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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 10 of 18

Device	Model / Reference	Registries	Class	Status
Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (RT-Digital PCR)	S3291E-48	EUDAMED	IVD General	Active
Human Coronavirus HCoV-229E Nucleic Acid Diagnostic Kit(PCR-Fluorescence Probing)	S3175E-24	EUDAMED	IVD General	Active
Carbohydrate Antigen 19-9 Chemiluminescence Immunoassay Kit	S2010E-100	EUDAMED	IVD General	Active
Nucleic Acid Extraction-Purification Kit	S50016E-96	EUDAMED	Class A	Active
Enterovirus/Coxsackievirus A16/Enterovirus 71 RNA Diagnostic Kit (PCR-Fluorescence Probing)	S3053E	EUDAMED	IVD General	Active
25-Hydroxy Vitamin D Chemiluminescence Immunoassay Kit	S2001E-200	EUDAMED	IVD General	Active
Acinetobacter baumannii and Canidia albican Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3100E	EUDAMED	IVD General	Active
Total Thyroxine Chemiluminescence Immunoassay Kit	S2065E-200	EUDAMED	IVD General	Active
Reverse Triiodothyronine Chemiluminescence Immunoassay Kit	S2149E-75	EUDAMED	IVD General	Active
Human Rotavirus A/B/C Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3242E-24	EUDAMED	IVD General	Active
Renin Chemiluminescence Immunoassay Kit	S2148E-50	EUDAMED	IVD General	Active
Clostridium Perfringens Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3248E-48	EUDAMED	IVD General	Active
Lipoprotein-associated Phospholipase A2 Chemiluminescence Immunoassay Kit	S2038E-100	EUDAMED	IVD General	Active
Influenza A/B Virus Nucleic Acid Diagnostic Kit ( PCR-Fluorescence Probing)	S3353E-48	EUDAMED	IVD General	Active
Osteocalcin Chemiluminescence Immunoassay Kit	S2146E-150	EUDAMED	IVD General	Active
Estradiol Assay Kit (Chemiluminescent Immunoassay)	S2085E-48	EUDAMED	IVD General	Active
Neutrophil Gelatinase-associated Lipocalin Chemiluminescence Immunoassay Kit	S2158E-200	EUDAMED	IVD General	Active
Sample Storage Reagent	X1003E-48-3	EUDAMED	Class A	Active
SARS-CoV-2 S-RBD Antibody Assay Kit (ELISA)	S3133E-96	EUDAMED	IVD General	Active
Pro-gastrin-releasing Peptide Chemiluminescence Immunoassay Kit	S2050E-150	EUDAMED	IVD General	Active
Human Rotavirus A and B Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3241E-48	EUDAMED	IVD General	Active
Heparin Binding Protein Chemiluminescence Immunoassay Kit	S2025E-200	EUDAMED	IVD General	Active
Adenovirus Group F Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3236E-48	EUDAMED	IVD General	Active
Tumor Necrosis Factor α Chemiluminescence Immunoassay Kit	S2067E-75	EUDAMED	IVD General	Active
Human Coronavirus HCoV-HKU1 Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3176E-24	EUDAMED	IVD General	Active
Sample Release Reagent	S1012E-48	EUDAMED	Class A	Active
Analysis Software for BRCA Gene Genetic Variants	Sa_BGT	EUDAMED	IVD General	Active
SARS-CoV-2 del247-253 Mutation Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3161E-48	EUDAMED	IVD General	Active
Human ApoE Genetic Polymorphism Detection Kit (PCR-Fluorescence Probing)	S3089E	EUDAMED	IVD General	Active
Carcinoembryonic antigen Assay Kit (Chemiluminescent Immunoassay)	S2103E-48	EUDAMED	IVD General	Active
Dengue Virus RNA Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3188E-24	EUDAMED	IVD General	Active
SARS-CoV-2 E484K Mutation Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3145E-24	EUDAMED	IVD General	Active
Reverse Triiodothyronine Chemiluminescence Immunoassay Kit	S2149E-200	EUDAMED	IVD General	Active
Troponin I Assay Kit(Chemiluminescent Immunoassay)	S2073E-24	EUDAMED	IVD General	Active
Phosphorylated Tau 181 Protein Chemiluminescence Immunoassay Kit	S2046E-25	EUDAMED	IVD General	Active
SARS-CoV-2 BA.1/BA.2 Mutation Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3340E-48	EUDAMED	IVD General	Active
Campylobacter coli Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3247E-48	EUDAMED	IVD General	Active
Placental Growth Factor Chemiluminescence Immunoassay Kit	S2047E-100	EUDAMED	IVD General	Active
Protein Induced by Vitamin K Absence or Antagonist-II Chemiluminescence Immunoassay Kit	S2147E-150	EUDAMED	IVD General	Active
Parainfluenza Virus type 1, 2 and 3 Nucleic Acid Diagnostic Kit (PCR Fluorescence Probing)	S3149E-48	EUDAMED	IVD General	Active
High-risk Human Papillomavirus DNA (Genotype) Diagnostic Kit (PCR-Fluorescence Probing)	S3027E-48	EUDAMED	IVD General	Active
Norovirus GI/GII/Rotavirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3222E-24	EUDAMED	IVD General	Active
Placental Growth Factor Chemiluminescence Immunoassay Kit	S2047E-200	EUDAMED	IVD General	Active
Nucleic Acid Extraction-Purification Kit V-VI	S5006E-48	EUDAMED	Class A	Active
Campylobacter jejuni Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3209E-48	EUDAMED	IVD General	Active
Pepsinogen II Chemiluminescence Immunoassay Kit	S2045E-25	EUDAMED	IVD General	Active
Vibrio Parahaemolyticus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3208E-48	EUDAMED	IVD General	Active
Heart-type Fatty Acid Binding Protein Chemiluminescence Immunoassay Kit	S2140E-200	EUDAMED	IVD General	Active
C-Peptide Chemiluminescence Immunoassay Kit	S2012E-50	EUDAMED	IVD General	Active
Enteropathogenic Escherichia Coli Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3288E-48	EUDAMED	IVD General	Active

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Sansure Biotech Inc. US