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 16 of 18

Device	Model / Reference	Registries	Class	Status
Type Ⅳ Collagen Chemiluminescence Immunoassay Kit	S2155E-50	EUDAMED	IVD General	Active
Growth Hormone Chemiluminescence Immunoassay Kit	S2024E-150	EUDAMED	IVD General	Active
Laminin Chemiluminescence Immunoassay Kit	S2144E-200	EUDAMED	IVD General	Active
Luteinizing hormone Assay Kit (Chemiluminescent Immunoassay)	S2082E-48	EUDAMED	IVD General	Active
SARS-CoV-2 Neutralizing Antibody Test Kit (ICA)	S3135E-5	EUDAMED	IVD General	Active
Human Metapneumovirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3157E-24-P	EUDAMED	IVD General	Active
Neuron-specific enolase Assay Kit (Chemiluminescent Immunoassay)	S2110E-24	EUDAMED	IVD General	Active
Sapovirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3217E-48	EUDAMED	IVD General	Active
Sample Release Reagent	S1013E-12B-P	EUDAMED	Class A	Active
Thyroid Stimulating Hormone Chemiluminescence Immunoassay Kit	S2063E-100	EUDAMED	IVD General	Active
Myoglobin Assay Kit (Chemiluminescent Immunoassay)	S2072E-24	EUDAMED	IVD General	Active
Novel Coronavirus (2019-nCoV) Multiplex Nucleic Acid Diagnostic Kit (PCR Fluorescence Probing)	S3172E-96	EUDAMED	IVD General	Active
SARS-CoV-2 IgG Antibody Test Kit (Chemiluminescence Immunoassay)	S2054E-75	EUDAMED	IVD General	Active
Neutrophil Gelatinase-associated Lipocalin Chemiluminescence Immunoassay Kit	S2157E-50	EUDAMED	IVD General	Active
Procalcitonin Chemiluminescence Immunoassay Kit	S2049E-150	EUDAMED	IVD General	Active
SARS-CoV-2 and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (Isothermal Amplification)	S3344E-1	EUDAMED	IVD General	Active
N-terminal pro-B-type Natriuretic Peptide Chemiluminescence Immunoassay Kit	S2043E-150	EUDAMED	IVD General	Active
Pro-gastrin-releasing Peptide Chemiluminescence Immunoassay Kit	S2050E-25	EUDAMED	IVD General	Active
Echovirus E30 Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3231E-24	EUDAMED	IVD General	Active
Insulin-Like Growth Factor-Ⅰ Chemiluminescence Immunoassay Kit	S2032E-25	EUDAMED	IVD General	Active
15 High-risk Human Papillomavirus DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)	S3359E-12	EUDAMED	IVD General	Active
Neuron Specific Enolase Chemiluminescence Immunoassay Kit	S2042E-150	EUDAMED	IVD General	Active
Avian influenza virus H5 RNA Diagnostic Kit (PCR-Fluorescence Probing)	S3095E	EUDAMED	IVD General	Active
Interleukin-10 Chemiluminescence Immunoassay Kit	S2037E-150	EUDAMED	IVD General	Active
Follicle-stimulating hormone Assay Kit (Chemiluminescent Immunoassay)	S2083E-24	EUDAMED	IVD General	Active
Human BRAF Gene V600E Mutation Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)	S3064E	EUDAMED	IVD General	Active
Human Papillomavirus DNA Diagnostic Kit (PCR-Fluorescence Probing)	S3057E-48	EUDAMED	Class C	Active
Sample Release Reagent	S1012E-12B-P	EUDAMED	Class A	Active
Tissue Plasminogen Activator/ Plasminogen Activator Inhibitor-1 Complex Chemiluminescence Immunoassay Kit	S2064E-150	EUDAMED	IVD General	Active
α-Thalassemia Gene Diagnostic Kit(gap-PCR)	S3045E	EUDAMED	IVD General	Active
Nucleic acid extraction (DNA/RNA) or purification kit(Magnetic beads method)	S10013E-48	EUDAMED	Class A	Active
Candida Albicans, Cryptococcus Neoformans and Pneumocystis Jiroveci Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3142E-48	EUDAMED	IVD General	Active
Nucleic Acid Extraction-Purification Kit	S10018E-32T-N8	EUDAMED	Class A	Active
Vascular Endothelial Growth Factor Chemiluminescence Immunoassay Kit	S2068E-200	EUDAMED	IVD General	Active
Novel Coronavirus (2019-nCoV) Multiplex Nucleic Acid Diagnostic Kit (PCR Fluorescence Probing)	S3172E-48	EUDAMED	IVD General	Active
Anti-Thyroglobulin Antibody Chemiluminescence Immunoassay Kit	S2005E-75	EUDAMED	IVD General	Active
Salmonella Typhi Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	S3235E-24	EUDAMED	IVD General	Active
Sex Hormone-binding Globulin Chemiluminescence Immunoassay Kit	S2152E-150	EUDAMED	IVD General	Active
SARS-CoV-2 IgM Antibody Test Kit (Chemiluminescence Immunoassay)	S2055E-150	EUDAMED	IVD General	Active
Soluble Fms‑like Tyrosine Kinase‑1 Chemiluminescence Immunoassay Kit	S2057E-100	EUDAMED	IVD General	Active
Human EGFR Gene L858R Mutation Detection Kit (Digital PCR)	S3289E-24	EUDAMED	IVD General	Active
Renin Chemiluminescence Immunoassay Kit	S2148E-200	EUDAMED	IVD General	Active
Pepsinogen Ⅰ Chemiluminescence Immunoassay Kit	S2044E-100	EUDAMED	IVD General	Active
Anti-Thyroglobulin Antibody Chemiluminescence Immunoassay Kit	S2005E-200	EUDAMED	IVD General	Active
Carbohydrate antigen 125 Assay Kit (Chemiluminescent Immunoassay)	S2108E-24	EUDAMED	IVD General	Active
Human Herpers Virus 6 DNA Diagnostic Kit (PCR-Fluorescence Probing)	S3071E	EUDAMED	IVD General	Active
Tissue Plasminogen Activator/ Plasminogen Activator Inhibitor-1 Complex Chemiluminescence Immunoassay Kit	S2064E-100	EUDAMED	IVD General	Active
Neisseria Meningitidis Serogroup W, X, and Y nucleic acid Diagnostic Kit（PCR-Fluorescence Probing)	S3264E-24	EUDAMED	IVD General	Active
Total Triiodothyronine Chemiluminescence Immunoassay Kit	S2066E-150	EUDAMED	IVD General	Active
Alpha-Fetoprotein Chemiluminescence Immunoassay Kit	S2002E-200	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