GeneSign Biotech (Xiamen)Co., Ltd.

SRN CN-MF-000044463

manufacturer · Xiamen, CN · 228 devices

Unit 03, 8th Floor, Building B14 Xiamen Biomedical, Industrial Park, 2076 Wengjiao West Road, Haicang District, 361000

Devices

Name	UDI-DI	Class	Badge
GeneSign Insulin FIA	06977903341049	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign JEV IgG/IgM Rapid Test	06977903348215	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign JEV IgG/IgM Rapid Test	06977903348222	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign LH FIA	06977903340332	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign LH FIA	06977903340349	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign Malaria P.f/P.v Ab Rapid Test	06977903349410	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign Malaria P.f/P.v Ab Rapid Test	06977903349427	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign Measles IgG/IgM Rapid Test	06977903347713	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign Measles IgG/IgM Rapid Test	06977903347720	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign Microalbumin Rapid Test Cassette	06977903347614	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign Microalbumin Rapid Test Cassette	06977903347621	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign Nipah Virus Antigen Rapid Test	06977903347416	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign Nipah Virus Antigen Rapid Test	06977903347423	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign Nipah Virus IgG/IgM Rapid Test	06977903347515	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign Nipah Virus IgG/IgM Rapid Test	06977903347522	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign One Step COC Test	06977903341131	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign One Step COC Test	06977903341148	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign One Step COD Test	06977903341339	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign One Step COD Test	06977903341346	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign One Step Heroin Test	06977903341230	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign One Step Heroin Test	06977903341247	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign One Step Multi-Drug Screening Test (One Step Multi-10 DOA Test)	06977903341537	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign One Step Multi-Drug Screening Test (One Step Multi-10 DOA Test)	06977903341544	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign One Step Multi-Drug Screening Test (One Step Multi-5 DOA Test)	06977903341438	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign One Step Multi-Drug Screening Test (One Step Multi-5 DOA Test)	06977903341445	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED