Is this your brand? Sign in to claim ownership.

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 1 of 18

Device	Model / Reference	Registries	Class	Status
High-sensitivity Cardiac Troponin T Chemiluminescence Immunoassay Kit	S2026E-75	EUDAMED	IVD General	Active
Human papillomavirus (Type 6 and 11) DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)	S3017E	EUDAMED	IVD General	Active
Monkeypox Virus (MPV) Rapid Antigen Test Kit (Colloidal Gold Method)	S3355E-1	EUDAMED	IVD General	Active
Monkeypox virus DNA Fluorescence Diagnostic Kit (LAMP)	S3362E-48	EUDAMED	IVD General	Active
Monkeypox Virus (MPV) Rapid Antigen Test Kit (Colloidal Gold Method)	S3355E-5	EUDAMED	IVD General	Active
15 High-risk Human Papillomavirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3360E-12-P	EUDAMED	IVD General	Active
Acinetobacter baumannii and Canidia albican Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3100E	EUDAMED	IVD General	Active
High-sensitivity Cardiac Troponin T Chemiluminescence Immunoassay Kit	S2026E-100	EUDAMED	IVD General	Active
High-sensitivity Cardiac Troponin I Chemiluminescence Immunoassay Kit	S2141E-50	EUDAMED	IVD General	Active
High-sensitivity Cardiac Troponin T Chemiluminescence Immunoassay Kit	S2026E-25	EUDAMED	IVD General	Active
High-sensitivity Cardiac Troponin T Chemiluminescence Immunoassay Kit	S2026E-50	EUDAMED	IVD General	Active
Human Papillomavirus DNA Diagnostic Kit (PCR-Fluorescence Probing)	S3057E	EUDAMED	IVD General	Active
High-sensitivity Cardiac Troponin I Chemiluminescence Immunoassay Kit	S2141E-25	EUDAMED	IVD General	Active
Prolactin Chemiluminescence Immunoassay Kit	S2052E-150	EUDAMED	IVD General	Active
Interleukin-1β Chemiluminescence Immunoassay Kit	S2033E-100	EUDAMED	IVD General	Active
Collagen Type Ⅲ N-peptide Chemiluminescence Immunoassay Kit	S2134E-150	EUDAMED	IVD General	Active
Six Respiratory Pathogens Multiplex Nucleic Acid Diagnostic Kit (Multiplex PCR-Fluorescence Probing)	S3310E-24	EUDAMED	IVD General	Active
Fully Automated Nucleic Acid Extraction System Natch CS4	S-S13C	EUDAMED	Class A	Active
Alpha-Fetoprotein Chemiluminescence Immunoassay Kit	S2002E-50	EUDAMED	IVD General	Active
Reverse Triiodothyronine Chemiluminescence Immunoassay Kit	S2149E-25	EUDAMED	IVD General	Active
Free Triiodothyronine Chemiluminescence Immunoassay Kit	S2021E-75	EUDAMED	IVD General	Active
Automated CLEIA system	Surelite 16	EUDAMED	Class A	Active
Parathyroid hormone Assay Kit (Chemiluminescent Immunoassay)	S2128E-24	EUDAMED	IVD General	Active
Progesterone Assay Kit (Chemiluminescent Immunoassay)	S2086E-48	EUDAMED	IVD General	Active
Helicobacter pylori universal Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3204E-48	EUDAMED	IVD General	Active
Coxsackievirus A16/Enterovirus 71 RNA Diagnostic Kit (PCR-Fluorescence Probing)	S3052E	EUDAMED	IVD General	Active
Nucleic Acid Extraction-Purification Kit IV-IX	S4009E-64-T	EUDAMED	Class A	Active
Nucleic acid extraction (DNA) or purification kit (Magnetic beads method)	S10012E-48A	EUDAMED	Class A	Active
Folate Chemiluminescence Immunoassay Kit	S2137E-50	EUDAMED	IVD General	Active
Type Ⅳ Collagen Chemiluminescence Immunoassay Kit	S2155E-75	EUDAMED	IVD General	Active
Nucleic Acid Extraction-Purification Kit	S10018E-96B-N48	EUDAMED	Class A	Active
Human Coronavirus HCoV-OC43 Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3178E-24	EUDAMED	IVD General	Active
Astrovirus/Sapovirus/Enteric Adenovirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3218E-24	EUDAMED	IVD General	Active
Human MTHFR Genetic Polymorphism Detection Kit (PCR-Fluorescence Probing)	S3086E	EUDAMED	IVD General	Active
Sample Storage Reagent XI	X1011E-24C-3	EUDAMED	Class A	Active
Japanese Encephalitis virus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3253E-24	EUDAMED	IVD General	Active
Echovirus E30 Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3231E-48	EUDAMED	IVD General	Active
Clostridium Perfringens Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3248E-24	EUDAMED	IVD General	Active
Bocavirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3117E-24	EUDAMED	IVD General	Active
Human Rotavirus A and B Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3241E-24	EUDAMED	IVD General	Active
Carbohydrate Antigen 19-9 Chemiluminescence Immunoassay Kit	S2010E-25	EUDAMED	IVD General	Active
Sample Storage Reagent	X1003E-24-6	EUDAMED	Class A	Active
Influenza B Virus RNA Diagnostic Kit (PCR-Fluorescence Probing)	S3083E	EUDAMED	IVD General	Active
Thyroid Stimulating Hormone Chemiluminescence Immunoassay Kit	S2063E-150	EUDAMED	IVD General	Active
BK Virus DNA Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3185E-24	EUDAMED	IVD General	Active
Plasmin-Alpha 2 Plasmin Inhibitor Complex Chemiluminescence Immunoassay Kit	S2048E-50	EUDAMED	IVD General	Active
Enterococcus Faecium Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3199E-24	EUDAMED	IVD General	Active
Legionella pneumophila DNA Diagnostic Kit（PCR-Fluorescence Probing）	S3072E	EUDAMED	IVD General	Active
Monkeypox Virus (MPV) Rapid Antibody Test Kit (Colloidal Gold Method)	S3357E-50	EUDAMED	IVD General	Active
Folate Assay Kit (Chemiluminescent Immunoassay)	S2124E-48	EUDAMED	IVD General	Active

Related Companies

Authorised Representatives

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Sansure Biotech Inc. US