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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 8 of 18

Device	Model / Reference	Registries	Class	Status
Vibrio Vulnificus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3249E-48	EUDAMED	IVD General	Active
Red Blood Cell Lysis Buffer	S1004E-48	EUDAMED	Class A	Active
Sample Storage Reagent	X1006E-400	EUDAMED	Class A	Active
Thrombin-Antithrombin III Complex Chemiluminescence Immunoassay Kit	S2061E-100	EUDAMED	IVD General	Active
Human Papillomavirus DNA Diagnostic Kit (PCR-Fluorescence Probing)	S3057E	EUDAMED	IVD General	Active
Sample Storage Reagent	X1004E-24-3	EUDAMED	Class A	Active
Sample Storage Reagent X	X1010E-48-6	EUDAMED	Class A	Active
Helicobacter pylori Quinolone resistant Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3257E-48	EUDAMED	IVD General	Active
Lipoprotein-associated Phospholipase A2 Chemiluminescence Immunoassay Kit	S2038E-50	EUDAMED	IVD General	Active
Group B Streptococcus DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)	S3056E	EUDAMED	IVD General	Active
Cancer Antigen 15-3 Chemiluminescence Immunoassay Kit	S2007E-50	EUDAMED	IVD General	Active
6 Diarrhea Bacteria Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3287E-24	EUDAMED	IVD General	Active
Influenza A and BV/BY RNA Diagnositc Kit（PCR-Fluorescence Probing）	S3164E-48	EUDAMED	IVD General	Active
Nucleic Acid Extraction-Purification Kit	S5005E-64-A	EUDAMED	Class A	Active
Type Ⅳ Collagen Chemiluminescence Immunoassay Kit	S2155E-200	EUDAMED	IVD General	Active
Adenovirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3334E-48	EUDAMED	IVD General	Active
Intact Parathyroid Hormone Chemiluminescence Immunoassay Kit	S2143E-50	EUDAMED	IVD General	Active
Sample Storage Reagent X	X1010E-48A-3	EUDAMED	Class A	Active
Portable Molecular Diagnostic System	S-Q37A	EUDAMED	Class A	Active
Nucleic Acid Extraction-Purification Kit	S10016E-64-A	EUDAMED	Class A	Active
Nucleic Acid Extraction-Purification Kit	S50016E-48A	EUDAMED	Class A	Active
Echovirus E11 Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3232E-24	EUDAMED	IVD General	Active
Osteocalcin Chemiluminescence Immunoassay Kit	S2146E-200	EUDAMED	IVD General	Active
Plasmin-Alpha 2 Plasmin Inhibitor Complex Chemiluminescence Immunoassay Kit	S2048E-100	EUDAMED	IVD General	Active
Enterococcus Faecalis Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3198E-48	EUDAMED	IVD General	Active
Salmonella Paratyphi Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3234E-48	EUDAMED	IVD General	Active
5 Diarrhea Escherichia coli Nucleic Acid Detection Kit (PCR-Fluorescence Probing)	S3246E-48	EUDAMED	IVD General	Active
Human PIK3CA Gene Mutation Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)	S3063E	EUDAMED	IVD General	Active
Vitamin B12 Chemiluminescence Immunoassay Kit	S2156E-50	EUDAMED	IVD General	Active
SARS-CoV-2 E484Q Mutation Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3152E-24	EUDAMED	IVD General	Active
Soluble Fms‑like Tyrosine Kinase‑1 Chemiluminescence Immunoassay Kit	S2057E-75	EUDAMED	IVD General	Active
SARS-CoV-2 and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3113E-12-S	EUDAMED	IVD General	Active
Mycobacterium Tuberculosis DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)	S3018E	EUDAMED	IVD General	Active
Collagen Type Ⅲ N-peptide Chemiluminescence Immunoassay Kit	S2134E-50	EUDAMED	IVD General	Active
Nucleic Acid Extraction-Purification Kit	S10018E-32A-N8	EUDAMED	Class A	Active
Severe Fever with Thrombocytopenia Syndrome Bunyavirus（SFTSV） Nucleic Acid Detection Kit(PCR-Fluorescence Probing)	S3251E-48	EUDAMED	IVD General	Active
Matrix Metalloproteinase-3 Chemiluminescence Immunoassay Kit	S2040E-200	EUDAMED	IVD General	Active
Ferritin Assay Kit (Chemiluminescent Immunoassay)	S2119E-24	EUDAMED	IVD General	Active
Growth Hormone Chemiluminescence Immunoassay Kit	S2024E-50	EUDAMED	IVD General	Active
Neuron Specific Enolase Chemiluminescence Immunoassay Kit	S2042E-25	EUDAMED	IVD General	Active
Cancer Antigen 15-3 Chemiluminescence Immunoassay Kit	S2007E-75	EUDAMED	IVD General	Active
Thyroid Stimulating Hormone Chemiluminescence Immunoassay Kit	S2063E-50	EUDAMED	IVD General	Active
Thrombin-Antithrombin III Complex Chemiluminescence Immunoassay Kit	S2061E-75	EUDAMED	IVD General	Active
Human Coronavirus 229E, NL63, OC43, HKU1, MERS, SARS Multiple Nucleic Acid Diagnostic Kit (Multiple Fluorescence PCR)	S3168E-24	EUDAMED	IVD General	Active
D-Dimer Chemiluminescence Immunoassay Kit	S2015E-75	EUDAMED	IVD General	Active
Thrombin-Antithrombin III Complex Chemiluminescence Immunoassay Kit	S2061E-200	EUDAMED	IVD General	Active
Pepsinogen I Assay Kit (Chemiluminescent Immunoassay)	S2113E-48	EUDAMED	IVD General	Active
Tumor Necrosis Factor α Chemiluminescence Immunoassay Kit	S2067E-50	EUDAMED	IVD General	Active
Carbohydrate antigen 72-4 Assay Kit (Chemiluminescent Immunoassay)	S2109E-48	EUDAMED	IVD General	Active
Soluble Fms‑like Tyrosine Kinase‑1 Chemiluminescence Immunoassay Kit	S2057E-50	EUDAMED	IVD General	Active

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Sansure Biotech Inc. US