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Snapshot 2026-10-28 · Link to EUDAMED

Igenesis(Shanghai)Co.,Ltd.

SRN CN-MF-000001552

manufacturer · Shanghai, CN · 30 devices

Floor 3,building 1,Lane 500,Furonghua Road,Pudong New Area,201318 Shanghai,P.R.China, 201318

Devices

NameUDI-DIClassBadge
Carbapenem Resistance Diagnostic Kit ( PCR-Fluorescence )06975447582188Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Coxsackievirus A16/ Enterovirus 71/ Enterovirus RNA Diagnostic Kit06975447582089Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Coxsackievirus A6/ A10/ A16/ Enterovirus 71 RNA Diagnostic Kit06975447582096Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Dengue Serotyping Diagnostic Kit (PCR-Fluorescence)06975447582034Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Dengue virus/Chikungunya virus/Zika virus Diagnostic Kit (PCR-Fluorescence)06975447582041Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Diagnostic Kit for detecting of 16 high-risk and genotyping of 16&18 human papillomavirus (HPV)(PCR fluorescence probe method)06975447582157Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Diarrheal Syndrome 12-Pathogen Nucleic Acid Detection Kit (PCR Melting Curve Method)06975447582263Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Encephalitis and Meningitis Syndrome 11-Pathogen Nucleic Acid Detection Kit (PCR Melting Curve Method)06975447582225Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Five Strains of Diarrheagenic Escherichia coli Multi-Target Nucleic Acid Detection Kit (PCR Melting Curve Method)06975447582270Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Galaxy CT/NG/UU Assay06975447582164Class C
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Galaxy Lite06975447581044Class A
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Galaxy MTB/RIF Assay06975447582119Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Galaxy Nano06975447581013Class A
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Galaxy Neo06975447581068Class A
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Galaxy Pro06975447581037Class A
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Influenza A Virus / Influenza B Virus/Respiratory Syncytial Virus Diagnostic Kit (PCR-Fluorescence)06975447582072Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Mycoplasma Pneumoniae / Adenovirus / Rhinovirus / Human Metapneumovirus Diagnostic Kit (PCR-Fluorescence)06975447582171Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Nucleic Acid Detection Kit for 16&18 Human Papillomavirus (HPV) Genotypes (PCR fluorescence probe method)06975447582140Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Nucleic Acid Detection Kit for 18 High-risk and Low-risk 6&11 Human Papillomavirus (HPV) Genotypes (PCR-Fluorescence)06975447582133Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Nucleic Acid Extraction and Purification Kit06975447582065Class A
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Nucleic Acid Extraction and Purification Kit06975447582195Class A
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Other Fever Syndrome 14-Pathogen Nucleic Acid Detection Kit (PCR Melting Curve Method)06975447582232Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Respiratory Pathogens Detection Kit06975447582218Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

SARS-2-CoV (Covid-19)/ Influenza A Virus/ Influenza B Virus/ Respiratory Syncytial Virus Diagnostic Kit06975447582126Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

SARS-2-CoV(Covid-19) nucleic acid detection cartridge (Real-time reverse transcription PCR method)06975447582058Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED