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Igenesis(Shanghai)Co.,Ltd.

China·CN-MF-000001552

Last updated June 8, 2026

Information

Country: China
Address: Floor 3,building 1,Lane 500,Furonghua Road,Pudong New Area,201318 Shanghai,P.R.China, Shanghai, China
Website: igenesisbio.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Xiaomin Zhang
EUDAMED SRN: CN-MF-000001552
FDA FEI Number: —
DUNS Number: —

Catalogue (26)

Device	Model / Reference	Registries	Class	Status
Dengue Serotyping Diagnostic Kit (PCR-Fluorescence)	106-0043-01	EUDAMED	IVD General	Active
Carbapenem Resistance Diagnostic Kit ( PCR-Fluorescence )	106-0102-01	EUDAMED	IVD General	Active
Other Fever Syndrome 14-Pathogen Nucleic Acid Detection Kit (PCR Melting Curve Method)	106-0150-01	EUDAMED	IVD General	Active
Toxigenic Clostridium difficile Gene (toxinA, toxinB) Detection Kit (PCR Fluorescence )	106-0159-01	EUDAMED	IVD General	Active
Diarrheal Syndrome 12-Pathogen Nucleic Acid Detection Kit (PCR Melting Curve Method)	106-0146-01	EUDAMED	IVD General	Active
Five Strains of Diarrheagenic Escherichia coli Multi-Target Nucleic Acid Detection Kit (PCR Melting Curve Method)	106-0147-01	EUDAMED	IVD General	Active
Coxsackievirus A6/ A10/ A16/ Enterovirus 71 RNA Diagnostic Kit	106-0054-01	EUDAMED	IVD General	Active
Vancomycin-Resistant Enterococcus Gene (vanA, vanB) Detection Kit (PCR Fluorescence)	106-0142-01	EUDAMED	IVD General	Active
Streptococcus Pneumoniae/ Klebsiella Pneumoniae/ Legionella Pneumophila/ Haemophilus influenzae/ Bordetella Pertussis Diagnostic Kit	106-0055-01	EUDAMED	IVD General	Active
Encephalitis and Meningitis Syndrome 11-Pathogen Nucleic Acid Detection Kit (PCR Melting Curve Method)	106-0149-01	EUDAMED	IVD General	Active
Staphylococcus aureus and Methicillin-Resistant Staphylococcus aureus Drug-Resistance Gene Detection Kit (PCR Fluorescence Probe Method)	106-0141-01	EUDAMED	IVD General	Active
Coxsackievirus A16/ Enterovirus 71/ Enterovirus RNA Diagnostic Kit	106-0053-01	EUDAMED	IVD General	Active
Mycoplasma Pneumoniae / Adenovirus / Rhinovirus / Human Metapneumovirus Diagnostic Kit (PCR-Fluorescence)	106-0069-01	EUDAMED	IVD General	Active
SARS-2-CoV (Covid-19)/ Influenza A Virus/ Influenza B Virus/ Respiratory Syncytial Virus Diagnostic Kit	106-0057-01	EUDAMED	IVD General	Active
SARS-2-CoV(Covid-19) nucleic acid detection cartridge (Real-time reverse transcription PCR method)	106-0050-01	EUDAMED	IVD General	Active
Dengue virus/Chikungunya virus/Zika virus Diagnostic Kit (PCR-Fluorescence)	106-0044-01	EUDAMED	IVD General	Active
Nucleic Acid Detection Kit for 16&18 Human Papillomavirus (HPV) Genotypes (PCR fluorescence probe method)	106-0064-01	EUDAMED	IVD General	Active
Ultrasoner	101-0029-01	EUDAMED	Class A	Active
Nucleic Acid Extraction and Purification Kit	106-0119-01	EUDAMED	Class A	Active
Galaxy Neo	101-0062-01	EUDAMED	Class A	Active
Galaxy Nano	101-0022-02	EUDAMED	Class A	Active
Galaxy Lite	101-0038-01	EUDAMED	Class A	Active
Nucleic Acid Extraction and Purification Kit	106-0051-01	EUDAMED	Class A	Active
Influenza A Virus / Influenza B Virus/Respiratory Syncytial Virus Diagnostic Kit (PCR-Fluorescence)	106-0052-01	EUDAMED	IVD General	Active
Galaxy Pro	101-0037-01	EUDAMED	Class A	Active
Galaxy MTB/RIF Assay	106-0056-01	EUDAMED	IVD General	Active

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