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Snapshot 2026-10-28 · Link to EUDAMED

Amoy Diagnostics Co., LTD.

SRN CN-MF-000021843

manufacturer · Xiamen, CN · 48 devices

No.39 Dingshan Road, Haicang District, 361027

Devices

NameUDI-DIClassBadge
AmoyDx® KRAS/NRAS/BRAF Mutations Detection Kit06959094210939Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

AmoyDx® KRAS/NRAS Mutations Detection Kit06959094206192Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

AmoyDx® KRAS/NRAS Mutations Detection Kit06959094210885Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

AmoyDx® Magnetic FFPE DNA Extraction Kit06959094210458Class A
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

AmoyDx® Multi-Gene Mutations Detection Kit06959094210991Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

AmoyDx® Multi-Gene Mutations Detection Kit06959094211004Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

AmoyDx® NRAS Mutation Detection Kit06959094206130Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

AmoyDx® NRAS Mutation Detection Kit06959094210762Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

AmoyDx® NRAS Mutation Detection Kit06959094210786Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

AmoyDx Nucleic Acid Extraction System06959094214463Class A
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

AmoyDx® Pan Lung Cancer PCR Panel06959094210809Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

AmoyDx® Pan Lung Cancer PCR Panel06959094210816Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

AmoyDx® PIK3CA Mutation Detection Kit06959094210953Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

AmoyDx® ROS1 Gene Fusions Detection Kit06959094210571Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

AmoyDx® ROS1 Gene Fusions Detection Kit06959094210830Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

AmoyDx® ROS1 Gene Fusions Detection Kit06959094210847Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

AmoyDx® ROS1 Gene Fusions Detection Kit06959094212636Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

AmoyDx® Tissue DNA Kit06959094210427Class A
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

AmoyDx® Tissue RNA Kit06959094210434Class A
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

ANDAS Software06959094210281Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

ANDAS Software (Model: ANDAS-HRD)06959094213046Class C
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Super-ARMS® EGFR Mutation Detection Kit06959094210823Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Super-ARMS® EGFR Mutation Detection Kit06959094212483Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Amoy Diagnostics Co., LTD. (SRN CN-MF-000021843) — registered devices | UDI Compass