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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 9 of 18
DeviceModel / ReferenceRegistriesClassStatus
Hyaluronic Acid Chemiluminescence Immunoassay Kit S2142E-50
EUDAMED
IVD GeneralActive
15 High-risk Human Papillomavirus DNA Diagnostic Kit (PCR-Fluorescence Probing) S3031E
EUDAMED
IVD GeneralActive
SARS-CoV-2, Influenza A and Influenza B Virus Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3324E-24
EUDAMED
IVD GeneralActive
Urine Sample Collector N101E-40T
EUDAMED
Class AActive
Human Papillomavirus DNA (23 genotypes) Diagnostic Kit (PCR-Fluorescence Probing) S3108E
EUDAMED
IVD GeneralActive
Myoglobin Chemiluminescence Immunoassay Kit S2041E-75
EUDAMED
IVD GeneralActive
Insulin-Like Growth Factor-Ⅰ Chemiluminescence Immunoassay Kit S2032E-150
EUDAMED
IVD GeneralActive
Collagen Type Ⅲ N-peptide Chemiluminescence Immunoassay Kit S2134E-100
EUDAMED
IVD GeneralActive
Placental Growth Factor Chemiluminescence Immunoassay Kit S2047E-75
EUDAMED
IVD GeneralActive
SARS-CoV-2/InFluA/InFluB Rapid Antigen Test (Immunochromatography Assay) S3121E-25
EUDAMED
IVD GeneralActive
Plasmodium DNA Diagnostic Kit (PCR-Fluorescence Probing) S3093E
EUDAMED
IVD GeneralActive
Alpha fetoprotein Assay Kit (Chemiluminescent Immunoassay) S2102E-24
EUDAMED
IVD GeneralActive
SARS-CoV-2, Influenza Viruses and Respiratory Syncytial Virus Multiple Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3325E-24
EUDAMED
IVD GeneralActive
Free Testosterone Chemiluminescence Immunoassay Kit S2139E-100
EUDAMED
IVD GeneralActive
Pepsinogen II Chemiluminescence Immunoassay Kit S2045E-75
EUDAMED
IVD GeneralActive
Progesterone Chemiluminescence Immunoassay Kit S2051E-75
EUDAMED
IVD GeneralActive
Creatine Kinase MB Isoenzyme Chemiluminescence Immunoassay Kit S2013E-75
EUDAMED
IVD GeneralActive
Human Chorionic Gonadotropin plus the hCG β-subunit Chemiluminescence Immunoassay Kit S2027E-200
EUDAMED
IVD GeneralActive
SARS Virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3173E-24
EUDAMED
IVD GeneralActive
SARS-CoV-2 S-protein RBD IgG Antibody Test Kit (Chemiluminescence Immunoassay) S2150E-150
EUDAMED
IVD GeneralActive
Human Epididymis Protein 4 Chemiluminescence Immunoassay Kit S2028E-50
EUDAMED
IVD GeneralActive
Human Parvovirus B19 DNA Diagnostic Kit (PCR-Fluorescence Probing) S3214E-24
EUDAMED
IVD GeneralActive
Nucleic acid extraction (DNA/RNA) or purification kit(Magnetic beads method) S10013E-24
EUDAMED
Class AActive
Inhibin B Chemiluminescence Immunoassay Kit S2029E-50
EUDAMED
IVD GeneralActive
SARS-CoV-2 IgM Antibody Test Kit (Chemiluminescence Immunoassay) S2055E-75
EUDAMED
IVD GeneralActive
Mycoplasma Pneumoniae DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) S3016E
EUDAMED
IVD GeneralActive
Coxsackievirus A6/A10/A16/Enterovirus 71 Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3223E-24
EUDAMED
IVD GeneralActive
Varicella-Zoster Virus/Enterovirus (VZV/EV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3265E-48
EUDAMED
IVD GeneralActive
Group B Streptococcus DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) S3056E-48
EUDAMED
Class CActive
Renin Chemiluminescence Immunoassay Kit S2148E-100
EUDAMED
IVD GeneralActive
Human MTHFR and MTRR Genetic Polymorphism Nucleotide Detection Kit (PCR-Fluorescence Probing) S3098E
EUDAMED
IVD GeneralActive
Troponin I Chemiluminescence Immunoassay Kit S2154E-50
EUDAMED
IVD GeneralActive
Inhibin A Assay Kit (Chemiluminescent Immunoassay) S2090E-24
EUDAMED
IVD GeneralActive
Phosphorylated Tau 181 Protein Chemiluminescence Immunoassay Kit S2046E-50
EUDAMED
IVD GeneralActive
Adenovirus and Adenovirus 3/7 Subtypes Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) S3137E-24
EUDAMED
IVD GeneralActive
SARS-CoV-2 Neutralizing Antibodies Test (Colloidal Gold) S3131E-25
EUDAMED
IVD GeneralActive
Diagnostic Kit for Coxsackievirus A16 RNA (PCR-Fluorescence Probing) S3020E
EUDAMED
IVD GeneralActive
Human SLCO1B1 Genetic Polymorphism Detection Kit (PCR-Fluorescence Probing) S3087E
EUDAMED
IVD GeneralActive
Folate Chemiluminescence Immunoassay Kit S2137E-200
EUDAMED
IVD GeneralActive
Sample Storage Reagent X1003E-96-1
EUDAMED
Class AActive
Human MTHFR and MTRR Genetic Polymorphism Nucleotide Detection Kit (PCR-Fluorescence Probing) S3098E
EUDAMED
IVD GeneralActive
Human Coronavirus HCoV-229E Nucleic Acid Diagnostic Kit(PCR-Fluorescence Probing) S3175E-48
EUDAMED
IVD GeneralActive
Cancer Antigen 242 Chemiluminescence Immunoassay Kit S2132E-150
EUDAMED
IVD GeneralActive
Chlamydia Trachomatis DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) S3001E
EUDAMED
IVD Annex II List BActive
Thyroid Stimulating Hormone Chemiluminescence Immunoassay Kit S2063E-200
EUDAMED
IVD GeneralActive
SARS-CoV-2 Neutralizing Antibody Chemiluminescence Immunoassay Kit S2056E-75
EUDAMED
IVD GeneralActive
Nucleic acid extraction (DNA) or purification kit (Magnetic beads method) S10012E-48B
EUDAMED
Class AActive
B-type Natriuretic Peptide Chemiluminescence Immunoassay Kit S2130E-200
EUDAMED
IVD GeneralActive
Multi-type Sample DNA/RNA Extraction-Purification Kit (Magnetic beads method) S1006E-48
EUDAMED
Class AActive
Sample Release Reagent S1015E-96
EUDAMED
Class AActive

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FDA Establishments (1)

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  • Sansure Biotech Inc. US