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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 17 of 18

Device	Model / Reference	Registries	Class	Status
Glycated Hemoglobin Chemiluminescence Immunoassay Kit	S2023E-150	EUDAMED	IVD General	Active
This product is manufactured by Sansure Biotech Inc..	S2019E-75	EUDAMED	IVD General	Active
Nucleic Acid Extraction System	Natch 48	EUDAMED	Class A	Active
Total Triiodothyronine Chemiluminescence Immunoassay Kit	S2066E-75	EUDAMED	IVD General	Active
Respiratory Syncytial Virus Rapid Antigen Test (Colloidal Gold Method)	S3347E-25	EUDAMED	IVD General	Active
Thyroid Stimulating Hormone Chemiluminescence Immunoassay Kit	S2063E-25	EUDAMED	IVD General	Active
Human Herpes Virus 7 DNA Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3181E-24	EUDAMED	IVD General	Active
β2-microglobulin Chemiluminescence Immunoassay Kit	S2145E-75	EUDAMED	IVD General	Active
Fibrin/fibrinogen Degradation Products Chemiluminescence Immunoassay Kit	S2018E-100	EUDAMED	IVD General	Active
Cancer Antigen 50 Chemiluminescence Immunoassay Kit	S2133E-100	EUDAMED	IVD General	Active
Squamous Cell Carcinoma Antigen Chemiluminescence Immunoassay Kit	S2059E-100	EUDAMED	IVD General	Active
SARS-CoV-2 L452R Mutation Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3162E-24	EUDAMED	IVD General	Active
Prolactin Assay Kit (Chemiluminescent Immunoassay)	S2084E-24	EUDAMED	IVD General	Active
Red Blood Cell Folate Chemiluminescence Immunoassay Kit	S2138E-75	EUDAMED	IVD General	Active
Nucleic Acid Analysis Device	S-Q35C	EUDAMED	Class A	Active
Creatine Kinase MB Isoenzyme Chemiluminescence Immunoassay Kit	S2013E-200	EUDAMED	IVD General	Active
Thyroid stimulating hormone Assay Kit (Chemiluminescent Immunoassay)	S2094E-48	EUDAMED	IVD General	Active
Severe Fever With Thrombocytopenia Syndrome Bunyavirus RNA Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3189E-24	EUDAMED	IVD General	Active
Human Coronavirus HCoV-NL63 Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3177E-48	EUDAMED	IVD General	Active
Helicobacter pylori Metronidazole Resistant Nucleic Acid Detection Kit (PCR-Fluorescence Probing)	S3255E-24	EUDAMED	IVD General	Active
Interleukin-8 Chemiluminescence Immunoassay Kit	S2036E-50	EUDAMED	IVD General	Active
Insulin Assay Kit (Chemiluminescent Immunoassay)	S2123E-24	EUDAMED	IVD General	Active
Nucleic Acid Extraction-Purification Kit	S5005E-96A	EUDAMED	Class A	Active
Plasmin-Alpha 2 Plasmin Inhibitor Complex Chemiluminescence Immunoassay Kit	S2048E-200	EUDAMED	IVD General	Active
Thrombomodulin Chemiluminescence Immunoassay Kit	S2062E-200	EUDAMED	IVD General	Active
Vibrio Cholerae O1 and O139 Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3224E-48	EUDAMED	IVD General	Active
Serum Amyloid A Chemiluminescence Immunoassay Kit	S2151E-75	EUDAMED	IVD General	Active
Mycoplasma genitalium/Mycoplasma hominis/Trichomonas vaginalis Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3250E-24-P	EUDAMED	IVD General	Active
Nucleic Acid Extraction-Purification Kit	S50016E-32-T	EUDAMED	Class A	Active
SARS-CoV-2 Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3123E-12-P	EUDAMED	IVD General	Active
Amyloid β Protein 1-42 Chemiluminescence Immunoassay Kit	S2003E-50	EUDAMED	IVD General	Active
Intact Parathyroid Hormone Chemiluminescence Immunoassay Kit	S2143E-200	EUDAMED	IVD General	Active
Interleukin-10 Chemiluminescence Immunoassay Kit	S2037E-75	EUDAMED	IVD General	Active
SARS-CoV-2 L452Q Mutation Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3144E-24	EUDAMED	IVD General	Active
Carbohydrate antigen 15-3 Assay Kit (Chemiluminescent Immunoassay)	S2105E-24	EUDAMED	IVD General	Active
Soluble Fms‑like Tyrosine Kinase‑1 Chemiluminescence Immunoassay Kit	S2057E-150	EUDAMED	IVD General	Active
C-Peptide Assay Kit (Chemiluminescent Immunoassay)	S2122E-24	EUDAMED	IVD General	Active
N-terminal pro-brain natriuretic peptide Assay Kit (Chemiluminescent Immunoassay)	S2074E-24	EUDAMED	IVD General	Active
Monkeypox Virus (MPV) Rapid Antigen Test Kit (Immunochromatography Assay)	S3356E-5	EUDAMED	IVD General	Active
High-sensitive cardiac troponin I Assay Kit (Chemiluminescent Immunoassay)	S2076E-24	EUDAMED	IVD General	Active
Testosterone Chemiluminescence Immunoassay Kit	S2060E-50	EUDAMED	IVD General	Active
Human papillomavirus (Type 16 and 18) DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)	S3019E	EUDAMED	IVD General	Active
Lipoprotein-associated Phospholipase A2 Chemiluminescence Immunoassay Kit	S2038E-25	EUDAMED	IVD General	Active
Interleukin-6 Chemiluminescence Immunoassay Kit	S2035E-25	EUDAMED	IVD General	Active
Monkeypox Virus (MPV) Rapid Antibody Test Kit (Colloidal Gold Method)	S3357E-1	EUDAMED	IVD General	Active
Prolactin Chemiluminescence Immunoassay Kit	S2052E-100	EUDAMED	IVD General	Active
Calcitonin Chemiluminescence Immunoassay Kit	S2131E-50	EUDAMED	IVD General	Active
Neuron Specific Enolase Chemiluminescence Immunoassay Kit	S2042E-100	EUDAMED	IVD General	Active
β2-microglobulin Assay Kit (Chemiluminescent Immunoassay)	S2104E-24	EUDAMED	IVD General	Active
Nucleic Acid Extraction-Purification Kit	S10016E-32-A	EUDAMED	Class A	Active

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Sansure Biotech Inc. US