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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 12 of 18

Device	Model / Reference	Registries	Class	Status
Thyroglobulin Assay Kit (Chemiluminescent Immunoassay)	S2100E-24	EUDAMED	IVD General	Active
Monkeypox Virus (MPV) Rapid Antibody Test Kit (Immunochromatography Assay)	S3358E-1	EUDAMED	IVD General	Active
Adrenocorticotropic Hormone Chemiluminescence Immunoassay Kit	S2129E-75	EUDAMED	IVD General	Active
Novel Coronavirus(COVID-19) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3327E-24	EUDAMED	IVD General	Active
Hyaluronic Acid Chemiluminescence Immunoassay Kit	S2142E-150	EUDAMED	IVD General	Active
Vibrio Cholerae Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3201E-24	EUDAMED	IVD General	Active
Staphylococcus Aureus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3143E-24	EUDAMED	IVD General	Active
Anti-Mullerian Hormone Chemiluminescence Immunoassay Kit	S2004E-150	EUDAMED	IVD General	Active
Human Coronavirus (MERS) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3174E-24	EUDAMED	IVD General	Active
Novel Coronavirus(SARS-CoV-2) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3125E-48	EUDAMED	IVD General	Active
Squamous Cell Carcinoma Antigen Chemiluminescence Immunoassay Kit	S2059E-150	EUDAMED	IVD General	Active
Cancer Antigen CA 72-4 Chemiluminescence Immunoassay Kit	S2009E-150	EUDAMED	IVD General	Active
Nucleic Acid Extraction System	Natch 24	EUDAMED	Class A	Active
Sample Storage Reagent	X1002E-48-1	EUDAMED	Class A	Active
Heparin Binding Protein Chemiluminescence Immunoassay Kit	S2025E-50	EUDAMED	IVD General	Active
Procalcitonin Chemiluminescence Immunoassay Kit	S2049E-25	EUDAMED	IVD General	Active
Nucleic Acid Extraction-Purification Kit	S50016E-48B	EUDAMED	Class A	Active
Adenovirus and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3335E-24	EUDAMED	IVD General	Active
Growth Hormone Chemiluminescence Immunoassay Kit	S2024E-200	EUDAMED	IVD General	Active
Nocardia Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3338E-48	EUDAMED	IVD General	Active
Myoglobin Chemiluminescence Immunoassay Kit	S2041E-150	EUDAMED	IVD General	Active
Interleukin-1β Chemiluminescence Immunoassay Kit	S2033E-150	EUDAMED	IVD General	Active
Sample Diluent	Y1001E-24	EUDAMED	Class A	Active
Monkeypox virus DNA Fluorescence Diagnostic Kit (LAMP)	S3362E-24	EUDAMED	IVD General	Active
Interleukin-8 Chemiluminescence Immunoassay Kit	S2036E-200	EUDAMED	IVD General	Active
Influenza A/B Virus and Respiratory Syncytial Virus Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3336E-48	EUDAMED	IVD General	Active
Legionella pneumophila Nucleic Acid Diagnostic Kit (PCR Fluorescence Probing)	S3313E-24	EUDAMED	IVD General	Active
Avian influenza virus H9 RNA Diagnostic Kit (PCR-Fluorescence Probing)	S3167E-24	EUDAMED	IVD General	Active
Cancer Antigen 15-3 Chemiluminescence Immunoassay Kit	W0102030102	EUDAMED	IVD General	Active
Pepsinogen Ⅰ Chemiluminescence Immunoassay Kit	S2044E-50	EUDAMED	IVD General	Active
Inhibin B Assay Kit (Chemiluminescent Immunoassay)	S2089E-24	EUDAMED	IVD General	Active
Sample Storage Reagent XI	X1011E-24A-3	EUDAMED	Class A	Active
Free Triiodothyronine Chemiluminescence Immunoassay Kit	S2021E-50	EUDAMED	IVD General	Active
Sample Storage Reagent XI	X1011E-48C-3	EUDAMED	Class A	Active
Cryptosporidium/Entamoeba histolytica/Giardia lamblia Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3227E-48	EUDAMED	IVD General	Active
Protein Induced by Vitamin K Absence or Antagonist-II Assay Kit (Chemiluminescent Immunoassay)	S2120E-48	EUDAMED	IVD General	Active
Campylobacter fetus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3210E-24	EUDAMED	IVD General	Active
Renin Chemiluminescence Immunoassay Kit	S2148E-75	EUDAMED	IVD General	Active
Adenovirus 41 Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3330E-48	EUDAMED	IVD General	Active
Troponin I Assay Kit(Chemiluminescent Immunoassay)	S2073E-48	EUDAMED	IVD General	Active
Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)	S3118E-48	EUDAMED	IVD Annex II List A	Active
Reverse Triiodothyronine Chemiluminescence Immunoassay Kit	S2149E-150	EUDAMED	IVD General	Active
Q Fever Rickettsia Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3171E-48	EUDAMED	IVD General	Active
Human EGFR Gene 29 Mutations Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)	S3059E	EUDAMED	IVD General	Active
Enterococcus Faecium Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3199E-48	EUDAMED	IVD General	Active
Human Rotavirus A Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3239E-48	EUDAMED	IVD General	Active
Amyloid β Protein 1-42 Chemiluminescence Immunoassay Kit	S2003E-100	EUDAMED	IVD General	Active
Nucleic Acid Extraction-Purification Kit V-VII	S5007E-96A	EUDAMED	Class A	Active
Human Epidermal Growth Factor Receptor Assay Kit (Chemiluminescent Immunoassay)	S2121E-24	EUDAMED	IVD General	Active
Cortisol Chemiluminescence Immunoassay Kit	S2135E-25	EUDAMED	IVD General	Active

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Sansure Biotech Inc. US