UDI CompassNo Certificate Found
Snapshot 2026-10-28 · Link to EUDAMED
Suzhou GenDx Biotech Co., Ltd.
SRN CN-MF-000018830
manufacturer · Suzhou, Jiangsu, CN · 4 devices
No.38 Beiguandu Road 2F, Building 3, No.38 Beiguandu Road, Yuexi Street, Wuzhong District, 215128
Devices
| Name | UDI-DI | Class | Badge |
|---|---|---|---|
| GENEYE® Influenza Virus （FluA/B）ERA Assay | 06975102280176 | Unknown class | No Certificate Found Snapshot 2026-10-28 · Link to EUDAMED |
| GENEYE® Mycoplasma Pneumoniae Assay | 06975102280190 | Unknown class | No Certificate Found Snapshot 2026-10-28 · Link to EUDAMED |
| GENEYE® Respiratory Syncytial Virus（RSV）ERA Assay | 06975102280183 | Unknown class | No Certificate Found Snapshot 2026-10-28 · Link to EUDAMED |
| GENEYE® System | 06975102280169 | Class A | No Certificate Found Snapshot 2026-10-28 · Link to EUDAMED |