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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
Website: www.sansureglobal.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +86-731-88883176-6116
PRRC Contact: Ren Xiaomei
EUDAMED SRN: CN-MF-000011392
FDA FEI Number: 3016619649
DUNS Number: —

Catalogue (894)

Page 15 of 18

Device	Model / Reference	Registries	Class	Status
Hepatitis A Virus RNA Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3179E-24	EUDAMED	IVD General	Active
Serum Amyloid A Chemiluminescence Immunoassay Kit	S2151E-50	EUDAMED	IVD General	Active
Herpes Simplex Virus DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)	S3028E	EUDAMED	IVD General	Active
Cryptosporidium Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3219E-24	EUDAMED	IVD General	Active
Mycobacterium Multiplex Nucleic Acid Diagnostic Kit(Multiplex PCR-Fluorescence Probing)	S3099E	EUDAMED	IVD General	Active
15 High-risk Human Papillomavirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3360E-48	EUDAMED	IVD General	Active
Pepsinogen II Chemiluminescence Immunoassay Kit	S2045E-200	EUDAMED	IVD General	Active
Matrix Metalloproteinase-3 Chemiluminescence Immunoassay Kit	S2040E-100	EUDAMED	IVD General	Active
Sample Storage Reagent X	X1010E-48B-3	EUDAMED	Class A	Active
Diagnostic Kit for Enterovirus 71 RNA (PCR-Fluorescence Probing)	S3022E	EUDAMED	IVD General	Active
Phosphorylated Tau 181 Protein Chemiluminescence Immunoassay Kit	S2046E-75	EUDAMED	IVD General	Active
Soluble Growth Stimulation Expressed Gene 2 Chemiluminescence Immunoassay Kit	S2058E-75	EUDAMED	IVD General	Active
SARS-CoV-2, Influenza Virus and Respiratory Syncytial Virus Multiple Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3148E-24-P	EUDAMED	IVD General	Active
D-Dimer Chemiluminescence Immunoassay Kit	S2015E-100	EUDAMED	IVD General	Active
Amyloid β Protein 1-42 Chemiluminescence Immunoassay Kit	S2003E-200	EUDAMED	IVD General	Active
Human papillomavirus (Type 6 and 11) DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)	S3017E	EUDAMED	IVD General	Active
Adenovirus Group F Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3236E-24	EUDAMED	IVD General	Active
Protein Induced by Vitamin K Absence or Antagonist-II Chemiluminescence Immunoassay Kit	S2147E-50	EUDAMED	IVD General	Active
9 Diarrhea Bacteria Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3283E-48	EUDAMED	IVD General	Active
SARS-CoV-2, Influenza Virus and Respiratory Syncytial Virus Multiple Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3148E-12-S	EUDAMED	IVD General	Active
Bacillus anthracis Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3299E-24	EUDAMED	IVD General	Active
Heart fatty acid binding protein Assay Kit (Chemiluminescent Immunoassay)	S2077E-24	EUDAMED	IVD General	Active
15 High-risk Human Papillomavirus DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)	S3359E-48	EUDAMED	IVD General	Active
Streptococcus suis DNA Diagnostic Kit（PCR-Fluorescence Probing)	S3254E-24	EUDAMED	IVD General	Active
Total Thyroxine Chemiluminescence Immunoassay Kit	S2065E-50	EUDAMED	IVD General	Active
MB isoenzyme of creatine kinase Assay Kit (Chemiluminescent Immunoassay)	S2071E-24	EUDAMED	IVD General	Active
SARS-CoV-2 and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3113E-24-P	EUDAMED	IVD General	Active
Herpes Simplex Virus Type 2 DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)	S3002E	EUDAMED	IVD General	Active
Free Thyroxine Chemiluminescence Immunoassay Kit	S2020E-150	EUDAMED	IVD General	Active
Monkeypox Virus (MPV) Rapid Antigen Test Kit (Colloidal Gold Method)	S3355E-25	EUDAMED	IVD General	Active
β2-microglobulin Assay Kit (Chemiluminescent Immunoassay)	S2104E-48	EUDAMED	IVD General	Active
Heparin Binding Protein Chemiluminescence Immunoassay Kit	S2025E-75	EUDAMED	IVD General	Active
4 HFMD related Pathogens Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3269E-48	EUDAMED	IVD General	Active
Insulin-Like Growth Factor Binding Protein-3 Chemiluminescence Immunoassay Kit	S2031E-150	EUDAMED	IVD General	Active
Tumor Necrosis Factor α Chemiluminescence Immunoassay Kit	S2067E-200	EUDAMED	IVD General	Active
SARS-CoV-2 Rapid Antigen Test (Immunochromatography Assay)	S3120E-25-H	EUDAMED	IVD devices for self-testing	Active
Serum Amyloid A Chemiluminescence Immunoassay Kit	S2151E-200	EUDAMED	IVD General	Active
Nucleic Acid Extraction-Purification Kit	S50015E-96B	EUDAMED	Class A	Active
Free Thyroxine Assay Kit (Chemiluminescent Immunoassay)	S2098E-48	EUDAMED	IVD General	Active
Alpha-Fetoprotein Chemiluminescence Immunoassay Kit	S2002E-150	EUDAMED	IVD General	Active
Protein Induced by Vitamin K Absence or Antagonist-II Chemiluminescence Immunoassay Kit	S2147E-25	EUDAMED	IVD General	Active
Interleukin-6 Chemiluminescence Immunoassay Kit	S2035E-150	EUDAMED	IVD General	Active
Helicobacter pylori Amoxicillin resistant Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3256E-48	EUDAMED	IVD General	Active
Insulin Chemiluminescence Immunoassay Kit	S2030E-50	EUDAMED	IVD General	Active
Ebola Virus and Lassa Fever Virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3139E-48	EUDAMED	IVD General	Active
Novel Coronavirus(2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3102E	EUDAMED	IVD General	Active
Thrombin-Antithrombin III Complex Chemiluminescence Immunoassay Kit	S2061E-150	EUDAMED	IVD General	Active
Insulin-Like Growth Factor Binding Protein-3 Chemiluminescence Immunoassay Kit	S2031E-75	EUDAMED	IVD General	Active
Human Papillomavirus DNA (23 genotypes) Diagnostic Kit (PCR-Fluorescence Probing)	S3108E	EUDAMED	IVD General	Active
Folate Chemiluminescence Immunoassay Kit	S2137E-150	EUDAMED	IVD General	Active

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Sansure Biotech Inc. US