Amoy Diagnostics Co., LTD.

SRN CN-MF-000021843

manufacturer · Xiamen, CN · 48 devices

No.39 Dingshan Road, Haicang District, 361027

Devices

Name	UDI-DI	Class	Badge
AmoyDx® AutoExtract Kit (Circulating DNA)	06959094214869	Class A	No Certificate Found Snapshot 2026-10-28 · Link to EUDAMED
AmoyDx® AutoExtract Kit (FFPE DNA)	06959094214838	Class A	No Certificate Found Snapshot 2026-10-28 · Link to EUDAMED
AmoyDx® AutoExtract Kit (FFPE DNA/RNA)	06959094214692	Class A	No Certificate Found Snapshot 2026-10-28 · Link to EUDAMED
AmoyDx® AutoExtract Kit (FFPE RNA)	06959094215019	Class A	No Certificate Found Snapshot 2026-10-28 · Link to EUDAMED
AmoyDx® AutoExtract Kit (FNA Nucleic Acid)	06959094214999	Class A	No Certificate Found Snapshot 2026-10-28 · Link to EUDAMED
AmoyDx® AutoExtract Kit (Whole Blood DNA)	06959094215026	Class A	No Certificate Found Snapshot 2026-10-28 · Link to EUDAMED
AmoyDx® Blood/Bone Marrow DNA Kit	06959094210441	Class A	No Certificate Found Snapshot 2026-10-28 · Link to EUDAMED
AmoyDx® BRAF V600 Mutations Detection Kit	06959094206062	Unknown class	No Certificate Found Snapshot 2026-10-28 · Link to EUDAMED
AmoyDx® BRCA Pro Panel	06959094210519	Unknown class	No Certificate Found Snapshot 2026-10-28 · Link to EUDAMED
AmoyDx® Circulating DNA Kit	06959094210472	Class A	No Certificate Found Snapshot 2026-10-28 · Link to EUDAMED
AmoyDx® EGFR 29 Mutations Detection Kit	06959094206024	Unknown class	No Certificate Found Snapshot 2026-10-28 · Link to EUDAMED
AmoyDx® EGFR 29 Mutations Detection Kit	06959094210595	Unknown class	No Certificate Found Snapshot 2026-10-28 · Link to EUDAMED
AmoyDx® Essential NGS Panel	06959094210588	Unknown class	No Certificate Found Snapshot 2026-10-28 · Link to EUDAMED
AmoyDx® FFPE DNA Kit	06959094210489	Class A	No Certificate Found Snapshot 2026-10-28 · Link to EUDAMED
AmoyDx® FFPE DNA/RNA Kit	06959094210410	Class A	No Certificate Found Snapshot 2026-10-28 · Link to EUDAMED
AmoyDx® FFPE RNA Kit	06959094210465	Class A	No Certificate Found Snapshot 2026-10-28 · Link to EUDAMED
AmoyDx® HANDLE Classic NGS Panel	06959094210557	Unknown class	No Certificate Found Snapshot 2026-10-28 · Link to EUDAMED
AmoyDx® HANDLE HRR NGS Panel	06959094212384	Unknown class	No Certificate Found Snapshot 2026-10-28 · Link to EUDAMED
AmoyDx® HRD Complete Panel	06959094210274	Unknown class	No Certificate Found Snapshot 2026-10-28 · Link to EUDAMED
AmoyDx® HRD Complete Panel	06959094212070	Class C	Certificate valid Snapshot 2026-10-28 · Link to EUDAMED
AmoyDx® HRD Focus Panel	06959094210564	Unknown class	No Certificate Found Snapshot 2026-10-28 · Link to EUDAMED
AmoyDx® KRAS Mutation Detection Kit	06959094206154	Unknown class	No Certificate Found Snapshot 2026-10-28 · Link to EUDAMED
AmoyDx® KRAS Mutation Detection Kit	06959094210755	Unknown class	No Certificate Found Snapshot 2026-10-28 · Link to EUDAMED
AmoyDx® KRAS/NRAS/BRAF Mutations Detection Kit	06959094210649	Unknown class	No Certificate Found Snapshot 2026-10-28 · Link to EUDAMED
AmoyDx® KRAS/NRAS/BRAF Mutations Detection Kit	06959094210922	Unknown class	No Certificate Found Snapshot 2026-10-28 · Link to EUDAMED