Chemiluminescence Immunoassay Kit S2053E-25
EUDAMED
IVD GeneralActive
Escherichia coli O157 Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3237E-24
EUDAMED
IVD GeneralActive
Hepatitis B Virus Genotype Diagnostic Kit (PCR-Fluorescence Probing) S3035E
EUDAMED
IVD GeneralActive
Nucleic Acid Extraction-Purification Kit V-VI S5006E-48B
EUDAMED
Class AActive
Vitamin B12 Assay Kit (Chemiluminescent Immunoassay) S2125E-24
EUDAMED
IVD GeneralActive
Pro-gastrin-releasing Peptide Chemiluminescence Immunoassay Kit S2050E-50
EUDAMED
IVD GeneralActive
Pepsinogen II Chemiluminescence Immunoassay Kit S2045E-50
EUDAMED
IVD GeneralActive
Six Bacterial Meningitis Pathogens Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3268E-48
EUDAMED
IVD GeneralActive
Glycated Hemoglobin Chemiluminescence Immunoassay Kit S2023E-50
EUDAMED
IVD GeneralActive
Sapovirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3217E-24
EUDAMED
IVD GeneralActive
Sample Storage Reagent X1001E-24
EUDAMED
Class AActive
SARS-CoV-2 Rapid Antigen Test (Immunochromatography Assay) S3120E-1-H
EUDAMED
IVD devices for self-testingActive
Vascular Endothelial Growth Factor Chemiluminescence Immunoassay Kit S2068E-150
EUDAMED
IVD GeneralActive
Free Thyroxine Chemiluminescence Immunoassay Kit S2020E-100
EUDAMED
IVD GeneralActive
SARS-CoV-2 Neutralizing Antibody Test Kit (ICA) S3135E-1
EUDAMED
IVD GeneralActive
Streptococcus suis DNA Diagnostic Kit(PCR-Fluorescence Probing) S3254E-48
EUDAMED
IVD GeneralActive
Pregnancy-associated plasma protein-A Assay Kit (Chemiluminescent Immunoassay) S2093E-24
EUDAMED
IVD GeneralActive
Collagen Type Ⅲ N-peptide Chemiluminescence Immunoassay Kit S2134E-25
EUDAMED
IVD GeneralActive

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FDA Establishments (1)

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  • Sansure Biotech Inc. US